Slide 1: Enabling the Nervous System to Repair Itself
Enabling the Nervous System to Repair Itself CONNECT SCI Trial Chronic Cohort Update June 3, 2025
Slide 2: Cautionary Statement
Cautionary Statement Forward-looking statements: Certain statements in this document about the Company’s current and future plans, expectations and intentions, results, levels of activity, performance, goals or achievements, or any other future events or developments constitute "forward-looking info
Slide 3: Agenda for Today's Discussion
Agenda for Today’s Discussion Spinal Cord Injury (SCI) & NVG-291 Background CONNECT SCI Study Chronic Cohort Results Update Next Steps and Near-Term Milestones 3
Slide 4: CONNECT SCI Study Chronic Cohort Key Results
CONNECT SCI Study Chronic Cohort Key Results Observed evidence of motor recovery in a chronic cervical motor incomplete population receiving NVG-291 Co-Primary Endpoint Achieved • Statistically significant 3-fold increase in normalized first dorsal interosseus (FDI) motor evoked potential (MEP) ampl
Slide 5: NVG-291: Phase 1b/2a CONNECT SCI Trial Design
NVG-291: Phase 1b/2a CONNECT SCI Trial Design Primary Efficacy Analyses at End of Treatment: Δ in Motor Evoked Potential (MEP) Amplitude and Clinical Function No NVG-291 Daily Subcutaneous Injections Intervention Screening No Placebo Daily Subcutaneous Injections Intervention Assessments: Baseline W
Slide 6: NVG-291: Phase 1b/2a Trial Endpoint Summary
NVG-291: Phase 1b/2a Trial Endpoint Summary Co-Primary Electrophysiological Endpoints Statistical Analysis Change in MEP Amplitude of FDI (Hand) Muscle • To control the type 1 error (alpha), both co- primary endpoints tested using an alpha of Change in MEP Amplitude of TA (Leg) Muscle 0.025 Secondar
Slide 7: NVG-291 Chronic Cohort – Baseline Demographic / Clinical Characteristics
NVG-291 Chronic Cohort – Baseline Demographic / Clinical Characteristics NVG-291 (N=10) Placebo (N=10) Age (years) Mean (SD) 43.0 (19.7) 50.3 (15.0) Sex N (% male) 8 (80%) 9 (90%) Ethnicity Not Hispanic or Latino N (%) 9 (90.0%) 10 (100%) Race Black or African American N (%) 1 (10.0%) 0 White N (%)
Slide 8: Co-Primary Efficacy Endpoints: Normalized MEP Amplitude
Co-Primary Efficacy Endpoints: Change from Baseline to Week 12 in Normalized MEP Amplitude (% of M-max) 25 25 CFB – Normalized MEP Amplitude (% of M- CFB – Normalized MEP Amplitude (% of M- 20 First Dorsal Interosseus (Hand) 15 Tibialis Anterior (Leg) 20 15 15 * 12.566 10 6.864 Max) Max) 10 5.047 10
Slide 9: GRASSP QtP – Positive Trends in Quantitative Prehension Sub-Score
GRASSP QtP – Positive Trends Towards Statistically Significant Improvement in Quantitative Prehension Sub-Score Change in Score NVG-291 Placebo Placebo p-value Min-Max N=10 N=10 Adjusted (LME) GRASSP Total Score Change 8.9 4.1 +4.7 0.2678 0-188 quantitative prehension 3.1 1.0 +2.2 0.1416 0-40 qualit
Slide 10: Secondary Endpoints: GRASSP QtP Change from Baseline to Week 12
Secondary Endpoints: GRASSP QtP – Promising Change from Baseline to Week 12 Seven of ten patients that received NVG-291 showed improvement vs. four of ten patients that received placebo NVG-291 Treated Patients Placebo Treated Patients 12 12 10 10 Change from Baseline Change from Baseline 8 8 6 6 4
Slide 11: GRASSP: Graded Redefined Assessment of Strength, Sensation and Prehension
GRASSP: Graded Redefined Assessment of Strength, Sensation and Prehension A validated clinical endpoint Quantitative Prehension Sub-Score Parameters 1. Take the bottle and pour the water into the cup, approx. ¾ full; cylindrical grasp 2. Pull the 9 pegs, one by one, out of the foam and stick them ba
Slide 12: Other Secondary Endpoints: 10mWT, 9-HPT, Pinch Force, UEMS, LEMS
Other Secondary Endpoints: 10mWT, 9-HPT, Pinch Force, UEMS, LEMS Did not see clear separation / trends between drug-treated and placebo-treated Possible reasons vary across endpoints Endpoint Result Learnings / Implications 9-HPT • Subjects who could not finish the test • Excluding those who could n
Slide 13: Treatment-Emergent Adverse Events
Treatment-Emergent Adverse Events Treatment-Emergent adverse events (TEAEs) generally mild to moderate; most common were injection site reactions NVG-291 Placebo % of Subjects with each at least one TEAE (N=10) (N=10) All 10 (100%) 8 (80.0%) Injection site reaction (ISR)-related 9 (90.0%) 3 (30.0%)
Slide 14: CONNECT SCI Study Chronic Cohort Key Results
CONNECT SCI Study Chronic Cohort Key Results Observed evidence of motor recovery in a chronic cervical motor incomplete population receiving NVG-291 Co-Primary Endpoint Achieved • Statistically significant 3-fold increase in normalized first dorsal interosseus (FDI) motor evoked potential (MEP) ampl
Slide 15: Untapped Potential Market Opportunity with No Current Approved Therapies
Untapped Potential Market Opportunity with No Current Approved Therapies SCI affects ~15M people worldwide, with ~250-500K new cases every year1 Total U.S. SCI Patients U.S. Prevalence: ~300K2 U.S. Incidence: ~18K Total U.S. Cervical SCI Patients U.S. Prevalence: ~165K3 U.S. Incidence: ~9K Total U.S
Slide 16: Anticipated Next Steps and Near-Term Milestones
Anticipated Next Steps and Near-Term Milestones 3Q/4Q FDA Regulatory Feedback 2025 Ongoing Continued Subacute Cohort Enrollment Ongoing Pipeline Expansion into Additional Neurological Injuries and Disorders 16