Lumosa Therapeutics Co Ltd · TPEX:6535
Lumosa Therapeutics — Investors' Conference 2025.10.27
24 slides from Lumosa Therapeutics's conference presentation, Oct 27, 2025
Slide 1: Lumosa Therapeutics Co., Ltd. (TPEX:6535)
—_- Lumosa Therapeutics Co., Ltd. (TPEX:6535) 2025/10 (a)
Slide 2: Disclaimer
Disclaimer • The forward-looking statements mentioned in this presentation and related information released concurrently, including operational outlook, financial condition, and business forecasts, are based on information obtained by the Company from internal and external sources. Such forward-look
Slide 3: LT3001 Innovative Small Molecule Drug for Acute Ischemic Stroke
LT3001 Innovative Small Molecule Drug for Treating Acute Ischemic Stroke Development Progress Phase 3 Regulatory Consultation with China’s CDE and the US FDA Planned for 2025 Phase 3 Patient Enrollment in China Planned for 2026 China Market Launch Targeted for 2030 3
Slide 4: LT3001 Development Goal - Superior Efficacy, Enhanced Safety
LT3001 Development Goal - Superior Efficacy, Enhanced Safety – A Novel Stroke Treatment for Broader Patient Populations Unmet Medical Needs ACTIVASE rt-PA AHA 2019 Treatment Guidelines for Acute Therapeutic dilemma for – IV tPA package insert Ischemic Stroke (2019): acute ischemic stroke treatments
Slide 5: LT3001 Opportunities – Thrombolysis without Bleeding + Neuroprotection
LT3001 Opportunities – Thrombolysis without Bleeding+Neuroprotection – May be administered for several days to improve brain functions continuously In-vitro studies showed that thrombus volume Animal studies showed that LT3001 effectively restores Novel Thrombolytic Mechanism (MoA): significantly re
Slide 6: LT3001 Research Milestones – Global Collaboration
LT3001 Research Milestones – Global Collaboration – Molecular Design to Phase 2a Discovery of LT3001 Functional Optimization and Preclinical Validation Early Clinical Results Structural Innovation The endogenous thrombolytic Preclinical studies conducted by The LT3001-201 trial (Phase 2A, peptide un
Slide 7: LT3001 Clinical Development – Multinational Phase 1 and 2 Trials
LT3001 Clinical Development – Completion of Several Multinational Phase 1 and 2 Trials – Demonstrating Safety and Efficacy • Treatment Window=Within 24 hours after stroke onset 2017 2018 2019 2020 2021 2022 2023 2024 2025 2026 2027 2028 2029 2030 2031 IND IND IND US Fast IND P3 CN Market Global Mark
Slide 8: LT3001-202 Phase 2 Study in Acute Ischemic Stroke
LT3001-202 A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Multiple Doses of LT3001 in Patients with Acute Ischemic Stroke (AIS) Leading Site： Beijing Tiantan Hospital, Capital Medical University Leading PI： Professor Yongjun Wang Sponsor： Shangha
Slide 9: LT3001-202: Study Design
LT3001-202: Study Design A multicenter, randomized, double-blind, placebo-controlled phase 2 clinical trial in China Screening Treatment Follow-up -24h Day 0 - 72h Day 7- day 90 -24-0h Day 0 (0-24h) Day 1 (24-48h) Day 2(48-72h) Day 7±2 Day 14±2 Day 30±5 Day 90±7 NCCT MRI NIHSS NIHSS MRI NIHSS NIHSS
Slide 10: List of Study Sites and Investigators
List of Study Sites and Investigators Site Name Investigator A total of 28 study sites participated in this study Beijing Tiantan Hospital, Capital Medical University (Leading site) Yongjun Wang and had subjects enrolled. The First Hospital of Jilin University Yi Yang The First Affiliated Hospital o
Slide 11: LT3001-202: Baseline Demographic
LT3001-202: Baseline Demographic • LT3001-202 enrolled 297 AIS patients (median age 63, ~70% male) with median baseline NIHSS 8. The majority were treated >12 h from onset (Q1–Q3 ~11–20 h, up to 24 h). ~55% were moderate strokes and ~55–60% LAA etiology, balanced across groups. 0.05 mg/kg 0.025 mg/k
Slide 12: LT3001-202 Safety Result: No Increased Risk of sICH
LT3001-202 Safety Result: No Increased Risk of sICH • Primary Endpoint： • LT3001 was well tolerated across all dose groups. • The incidence of adverse events (AEs) and adverse drug reactions (ADRs) within 90 days after first dosing was similar among the high-dose LT3001, low-dose LT3001, and placebo
Slide 13: LT3001-202 Efficacy: mRS=0-1, mRS=0-2, NIHSS outcome
LT3001-202 Efficacy: mRS=0-1, mRS=0-2, NIHSS outcome 1. Favorable indicators were observed in mRS0-1, mRS0-2, and NIHSS results. 2. An 7.3% enhancement in mRS0-2 was detected in all study population. 3. Early improvement in NIHSS scores, signaling reperfusion, has been consistently observed. LT3001
Slide 14: LT3001-202 Efficacy: Stroke Severity Subgroups
LT3001-202 Efficacy: Stroke Severity Subgroups 1. Moderate strokes (NIHSS 7–10) were well represented (≥50 participants per group) and showed consistent efficacy, with a +9% improvement in 90-day mRS across both dose levels. 2. The 0.05 mg/kg dose demonstrated greater therapeutic potential than 0.02
Slide 15: LT3001-202 Efficacy: TOAST Subgroups
LT3001-202 Efficacy: TOAST Subgroups • LT3001 shows potential for a better treatment effect in AIS patients with large artery atherosclerosis (LAA) compared to small artery occlusion (SAO) based on their TOAST classification upon hospital presentation. LT3001 LT3001 0.05 mg/kg 0.025 mg/kg Combined 0
Slide 16: LT3001-202 Efficacy: Disabling Stroke Subgroups
LT3001-202 Efficacy: Disabling Stroke Subgroups • LT3001 shows potential for a better treatment effect in AIS patients with disabling stroke, such as arm motor drift, and leg motor drift, based on their baseline NIHSS deficits upon hospital presentation. LT3001 LT3001 0.05 mg/kg 0.025 mg/kg Combined
Slide 17: Key Takeaways from the LT3001-202 Study
Key Takeaways from the LT3001-202 Study 1. Primary safety outcomes: LT3001's six-dose, three-day regimen showed no increased bleeding risk in ~200 patients, meeting the primary endpoint. 2. Secondary efficacy outcomes: 1) Moderate strokes (NIHSS 7–10) showed +9% 90-day mRS improvement across both do
Slide 18: LT3001 Phase 2b Program
LT3001 Phase 2b Program LT3001-205 (early LT3001-202 (completed) termination) LT3001-205 LT3001-202 Number of 21 Centers • Patients number: 88 • Patients number: 297 34 Centers • Sites activated: 21 centers in the • Sites activated: 34 centers centers US, TW, EU CN US, EU, UK and Taiwan in China act
Slide 19: LT3001-202 and LT3001-205: Baseline Characteristics
LT3001-202 and LT3001-205: Baseline Characteristics • LT3001-205 enrolled a smaller global cohort (n=88, US/EU/Taiwan) vs. 202 in China (n=297), with later treatment (~15–17h vs. ~12h), more moderate-to-severe strokes, and inclusion of mismatch imaging. LT3001-202 LT3001-205 0.05 mg/kg 0.025 mg/kg P
Slide 20: Consistent Functional Improvement Benefit Observed
LT3001-202 and LT3001-205: Consistent Functional Improvement Benefit Observed • Safety broadly confirmed; No LT3001-related symptomatic intracranial hemorrhage (sICH) observed in either Phase 2 trial. • Consistent efficacy across key populations: moderate-to-severe stroke, disabling stroke, large ar
Slide 21: LT3001-301 Phase 3 Trial Design
LT3001-301 Phase 3 Trial Design Primary endpoint: Target patient population: LT3001 Day 90 mRS 0-2 improvement • Acute ischemic stroke rate 0.025 mg/kg • 24 Hrs within symptomatic LT3001 onset Optimal dose Secondary endpoints: Random- LT3001 Interim • mRS shift • Ineligible for tPA ization 0.050 mg/
Slide 22: LT3001 Development Goal - Superior Efficacy, Enhanced Safety
LT3001 Development Goal - Superior Efficacy, Enhanced Safety – A Novel Stroke Treatment for Broader Patient Populations Unmet Medical Needs ACTIVASE rt-PA AHA 2019 Treatment Guidelines for Acute Therapeutic dilemma for – IV tPA package insert Ischemic Stroke (2019): acute ischemic stroke treatments
Slide 23: LT3001: Phase 2 Achievements and Phase 3 Outlook
LT3001: Phase 2 Achievements and Phase 3 Outlook 1. Established safety: No LT3001-related symptomatic intracranial hemorrhage (sICH) observed in either Phase 2 trial, confirming the drug’s safety profile. 2. Clear efficacy trends: Most pronounced benefit observed in disabling stroke patients, with c
Slide 24: Thank you
Thank you 24
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