Coya Therapeutics, Inc. · NASDAQ:COYA
Coya Therapeutics — Clinical Trials on Alzheimer's Disease Conference (CTAD24) 2024
16 slides from Coya Therapeutics's conference presentation, Oct 29, 2024
Slide 1: Low Dose Interleukin-2 in Patients with Mild to Moderate Alzheimer's Disease
Low Dose Interleukin-2 (LD IL-2) in Patients with Mild to Moderate Alzheimer’s Disease: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial An Investigator Initiated Trial Led by Dr. Alireza Faridar at Houston Methodist Hospital* *Trial funded by Alzheimer’s Association, Gates Foundation,
Slide 2: Cautionary Note of Forward-Looking Statements and Disclaimers
Cautionary Note of Forward-Looking Statements and Disclaimers This presentation and the accompanying oral presentation contain “forward-looking” statements that are based on our management’s beliefs and assumptions and on information currently available to management. Forward-looking statements incl
Slide 3: LD IL-2 Meets Primary and Secondary Endpoints for Potential Treatment of Alzheimer's Disease
LD IL-2 Meets Primary and Secondary Endpoints for Potential Treatment of Alzheimer’s Disease (AD) ✓ Cognition Stabilization (Exploratory Endpoint) Throughout Drug Treatment vs. Placebo: • 2 out of 3 scales showed cognitive stabilization (ADAS-Cog14 and ADCS-CGIC)* for the Administering 5-day LD IL-2
Slide 4: LD IL-2 Study Results
THERAPEUTICS LD IL-2 Study Results ee rT ye = 5 - : : i." [-, 4 ‘ a . 7m ~
Slide 5: Overall Study Endpoints
LD IL-2 in Mild to Moderate Alzheimer’s Disease Overall Study Endpoints The trial was designed to detect significant differences in primary and secondary endpoints: Primary Endpoint: Secondary Endpoint: Exploratory Endpoints: Safety and Tolerability Treg Cell Populations CSF Biomarkers and Clinical
Slide 6: Overview of Study Design
LD IL-2 Overview of Study Design Randomized, Double-Blind, Placebo-Controlled Trial (N=38) Treatment Groups • LD IL-2 Q4wk: (n=9) • LD IL-2 Q2wk: (n=10) • Placebo: (n=19) 6
Slide 7: Baseline Characteristics
LD IL-2 Baseline Characteristics Consistent Across Groups Characteristics of the participants at baseline IL-2 q 4 wks IL-2 q 2 wks Placebo Characteristics (n=9) (n=10) (n=19) Age-yr (MEAN±SD) 68.67±6.96 75.9±6.54 68.68±7.63 Sex- no. (%) Female 6 (66%) 6 (60%) 11 (58%) Male 3 (33%) 4 (40%) 8 (42%) R
Slide 8: Primary Endpoint: Safety & Tolerability
LD IL-2 Primary Endpoint Safety & Tolerability ADVERSE EVENTS SUMMARY Events IL-2 q 4 IL-2 q 2 Placebo Relation to wks wks (n=19) intervention (n=9) (n=10) Subjects with at least one AE: 6(66%) 8(80%) 14(73%) N/A Subjects with related AEs: 3(33%) 5(50%) 3(15.7%) N/A Death 0 0 0 - Serious AEs 0 0 0 -
Slide 9: Secondary Endpoint: Expansion of Treg Populations
Secondary Endpoint Effective, Sustainable, and Significant Expansion of Treg Populations ✓ LD IL-2 q4wks resulted in effective and sustainable expansion of Tregs without off-target effects : 21 week or 148 day on-treatment period 9
Slide 10: Exploratory Endpoints: CSF Modifications of Disease Pathology
Exploratory Endpoints CSF Modifications of Disease Pathology Treg Percentage ✓ LD IL-2 q4wks resulted in stabilized or improved key CSF biomarkers related to AD : 21 week or 148 day on-treatment period 10
Slide 11: Exploratory Endpoint: Clinical Scales Demonstrating Cognitive Stabilization
Exploratory Endpoint Clinical Scales Demonstrating Cognitive Stabilization 0.45 Point Improvement (LD IL2 Q4w) 27% Slower Decline (LD IL2 Q4w) Treg Percentage ∆ of 4.93 points No Change (LD IL2 Q4w) Cognition Stabilized (LD IL2 Q4w) ✓ LD IL-2 q4wks resulted in slight improvement of ADAS- Cog Score,
Slide 12: LD IL-2 Study in Support of COYA 301 & 302
LD IL-2 Study in Support of COYA 301 & 302 COYA 301 and 302 are investigational products, not yet approved by the US Food and Drug Administration
Slide 13: What's Next?
What’s Next? ➢ Reporting of additional data from the LD IL-2 study documenting the effect of LD IL- 2 treatment vs. placebo on systemic and CNS inflammatory markers (including peripheral blood cytokines and chemokines, and PET brain imaging) ➢ Discussions ongoing to advance other combination strateg
Slide 14: LD IL-2 Trial Tested Single Component of COYA 302
LD IL-2 Trial Tested Single Component of COYA 302 (proprietary LD rh IL-2 + CTLA-4 Ig) Dysfunctional Tregs Pro-inflammatory Macrophages Adaptive and Innate Immune-Mediated Neuroinflammation CD80 CD80 LD IL-2 + CTLA-4 Ig LD IL-2 CTLA4-Ig FoxP3 FoxP3 FoxP3 FoxP3 Tregs Increased Numbers and Anti-Inflam
Slide 15: COYA 302: Dual Immunomodulatory Activity Against Inflammation
COYA 302: Dual Immunomodulatory Activity Against Inflammation (Blood Brain Barrier) ➢ The synergistic dual mechanism of COYA 302 increases Treg numbers and function, and suppresses pro- inflammatory myeloid cells (monocytes, macrophages) LD IL-2 COYA 302 (Proprietary LD rh IL-2 + CTLA-4 Ig) 15
Slide 16: Takeaways
Takeaways ➢ We believe LD IL-2 study results further validate the hypothesis that restoring the numbers and function of Tregs with systemic LD IL-2 alone targets neuroinflammation. ➢ We believe LD IL-2 study results indicate that systemically administered LD IL-2 directly mediates significant diseas
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