Coya Therapeutics, Inc. · NASDAQ:COYA
Coya Therapeutics — Investor Presentation (April 2024)
38 slides from Coya Therapeutics's investor presentation, April 2024
Slide 1: Unleashing the Power of Regulatory T cells (Tregs)
Unleashing the Power of Regulatory T cells (Tregs) Investor Presentation April 2024 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: Investment Highlights
Investment Highlights • Clinically-advanced company focused on Regulatory T cell (Treg) therapies with strong Market Capitalization Table early clinical data Symbol NASDAQ: COYA ⎼ COYA 302 – Expected to file IND for lead asset in 1H24 in ALS (aka “Lou Gehrig’s disease”); also being explored in Alzhe
Slide 4: Coya – Critical Milestones Over the Next 2 Years
Coya – Critical Milestones Over the Next 2 Years 1H 2024 2H 2024 2025 • COYA 301 Presentation of • COYA 301 Proof of Concept • COYA 302 Phase 2 Topline Data in ✓ Investigator Initiated Trial data in AD combination data with Drug X in AD ALS Patients Patients at AD + PD Conference mice model • COYA 3
Slide 5: COYA 302
Neurodegenerative Diseases Involve Complex Pathophysiology Multi-modal Combination Therapies May be Transformative Journal of Neuroinflammation volume 19, Article number: 251 (2022 COYA 302 Proprietary Combination Biologic Lead Asset Like Oncology and Viral Disease, Combination Therapies May Be Tran
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 301 COYA 301 for for the the Treatment Treatment of of Alzheimer’s Alzheimer’s Amyotrophic Lateral Sclerosis* Disease* disease* Open-label academic study in 4 ALS patients, Open-label academic stud
Slide 7: 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 Chief Executive Officer & President & Chief Medical Chief Financial Officer & Chief Business Development Officer Senior Vi
Slide 8: 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 9: COYA 302 Program
COYA 302 Program Partnerships / Product Type Discovery Preclinical IND-Enabling Phase 1 Phase 2 Phase 3 2024 Milestones Collaborations Licensing 1H 2024: IND filing and Ph2 COYA 302 initiation upon IND acceptance Transaction Treg-Enhancing / COYA 302 (Low Dose IL-2 + CTLA4-Ig) on 12/6/23: 1H 2024: P
Slide 10: 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 11: Other Treg Enhancing Therapeutics
Other Treg Enhancing Therapeutics Partnerships / Product Type Discovery Preclinical IND-Enabling Phase 1 Phase 2 Phase 3 2024 Milestones Collaborations 2H 2024 (Summer): Academic IIT double-blind COYA 301 COYA 301 (Low Dose IL-2) Retained Ph2 data Treg-Enhancing Worldwide Rights **Note: Data from 30
Slide 12: Inflammation Plays a Critical Role in Neurodegeneration
Inflammation Plays a Critical Role in Neurodegeneration: Regulatory T cells (Tregs) Dysfunction 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 neurodegener
Slide 13: 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 14: Tregs Regulate Multiple Downstream Pathways to Reduce Inflammation
Tregs 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 14
Slide 15: Adaptive Immune System Involvement in ALS: Treg Dysfunction
Adaptive Immune System Involvement in ALS: Treg Dysfunction Is a Core Driver of Neurodegeneration Treg dysfunction is associated with ALS disease progression and …and is similarly associated in burden of disease… other neurodegenerative diseases Treg Dysfunction is Associated Treg Dysfunction Plays
Slide 16: Multiple Immune Pathways Involved in Complex Neurodegenerative Diseases
Multiple Immune Pathways Involved in Complex Neurodegenerative Diseases Macrophages Promote Dysfunction of Tregs Releasing Regulatory T Cell Proinflammatory Cytokines and Oxidative Stress IL-1β NO, O2- FoxP3 IL-18 4-HNE IL-6 H2O2 TNF Oxidative Stress/Cytokines contribute to pathophysiology of neuro
Slide 17: COYA 302
COYA 302 A Proprietary Dual Biologic Combination Therapy to Address the Complex Pathophysiology in Neurodegeneration 17
Slide 18: COYA 302: Combination Immunotherapy Targeting Adaptive and Innate Immune System
COYA 302: Combination Immunotherapy Targeting the Adaptive and Innate Immune System that Drives ALS Pathophysiology Dysfunctional Treg Proinflammatory 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
Slide 19: COYA 302: A Novel Approach to the Treatment of Neurodegenerative Diseases
COYA 302: A Novel Approach to the Treatment of Neurodegenerative Diseases Unique combination 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 subc
Slide 20: 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 21: 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 22: COYA 302: PoC Trial Patient Demographics and Baseline Characteristics
COYA 302: PoC Trial Patient Demographics and 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 Non-invasive
Slide 23: COYA 302: Appears to Ameliorate ALS Progression Over 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 24: 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 50 6 ✓ COYA 302 significantly expands Treg 40 suppre
Slide 25: 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 26: COYA 301
COYA 301 A Proprietary Low-Dose IL-2 to Address Neurodegenerative Diseases as Monotherapy and as a Platform to Add Novel Synergistic Biologic Agents 26
Slide 27: 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 cells
Slide 28: 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 29: COYA 301: 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 Da
Slide 30: COYA 301: Enhanced Treg Function and Numbers in vivo in AD Patients
COYA 301: Enhanced 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 Mea
Slide 31: COYA 301: Significantly Lowered Plasma Proinflammatory Chemokines and Cytokines
COYA 301: Significantly Lowered 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
Slide 32: COYA 301: Significantly Lowers Expression of Proinflammatory Cytokines
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 6
Slide 33: 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) 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 34: 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 deaths or other serious AE occurred over the course of the study 34
Slide 35: 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) supported conducting the ongoing randomized, double-blind, well-controlled phase 2 study in 38 patients with mild-to-moderate AD. Low Dose IL-2– Do
Slide 36: Low Dose IL-2 as a Backbone Treatment In Combination With Immunomodulatory Biologics
Low Dose IL-2 as a Backbone Treatment In Combination With Immunomodulatory Biologics Biosimilar CTLA4-Ig (COYA 302)* IL-17 GM-CSF Biosimilar Inhibitor (Filgrastim)* Low Dose IL-2 Anti CD20 Biosimilar TNF-alpha Antibody Inhibitor (Rituximab) * Coya has IP filed on the Combination 36
Slide 37: Coya – Critical Milestones Over the Next 2 Years
Coya – Critical Milestones Over the Next 2 Years 1H 2024 2H 2024 2025 • COYA 301 Presentation of • COYA 301 Proof of Concept • COYA 302 Phase 2 Topline Data in ✓ Investigator Initiated Trial data in AD combination data with Drug X in AD ALS Patients Patients at AD + PD Conference mice model • COYA 3
Slide 38: Investor Contact
Investor Contact: David Snyder david@coyatherapeutics.com CORE IR Media Contact: Bret Shapiro Kati Waldenburg brets@coreir.com media@coyatherapeutics.com 561-479-8566 NASDAQ: COYA 212-655-0924
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