Coya Therapeutics, Inc. · NASDAQ:COYA
Coya Therapeutics — Investor Presentation (March 2025)
40 slides from Coya Therapeutics's investor presentation, March 2025
Slide 1: Unleashing the Power of Regulatory T cells (Tregs)
Unleashing the Power of Regulatory T cells (Tregs) Investor Presentation March 2025 NASDAQ: COYA www.coyatherapeutics.com
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: Coya Therapeutics: Overview
Coya Therapeutics: Overview ➢ Develop innovative therapies to address the significant unmet medical needs of patients with serious Our Mission neurodegenerative and autoimmune diseases ➢ Tregs modulate the immune system's response and ameliorate inflammatory mechanisms and inhibit pro- Targeting Reg
Slide 4: Key Catalysts and Milestones - 2025
Key Catalysts and Milestones - 2025 ➢ 1Q 2025: Phase 2 LD IL-2 investigator-initiated trial in patients with AD additional clinical data release: Publication and release of additional and comprehensive systemic immune panel and inflammatory cerebrospinal fluid (CSF) Additional Clinical Data biomarke
Slide 5: Inflammation Plays a Critical Role in Neurodegeneration
Inflammation Plays a Critical Role in Neurodegeneration: Regulatory T cells (Tregs) are Dysfunctional: COYA aims to repair these cells Neurodegeneration: Loss of Selective Inflammation in the Nervous System Population of Neurons Healthy Neuron Sick Neuron Dead Neuron Regulatory T Cells (Tregs) “The
Slide 6: Combination Therapies Are Integral for Complex Neurodegenerative Diseases
Coya Therapeutics: Combination Therapies Are Integral for Complex Neurodegenerative Diseases “ Inflammation has emerged as a promising novel pathway for chronic neurological diseases like FTD. A combination drug, like COYA 302, is an innovative approach being developed to suppress neuroinflammation
Slide 7: COYA 302: Low Dose IL-2 and CTLA4-Ig
COYA 302 Proprietary recombinant human Low Dose Interleukin-2 (rh LD IL-2) and CTLA4-Ig
Slide 8: Combination Therapies are the Future of Neurodegenerative Disease Therapy
Combination Therapies are the Future of Neurodegenerative Disease Therapy COYA 302 (proprietary rh LD IL-2 + CTLA4-Ig Combination Immunotherapy Dysfunctional Tregs Pro-inflammatory Macrophages Adaptive and Innate Immune-Mediated Neuroinflammation CD80 CD80 LD IL-2 + CTLA4-Ig LD IL-2 CTLA4-Ig FoxP3 F
Slide 9: COYA-302: A Pipeline Within a Product With >$10B Potential
COYA-302: A Pipeline Within a Product With > $10B Potential Coya is prioritizing ALS, FTD, AD, and PD as key initial neurodegenerative diseases ALS FTD AD PD • High Unmet Need • No Approved Therapies • High Unmet Need • High Unmet Need • Regulatory Flexibility • Regulatory Flexibility • Most common
Slide 10: COYA 302 Program
COYA 302 Program Partnerships / Product Type Discovery Preclinical IND-Enabling Phase 1 Phase 2 Phase 3 2025 Milestones Collaborations Licensing 2Q 2025: IND data submission COYA 302 COYA 302 (Low Dose IL-2 + CTLA4-Ig) and Phase 2b Trial initiation Transaction upon acceptance Treg-Enhancing / on 12/
Slide 11: COYA 302 in Amyotrophic Lateral Sclerosis (ALS)
COYA 302 (Low Dose IL-2 + CTLA4-Ig) in Amyotrophic Lateral Sclerosis (ALS) 11
Slide 12: Current Therapies for ALS Aim to Slow Disease Progression
Current Therapies for ALS Aim to Slow Disease Progression Many companies have garnered significant value by demonstrating a limited benefit of slowing the rate of ALS progression PRO-ACT ALS Database RELYVRIO Clinical Data2 RADICAVA Clinical Data3 ALSFRS-R Mean Change at Week ALSFRS-R Mean Change at
Slide 13: LD IL-2 + CTLA4-Ig Investigator Initiated Clinical Trial
LD IL-2 + CTLA4-Ig Investigator Initiated Clinical Trial Open-Label, Single-Arm PoC Clinical Study in ALS Patients (N=4) Screening Treatment Period Follow-Up 20 weeks LD IL-2 + CTLA4-Ig was administered via 8 weeks subcutaneous injection over 48 weeks Screening Assessments Treatment Period Assessmen
Slide 14: Baseline Characteristics
LD IL-2 + CTLA4-Ig Investigator Initiated Clinical Trial Baseline Characteristics ALS Progression Age Prior to Baseline Respiratory (years) Sex Type Onset (ALSFRS-R score) Respiratory Status Support No Respiratory Patient 1 47 Female Familial Limb -1.6 points / month None Insufficiency Respiratory N
Slide 15: ALSFRS-R Individual Scores
LD IL-2 + CTLA4-Ig Investigator Initiated Clinical Trial ALSFRS-R Individual Scores Participant 1: +4 points Participant 2: +3 points Participant 3: Stable Participant 4: -6 points* *Declined at month 1 and remained stable thereafter Thonhoff JR, Beers DR, Zhao W, et al. A Phase 1 Proof-of- Concept
Slide 16: Appears to Ameliorate ALS Progression Over 48 Weeks
LD IL-2 + CTLA4-Ig Investigator Initiated Clinical Trial Appears to Ameliorate ALS Progression Over 48 Weeks Mean (±SD) ALSFRS-R Score (N=4) 48 44 33.5 32 30 33.75 40 36 ALSFRS-R Score 32 28 24 20 16 48-Week Treatment Follow-Up 12 n.s. 8 n.s. 4 0 (Weeks) B 4 8 12 16 20 24 28 32 36 40 44 48 52 56 LD
Slide 17: Lowered Oxidative Stress Markers
LD IL-2 + CTLA4-Ig Investigator Initiated Clinical Trial Lowered Oxidative Stress Markers Mean (SD) Treg Suppressive Function (N=4) Mean (SD) Percentage of CD4+CD25+FoxP3+ Treg Cells (N=4) CD4+CD25+FoxP3+ Treg Cells (%) 100 Treg Suppressive Function (%) 90 ** ** ** 12 Key Takeaways 80 * 10 70 * 8 60
Slide 18: COYA 302: Overview of Phase 2 Study Design in ALS
COYA 302: Overview of Phase 2 Study Design in ALS Key Inclusion Criteria Randomized, Double-Blind, Placebo- • Diagnosis of sporadic or familial Controlled Phase 2 with Open-Label Extension Primary Endpoint ALS Change in disease • Time since onset of ALS 4 wk. 24 wk. Double Blind 4 wk. Safety 24 wk.
Slide 19: COYA 302 in Frontotemporal Dementia (FTD)
COYA in 302 Frontotemporal Dementia (FTD) 19
Slide 20: Alzheimer's Drug Discovery Foundation $5M Investment
Alzheimer’s Drug Discovery Foundation $5M Investment Alzheimer's Drug Discovery Foundation • $5M investment for funding of Phase 2 FTD study Title: A Phase II, Randomized, Double-Blind, Placebo-Controlled, Multi-Center, 26-Week Study to Evaluate the Safety and Efficacy of COYA 302 for the Treatment
Slide 21: FTD is a Rare Disease but One of Most Common Dementias in Younger People
Frontotemporal Disorder (FTD) is a Rare Disease but is One of Most Common Dementias in Younger People Frontotemporal disorder progresses to death faster than Alzheimer’s disease, and, unfortunately, there is no effective treatment 21
Slide 22: Exacerbated Systemic and Central Inflammatory Responses in FTD
Exacerbated Systemic and Central Inflammatory Responses in FTD 6 LTB4R -log10(P value) 4 NLRP3 NGF CCL25 PTPRK NOS2 CXCR3 2 IL4I1 CCL21 COL10A1 Core Inflammation 0 -1.0 -0.5 0.0 0.5 Difference 22 Internal Data
Slide 23: Targeting Inflammation in FTD to Slow Disease Progression
Targeting Inflammation in FTD to Slow Disease Progression Periphery BBB CNS CTLA4-IgG Homeostatic glial Treg expansion and restoration TH1 Dysfunctional FTD Tregs X IL-2 CTLA4-IgG Inflammatory glia X pro- inflammatory monocytes 23
Slide 24: COYA 302 FTD Phase 2a Study
COYA 302 FTD Phase 2a Study Houston Methodist Center is a center of excellence in ALLFTD: a single infrastructure clinical data platform in FTD with collaborative decision making among 5 leading centers around the USA Group 1 COYA 302 SC Administration 48 Patients 2:1 Randomized Group 2 Placebo SC A
Slide 25: Additional Pipeline Assets
Additional Pipeline Assets Product Type Discovery Preclinical IND-Enabling Phase 1 Phase 2 Phase 3 2025 Milestones COYA 301 (Low Dose IL-2) 2H 2025: Additional single cell COYA 301 proteomics data from the Proprietary Low academic IIT double-blind Ph2 Dose IL-2 Alzheimer’s Disease (AD) data presente
Slide 26: COYA 301 Proprietary Recombinant Low Dose IL-2
COYA 301 Proprietary Recombinant Low Dose IL-2 26
Slide 27: Phase 2 Proof of Concept Open-Label Trial with LD IL-2 in AD
Phase 1 Proof of Concept Open-Label Trial with LD IL-2 in AD Enhanced Treg Function and halted Cognitive decline Improved Treg Function Improved Cognition Translational Neurodegeneration volume 12, Article number: 54 (2023) 27
Slide 28: Case Study of Brain Imaging of AD Patient Before And After LD IL-2 Treatment
Case Study of Brain Imaging of AD Patient Before And After LD IL-2 Treatment Mini-Mental State Examination (MMSE) Neuroinflammation (TSPO) 70-Year-Old Male 18 17 (11C) ER-176 PET Scan at Better 16 Baseline MMSE: 12 16 15 baseline and after 4-monthly 15 Positive PIB PET Scan 14 cycles of low dose IL-
Slide 29: A Primer on IL-2 Dosing and Treg Function
A Primer on IL-2 Dosing and Treg Function: Lower IL-2 Dose is Better for Tregs Graphical abstract undfig1 Previous studies have shown that lower IL-2 doses selectively enhance and increase Treg function reducing pro-inflammatory T Cells while higher IL-2 doses reduce Treg function and enhance pro-in
Slide 30: Phase 2 Low Dose IL-2 in Mild to Moderate Alzheimer's Disease
Phase 2 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 Foun
Slide 31: Double-Blind, Placebo-Controlled Study in AD Patients Completed
Double-Blind, Placebo-Controlled Study in AD Patients Completed The encouraging results of the open-label, proof-of-concept study in AD (N=8) supported conducting the ongoing randomized, double-blind, controlled Phase 2 study in 38 patients with mild-to-moderate AD. Low Dose IL-2– Dose Regimen 1 (Lo
Slide 32: LD IL-2 Meets Primary and Secondary Endpoints in Alzheimer's Disease
LD IL-2 Meets Primary and Secondary Endpoints for Potential Treatment of Alzheimer’s Disease (AD) ✓ Cognition Stabilization (Exploratory Endpoint) for Lower IL-2 Dose Through Drug Treatment vs. Placebo: • 2 out of 3 scales showed cognitive stabilization (ADAS-Cog14 and ADCS-CGIC)* for the Administer
Slide 33: LD IL-2 in Mild to Moderate AD: Validated Lower Dose IL-2 is Better
LD IL-2 in Mild to Moderate Alzheimer’s Disease: Validated Lower Dose IL-2 is Better 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
Slide 34: Key Takeaways
Key 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 dis
Slide 35: Key Catalysts and Milestones - 2025
Key Catalysts and Milestones - 2025 ➢ 1Q 2025: Phase 2 LD IL-2 investigator-initiated trial in patients with AD additional clinical data release: Publication and release of additional and comprehensive systemic immune panel and inflammatory cerebrospinal fluid (CSF) Additional Clinical Data biomarke
Slide 36: COYA 303: COYA 301 + GLP-1 Agonist
COYA 303 COYA-301 (Proprietary LD-IL-2) + GLP-1 Agonist 36
Slide 37: COYA 303 Potential in Neurodegenerative and Other Diseases
COYA- 303 (COYA 301 + GLP-1 Receptor Agonist) Potential in Neurodegenerative and Other Diseases ✓ Low Dose IL-2 alone has demonstrated efficacy in patients with Alzheimer's Disease • Scientific publications support the efficacy of low dose Il-2 in additional indications • COYA-301 is a proprietary l
Slide 38: Thank you!
Thank you! THERAPEUTICS
Slide 39: Coya's Leadership Has Demonstrated Deep Expertise in Biotech
Coya’s Leadership Has Demonstrated Deep Expertise in Biotech Management Team Howard Berman, Ph.D. Arun Swaminathan, Ph.D. Fred Grossman, D.O., FAPA David Snyder Michelle Frazier Executive Chairman of the Board Chief Executive Officer President & Chief Medical Chief Financial Officer & Senior Vice Pr
Slide 40: SAB Comprised of Seminal Leadership in Tregs
SAB Comprised of Seminal Leadership in Tregs Following the discoveries of Dr. Sakaguchi and Dr. Appel, Coya is developing multiple product modalities to enhance the therapeutic Shimon Sakaguchi, MD, PhD Stanley Appel, MD potential of Tregs for the Distinguished Professor at the World Premier Former
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