Kaleido Biosciences, Inc. · OTC:KLDO
Kaleido Biosciences — Investor Presentation (December 2019)
32 slides from Kaleido Biosciences's investor presentation, Dec 12, 2019
Slide 1: Company Overview December 2019
Exhibit 99.2 Company Overview December 2019 1 ©2 ©201 019 K 9 KA ALE LEIDO IDO™ ™Exhibit 99.2 Company Overview December 2019 1 ©2 ©201 019 K 9 KA ALE LEIDO IDO™ ™
Slide 2: Forward-Looking Statements
Forward-Looking Statements This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, statements regarding the anticipated use of our existing cash resources, the duration for which our
Slide 3: The Kaleido Opportunity
The Kaleido Opportunity Human-Centric Faster, More Broad Pipeline Proprietary Discovery & Cost-Efficient with Large Market Chemistry Development Clinical Model Opportunity Platform First Company with Novel Chemistry to Systematically Drive Functional Outputs of the Microbiome and Rapidly Translate i
Slide 4: Delivered Positive Clinical Data in 2019 to Support Lead Programs
Delivered Positive Clinical Data in 2019 to Support Lead Programs Further Validation of MMT Platform • KB195 – Urea Cycle Disorders 15 – RESULTS: Small open label clinical study of KB195 showed reduction in urinary N Pathologies Resulting from an excretion (biomarker of ammonia production) in 2 out
Slide 5: Broad Pipeline of Microbiome Metabolic Therapies (MMT)
Broad Pipeline of Microbiome Metabolic Therapies (MMT™) Clinical Data in Two Patient Populations Mechanism PROGRAM Target of Action Development Status 1 Clinical study in patients Urea Cycle Disorders (KB195) Ammonia Phase 2 clinical trial under IND/CTAs 1 Clinical study in healthy volunteers Ammoni
Slide 6: The Microbiome Organ Has the Potential to Address a Broad Range of Diseases
The Microbiome Organ Has the Potential to Address a Broad Range of Diseases • NASH/NAFLD Indigenous Bacteria from Gut Metabolic Microbiota Regulate Host Serotonin Gut Microbiota Regulate Motor • Chronic Kidney Disease Deficits and Neuroinflammation Biosynthesis Health • Metabolic Syndrome in a Model
Slide 7: Kaleido Has a Unique and More Evolved Approach
Kaleido Has a Unique and More Evolved Approach FOCUS Drive Functions Existing Bacteria of the Microbiome Add Bacteria Subtract Microbiome Metabolic Bacteria Therapies, or MMTs (i.e. targeted glycans) “Bugs as drugs” (e.g. fecal microbiota transplants, “Kill the bugs” Composition bacterial therapy) (
Slide 8: Glycans are a Major Modality Shaping the Gut Microbiome
Glycans are a Major Modality Shaping the Gut Microbiome Kaleido is Using Novel Chemistry to Develop Proprietary, Synthetic Glycans CREATION OF LIBRARIES OF SYNTHETIC GLYCANS (MMTs) Mono- Humans: + Multiple Oligo- 17 bond types, Poly- and branching glycosidases saccharide Microbiome: >3000 carbohydra
Slide 9: Our Microbiome Metabolic Therapies Provide Unique Advantages
Our Microbiome Metabolic Therapies (MMTs) Provide Unique Advantages CHARACTERISTICS ADVANTAGES Metabolic output of microbiome not attainable Targeted, disease-specific activity from commercially available glycans Directional taxonomic changes are translated Ex vivo assay predicts response in humans
Slide 10: Human-Centric Discovery & Development Platform
Human-Centric Discovery & Development Platform Human Data Drives Learning 1 3 and MMT Optimization EX VIVO SCREENING RAPID IN HEALTHY ADVANCEMENT INTO MICROBIOME SAMPLES HUMAN CLINICAL 1,2 STUDIES Healthy & Patients Volunteers MMT DECISION POINT 2 • File IND or global equivalent and Proceed to Phase
Slide 11: Our MMTs Enable Faster, More Cost-Efficient Discovery & Development
Our MMTs Enable Faster, More Cost-Efficient Discovery & Development Year 1 Year 2 Year 3 Year 4 Year 5 Year 6 Year 7 Kaleido’s Human- IND Start Centric Discovery Discovery Human Clinical Studies 1 1 Year 2 Years Phase 2/3 and Development <3 Years Traditional Start IND Discovery, Preclinical Phase 1
Slide 12: Urea Cycle Disorders: Rare Inborn Errors of Metabolism
Urea Cycle Disorders: Rare Inborn Errors of Metabolism Resulting in Inability to Clear Ammonia Urea Cycle Disorders (UCD) LIVER KB195 Main Site of Ammonia Clearance • Inability to metabolize ammonia due to inborn deficiency of enzymes in the urea cycle GUT ‒ A significant proportion of ammonia is pr
Slide 13: Clinical Program for KB195 in UCD: Phase 2 Data Expected Mid-2020
Clinical Program for KB195 in UCD: Phase 2 Data Expected Mid-2020 • Safety/tolerability of KB195 in healthy volunteers Healthy Clinical study • Impact on microbiome-derived nitrogen metabolism as measured by (completed) Volunteers nitrogen tracer in urine • Safety/tolerability of KB195 in 4 patients
Slide 14: Lactose-[15N]-ureide Tracer for Assessing Ammonia Metabolism
15 Lactose-[ N]-ureide Tracer for Assessing Ammonia Metabolism • The microbiome contributes to ammonia production in the gut through protein degradation and cleavage of host-derived urea • Proposed MoA: MMTs reduce nitrogen metabolism by bacterial enzymes in the gut, decreasing free ammonia (includi
Slide 15: KB195 Clinical Study: Significantly Reduced a Biomarker of Ammonia Production in Healthy Volunteers
KB195 Clinical Study: Significantly Reduced a Biomarker of Ammonia Production in Healthy Volunteers KB195 Demonstrated a 33% Median Decrease in • KB195 chosen based on its ability to reduce ammonia in ex vivo 15 Urinary N Excretion Compared to Baseline screening and testing in healthy and patient mi
Slide 16: KB195 Clinical Study in Patients with Well-Controlled UCD
KB195 Clinical Study in Patients with Well-Controlled UCD Reinforce Results in Healthy Subjects that KB195 Reduces Biomarker of Ammonia Production 15 1 • N tracer data suggestive of KB195 activity • Open-label, single-arm, clinical study enrolled 4 in reducing nitrogen metabolism, a biomarker patien
Slide 17: Hepatic Encephalopathy: Cognitive Dysfunction as a Result of Liver Disease
Hepatic Encephalopathy: Cognitive Dysfunction as a Result of Liver Disease, including Cirrhosis Hepatic Encephalopathy (HE) LIVER KB174 Main Site of Ammonia Clearance • Clinical spectrum from covert neurocognitive findings to overt neuropsychiatric abnormalities in patients with liver dysfunction GU
Slide 18: KB174 Clinical Study in Patients with Cirrhosis: Study Design
KB174 Clinical Study in Patients with Cirrhosis: Study Design • A randomized, double-blind clinical study comparing the effect of KB174 to maltodextrin (a negative 15 control) on urinary nitrogen N excretion in patients with well-compensated liver cirrhosis 15 • Primary outcome: change in N in urine
Slide 19: Clinical Study of KB174 in Cirrhotic Patients: Positive Top-Line Data
Clinical Study of KB174 in Cirrhotic Patients: Positive Top-Line Data Show Reduction in a Biomarker of Ammonia Production KB174 Demonstrated a 26% Median Reduction 15 • Patients treated with KB174 had a 26% median in Urinary N Excretion Compared to Baseline 15 in Cirrhotic Patients reduction in urin
Slide 20: Microbiome Impact on Pathogens and Immune Function
Microbiome Impact on Pathogens and Immune Function Opportunity to Progress Development for Multi-drug Resistant Infections and Additional Diseases Caused by Imbalance of Immune Function Resulting from Dysbiosis Potential in Other Diseases Multi Drug Resistant Pathogens KB109 • Multi-drug resistant (
Slide 21: KB109 in Multi-Drug Resistant Pathogens, a Growing Public Health Threat
KB109 in Multi-Drug Resistant Pathogens, a Growing Public Health Threat Ex Vivo Testing Ex Vivo Screening 1 2 3 KB109 Observed to Reduce Our MMTs Observed to Pathogens by a Median • Initiated clinical study of KB109 in Reduce Pathogens of 45% Relative to Control patients colonized with multi-drug in
Slide 22: Research Pipeline: New Disease Opportunities & Enhancing Knowledge of MMTs
Research Pipeline: New Disease Opportunities & Enhancing Knowledge of MMTs AREA OF FOCUS Collaborator Status • Two lead MMTs identified in ex vivo testing Cardiometabolic and Liver Diseases • Mechanistic work ongoing to evaluate MMTs in validated preclinical models N/A – Related metabolic pathways e
Slide 23: Manufacturing is a Core Strategic Advantage
Manufacturing is a Core Strategic Advantage Proprietary Methods Standard Small Molecule Unit Operations Scalable and Transferable rd Internal Manufacturing 3 Party Manufacturers Production for ex vivo, toxicology, Large scale production for clinical trials and future and human clinical studies comme
Slide 24: Robust Global IP Portfolio
Robust Global IP Portfolio 9 U.S. Patents + 2 EPO Patents: • Glycan pharmaceutical compositions (Europe) • Methods to reduce ammonia (U.S.) • Methods to treat pathogen colonization (U.S.) • Methods to treat diarrhea (U.S.) • Methods to treat dysbiosis (U.S.) • Catalyst compositions (U.S. and Europe)
Slide 25: Significant Progress During 2019
Significant Progress During 2019 ✓ Raised $75 million in February IPO and began trading on NASDAQ (KLDO) Corporate✓ Bolstered manufacturing capabilities, tech transfer to large-scale manufacturing partner ✓ Strengthened leadership team with appointments of CSO, CBO, new CFO; expanded SAB & new Board
Slide 26: Important Catalysts Expected in 2020
Important Catalysts Expected in 2020 ❑ Data from Phase 2 clinical trial of KB195 in patients with UCD (mid-year) ❑ Data from clinical study of KB109 in patients colonized with multi-drug resistant pathogens (mid-year) ❑ Finalize development plan and trial design for HE program; initiate clinical stu
Slide 27: ©2 ©201 K KA ALE LEIDO IDO™ ™27 ©2 ©201 K KA ALE LEIDO
27 ©2 ©201 019 K 9 KA ALE LEIDO IDO™ ™27 ©2 ©201 019 K 9 KA ALE LEIDO IDO™ ™
Slide 28: World-Class Leadership Team
World-Class Leadership Team Alison Lawton Former GM, Genzyme Biosurgery, President & Chief Executive Officer COO Aura & OvaScience Katharine Knobil, M.D. Former CMO, GlaxoSmithKline Chief Medical Officer, Head of R&D Johan van Hylckama Vlieg, Ph.D. Former VP for Microbiome & Human Chief Scientific O
Slide 29: Collaborating with Gustave Roussy, Pioneer in Immunotherapy and Research in Microbiome and Cancer
Collaborating with Gustave Roussy, Pioneer in Immunotherapy and Research in Microbiome and Cancer Gustave Roussy Utilizes Advanced Preclinical Model with Human • Gustave Roussy is a leading center for Microbiomes of Responder (R) and Non-Responder (NR) Patients immunotherapy in Europe – Pioneer in u
Slide 30: MMT Program for Reduction of TMA in Cardiometabolic and Liver Diseases
MMT Program for Reduction of TMA in Cardiometabolic and Liver Diseases Our top MMTs reduced TMA by >90% • Two lead MMTs identified in ex vivo testing 1 2 in Ex Vivo Screening • Mechanistic work ongoing to evaluate Compared To Control several MMTs through validated preclinical models Control • Will b
Slide 31: KB109 in MDR Pathogens was Selected Via an Assay Cascade
KB109 in MDR Pathogens was Selected Via an Assay Cascade of Increasing Complexity and Disease Relevance 4 423 55 MMTs MMTs MMTs 1 2 Single-strain Ex vivo testing in assay 1 additional patient Process Defined community + populations scale-up and KB109 Healthy communities characterization 2 ICU patien
Slide 32: ©2 ©201 K KA ALE LEIDO IDO™ ™32 ©2 ©201 K KA ALE LEIDO
32 ©2 ©201 019 K 9 KA ALE LEIDO IDO™ ™32 ©2 ©201 019 K 9 KA ALE LEIDO IDO™ ™
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