Kaleido Biosciences, Inc. · OTC:KLDO
Kaleido Biosciences — Investor Day (October 2021)
40 slides from Kaleido Biosciences's investor day presentation, Oct 5, 2021
Slide 1: Kaleido R&D Day
Kaleido R&D Day October 5, 2021 Exhibit 99.1 Company Logo©2021KALEIDO®1
Slide 2: Forward-Looking Statements
Forward-Looking Statements This presentation also contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, statements regarding our strategy, business plans and focus, including the therapeutic potentia
Slide 3: Today's Agenda & Speakers
Today’s Agenda & Speakers Introduction to Kaleido’s MMT Platform Daniel Menichella President and CEO UC Update Preclinical Findings Johan van Hylckama Vlieg, Ph.D. CSO KB295 Clinical Data Mark Wingertzahn, Ph.D. SVP, Head of Development KOL Perspective Bruce Sands, M.D. Icahn School of Medicine at M
Slide 4: Kaleido Snapshot
Kaleido Snapshot Creating immunomodulators that target the gut microbiome Loss of immune homeostasis in the gut drives both local and systemic inflammation, which can lead to GI diseases, exacerbated infections and other devastating conditions and diseases Leveraging small molecules to systematicall
Slide 5: The Untapped Therapeutic Potential of the Human Microbiome
The Untapped Therapeutic Potential of the Human Microbiome These metabolites positively impact important biological systems, like the immune system, cell division, and metabolism Only Kaleido can differentially shift the composition and functional output of the entire microbiome in a targeted manner
Slide 6: Kaleido MMTs Modulate Immune Function Through the Microbiome
Kaleido MMTs Modulate Immune Function Through the Microbiome Provides systematic framework for testing and candidate selection Dysbiosis Homeostasis Microbiome Metabolic Therapies Large Set of Synthetic Glycans Target The Microbiome Metabolite Modulation Butyrate Bile acids Propionate Lipids Acetate
Slide 7: Kaleido Pipeline
Kaleido Pipeline *KBXXX indicates a lead candidate has not yet been selected CANDIDATE PROGRAM PRE-CLINICAL FIRST-IN-HUMAN PHASE 2 PHASE 3 COLLABORATORS IMMUNE MEDIATED DISEASES KB295 Ulcerative Colitis KBXXX Psoriasis KBXXX Atopic Immune Disease RESPIRATORY & PATHOGENS KB109 COPD KB174 Pathogens/ H
Slide 8: KB295 Summary
KB295 Summary 1 2 3 Data for KB295 provide validation of: Data show decreases in biomarkers of disease: Proceeding to Phase 2 – targeting 1H22 Preclinical findings Tolerability Decrease in inflammation Fecal calprotectin decreased by 69%* Fecal lactoferrin decreased by 69%* FimH decreased by 93%* IN
Slide 9: Ulcerative Colitis Preclinical Data
Ulcerative Colitis Preclinical Data Johan van Hylckama Vlieg, Ph.D. Chief Scientific Officer Kaleido TM©2021 KALEIDO® 9
Slide 10: Ulcerative Colitis Vicious Cycle of Inflammation and Gut Microbiome Dysbiosis
Ulcerative Colitis Vicious Cycle of Inflammation and Gut Microbiome Dysbiosis DYSBIOTIC MICROBIOME INFLAMED HOST EPITHELIUM UC drug development has focused on targeting host immune pathways Microbiome is a treatment target for the underlying cause of UC Anti-inflammatory drugs, immunosuppressors, an
Slide 11: KB295 Has Potential to Disrupt the Inflammation Cycle
KB295 Has Potential to Disrupt the Inflammation Cycle CYTOKINE PRODUCTION (IL-23, TNFα, IL-1β, IL-6, IL-5, IL-17 Impaired epithelial integrity Increased cytokine production leads to inflammation Production of beneficial active metabolites (like SCFA) rescue gut homeostasis Tregs are stimulated to fu
Slide 12: KB295 Identified by Kaleido Human-Centric Microbiome Platform
KB295 Identified by Kaleido Human-Centric Microbiome Platform Readouts Metabolite production including SCFAs (metabolomics) Microbiome taxonomic changes (16S and WGS) Functional pathway and effector molecule analysis Assessment to identify optimal synthetic glycan candidate Biological Activity and P
Slide 13: Community-Wide Changes and Desired Modulation of Remission-Associated Taxa with KB295
Community-Wide Changes and Desired Modulation of Multiple Remission-Associated Taxa were Observed with KB295 Enterobacteriaceae Escherichia Shigella Salmonella Citrobacter Parabacteroides Eisenbergiella Fusicatenibacter sp Lachnospiraceae sp. Eubacterium sp Pathobiont Depletion Commensal Enrichment
Slide 14: KB295 Increased Key SCFAs in ex-vivo Model
Eran Blacher et al. J . Immunol 2017 KB295 Increased Key SCFAs in ex-vivo Model - Documented Immunomodulators ©2021 KALEIDO® 14
Slide 15: Summary of Key Preclinical Findings
Summary of Key Preclinical Findings 1 2 3 UC is a vicious cycle of inflammation and microbiome dysbiosis KB295 demonstrated microbiome-wide changes, including key taxa in ulcerative colitis KB295 increased key SCFAs to reduce inflammation ©2021 KALEIDO® 15
Slide 16: Ulcerative Colitis KB295 Data
Ulcerative Colitis KB295 Data Mark Wingertzahn, Ph.D. Head of Development KaleidoTM©2021 KALEIDO® 16
Slide 17: Opportunity to Address Gut Microbiome Dysbiosis in UC
Opportunity to Address Gut Microbiome Dysbiosis in UC Mild-to-Moderate UC Moderate-to-Severe UC Late-Line Monotherapy ~1.5M patients4 ~900K patients5 Up to 85% have mild-moderate disease in a given year5,6 1. EvaluatePharma 2020 Worldwide Sales by Indication – Ulcerative Colitis. Accessed June 2021.
Slide 18: KB295 Summary
KB295 Summary 1 2 3 Data for KB295 provide validation of: Data show decreases in biomarkers of disease: Proceeding to Phase 2 – targeting 1H22 Preclinical findings Tolerability Decrease in inflammation Fecal calprotectin decreased by 69%* Fecal lactoferrin decreased by 69%* FimH decreased by 93%* IN
Slide 19: K030 Trial Design
K030 Trial Design Open-Label, 8-week intake with 2-month extension in adults with mild-to-moderate UC to assess safety and tolerability of KB295 V1 V2 V3 V4 V6 D-14 D 1 D 30 D 14 D 44 D 56 D 84 V7 V5 D 140 V8 28 Days ≤14 Days Screening KB295 Intake (56 Days) 7 7 42 Days 80g (40g BID) 20g 40g Extensi
Slide 20: Subject Disposition and Analysis Sets
Subject Disposition and Analysis Sets Enrolled (n=12) Intake Period 1: 20g (n=12) Intake Period 2: 40g (n=12) Intake Period 3: 80g (n=10) Discontinued (n=2) Subject Due to AE (1) Subject Due to Family Reasons Data Sets Analyzed Subject Demographics: 2/3 male, 1/3 female, with mean duration of UC 7.3
Slide 21: KB295 Was Well Tolerated
KB295 Was Well Tolerated No subjects reported product-emergent Serious Adverse Events 2 subjects discontinued study 1 subject due to UC exacerbation 1 subject due to family reasons 4 subjects had dose reduction 3 completed study Most frequently occurring Adverse Events were expected and consistent w
Slide 22: SCCAI (Simple Clinical Colitis Activity Index)
SCCAI (Simple Clinical Colitis Activity Index) SCCAI provides relevant information on tolerability in subjects with ongoing gut inflammation Units Symptom Score Bowel frequency day 13 0 46 1 79 2 9 3 Bowel frequency night 13 1 4 6 2 urgency of defecation hurry immediately incontinence 1 2 3 blood in
Slide 23: Fecal Calprotectin (FCP)
Fecal Calprotectin (FCP) Faecal calprotectin diagnostic tests for inflammatory diseases of the bowel. NICE guideline 2013.http://www.nice.org.uk/guidance/dg11; Menees B, Powell C, Kurlander J, et al. A Meta-Analysis of the Utility of C-Reactive Protein, Erythrocyte Sedimentation Rate, Fecal Calprote
Slide 24: KB295 Decreased Fecal Calprotectin in UC Subjects with a High Response
KB295 Decreased Fecal Calprotectin in UC Subjects with a High Response Fecal calprotectin (FCP) is a biomarker of inflammation trend to reduction after study intake period 8 out of 11 Median Fecal Calprotectin Levels (Evaluable; n=11) P=0.067 -69% Median Reduction Fecal Calprotectin (ug/g) Median Fe
Slide 25: KB295 Decreased FCP and Reduction Persisted During 28-Day Follow-Up
KB295 Decreased Fecal Calprotectin (FCP) in Subjects with UC and Reduction Persisted During 28-Day Follow-Up FCP is a biomarker of inflammation trend to reduction after study intake period and 28-day follow-up Median Fecal Calprotectin Levels (Completed; n=6) P < 0.035 P < 0.035 Fecal Calprotectin (
Slide 26: KB295 Resulted in 93% Median Decrease in FimH
KB295 Resulted in 93% Median Decrease in FimH Depleted gene counts by metagenomic sequencing of stool samples before/after KB295 intervention FimH gene counts (n=5) FimH activates TLR4 signaling which induces pro-inflammatory cytokines FimH inhibition is an active target for IBD drug discovery KB295
Slide 27: Lactoferrin, an Inflammation Biomarker, Was Reduced
Lactoferrin, an Inflammation Biomarker, Was Reduced Fecal Lactoferrin biomarkers of inflammation are reduced after study intake Fecal lactoferrin (n=6) Lactoferrin is produced by activated neutrophils associated with UC Lactoferrin decreased by mean value of 69.2% across participants Decreased by at
Slide 28: K030 Results Bridge ex vivo Findings to UC Patients
K030 Results Bridge ex vivo Findings to UC Patients Pathobiont Enterobacteriaceae Commensal Parabacteroides KB295 enriched commensal Parabacteroides and depleted pathobionts Enterobacteriaceae Median relative abundance of Parabacteroides increased after intake in 4 out of 5 subjects Median relative
Slide 29: K030 Data Encourages Move to Phase 2 Clinical Study
K030 Data Encourages Move to Phase 2 Clinical Study 1 2 3 K030 data Preclinical data Proceeding to Phase 2 – targeting 1H22 KB295 was well tolerated in subjects Decrease in biomarkers including FimH, FCP, and Lactoferrin KB295 selectively enriched commensal microbiota Decreases abundance of pro-infl
Slide 30: KB295 – A KOL's Perspective (Bruce Sands, M.D.)
Bruce Sands, M.D. Dr. Burrill B. Crohn Professor of Medicine Icahn School of Medicine at Mount Sinai Chief of the Division of Gastroenterology, Mount Sinai Former Medical Co-Director of the Crohn’s & Colitis Center Massachusetts General Hospital KB295 – A KOL’s Perspective ©2021 KALEIDO® 30
Slide 31: COPD KB109 Program Update
COPD KB109 Program Update Mark Wingertzahn, Ph.D. Head of Development Kaleido ©2021 KALEIDO® 31
Slide 32: Opportunity in Chronic Obstructive Pulmonary Disease
Opportunity in Chronic Obstructive Pulmonary Disease COPD Current options offer limited benefit on inflammation No treatment targets microbiome Few oral options available have safety and tolerability issues for patients The Opportunity A maintenance treatment to reduce risk of acute exacerbations in
Slide 33: KB109 May Affect COPD Inflammation via Gut-Lung Axis
KB109 May Affect COPD Inflammation via Gut-Lung Axis KB109 has the potential to modulate the gut and immune system to lessen exacerbations and mortality risk KB109 COVID-19 trial demonstrated activity against the pathologies associated with respiratory viral infections by modulating the gut microbio
Slide 34: KB109 Enriches Specific Microbes Beneficial to Respiratory Viral Infection Clearance
KB109 Enriches Specific Microbes Beneficial to Respiratory Viral Infection Clearance KB109 consistently depleted Enterobacteriaceae and Enterococcaceae pathobionts, and enriched commensal Parabacteroides across compositionally diverse fecal communities MMT selectivity takes advantage of carbohydrate
Slide 35: KB109 in COVID – Well Tolerated and Reduced Inflammation
Proportion of Patients with Resolution Kaplan- Meier Curve IFN-γ and TNF-⍺ data from K031 subjects as K032 samples remain to be analyzed. Includes subjects with screening samples and at least one of D14 or D35 samples available. * p-value<0.05, Wilcoxon rank sum test on differences between cohorts W
Slide 36: New Collaboration with the COPD Foundation
New Collaboration with the COPD Foundation Collaboration Partnership with leading experts in the Foundation and its COPD360Net® Joint clinical development support No financial obligations Advantages Leverage expertise to support trial design Provide access to top clinical sites Support trial enrollm
Slide 37: Partnership with the COPD Foundation
Ruth Tal-Singer, Ph.D. President and Chief Scientific Officer COPD Foundation Former VP of Medical Innovation, GSK Value Evidence and Outcomes, at GSK Former Industry Chair of COPD Biomarker Qualification Consortium Partnership with the COPD Foundation © 2021 KALEIDO® 37
Slide 38: Kaleido Pipeline
Kaleido Pipeline *KBXXX indicates a lead candidate has not yet been selected © 2021 KALEIDO® 38
Slide 39: Q&A
Q&A © 2021 KALEIDO® 39
Slide 40: Kaleido in Brief
Kaleido in Brief An Exceptional Team Leading A Novel Approach to Targeting the Microbiome Daniel Menichella President and Chief Executive Officer Former CEO,CureVac AG Jerald Korn, J.D. Chief Operating Officer, Tesaro Johan Van Hylckama Vliag, Ph.D. Chief Scientifin Officer Former VP for Microviome