Coya Therapeutics, Inc. · NASDAQ:COYA

Coya Therapeutics — Investor Presentation (October 2023)

31 slides from Coya Therapeutics's investor presentation, October 2023

  1. Slide 1: Unleashing the Power of Tregs

    2020 Unleashing the Power of Tregs COYA THERAPEUTICS, INC. NASDAQ: COYA | Investor Presentation October 2023 www.coyatherapeutics.com

  2. 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

  3. Slide 3: Coya's Leadership Has Demonstrated Deep Expertise in Biotech

    Coya’s Leadership Has Demonstrated Deep Expertise in Biotech Management Team Howard Berman, Ph.D. Fred Grossman, D.O., FAPA David Snyder Arun Swaminathan, Ph.D. Michelle Frazier John Centanni Chief Executive Officer & President & Chief Medical Chief Financial Officer & Chief Business Development Sen

  4. Slide 4: 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

  5. Slide 5: Robust Treg-focused Pipeline

    Robust Treg-focused Pipeline Partnerships / Upcoming Product Type Discovery Preclinical IND-Enabling Phase 1 Phase 2a Phase 2b/3 Collaborations Milestones H2 2023: PoC Biomarker data Treg-Enhancing / T COYA 302 (Low Dose IL-2 + CTLA4 Ig) release: Effector & Q1 2024: IND filing and Ph2 Macrophage Amy

  6. Slide 6: Coya Therapeutics' Highlights

    Coya Therapeutics’ Highlights Focused on Regulatory T Strong Early Multiple Near-Term Catalysts (12- Cells (Tregs) Clinical Data 18 months) • Most clinically-advanced company • COYA 301 completed PoC IIT study* in • COYA 301 clinical Phase 1 PoC data in focused on Treg-modulating therapies Alzheimer

  7. Slide 7: Inflammation Plays a Critical Role in Neurodegeneration: Tregs Dysfunctional

    Inflammation Plays a Critical Role in Neurodegeneration: Regulatory T cells (Tregs) Dysfunctional Neurodegeneration: Loss of Selective Inflammation in the Nervous System Population of Neurons Healthy Neuron Sick Neuron Dead Neuron Tregs play central role in inflammation and progression of neurodegen

  8. Slide 8: What Are Tregs and How They Are Dysfunctional

    What Are Tregs and How They Are Dysfunctional Tregs are a type of lymphocyte that modulate the body’s immune response The main functions of Tregs are: • Ameliorate inflammatory Healthy Tregs Dysfunctional Tregs mechanisms and reactions Tregs are important anti-inflammatory immune When Tregs become d

  9. Slide 9: Treg regulate multiple downstream pathways to reduce inflammation

    Treg regulate multiple downstream pathways to reduce inflammation Adaptive Immune System Innate Immune System Romano et al., Frontiers in Neurology, 31 January 2019 doi: 10.3389/fimmu.2019.00043 9

  10. Slide 10: Adaptive Immune System Involvement in ALS: Treg Dysfunction Is a Core Driver

    Adaptive Immune System Involvement in ALS: Treg Dysfunction Is a Core Driver of Neurodegeneration Treg dysfunction is associated with ALS disease progression …and is similarly associated in and burden of disease… other neurodegenerative diseases Treg Dysfunction is Associated Treg Dysfunction Plays

  11. Slide 11: Innate Immune System Involvement in ALS: Macrophages Promote Dysfunction of Tregs

    Innate Immune System Involvement in ALS : Macrophages Promote Dysfunction of Tregs Releasing Proinflammatory Cytokines and Oxidative Stress Regulatory T Cell FoxP3 IL-1β NO, O2- IL-18 4-HNE IL-6 H2O2 TNF Proinflammatory cytokines and oxidative stress/lipid peroxides contribute to the pathophysiolog

  12. Slide 12: Combination Immunotherapy: Targeting the Adaptive and Innate Immune System

    Combination Immunotherapy: Targeting the Adaptive and Innate Immune System that Drives ALS Pathophysiology Dysfunctional Treg Pro-inflammatory Macrophages Adaptive and Innate Immune-Mediated Neuroinflammation CD80 CD80 Low Dose IL-2 + CTLA4 Ig = Low Dose IL-2 CTLA4 Ig FoxP3 FoxP3 FoxP3 FoxP3 Tregs-I

  13. Slide 13: COYA 302: A Novel Approach to the Treatment of Neurodegenerative Diseases

    COYA 302: A Novel Approach to the Treatment of Neurodegenerative Diseases Unique products compared to commercial IL-2 (High Dose Lyophilized Format) or CTLA4-Ig (Orencia) New Indications Ready-to- including ALS, Unique low dose Well-established administer stable Alzheimer's, strength and GMP subcuta

  14. Slide 14: Strong Proof-of-Concept Clinical Data

    Strong Proof-of-Concept Clinical Data COYA 302 COYA 302 for for the the Treatment Treatment of of Coya COYA301 301for forthe theTreatment of Alzheimer’s Treatment of Alzheimer’s Amyotrophic Lateral Amyotrophic Lateral Sclerosis* Sclerosis* disease* disease* Open-label academic study in 4 ALS patient

  15. Slide 15: 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

  16. Slide 16: COYA 302: Open-Label, Single-Arm PoC Clinical Study in ALS Patients (N=4)

    COYA 302: Open-Label, Single-Arm PoC Clinical Study in ALS Patients (N=4) Screening Treatment Period Follow-Up 20 weeks COYA 302 was administered via subcutaneous 8 weeks injection over 48 weeks Screening Assessments Treatment Period Assessments Post-Treatment Assessments ✓ Clinical Labs ✓ Safety an

  17. Slide 17: COYA 302: Patients' Demographics and Baseline Characteristics

    COYA 302: Patients’ Demographics and Baseline Characteristics ALS Progression Prior to Age Sex Type Onset Baseline Respiratory Status Respiratory Support (years) (ALSFRS-R score) No Respiratory Patient 1 47 Female Familial Limb -1.6 points / month None Insufficiency Respiratory Non-invasive Patient

  18. Slide 18: COYA 302: Appears to Ameliorate ALS Progression Over 48-weeks

    COYA 302: 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 COYA 302 was well tolerated over 48 weeks; the mos

  19. Slide 19: COYA 302: Enhanced Biologic Activity

    COYA 302: Enhanced Biologic Activity 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 ✓COYA 302 significantly expands Treg 50 6 suppressiv

  20. Slide 20: COYA 302: Overview of Phase 2 Study Design in ALS

    COYA 302: Overview of Phase 2 Study Design in ALS Primary Endpoint Key Inclusion Criteria Randomized, Double-Blind, Placebo- Controlled Phase 2 with Open-Label Extension • Diagnosis of sporadic or familial Combined Assessment ALS 4 wk. 24 wk. Double Blind 4 wk. Safety 24 wk. Open-Label of Function (

  21. Slide 21: COYA 301: Proprietary Treg Enhancing Low-Dose IL-2 Suppresses Adaptive Immunity

    COYA 301: Proprietary Treg Enhancing Low-Dose Il-2 Suppresses Adaptive Immunity - Robustly - and Innate Immunity - Modestly Treg Expansion/Suppressive Function Dysfunctional Tregs COYA 301 are associated with neuroinflammation promoted by activated ALS Dysfunctional Treg Functional Tregs T effector

  22. Slide 22: COYA 301: Investigator-Initiated Study in Alzheimer's Disease (AD)

    COYA 301: Investigator-Initiated Study in Alzheimer’s Disease (AD) Overall Study Design • Proof-of-Concept open-label study, conducted at Houston Methodist Hospital • Population: 8 patients with mild-to-moderate AD • Treatment: 4 monthly COYA 301 cycles administered subcutaneously, followed by 2-mon

  23. Slide 23: Improved or Halted Cognitive Decline in AD Patients

    COYA 301 Improved or Halted Cognitive Decline in AD Patients MMSE Score (N=8) CDR-SB Score (N=8) ADAS-Cog Score (N=8) Treatment F/U 60 8 28 ns ns ** * * 50 * 24 6 Mean (SD) Score 40 Mean (SD) Score Mean (SD) Score 20 30 4 16 20 2 12 10 0 8 0 0 120 168 0 30 60 90 120 168 0 120 168 Study Day Study Day

  24. Slide 24: Enhances Treg Function and Numbers in vivo in AD Patients (N=8)

    COYA 301 Enhances Treg Function and Numbers in vivo in AD Patients (N=8) Statistically Significant Enhancement Statistically Significant Enhancement of Treg Suppressive Function of Treg Numbers Treatment F/U Treatment F/U 14 * *** * * Mean (SD) Percentage of Tregs (% of CD4) * ** *** *** 100 12 Mean

  25. Slide 25: Significantly Lowers Plasma Proinflammatory Chemokines and Cytokines in AD Patients

    COYA 301 Significantly Lowers Plasma Proinflammatory Chemokines and Cytokines in AD Patients CCL11 Plasma Levels (N=8) CCL2 Plasma Levels (N=8) IL-15 Plasma Levels (N=8) Treatment F/U 600 Treatment F/U 500 Treatment F/U 14 550 ** ** * *** *** * ** *** ** ** * ** 450 12 Mean (SD) Level (pg/mL) Mean (

  26. Slide 26: Significantly Lowers Expression of Proinflammatory Cytokines in AD Patients

    COYA 301 Significantly Lowers Expression of Proinflammatory Cytokines in AD Patients TNFα Monocyte Expression IL-6 Monocyte Expression IL-1β Monocyte Expression Percent Change from Baseline (N=5) Mean Change from Baseline (N=5) Mean Change from Baseline (N=5) Study Day Study Day Study Day 8 30 38 60

  27. Slide 27: Case Study of Brain Imaging of AD Patient before and after COYA 301 treatment

    Case Study of Brain Imaging of AD Patient before and after COYA 301 treatment Mini-Mental State Examination (MMSE) 18 17 Better 16 16 15 Neuroinflammation (TSPO) 70-Year-Old Male Baseline MMSE: 12 15 (11C) ER-176 PET Scan at 14 MMSE score 13 13 Positive PIB PET Scan 13 12 baseline and after 4-monthl

  28. Slide 28: COYA 301 Safety & Tolerability

    COYA 301 Safety & Tolerability • Overall, COYA 301 was well tolerated in patients with AD. • Most common adverse events (AEs) were mild injection site reactions and mild leukopenia. • All patients completed the study. • No death or other serious AE occurred over the course of the study. 28

  29. Slide 29: COYA 301: Double-Blind, Placebo-Controlled Study in AD Patients is Ongoing

    COYA 301: Double-Blind, Placebo-Controlled Study in AD Patients is Ongoing The encouraging results of the open-label, proof-of-concept study in AD (N=8) support conducting the ongoing randomized, double-blind, well-controlled phase 2 study in 38 patients with mild-to-moderate AD. COYA 301 – Dose Reg

  30. Slide 30: COYA 301 as a Backbone for Combination Immunotherapy

    COYA 301 as a Backbone for Combination Immunotherapy Activated T effector Cells Activated Macrophages/Microglia Treg Function CTLA4 Ig COYA Shown therapeutic and numbers benefit in ALS 302 patients COYA 301 Subcutaneous + Beta Amyloid Inhibitors COYA 303* Alzheimer’s Disease Low-Dose Interleukin-2 F

  31. Slide 31: Multiple Near-Term Preclinical and Clinical Catalysts

    Multiple Near-Term Preclinical and Clinical Catalysts H1 2023 H2 2023 2024 • Amyotrophic Lateral Sclerosis PoC IIT data publication in peer reviewed journal • IND Filing (Q1 2024) ▪ Amyotrophic Lateral Sclerosis PoC IIT data • Biomarker data release for PoC study COYA 302 presented (MDA Conference,

Coya Therapeutics — Investor Presentation (October 2023) on 6ix