Slide 1: Financial Results for FY02/2023
Financial Results for FY02/2023 TSE Growth：4891
Slide 2: Disclaimer
Disclaimer This document has been prepared by TMS Co., Ltd. (herein after referred to as the Company) solely for information purpose only. This document does not constitute or form part of and should not be construed as, an offer to sell or issue or the solicitation of an offer to buy or acquire s
Slide 3: Corporate Mission
Corporate Mission Create impactful therapeutics by the power of relentless exploration and challenge 2
Slide 4: Agenda
Agenda 1. Topics 2. Summary of Financial results for FY02/2023 3. TMS-007 4. TMS-008 / 009 5. Expansion of Pipelines 6. Appendix 3
Slide 5: Topics
Topics 4
Slide 6: Topics
Topics １ TMS-007 (BIIB131) update Biogen has announced to initiate a Ph2b clinical trial in the first half of 2023. (Detailed clinical trial information is available at ClinicalTrials.gov.) 1 ２ Reduced net loss for the full year Operating loss and net loss have been reduced, compared to the fore
Slide 7: Summary of Financial results for FY02/2023
Summary of Financial results for FY02/2023 6
Slide 8: Full Year Financial Results FY02/2023 - Statement of Income
Full Year Financial Results FY02/2023 - Statement of Income Recorded losses for Ordinary Income and Net Income for FY02/2023 (million yen) No revenue was recorded in FY Increase/ 02/2022 02/2023 02/2023, in contrast to FY02/2022 decrease when there was revenue from Operating revenue 1,946 - (1,946)
Slide 9: Full Year Financial Results FY02/2023 - Cash flows
Full Year Financial Results FY02/2023 - Cash flows Cash and cash equivalents increased by 986m yen mainly due to issuance of new shares with IPO in November 2022. Runway until TMS-007 next milestone event is estimated to be secured. (million yen) 02/2022 02/2023 Cash flows from operating activities
Slide 10: Full Year Financial Results FY02/2023 - Balance sheet
Full Year Financial Results FY02/2023 - Balance sheet Total assets increased due to financing from IPO in November 2022 (million yen) Increase/ 02/2022 02/2023 decrease Current assets 2,722 3,766 1,043 Cash and deposits 2,598 3,584 986 Cash and deposits increased due to IPO. Non-current assets 16 23
Slide 11: Growing and Differentiated Drug Pipeline
Growing and Differentiated Drug Pipeline TMS-007 Ph2a completed: Ph2b of TMS-007 (BIIB131) to be initiated by Biogen TMS-008 Preclinical stage: Being developed by TMS under grant-back license from Biogen Development Development Target Next MoA Research Preclinical Ph1 Ph2 Ph3 and Code Disease Commer
Slide 12: TMS-007
TMS-007 Potential Next Generation Acute Ischemic Stroke Treatment 11
Slide 13: Acute Ischemic Stroke - Important Unmet Medical Needs
Acute Ischemic Stroke - Important Unmet Medical Needs Acute Ischemic Stroke (AIS) Overview AIS is caused by blockages of blood supply to the Patient Population with AIS 1 brain (million) 1.84 1.57 1.29 0.69 Potentially leads to permanent brain damage : 0.60 Rupture 0.51 0.28 hemiplegia, memory l
Slide 14: t-PA - The only FDA-approved drug for AIS
t-PA - The only FDA-approved drug for AIS the only FDA-approved drug for AIS Market size 1 of the existing drug Challenges of the existing drug Sales of t-PA is estimated to be approx. $2.1bn in 2021 Incidence rate of fatal intracranial hemorrhage 3,5 (USD million) t-PA 2.7% 2,500 2,295 2,324 2,21
Slide 15: TMS-007: Mechanism of Action
TMS-007: Mechanism of Action Dual mechanism – “Anti-inflammatory” and “Thrombolytic” activities TMS-007 sEH Plasminogen Inhibition Inhibition of Soluble Epoxide Hydrolase1 Promotion of Plasminogen Activation4 Anti-inflammatory 1,2,3 Promotion of Endogenous thrombolysis 4,5,6 Inhibition of Phos activ
Slide 16: TMS-007 (BIIB131): Acquired by Biogen, the U.S. Biotech Company
TMS-007 (BIIB131): Acquired by Biogen, the U.S. Biotech Company Biogen exercised its option to acquire all IP and assets related to TMS-007 and SMTP compound in May 2021 1 Oct, 2015 Nov, 2017 Jun, 2018 May, 2021 Aug, 2021 TMS started Option TMS Completed TMS completed Biogen Exercises Ph2a Clinical
Slide 17: TMS-007: Ph2a clinical trial showed good results
TMS-007: Ph2a clinical trial showed good results TMS-007 has the potential to become the first line AIS treatment 1 Time Window Efficacy Safety mRS 2 0-1 ratio at 90 days Symptomatic Intracerebral Therapeutic time window hemorrhage risk 3,4 Gold-standard Endpoint Odds ratio 5 : 3.00 TM Adjusted odds
Slide 18: TMS-007: Ph2a clinical results Achieved the Gold-standard Endpoint
TMS-007: Ph2a clinical results Achieved the “Gold-standard” Endpoint TMS-007 achieved statistically significant improvement on mRS 0-1 ratio at 90 days, one of the most important indicators Placebo TMS-007 mRS (modified Rankin Scale) Number of patients (N) 38 52 Number of patients scored mRS 0-1 7 2
Slide 19: TMS-007: Ph2a clinical results Efficacy - Vessel Recanalization
TMS-007: Ph2a clinical results Efficacy - Vessel Recanalization TMS-007’s promising efficacy is potentially backed by good recanalization outcome 1 Effect of vessel recanalization confirmed for patients with full or partial vascular occlusion - MRA image Full or Partial Recanalization the percentage
Slide 20: TMS-007: Ph2a clinical results Safety
TMS-007: Ph2a clinical results Safety In terms of safety, the biggest concern of t-PA, TMS-007 demonstrated reduced risk of the incidence of symptomatic Intracerebral Hemorrhage (sICH) 1 Incidence rate of sICH1 TMS-007 vs Placebo 2 Ph2a t-PA vs Placebo 3 Meta-analysis TMS-007 Placebo t-PA Placebo 8%
Slide 21: TMS-007 (BIIB131): Outline of Ph2b Clinical Trial (DAISY)
TMS-007 (BIIB131): Outline of Ph2b Clinical Trial (DAISY) Summarized information, based on the publicly available information registered by Biogen 1 Outline Multicenter, operationally seamless, double-blind, dose-ranging, placebo-controlled, randomized, parallel-group Estimated enrollment: 760 p
Slide 22: TMS-007 (BIIB131): Ph2b (DAISY) / Ph2a comparison
TMS-007 (BIIB131): Ph2b (DAISY) / Ph2a comparison Summarized information, based on the publicly available information registered by Biogen 1 Ph2a Ph2b Basic design 1 stage 2 stages (Part 1、Part 2) Enrollment 90 760 (Estimated） Part 1・Arterial revasculization ・Reduction of at least 90% of Primary eff
Slide 23: Potential of TMS-007: Potential Market Size
Potential of TMS-007: Potential Market Size Potential Market Size for TMS-007 with possible outstanding Efficacy and Safety (Drug price) TMS-007 TMS-007 t-PA US drug price $8,800 t-PA approx. Time Window Penetration Expansion $2.1bn Expansion in 20211 (For illustrative purpose only) (Share of AIS tr
Slide 24: Potential of TMS-007: Expanding Time Window
Potential of TMS-007: Expanding Time Window Relationship between Prehospital Time and treatment 1 Number of t-PA treated patients is only a part of entire patient population arriving at a hospital Time window expansion for TMS-007 could expand the target patient population 2 (Percentage of patie
Slide 25: Potential of TMS-007: Expanding Penetration
Potential of TMS-007: Expanding Penetration How t-PA is treated for patients arriving within 2 hours from symptom onset 1 Due to its high safety profile, TMS-007 has a potential to expand its penetration It is estimated that TMS-007 may be used for up to 75% of patients, within the dosing window
Slide 26: TMS-008/009
TMS-008/009 Acute Kidney Injury and other indications 25
Slide 27: TMS-008 Indication: Acute Kidney Injury (AKI)
TMS-008 Indication: Acute Kidney Injury (AKI) 1,2,3,4 TMS-008 development is directed to take advantage of its strong anti-inflammatory properties No protein leakage Decreased renal function Patient population of AKI is projected to reach Appropriate toxin adversely affects heart and 11.1mn by 2030
Slide 28: TMS-008 Indication: Anti-inflammatory activities with potential for broad indications
TMS-008 Indication: Anti-inflammatory activities with potential for broad indications High anti-inflammatory and antioxidant activity Inflammation-related parameter using AIS model mouse 1 Antioxidant activity test 1,2 One hour after the start of ischemia, 10 mg/kg was H-ORAC： hydrophilic oxygen
Slide 29: TMS-008 Indication: Acute Kidney Injury (AKI)
TMS-008 Indication: Acute Kidney Injury (AKI) Preclinical studies in collaboration with Japanese university using AKI mouse models confirmed its potential as a new treatment for AKI Preclinical studies confirmed efficacy in two animal models, indicating the feasibility of TMS-008 for practical use
Slide 30: TMS-009: Backup for TMS-008
TMS-009: Backup for TMS-008 TMS-009 showed compelling potential as an anti-inflammatory agent with strong sEH 1 inhibition observed TMS-009 is protective of renal function in a mouse model of AKI Demonstrated equivalent pharmacological activity as TMS-008 in vitro 2 and in vivo 3 studies Designa
Slide 31: Expansion of Pipelines
Expansion of Pipelines 30
Slide 32: Pipeline expansion both internally and externally
Pipeline expansion both internally and externally Pursue internal and external paths for pipeline expansion, leveraging knowledge and experience through SMTP compounds development External programs Program (Academia and others) acquisition R&D and business development capabilities cultivated through
Slide 33: Approaches to external programs
Approaches to external programs Bridge science from Japanese academia to the global market Business opportunities through bridging innovative science from local to global market Evaluating hundreds of seeds Global IPO: 1 company Biotech innovation Partnering with global pyramid in Japan 1 pharma
Slide 34: Appendix
Appendix 33
Slide 35: Corporate Profile
Corporate Profile TMS Co., Ltd. Name History (Stock Code: 4891) Established February 17, 2005 Feb. 2005 TMS Co., Ltd. founded Closing month February Demonstrated thrombolytic and anti- inflammatory activities of SMTP ameliorate Representative Takuro Wakabayashi 2005 - 2011 ischemic stroke in pharmac
Slide 36: Business Model
Business Model Approval / Research Preclinical Studies Clinical Trials Launch Collaborative License Research Research Pharmaceutical Institutes Companies Intellectual Development rights properties Market rights Royalties Upfront / Milestones Royalties DS/DP manufacturing In vitro / in vivo Testing F
Slide 37: History of TMS Co., Ltd.
History of TMS Co., Ltd. SMTP Stachybotrys Keiji Hasumi Dr. Akira Endo Microspora Ph.D. Distinguished Professor Emeritus Triprenyl Founder of Tokyo University of Agriculture and Technology Phenol Chief Scientific Officer Invention of the hyperlipidemia drug A small molecule compound Worked alongside
Slide 38: TMS-007 Mechanism of Action: Mechanism of thrombolysis (1)
TMS-007 Mechanism of Action: Mechanism of thrombolysis1 (1) Plasminogen changes to plasmin by binding Thrombolysis to blood clots General t-PA t-PA Plasminogen Plasminogen Plasmin Plasmin Fibrin Promotes binding of plasminogen to Rapid thrombolysis blood clots TMS-007 TMS-007 Plasminogen Plasmin Fib
Slide 39: TMS-007 Mechanism of Action: Mechanism of thrombolysis (2)
TMS-007 Mechanism of Action: Mechanism of thrombolysis (2) TMS-007 promotes binding of fibrin to blood clots1 Native plasminogen Relaxed plasminogen E1 E1 PAN K5 PAN K5 SMTP K4 SMTP K4 K1 K1 K2 K2 Conformational change P K3 K3 P Closed, spiral conformation SMTP-7 stabilizes the open conformation of
Slide 40: www.tms-japan.co.jp
IMs... www.tms-japan.co.jp