Coya Therapeutics, Inc. · NASDAQ:COYA
Coya Therapeutics — Investor Presentation (June 2023)
31 slides from Coya Therapeutics's investor presentation, June 2023
Slide 1: Unleashing the Power of Tregs
2020 Unleashing the Power of Tregs COYA THERAPEUTICS, INC. NASDAQ: COYA | Investor Presentation June 2023 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' 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
Slide 4: Inflammation Plays a Critical Role in Neurodegeneration
Inflammation Plays a Critical Role in Neurodegeneration Neurodegeneration: Loss of Selective Inflammation in the Nervous System Population of Neurons Healthy Neuron Sick Neuron Dead Neuron Dysfunctional Tregs play central role in inflammation and progression of neurodegeneration Motor neurons Materi
Slide 5: 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
Slide 6: 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 Sclerosis* disease* disease* Open-label academic study in 4 ALS patients, Open-label academic study in
Slide 7: 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
Slide 8: Coya's Leadership Has Demonstrated Deep Expertise in Biotech
Coya’s Leadership Has Demonstrated Deep Expertise in Biotech Management Team Howard Berman, Ph.D. Adrian Hepner, M.D., Ph.D. David Snyder Arun Swaminathan, Ph.D. John Centanni Chief Executive Officer & President & Chief Medical Chief Financial Officer & Chief Business Development Vice President Chai
Slide 9: 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
Slide 10: Treg Dysfunction Is a Core Driver of Neurodegeneration
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 a Role in Treg Dysfunction Is with ALS Surv
Slide 11: Initial Findings: Diverse Pipeline Addressing Treg Dysfunction
Initial Findings à Diverse Pipeline Addressing Treg Dysfunction Key Learnings From Two IIT Studies Conducted …Led to the Discovery and Advancement of COYA at Houston Methodist under Dr. Stanley Appel… 300 Series • Treg Cell Therapy was well-tolerated with no Serious Adverse Our initial learnings dem
Slide 12: COYA 302 Addresses Dysfunctional Tregs and Pro-inflammatory Macrophages
COYA 302 Addresses Dysfunctional Tregs and Pro-inflammatory Macrophages COYA 302 = (COYA 301) Low Dose IL-2 CTLA4-Ig Dysfunctional Tregs Treg Numbers & Suppressive Function + Pro-Inflammatory Macrophages Anti-Inflammatory Macrophages Pro-Inflammatory Macrophages COYA 301 CTLA4 Low Dose Fusion IL-2 P
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 other N
Slide 14: 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 15: 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 ü Clinical Labs ü Safety an
Slide 16: 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
Slide 17: 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
Slide 18: 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 * 60 8 üCOYA 302 significantly expands Treg 50 6 suppressiv
Slide 19: 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 (
Slide 20: 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
Slide 21: 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
Slide 22: 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 40 Mean (SD) Score 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
Slide 23: 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
Slide 24: 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 12 500 Mean (SD) Level (pg/mL) Me
Slide 25: 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
Slide 26: 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 Positive PIB PET Scan 13 12 13 baseline and after 4-monthl
Slide 27: 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. 27
Slide 28: 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 and numbers CTLA4 Ig COYA Shown therapeutic benefit in ALS 302 patients COYA 301 Subcutaneous + Cytokine Inhibition COYA 303* Neurodegenerative Autoimmune Metabolic Low-Dose
Slide 29: Total Addressable Market Exceeding $7B
Total Addressable Market Exceeding $7B US MARKET In the United States Alone: Coya is looking to treat ~1.7mm ALS Estimated 30k people in the US; The global market size is Americans $673mm in 20221 Estimated 60k people in the US; US market size extrapolated to FTD be $600mm2,6 Estimated 1.5 million A
Slide 30: 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,
Slide 31: 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
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