Kaleido Biosciences, Inc. · OTC:KLDO
Kaleido Biosciences — Investor Presentation (October 2019)
29 slides from Kaleido Biosciences's investor presentation, Oct 30, 2019
Slide 1: Company Overview October 30, 2019
Company Overview October 30, 2019 1 ©2019 KALEIDO™
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 1st Company to Use a Chemistry-Driven Approach to Drive Functional Outputs of the Microbiome Organ
The 1st Company to Use a Chemistry-Driven Approach to Systematically DRIVE FUNCTIONAL OUTPUTS OF THE MICROBIOME ORGAN Leveraging Human-Centric Discovery and Development to Rapidly Translate the Promise of the Microbiome Into Solutions for Patients 3 ©2019 KALEIDO™
Slide 4: The Kaleido Opportunity
The Kaleido Opportunity Broad Pipeline Human-Centric Faster, More World-Class Proprietary with Large Discovery & Cost-Efficient Leadership Product Platform Market Development Model Team Opportunity Significant Computational Biology and Data Science Capabilities Enable Kaleido to Learn MORE, and Lear
Slide 5: Built A World-Class Leadership Team
Built A World-Class Leadership Team Alison Lawton Former GM, Genzyme Biosurgery, President & Chief Executive Officer COO Aura & OvaScience Kate 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 Scientifi
Slide 6: Significant Progress During 2019
Significant Progress During 2019 Raised $75 million in February IPO and began 5 clinical studies initiated evaluating 3 Microbiome trading on NASDAQ (KLDO) Metabolic Therapy (MMT™) candidates in 3 different patient populations, including: Bolstered our manufacturing capabilities, including completin
Slide 7: 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 The Microbiome is Implicated in Numerous Conditions • NASH/NAFLD Indigenous Bacteria from Gut Microbiota Regulate Host Serotonin Gut Microbiota Regulate Motor Metabolic • Chronic Kidney Disease Biosynthesis Deficits and Neur
Slide 8: We Have a Unique and More Evolved Approach
We Have a Unique and More Evolved Approach FOCUS Functions Drive of the Existing Bacteria Microbiome Add Bacteria Subtract Bacteria Microbiome Metabolic Therapies, or MMTs (i.e. targeted glycans) “Bugs as drugs” (e.g. fecal microbiota transplants, Composition “Kill the bugs” bacterial therapy) of th
Slide 9: Our Microbiome Metabolic Therapies (MMTs) Enable Human-Centric Discovery and Development
Our Microbiome Metabolic Therapies (MMTs) Enable Human-Centric Discovery and Development CHARACTERISTICS ADVANTAGES Drivers of gut metabolism, long history of Initial MMTs are targeted glycans safe human consumption Ability to advance rapidly into the clinic; Related to a class of compounds that is
Slide 10: Human-Centric Discovery & Development Platform
Human-Centric Discovery & Development Platform Human Data Drives Learning 1 and MMT 3 Optimization EX VIVO SCREENING RAPID IN HEALTHY ADVANCEMENT INTO MICROBIOME SAMPLES HUMAN CLINICAL 1 Healthy & Patients STUDIES Volunteers MMT DECISION POINT 2 • File IND or global equivalent and Proceed to Phase 2
Slide 11: Faster, More Cost-Efficient Model
Faster, More Cost-Efficient Model Year 1 Year 2 Year 3 Year 4 Year 5 Year 6 Year 7 Kaleido’s Human- Centric Discovery Discovery Human Clinical Studies IND Start and Development1 1 Year 2 Years Phase 2/3 <3 Years Study of Traditional IND Start Pharmaceutical Discovery, Preclinical Phase 1 Phase 2 R&D
Slide 12: MMTs Work Through One or More Mechanisms of Action
MMTs Work Through One or More Mechanisms of Action DECREASE ADVANTAGE or DISADVANTAGE Production of Metabolites Certain Species in the Microbiome Community INCREASE Production of Metabolites 12 ©2019 KALEIDO™
Slide 13: Broad Pipeline in Multiple Disease Areas
Broad Pipeline in Multiple Disease Areas Human Clinical Studies1 Mechanism of Ex Vivo Ex Vivo Healthy PROGRAM Target Action Screening Testing Volunteers Patients IND 2 Phase 13 Phase 2 Phase 3 Hyperammonemia: Urea Ammonia Cycle Disorders (KB195) Hyperammonemia: Hepatic Encephalopathy Ammonia (KB174
Slide 14: The Hyperammonemia Opportunity
The Hyperammonemia Opportunity LIVER Main Site of Ammonia Clearance GUT BRAIN Ammonia Main Site of Production Ammonia Toxicity KB195 KB174 / KB195 Urea Cycle Disorders (UCD) Hepatic Encephalopathy (HE) • Neuropsychiatric abnormalities in patients with liver dysfunction • ~500,000 patients in U.S., ~
Slide 15: Ex Vivo Screening & Testing: KB195 Reduced Ammonia in Healthy & Patient Microbiomes
Ex Vivo Screening & Testing: KB195 Reduced Ammonia in Healthy & Patient Microbiomes Ability to Screen Many MMTs KB195 in UCD Patients 1 Across Our Compound Library for 2 Reduced Ammonia in All Microbiome Samples Ability to Reduce Ammonia Reduced Ammonia by > 50% in 10 Out of 12 Samples Control KB195
Slide 16: KB195 Clinical Studies Reduced Nitrogen Metabolism, a Biomarker of Ammonia Production
KB195 Clinical Studies Reduced Nitrogen Metabolism, a Biomarker of Ammonia Production Stable isotope tracer only metabolized by bacterial enzymes in the gut, which separate the urea and lactose portions. Bacterial urease then hydrolyzes urea to ammonia. In Two Clinical Studies: • KB195 was associate
Slide 17: KB195 Clinical Studies Generally Well Tolerated in Healthy Subjects & Patients with UCD
KB195 Clinical Studies Generally Well Tolerated in Healthy Subjects & Patients with Well-Controlled UCD Fewer Healthy Subjects Receiving KB195 Overall Tolerability of KB195 Was Good in Reported Diarrhea (BSS) 10 Patients with Well-Controlled UCD Negative control KB195 Comparator glycan 6 4 4 4 3 3 1
Slide 18: KB195 in UCD Clinical Program
KB195 in UCD Clinical Program • Safety/tolerability of KB195 in 4 pts with well-controlled UCD Clinical study (completed) • Impact on ammonia measured by nitrogen metabolism in blood and urine UCD Phase 2 open label clinical trial Data expected mid-2020 • 18-24 patients inadequately controlled on st
Slide 19: HE Program Advanced into Clinical Studies
HE Program Advanced into Clinical Studies 2 KB195 in Microbiome Samples from Initiated two clinical studies of KB174 Hepatically Impaired Patients 3 with data expected in Q4’19 Reduced Ammonia in 18 of 19 Microbiome Samples Outperformed Lactulose in Reducing Ammonia KB174 chosen as lead based on abi
Slide 20: Lead Programs in Hyperammonemia Demonstrate the Power of Our Proprietary Product Platform
Lead Programs in Hyperammonemia Demonstrate the Power of Our Proprietary Product Platform REGULATORY AGENCY FEEDBACK ON UCD Hyperammonemia • IND cleared in U.S.; KB195 is novel and unique • CTAs approved in UK, Belgium, Germany, Switzerland & Mexico Pathologies that Result in an Excess of Ammonia in
Slide 21: The Microbiome and the Immune System are Closely Linked
The Microbiome and the Immune System are Closely Linked; Many Immune-mediated Diseases Share Common Biology Healthy microbiome Genes, environment, therapeutic/ antibiotic treatment GOAL: GOAL: Increase immune response Reduce immune response (e.g., immuno-oncology) (e.g., MDR pathogens program) Decre
Slide 22: KB109 in Multi-Drug Resistant Pathogens, a Growing Public Health Threat
KB109 in Multi-Drug Resistant Pathogens, a Growing Public Health Threat 1 Ex Vivo Screening 2 Ex Vivo Testing 3 Our MMTs Observed to KB109 Observed to Reduce Reduce Pathogens Pathogens by a Median • Initiated clinical study of KB109 in of 45% Relative to Control patients colonized with multi-drug in
Slide 23: 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 is a leading center for Gustave Roussy Utilizes Advanced Preclinical Model with Human Microbiomes of Responder (R) and Non-Responder (NR) Patients immunotherapy in Europe – Pioneer in u
Slide 24: 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 in Ex Vivo Screening 2 • Mechanistic work ongoing to evaluate Compared To Control several MMTs through validated preclinical models Control • Will b
Slide 25: Manufacturing is a Core Strategic Advantage
Manufacturing is a Core Strategic Advantage Proprietary Methods Standard Small Molecule Unit Operations Scalable and Transferable Internal Manufacturing 3rd Party Manufacturers Production for ex vivo, toxicology, Large scale production for clinical trials and future and human clinical studies commer
Slide 26: 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 27: Important Upcoming Catalysts
Important Upcoming Catalysts Q4 2019 2020 • Data from clinical studies of • Data from Phase 2 clinical trial of KB195 in patients with UCD KB174 in patients with well- (mid-year) compensated cirrhosis and in healthy subjects • Data from clinical study of KB109 in patients colonized with multi- drug
Slide 28: The Kaleido Opportunity
The Kaleido Opportunity PLATFORM HUMAN-CENTRIC MODEL PIPELINE TEAM Multiple indications Extensive Enables rapid and MOAs targeting experience, including Expanding number advancement of unmet patient needs company building, Demonstrated of proprietary MMTs, broad portfolio of in significant product d
Slide 29: 29 ©2019 KALEIDO™
29 ©2019 KALEIDO™
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