Coya Therapeutics, Inc. · NASDAQ:COYA
Coya Therapeutics — IPO Roadshow (December 2022)
25 slides from Coya Therapeutics's IPO roadshow presentation, Dec 6, 2022
Slide 1: Unleashing the Power of Tregs – Initial Public Offering Investor Presentation
COYA THERAPEUTICS Unleashing the Power of Tregs Filed Pursuant to Rule 433 of the Securities Act of 1933 Issuer Free Writing Prospectus dated December 6, 2022 Relating to the Preliminary Prospectus dated December 5, 2022 Registration Statement File No. 333-268482 COYA THERAPEUTICS, INC. Initial Publ
Slide 2: Cautionary Note on Forward-Looking Statements and Disclaimers
Cautionary Note on 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: Offering Summary
Offering Summary Transaction Details Issuer Coya Therapeutics, Inc. Assumed Offering Price $5.00 Offering Size $15,250,000 Shares Offered 3,050,000 shares Warrants Offered Greenshoe Gross Spread Bookrunners Use of Proceeds 1,525,000 with $7.50 assumed exercise price (expire 2 years after issuance) 1
Slide 4: Coya's Leadership Has Demonstrated Deep Expertise in Biotech
Coya’s Leadership Has Demonstrated Deep Expertise in Biotech Management Team Howard Berman, Ph.D.Chief Executive Officer & Chairman of the Board Adrian Hepner, M.D., Ph.D.President & Chief Medical Officer David Snyder Chief Financial Officer & Chief Operating Officer John Centanni Vice President of
Slide 5: Unleashing the Power of Regulatory T Cells (Tregs)
Unleashing the Power of Regulatory T Cells (Tregs) Shimon Sakaguchi, MD, PhD Distinguished Professor at the World Premier International Research Initiative (WPI)-Immunology Frontier Research Center (IFReC) at Osaka University Discovered Tregs in 1995 and their role in inflammation and autoimmune con
Slide 6: What Are Tregs & How They Are Dysfunctional
What Are Tregs & 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 mechanisms and reactions Inhibit the release of pro-inflammatory cytokines Maintain self-tolerance Anti-inflammatory Healthy Tre
Slide 7: History of Treg Development – Future of Treg Modulation
History of Treg Development – Future of Treg Modulation 1990s 2000s 2010s 2020s Discovery of Tregs by Dr. Sakaguchi FOXP3 expression differentiate T cells into Tregs that help prevent autoimmunity First human trials of Polyclonal Tregs in inflammatory disorders/type 1 diabetes Developing Treg based
Slide 8: Evolving Multi-Modality Pipeline Addressing Treg Dysfunction
Evolving Multi-Modality Pipeline Addressing Treg Dysfunction Clinical data and proprietary know-how generated from our Treg cell therapy program have driven Coya to focus on biologic modalities and novel allogeneic exosomes while also expanding our therapeutic opportunities in neurodegenerative and
Slide 9: Pipeline
Pipeline Product Type Discovery Preclinical IND-Enabling Phase 1 Phase 2a Phase 2b Phase 3 Upcoming Milestones Treg-Enhancing Biologic H1 2023: IND Filing H1 2023: Initiate Phase 1 H2 2023: Interim Readout Treg-Enhancing / T Effector & Macrophage Depleting Biologics H1 2023: POC from IIT - clinical
Slide 10: Coya's Evolution: From Cell Therapy to Biologics
Coya’s Evolution: From Cell Therapy to Biologics • Well tolerated • Promising biological activity • Reduction of key biomarkers • Well tolerated • Biological activity confirmed • Confirmation of biomarkers • Treg dysfunction in ALS patients predicts survival COYA 300 Series COYA 301* Biologic Monoth
Slide 11: Serum ox-LDL levels and clinical status in Treg infusion trial
FIGURE 2: A, B. Subjects' clinical statuses reflects the level of the subjects' serum ox-LDL levels. These subjects were enrolled and completed a phase I clinical trial with Treg infusion, increased during the washout period, were then suppressed during the second round of Treg infusions, and rose f
Slide 12: 301: Treg Enhancing Biologics to Reduce Inflammation
COYA 301: Treg Enhancing Biologics to Reduce Inflammation COYA 301 Drives Selective Treg Expansion, Potentially Enhancing Ratio of Tregs to Pro-inflammatory Cells Baseline Inflammatory Environment Anti-infiammatory Healty Treg Cells Pro-infiammatory cells Anti-infiammatory Functional Treg cells Pro-
Slide 13: Neuroinflammation and the Pathophysiology of FTD
Neuroinflammation and the Pathophysiology of FTD Scientific evidence supports the role of neuroinflammation in the progression of FTD, inclu ding cortical inflammation and cell activation • Frontotemporal dementia, or FTD, is a group of disorders that occur when nerve cells in the frontal and tempor
Slide 14: Treg Function is Significantly Impacted in FTD
Treg Function is Significantly Impacted in FTD Data support the development of COYA 301 to enhance Treg function in vivo in patients with FTD • Our data show a statistically significant reduction of Treg function in FTD patients, compared to matching healthy controls • The Investigator-Initiated Tri
Slide 15: 302: Combination Biologic with a Dual Mechanism of Action
COYA 302: Combination Biologic with a Dual Mechanism of Action Drives selective Treg expansion We believe COYA 302 leverages synergistic enhancement of Treg function and depletion of proinflammatory T cells and macrophages Mechanism 1 Coya 301 Coya 300 Anti infiammatory Healthy Treg Cells Pro infiam
Slide 16: 302: The Next Generation of Treg Therapy
COYA 302: The Next Generation of Treg Therapy Following the positive lessons learned from our COYA 101 autologous cell therapy studies, we have designed COYA 302, a proprietary off-the-shelf biologic combination COYA 101 Autologous Expanded Treg Cell Therapy COYA 302 Biologic Combination Therapy Tol
Slide 17: 302: Treatment of ALS Phase 1 Study – Proof of Concept Trial
COYA 302: Treatment of ALS Phase 1 Study* – Proof of Concept Trial (interim results**)COYA 302: Treatment of ALS Phase 1 Study* – Proof of Concept Trial (interim results**) Study Assessments Functional Assessment (ALSFRS-R) Treg Suppressive Function Serum Biomarkers Safety and Tolerability Subjects’
Slide 18: 302: Average Improvement in ALSFRS-R Scores at 7 Months
COYA 302: Treatment of ALS Phase 1 Study* – Average Improvement in ALFRS Scores at 7 Months (interim data**) Key Takeaways Revised ALS Functional Rating Scale (ALSFRS-R) is the most widely accepted and validated outcome measure of activity limitation for patients with ALS. Each point decrease on the
Slide 19: 302: Sustained Enhancement of Treg Suppressive Function
COYA 302: Treatment of ALS Phase 1 Study* – Sustained Enhancement of Treg Suppressive Function (interim data**) Treg Suppressive Function by Subject (N=4) eg Suppressive Function (%) {bar chart} Better (coya therapeutics) Phase 1 study conducted with commercially available product ** Based on intern
Slide 20: Reduction of Oxidative Stress in ALS Patients
COYA 302 Mediates Reduction of Oxidative Stress in ALS Patients (interim data**) Phase 1 Study* Supports Use of Biomarkers of Efficacy Oxidized Low Density Lipoprotein (ox-LDL) Serum Levels by Patient (N=4) {bar chart}Better (coya therapeutics) 4-Hydroxynonenal (4-HNE) Serum Levels by Patient (N=4)
Slide 21: 201: Potential Benefits of Treg-Derived Exosomes
COYA 201: Potential Benefits of Treg-Derived Exosomes Exosomes are nanosized vesicles that shuttle proteins, lipids, and nucleic acids between both neighboring and distant cells Cannot convert back to dysfunctional Capacity to be loaded with a variety of molecules (coya therapeutics) Ability to guid
Slide 22: 206: Partnership with Carnegie Mellon University
COYA 206: Partnership with Carnegie Mellon University Collaboration for Targeting Exosomes Earlier this year, Coya secured an option to acquire the worldwide rights to exosome engineering technology from Carnegie Mellon University The option agreement involves the intellectual property rights to the
Slide 23: 101: Promising Clinical Activity in ALS Phase 2a
COYA 101: Promising Clinical Activity in ALS Phase 2a 6-Month Open-Label Data (N=8) ALSFRS-R Score - Mean Change From Baseline to Week 24 1 {bar chart} (coya therapeutics) Key Takeaways Six of the eight patients showed intermediate to no progression of the ALSFRS-R (average of -2.7 points) Two of th
Slide 24: 101: Promising Biological Activity in ALS Phase 2a
COYA 101: Promising Biological Activity in ALSPhase 2a 6-Month Open-Label Data (N=8) Treg Suppressive Function and Numbers 1 A. Treg suppressive function (OLE) Treg suppressive function (% suppression) {bar chart) (A) Treg suppressive function was assessed in each patient at screening, 4 weeks after
Slide 25: Thank You
Coya therapeutics unleashing the powerof tregs Thank You www.coyatherapeutics.com (COYA THERAPEUTICS)