Kaleido Biosciences, Inc. · OTC:KLDO
Kaleido Biosciences — Investor Presentation (August 2019)
30 slides from Kaleido Biosciences's investor presentation, Aug 1, 2019
Slide 1: Company Overview August 2019
Company Overview AUGUST 2019 | ⓒ 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, including proceeds from 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 Proprietary Faster, More Cost with Large World-Class Discovery & Product Platform Efficient Model Market Leadership Team Development 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 Josh Brumm Former COO & CFO, Versartis, Chief Operating Officer, Chief Financial Officer EVP Finance, Pharmacyclics & CFO, ZELTIQ Kate Knobil, M.D. Former CMO at
Slide 6: Significant Accomplishments Since Founding
Significant Accomplishments Since Founding IND Cleared, Phase 2 clinical trial initiated 12 non-IND human clinical studies conducted with our Microbiome Metabolic Therapy (MMT™) candidates (7 studies completed and 5 in progress) 1,000+ MMT candidates in our library today 5 current pipeline programs
Slide 7: Broad Pipeline in Multiple Disease Areas
Broad Pipeline in Multiple Disease Areas Non-IND Human Clinical Studies1 Mechanism of Ex Vivo Ex Vivo Healthy PROGRAM Target Action Screening Testing Volunteers Patients IND2 Phase 13 Phase 2 Phase 3 Hyperammonemia: Urea Ammonia Cycle Disorders (KB195) Hyperammonemia: Hepatic Encephalopathy Ammonia
Slide 8: 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 Metabolic Indigenous Bacteria from Gut • Chronic Kidney Disease Microbiota Regulate Host Serotonin Gut Microbiota Regulate Motor Health Biosynthesis Deficits a
Slide 9: We're Leveraging Years of Scientific Insights and Knowledge
We’re Leveraging 10 Years of Scientific Insights and Knowledge Growing Body of Research Powerful Enabling Tools Are Available $115M Human Microbiome Project launched More microbes than 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 human cells NUMBER Microbiome OF PAPERS Koch’s postulates structure re
Slide 10: 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 11: Our 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 12: 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 NON-IND HUMAN CLINICAL STUDIES Healthy & Patients Volunteers 2 MMT DECISION POINT • File IND and Proceed to Phase 2 EX VIVO TESTIN
Slide 13: 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 Discovery IND Start 1 Discovery Non-IND Human Clinical Studies and Development 1 Year 2 Years Phase 2/3 <3 Years Study of Traditional Pharmaceutical Discovery, Preclinical IND Phase 1 Start R&D2 ~5 Years ~1.
Slide 14: 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 Ammonia MDR Pathogens Hyperammonemia: Urea Cycle Disorders Liver Transplant Patients Hepatic Encephalopathy Hematopoietic Stem Cell Transplantat
Slide 15: Broad Pipeline in Multiple Disease Areas
Broad Pipeline in Multiple Disease Areas Non-IND Human Clinical Studies1 Mechanism of Ex Vivo Ex Vivo Healthy PROGRAM Target Action Screening Testing Volunteers Patients IND2 Phase 13 Phase 2 Phase 3 Hyperammonemia: Urea Ammonia Cycle Disorders (KB195) Hyperammonemia: Hepatic Encephalopathy Ammonia
Slide 16: 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., m
Slide 17: Ex Vivo Screening & Testing: KB195 Reduced Ammonia
Ex Vivo Screening & Testing: KB195 Reduced Ammonia in Healthy & Patient Microbiomes Ability to Screen Many MMTs 2 KB195 in UCD Patients 1 Across Our Compound Library for Ability to Reduce Ammonia Reduced Ammonia in All Microbiome Samples Reduced Ammonia by > 50% in 10 Out of 12 Samples Control KB195
Slide 18: KB195 Non-IND Clinical Study in Healthy Subjects
KB195 Non-IND Clinical Study in Healthy Subjects KB195 Observed to Have A Significant 3 Effect on Ammonia Reduction • Randomized, controlled, double-blind study in healthy subjects on a high protein diet n=11 • KB195 Significantly Lowered Nitrogen n=12 15 Lactulose − 40.5% Decrease in Urinary N Excr
Slide 19: KB195 Non-IND Clinical Study in Healthy Subjects
KB195 Non-IND Clinical Study in Healthy Subjects KB195 Observed to Have A Significant Fewer Subjects Receiving KB195 3 3 Effect on Ammonia Reduction Reported Diarrhea Negative control 10 KB195 Comparator glycan n=11 6 n=12 Lactulose 4 n=12 ~20% 4 4 reduction1 3 3 N Excreted; % Change from Baseline C
Slide 20: KB195 in UCD Clinical Program
KB195 in UCD Clinical Program Non-IND patient clinical study • Safety/tolerability of KB195 in ~5 pts with well-controlled UCD Safety & tolerability data expected • Impact on ammonia measured by nitrogen metabolism in blood and urine in Q3’19 UCD Phase 2 open label clinical trial Data expected mid-2
Slide 21: HE Program Advanced into Non-IND Clinical Studies
HE Program Advanced into Non-IND Clinical Studies 2 KB195 in Hepatically 3 Initiated two non-IND clinical studies of KB174 Impaired Patients 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 ability to
Slide 22: KB109 in Multi-Drug Resistant Pathogens
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 of 45% Relative to Control • Initiated Non-IND clinical in 10 of 13 Samples study of KB109 in patients
Slide 23: MMT Program for Reduction of TMA in Atherosclerotic Cardiovascular Disease
MMT Program for Reduction of TMA in Atherosclerotic Cardiovascular Disease 1 Our top MMTs reduced TMA by >90% in 2 • Two lead MMTs identified in ex vivo testing Ex Vivo Screening Compared To Control • Mechanistic work planned Control 3 • Initiation of non-IND clinical study planned by YE 2020 23 | ⓒ
Slide 24: Lead Programs in Hyperammonemia Demonstrate the Power of Our Platform
Lead Programs in Hyperammonemia Demonstrate the Power of Our Proprietary Product Platform REGULATORY AGENCY FEEDBACK ON UCD • IND cleared in U.S.; KB195 is novel and unique Hyperammonemia • CTAs approved in UK & Belgium Pathologies that Result in an Excess of Ammonia in the Blood CLINICAL • Reduced
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 8 U.S. Patents + 2 EPO Patents: • Glycan pharmaceutical compositions (Europe) • Methods to reduce ammonia (U.S.) • Methods to treat diarrhea (U.S.) • Methods to treat dysbiosis (U.S.) • Catalyst compositions (U.S. and Europe) 100+ Non-Provisional Applications Pending, Worl
Slide 27: Key Milestones
Key Milestones Data expected Non-IND clinical study in patients UCD Phase 2 clinical trial Non-IND clinical study in patients with cirrhosis HE Non-IND clinical study in healthy volunteers to explore dosing Ready to initiate Phase 2 trial Infections Caused Non-IND clinical study by MDR Bacteria TMA
Slide 28: The Kaleido Opportunity
The Kaleido Opportunity PLATFORM HUMAN-CENTRIC MODEL PIPELINE TEAM Multiple indications Extensive experience, Enables rapid and MOAs targeting including company Expanding number of advancement of unmet patient needs Demonstrated speed building, product proprietary MMTs, IP, broad portfolio of in sig
Slide 29: 29 | ⓒ 2019 KALEIDO™
29 | ⓒ 2019 KALEIDO™
Slide 30: Financial Overview
Financial Overview Cash and Cash Equivalents $100.0M (as of 6/30/19) Operating Expenses (1) $22.6M (for quarter ended 6/30/19) Debt $15.0M (as of 6/30/19) Note(s): 1. Excludes stock-based compensation 30 | ⓒ 2019 KALEIDO™
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