Coya Therapeutics, Inc. · NASDAQ:COYA
Coya Therapeutics — Investor Presentation (May 2023)
24 slides from Coya Therapeutics's investor presentation, May 2023
Slide 1: Unleashing the Power of Tregs
2020 Unleashing the Power of Tregs COYA THERAPEUTICS, INC. NASDAQ: COYA | Investor Presentation May 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 Cells (Tregs) Clinical Data (12-18 months) • Most clinically-advanced company • COYA 301 completed PoC IIT study* in • COYA 301 clinical PoC data in Alzheimer’s focused on Treg-modulating therapies Alzhei
Slide 4: 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 301 COYAfor301 thefor Treatment of Alzheimer’s the Treatment of Amyotrophic Lateral Amyotrophic Lateral Sclerosis* Sclerosis* disease* Alzheimer’s disease* Open-label academic study in 4 ALS patien
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 COYA 302 (Biologic Combination) H1 2023: POC from IIT - clinical Treg-Enhancing / T data release Effector & H2 2023: File IND Phase 2 study Amyot
Slide 6: 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 7: 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 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
Slide 9: 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 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 → 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 301: Proprietary Treg Enhancing Low-Dose IL-2
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 13: COYA 302 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 benefit in ALS and numbers 302 patients Cytokine COYA Neurodegenerative Inhibition Autoimmune COYA 301 Subcutaneous + Complement Inhibition 30
Slide 14: COYA 302 Addresses Dysfunctional Tregs and Pro-inflammatory Macrophages
COYA 302 Addresses Dysfunctional Tregs and Pro-inflammatory Macrophages COYA 302 = 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 Protein Anti
Slide 15: 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 16: 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 17: 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
Slide 18: 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 19: 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 20: 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
Slide 21: COYA 302: Overview of Phase 2 Study Design in ALS
COYA 302: Overview of Phase 2 Study Design in ALS Study Objectives • Efficacy • Safety and tolerability • Biological activity • Biomarkers Primary Efficacy Endpoint • Combined Assessment of Function and Survival (CAFS) Main Inclusion Criteria • Diagnosis of ALS (sporadic and familial), according to
Slide 22: Total Addressable Market Exceeding $7B
Total Addressable Market Exceeding $7B US MARKET In the United States Alone: Coya is looking to treat ~1.7mm Estimated 30k people in the US; The global market size is Americans ALS $673mm in 20221 Estimated 60k people in the US; US market size extrapolated to FTD be $600mm2,6 Estimated 1.5 million A
Slide 23: 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 published in peer review journal • Treg biomarker data published in peer review journal • Amyotrophic Lateral Sclerosis PoC IIT data • Enrollment completion COYA 302 presented (MDA
Slide 24: Coya Therapeutics' Highlights
Coya Therapeutics’ Highlights Focused on Regulatory T Strong Early Multiple Near-Term Catalysts Cells (Tregs) Clinical Data (12-18 months) • Most clinically-advanced company • COYA 301 completed PoC IIT study* in • COYA 301 clinical PoC data in Alzheimer’s focused on Treg-modulating therapies Alzhei