Coya Therapeutics, Inc. · NASDAQ:COYA
Coya Therapeutics — Investor Presentation (July 2025)
54 slides from Coya Therapeutics's investor presentation, July 2025
Slide 1: Addressing Neuro-Inflammation through Therapeutic Intervention
Addressing Neuro-Inflammation through Therapeutic Intervention Investor Overview July 2025
Slide 2: Cautionary Note of Forward-Looking Statements and Disclaimers
Cautionary Note of Forward-Looking Statements and Disclaimers in this Presentation 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-lo
Slide 3: Coya Therapeutics: Investment Highlights
Coya Therapeutics: Investment Highlights Novel Therapies, High Unmet Need ○ Differentiated approach targeting Treg dysfunction through combination therapies ○ Targeting high unmet diseases ALS, FTD, Alzheimer's Disease ○ De-Risked approach targeting diseases (ALS, FTD) with regulatory flexibility Hi
Slide 4: Presentation Overview
Presentation Overview ⛉ Company Overview ⛉ Neurodegenerative Overview ⛉ The Coya Solution ⛉ Therapeutic Pipeline ⛉ Our Experienced Team ⛉ Product Overviews (Coya 302, 301, 303)
Slide 5: A Large and Global Problem
A Large and Global Problem Neurodegeneration is affecting millions of people without clear therapeutic pathways. 1 in 3 people will be affected by neurological conditions in their lifetime. 3-5 50 Million+ $9 Trillion People Impacted Global Cost of Years Worldwide Dementia by 2050 Life Expectancy Af
Slide 6: The Coya Solution
The Coya Solution We will address neurodegeneration at its source by Alzheimer’s developing innovative therapies to meet the needs of Disease Parkinson’s patients with these diseases. Disease Combining Therapeutic Approaches Neurodegenerative disorders impact people in a variety of ways. There are c
Slide 7: Intro to TRegs
Intro to TRegs Healthy Treg cells Inflammation occurs when Treg block inflammation cells become dysfunctional What are Tregs? How do Tregs influence disease? How to treat disease by targeting Tregs? Tregs are cells within the body When Tregs do not function that keep the immune system properly, auto
Slide 8: Inflammation - A Critical Role in Neurodegeneration
Inflammation - A Critical Role in Neurodegeneration Regulatory T cells (Tregs) are Dysfunctional; COYA aims to repair these cells Neurodegeneration: Inflammation in the Loss of Selective Population of Neurons Nervous System Healthy Neuron Sick Neuron Dead Neuron Regulatory T Cells (Tregs) play a cen
Slide 9: Introducing Coya 302
Introducing Coya 302 Our Lead Therapy - Coya 302 Our research indicates that by decreasing inflammation and increasing Treg suppressive function we can unlock a therapeutic pathway that may be more effective than a singular solution Boost the Good Combine for Success Reduce the Bad Strengthen the fu
Slide 10: LD IL-2 + CTLA4-Ig Investigator Initiated Clinical Trial (ALS)
LD IL-2 + CTLA4-Ig Investigator Initiated Clinical Trial (ALS) Trial in Patients with ALS, appears to Ameliorate ALS Progression Over 48 Weeks LD IL-2 + CTLA4-Ig was well tolerated over 48 weeks; the most common AE was mild injection site reaction. All patients completed the study; no deaths or seri
Slide 11: Interim Results in Patients with Frontotemporal Dementia
Interim Results in 5 patients with Frontotemporal Dementia Patients treated with low dose IL-2 and CTLA-4 Combination in Investigator Initiated Clinical Trial Treg numbers and suppressive function increased after the first treatment cycle (p < 0.01 and p < 0.05, respectively), and remained at higher
Slide 12: Accelerating Research to Commercial
Accelerating Research to Commercial Commercial Growth enabled by Strategic Partnerships With an already solidified partnership with Dr. Reddy’s for Coya 302 for ALS, partnerships will be catalysts for business growth, regulatory approvals and clinical adoption Research agreements in place Leveraging
Slide 13: Coya Program Pipeline
Coya 302 Program Pipeline Product Type Discovery Preclinical IND-Enabling Phase 1 Phase 2 Phase 3 Partnerships ALS COYA 302 Licensing Amyotrophic Transaction on (Low Dose IL-2 + CTLA4-Ig) Lateral Sclerosis 12/6/23 with Dr. Reddy’s Laboratories FTD COYA 302 Frontotemporal (Low Dose IL-2 + CTLA4-Ig) R
Slide 14: 2025 Key Catalysts and Milestones
2025 Key Catalysts and Milestones Additional Clinical ⮚ 1Q 2025: Phase 2 LD IL-2 investigator initiated trial in patients with AD additional clinical data release: Data Release: Publication and release of additional and comprehensive systemic immune panel and inflammatory Phase 2 IIT AD Trial cerebr
Slide 15: Additional Pipeline Assets
Additional Pipeline Assets Product Type Discovery Preclinical IND-Enabling Phase 1 Phase 2 Phase 3 Key Milestones Coya 301 1H 2025: Proprietary Low COYA 301 in AD Additional biomarker and blood panel Dose IL-2 data from the academic IIT double- blind Ph2 data that was presented at CTAD in October 20
Slide 16: Our Pipeline is > $10Bn Opportunity
Our Pipeline is > $10Bn Opportunity Coya is prioritizing therapies for ALS, FTD, AD, and PD Alzheimer’s as key initial neurodegenerative diseases Disease Parkinson’s Disease ALS and Frontotemporal Dementia ALS and FTD both have high unmet need, are designated as orphan indications, and have flexible
Slide 17: Investment by ADDF
Investment by ADDF “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 by targeting multiple inflammatory pathways. Combination therapy will be in
Slide 18: Appendix
Appendix ⛉ Coya 302 Overview ⛉ Coya 302 in ALS ⛉ Coya 302 in FTD ⛉ Coya 301 in AD ⛉ Coya 303 (Coming Soon)
Slide 19: COYA 302
LEAD PRODUCT COYA 302 Proprietary, Recombinant Human Low Dose Interleukin-2 (rh LD IL-2) and CTLA4-Ig
Slide 20: The Future of Neurodegenerative Disease Therapy
The Future of Neurodegenerative Disease Therapy COYA 302 (proprietary rh LD IL-2 + CTLA4-Ig Combination Immunotherapy Dysfunctional Tregs Pro-inflammatory Adaptive and Innate Macrophages Immune-Mediated Neuroinflammation CD80 CD80 LD IL-2 + CTLA4-Ig LD IL-2 CTLA4-Ig FoxP3 FoxP3 FoxP3 FoxP3 Tregs Inc
Slide 21: Coya 302 is a Pipeline within a Product with > $10BN Potential
Coya 302 is a Pipeline within a Product with > $10BN Potential Coya is prioritizing ALS, FTD, AD, and PD as key initial neurodegenerative diseases ALS FTD AD PD ALS or Amyotrophic FTD or Frontotemporal AD or Alzheimer's Disease PD or Parkinson’s Disease Lateral Sclerosis and is Dementia and is an •
Slide 22: COYA 302 in ALS
COYA 302 in ALS Proprietary, Recombinant Human Low Dose Interleukin-2 (rh LD IL-2) and CTLA4-Ig
Slide 23: Current Therapies for ALS aim to slow disease progression
Current Therapies for ALS aim to slow disease progression Average rate of patient decline is 1.02 points/month in ALSFRS-R score1 Many companies have garnered significant value by demonstrating a limited benefit of slowing the rate of ALS progression Weeks 1. The PRO-ACT database is the largest ALS
Slide 24: 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 25: LD IL-2 + CTLA4-Ig Trial: Baseline Characteristics
LD IL-2 + CTLA4-Ig Investigator Initiated Clinical Trial Baseline Characteristics ALS Progression Age Respiratory Respiratory Sex Type Onset Prior to Baseline (years) Status Support (ALSFRS-R score) No Respiratory Patient 1 47 Female Familial Limb -1.6 points / month None Insufficiency Respiratory N
Slide 26: ALSFRS-R Individual Scores remained mostly stable or improved
LD IL-2 + CTLA4-Ig Investigator Initiated Clinical Trial ALSFRS-R Individual Scores remained mostly stable or improved 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,
Slide 27: 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 LD IL-2 + CTLA4-Ig was well tolerated over 48 weeks; the most common AE was mild injection site reaction. All patients completed the study; no deaths or serious AEs (SAEs) occurred over the c
Slide 28: Lowered Oxidative Stress Markers
LD IL-2 + CTLA4-Ig Investigator Initiated Clinical Trial Lowered Oxidative Stress Markers Key Takeaways * ** ** * * * ✔ LD IL-2 + CTLA4-Ig significantly expanded Treg suppressive function as early as 4 weeks after initiation of treatment and maintained a ** significantly increased Treg function. ✔ L
Slide 29: Overview of Phase 2 Study Design in ALS
Overview of Phase 2 Study Design in ALS Trial will be conducted starting later in H2-2025 Key Inclusion Criteria Randomized, Double-Blind, Placebo-Controlled Phase 2 with Open-Label Extension Primary Endpoint • Diagnosis of sporadic or familial ALS Change in disease 4 wk. 24 wk. Double Blind 4 wk. S
Slide 30: COYA 302 in FTD
COYA 302 in FTD Proprietary, Recombinant Human Low Dose Interleukin-2 (rh LD IL-2) and CTLA4-Ig
Slide 31: Partnership with Alzheimer's Drug Discovery Foundation
Partnership with Alzheimer’s Drug Discovery Foundation $5M Investment to accelerate Phase 2b trial in FTD Frontotemporal Disorder (FTD) is a Rare Disease and is one of Alzheimer's Drug Discovery Foundation Most Common Dementias in Younger People. Frontotemporal disorder progresses to death faster th
Slide 32: Exacerbated Systemic and Central Inflammatory Responses
Exacerbated Systemic and Central Inflammatory Responses FTD is a devastating disease that unfortunately has no effective treatment Core Inflammation
Slide 33: 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 Inflammation
Slide 34: COYA 302 FTD Phase 2a Study
COYA 302 FTD Phase 2a Study Houston Methodist Center is a CoE 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 Administration El
Slide 35: COYA 301
PIPELINE PRODUCT COYA 301 Proprietary Recombinant Low Dose IL-2
Slide 36: Improved Treg Function, Improved Cognition
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 Core Translational Neurodegeneration volume 12, Article number: 54 (2023)
Slide 37: Case Study of Brain Imaging of AD Patient Before and After LD IL-2
Case Study of Brain Imaging of AD Patient Before and After LD IL-2 Treatment Neuroinflammation (TSPO) 70-Year-Old Male (11C) ER-176 PET Scan at baseline and Baseline MMSE: 12 after 4-monthly cycles of low dose IL- Positive PIB PET Scan 2. Positive Neurodegeneration MRI The second PET scan was done 2
Slide 38: 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 Study Summary 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 e
Slide 39: COYA 301 in AD
COYA 301 in AD Phase 2 Low Dose Interleukin-2 (LD IL-2) in Patients with Mild to Moderate Alzheimer’s Disease An Investigator Initiated, Randomized, Double-Blind, Placebo-Controlled Clinical Trial led by Dr. Alireza Faridar at Houston Methodist Hospital
Slide 40: Double-Blind, Placebo-Controlled Study in AD Patients
Double-Blind, Placebo-Controlled Study in AD Patients Study funded by the Gates Foundation and Alzheimer’s Association The encouraging results of the open-label, proof-of-concept study in AD (N=8) supported conducting the ongoing randomized, double- Low Dose IL-2– Dose Regimen 1 (Lower Dose) blind,
Slide 41: LD IL-2 Meets Primary and Secondary Endpoints for 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 42: LD IL-2 in Mild to Moderate Alzheimer's Disease
LD IL-2 in Mild to Moderate Alzheimer’s Disease The trial was designed to detect significant differences in primary and secondary endpoints, and validated that Lower Dose IL-2 is Better Primary Endpoint: Secondary Endpoint: Exploratory Endpoints: Safety and Tolerability Treg Cell Populations CSF Bio
Slide 43: Key Takeaways of the Trial
Key Takeaways of the Trial Trial validated that Lower Dose IL-2 is Better 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 indica
Slide 44: COYA 303
COYA 303 An investigational biologic combination of COYA 301, Coya’s low-dose interleukin 2 (LD IL-2) and a GLP-1 receptor agonist (GLP-1RA), designed to deliver a multi- targeted immunomodulatory therapeutic in autoimmune and neurodegenerative diseases
Slide 45: Evaluation of COYA 301 and GLP-1RA combination
Evaluation of COYA 301 and GLP-1RA combination Glucagon-like peptide-1 receptor agonists (GLP-1RA) demonstrate promising immunomodulatory effects in preclinical models and clinical trials. To determine whether there are potential additive beneficial effects of GLP-1RA in combination with COYA 301, w
Slide 46: Evaluation of COYA 301 and GLP-1RA combination
Evaluation of COYA 301 and GLP-1RA combination COYA 301 and GLP-1RA combination suppresses proinflammatory macrophages and responder T cell proliferation in vitro Suppression of Activated Suppression of Responder Macrophages T Cell Proliferation
Slide 47: Evaluation of COYA 301 and GLP-1RA combination
Evaluation of COYA 301 and GLP-1RA combination COYA 301 and GLP-1RA combination increases mRNA transcripts associated with Treg function and survival Upregulation of Treg survival and function Protection of Tregs from apoptosis
Slide 48: Evaluation of COYA 301 and GLP-1RA combination
Evaluation of COYA 301 and GLP-1RA combination COYA 301 and GLP-1RA in a mouse model of Parkinson’s disease 10 μg 6-OHDA injected into dorsolateral striatum (coronal sections of tyrosine hydroxylase in midbrain) Lesioned Unlesioned 6-OHDA model of PD with the following endpoints: 7 days post-injecti
Slide 49: Coya Teams
Coya Teams ⛉ Leadership Team ⛉ Operational Team ⛉ Scientific Advisory Team ⛉ Board of Directors
Slide 50: Expert Leadership Team
Expert Leadership Team Arun Swaminathan, Ph.D. Fred Grossman, D.O., FAPA David Snyder Chief Executive Officer President & Chief Chief Financial Officer & Medical Officer Chief Operating Officer <– Prior Experiences –> Bristol Myers Squibb Johnson-Johnson DisperSol Technologies Actinium Sunovion Phar
Slide 51: Experienced Operational Team
Experienced Operational Team Michelle Frazier Karen King Daniel Barvin Senior Vice President of Senior Vice President of Vice President of Operations Regulatory Affairs Program Management & Patient Advocacy and Clinical Operations <– Prior Experiences –> Revance Therapeutics Recursion End The Legacy
Slide 52: World Class Scientific Advisors
World Class Scientific Advisors Shimon Sakaguchi, M.D., Ph.D. Clive Svendsen, Ph.D. Malcolm Brenner, M.D., Stanley Appel, M.D. Member of the National Director, Cedars-Sinai Ph.D. Co-Director, Houston Methodist Academy of Sciences Regenerative Medicine Institute Director, Center for Cell and Neurolog
Slide 53: Distinguished Board of Directors
Distinguished Board of Directors Howard Berman, Ph.D. Ann Lee, Ph.D. Dov Goldstein, M.D., MBA Executive Chairman Chief Technical Officer Chief Financial Officer of the Board of Prime Medicine of BioAge Labs Wilbur Ross Anabella Villalobos, Ph.D. Dieter Weinand Former U.S. Secretary of Head of Biothe
Slide 54: Thank You!
THERAPEUTICS Thank You! ,
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