Kaleido Biosciences, Inc. · OTC:KLDO
Kaleido Biosciences — Investor Presentation (May 2020)
43 slides from Kaleido Biosciences's investor presentation, May 14, 2020
Slide 1: Company Overview May 2020
1 ©2020 KALEIDO™ ©2020 KALEIDO™ Company Overview May 2020
Slide 2: Forward-Looking Statements
2 ©2020 KALEIDO™ 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
Slide 3: Kaleido: A Differentiated Product Platform Company
3 ©2020 KALEIDO™ Kaleido : A Differentiated Product Platform Company Broad Pipeline to Address Significant Unmet Patient Needs Rapid, Cost - Efficient Discovery & Development Model Proprietary Product Platform Chemistry targeted at changing the metabolic output and construct of the microbiome Transf
Slide 4: Microbiome Drives the Progression of a Broad Range of Diseases
4 ©2020 KALEIDO™ Microbiome Drives the Progression of a Broad Range of Diseases Image Picture 41 • Cardiometabolic and Liver Diseases • Chronic Kidney Disease Metabolic Health • Urea Cycle Disorders • Hepatic Encephalopathy Nitrogen Metabolism • Pathogens • GvHD Microbial Ecology • Immuno-oncology •
Slide 5: Glycans Play a Major Role in Shaping the Gut Microbiome
5 ©2020 KALEIDO™ Source: Koropatkin et al., Nature Reviews Microbiology , 10 , 323 – 335 (2012) Glycans Play a Major Role in Shaping the Gut Microbiome and Drive Metabolites that Modulate Disease Pathways Natural glycans from multiple sources e.g. plant, mucus, meat, microbial, milk Humans: 17 glyco
Slide 6: Synthetic Glycan Chemistry enables Extensive Array of MMTs
6 ©2020 KALEIDO™ Synthetic Glycan Chemistry enables Extensive Array of Microbiome Metabolic Therapies (MMTs) • Target enzymes across taxa rather than only in specific species, driving ecosystem and metabolic output changes • Related to a class of compounds that is Generally Recognized as Safe (GRAS)
Slide 7: MMTs Targeted at Multiple Metabolites and Pathways of Disease
7 ©2020 KALEIDO™ MMTs Targeted at Multiple Metabolites and Pathways of Disease Further Expansion into Immune Modulation - Multiple pathways - I/O, Viral infections (COVID - 19), IBD, other immune - mediated disorders - HE program to . both ammonia and MDR pathogens Platform Validating: Single Metabo
Slide 8: Significant Progress: Validating the Platform and Advancing the Technology
8 ©2020 KALEIDO™ Significant Progress: Validating the Platform and Advancing the Technology. Established I - O collaboration with Gustave Roussy, Europe’s largest cancer treatment center. Initiated in vivo mechanistic work for lead MMTs in cardiometabolic/liver diseases. Initiated collaboration with
Slide 9: Opportunity to Deliver Key Data Readouts in 2020 and 2021
9 ©2020 KALEIDO™ Opportunity to Deliver Key Data Readouts in 2020 and 2021 COVID - 19 impacting healthcare system, including execution of current and new clinical studies Kaleido leveraging platform to progress pipeline activities Opportunity in COVID - 19 Environment to Deliver Clinical Data & Adva
Slide 10: Product Candidate Program Clinical Development Status
10 ©2020 KALEIDO™ Note: 1. Our human clinical studies of our MMT candidates are conducted under regulations supporting research with food, evaluating safety, tolerability and potential markers of effect in human subjects. For MMT candidates that are further developed as therapeutics, the Company con
Slide 11: Advancing Our MMTs for Lead Identification
11 ©2020 KALEIDO™ Preclinical Program Collaborator Clinical - Ready Lead MMT Expected in 2021 Immuno - oncology Cardiometabolic & Liver Diseases Immune - mediated Diseases New Prevention of Childhood - Onset Atopic & Immune Conditions Advancing Our MMTs for Lead Identification Poised to Deliver Mult
Slide 12: Key Expected Upcoming Milestones
12 ©2020 KALEIDO™ Phase 2 clinical trial results of KB195 in patients with UCD (2H’21) cardiometabolic /liver diseases (Q4’20) Key Expected Upcoming Milestones 2020 immuno-oncology (Q4’20) immune - mediated disease (1H’21) Clinical study results of KB295 in UC (mid - ’21) 2021 Clinical study results
Slide 13: COVID-19
13 ©2020 KALEIDO™ ©2020 KALEIDO™ COVID - 19
Slide 14: Microbiome Opportunity to Target COVID-19
14 ©2020 KALEIDO™ Microbiome Opportunity to Target COVID - 19 with Potential Applicability in Broader Respiratory Viral Infections A picture containing cake, fruit, colored, decorated Description automatically generated Public Health Threat • COVID - 19 infection is associated with inappropriate act
Slide 15: Vital Healthcare Need to Reduce COVID-19 Hospitalizations
15 ©2020 KALEIDO™ Sources: CDC website: https://www.cdc.gov/flu/prevent/keyfacts.htm ; https://www.cdc.gov/flu/fluvaxview/coverage - 1819estimates.htm ; https://www.cdc.gov/coronavirus/2019 - ncov/covid - data/covidview/index.html ; accessed May 2020 Vital Healthcare Need to Reduce The Number Of COV
Slide 16: Scientific Rationale for MMTs in Viral Infections
16 ©2020 KALEIDO™ Scientific Rationale for MMTs in Viral Infections • Ever - increasing body of scientific literature elucidating the understanding of gut - lung axis • MMT fermentation end - products by the gut microbiome are short - chain fatty acids (SCFAs) • SCFAs modulate host inflammation, con
Slide 17: Gut Microbiome Positively Impacts Host Immunity to Mitigate Respiratory Viral Infections
17 ©2020 KALEIDO™ Gut Microbiome Positively Impacts Host Immunity To Mitigate Respiratory Viral Infections High butyrate associated with lower clinical respiratory tract infection, including coronavirus Haak et al, 2018 Blood. Trompette et al, 2018 Immunity Dietary fiber protects against lethal Infl
Slide 18: KB109 Improves Microbiome Characteristics Associated with Immune Response
18 ©2020 KALEIDO™ KB109 Improves Microbiome Characteristics Associated with Immune Response 170AD893-6CF2-406A-BF4A-864DF3510D2B@pexlabs Hours % Pathogen Reduce Pathogens in Healthy Microbiomes KB109 Consistently Induces SCFA Production Across Healthy Microbiomes Microbiome Samples from 13 ICU Patie
Slide 19: Clinical Plan for KB109 in COVID-19
19 ©2020 KALEIDO™ Clinical Plan for KB109 in COVID - 19 High propionate High acetate • 2 studies designed to evaluate the effects of Supportive Self - Care (SSC)+ KB109 compared to SSC in outpatients with mild - to - moderate COVID - 19 • Larger study at multiple centers: ~350 patients (1:1 randomiz
Slide 20: Potential for KB109 Success in Outpatients with COVID-19
20 ©2020 KALEIDO™ Potential for KB109 Success in Outpatients with COVID - 19 Positive data in one or more would provide confidence for further development Clinical Data Inflammatory Markers Time to resolution of fever Resolution of symptoms 1 Improvement in seroconversion Decrease in cellular inflam
Slide 21: KB109 Potential in COVID-19 Landscape & Broader Viral Respiratory Infections
21 ©2020 KALEIDO™ Sources: CDC website: https://www.cdc.gov/flu/prevent/keyfacts.htm ; https://www.cdc.gov/flu/fluvaxview/coverage - 1819estimates.htm ; https://www.cdc.gov/coronavirus/2019 - ncov/covid - data/covidview/index.html ; accessed May 2020 KB109 Potential in COVID - 19 Landscape & Broader
Slide 22: Inflammatory Bowel Disease (IBD)
22 ©2020 KALEIDO™ ©2020 KALEIDO™ Inflammatory Bowel Disease (IBD)
Slide 23: Ulcerative Colitis Linked to Microbiome Dysbiosis
23 ©2020 KALEIDO™ .SCFA producing taxa and . pathobionts are a key signature of UC - dysbiosis Ulcerative Colitis Linked to Microbiome Dysbiosis Microbiome Restoration Leads to Clinical Remission Clinical efficacy by targeting microbiome via FMT is Superior to Standard of Care 20% 9% 5% 20% 17% 44%
Slide 24: Downregulation of Microbiome SCFAs in UC Can Be Improved By Glycans
24 ©2020 KALEIDO™ Downregulation Of Microbiome SCFAs Associated With Ulcerative Colitis Can Be Improved By Glycans SCFA produced by the microbiome are key regulators of gut immune tone SCFA and associated taxa are consistently observed as downregulated in UC patients Adapted from Melhem et al ., 201
Slide 25: KB295 Improves Microbiome Characteristics Associated with Ulcerative Colitis
25 ©2020 KALEIDO™ KB295 Improves Microbiome Characteristics Associated with Ulcerative Colitis KB295 increases S CFA production across 8 healthy stool communities • Ratio of SCFA is broadly in line with that tested with UC patients in a double - blind, placebo - controlled trial with rectal enemas:
Slide 26: Immuno-oncology
26 ©2020 KALEIDO™ ©2020 KALEIDO™ Immuno-oncology
Slide 27: Data Support That Glycans Improve Response to ICI Therapy
27 ©2020 KALEIDO™ Li et al, 2020 Cell Rep Kaleido preliminary data MMTs and glycans improve tumor control in mice Fiber improves melanoma IO response rates in patients* Fiber improves melanoma IO survivorship* Data Support That Glycans Improve Response to ICI Therapy and Tumor Control * * Source: ht
Slide 28: Antibiotics Usage Reduces Patient Survival Following ICI Treatment
28 ©2020 KALEIDO™ Antibiotics Usage Reduces Patient Survival Following Immune Checkpoint Inhibitor (ICI) Treatment Source: Elkrief et al, 2019 • Many cancer patients need antibiotics before and during ICI treatment • But antibiotic treatment reduces survival of cancer patients receiving ICI treatmen
Slide 29: Collaborating with Gustave Roussy
29 ©2020 KALEIDO™ Collaborating with Gustave Roussy , Pioneer in Immunotherapy and Research in Microbiome and Cancer • Gustave Roussy is a leading center for immunotherapy in Europe – Pioneer in understanding relationship between the microbiome and cancer • Collaboration aimed at improving cancer im
Slide 30: Metabolic and Liver Diseases
30 ©2020 KALEIDO™ ©2020 KALEIDO™ Metabolic and Liver Diseases
Slide 31: Platform Validated as Predictive of Human Response for UCD & HE Programs
31 ©2020 KALEIDO™ Platform Validated as Predictive of Human Response for Urea Cycle Disorders & Hepatic Encephalopathy Programs Source: 1. Mean reduction as referenced in: De Preter V. et al., Alimentary Pharmacology & Therapeutics 23, 963 - 974 (2006) Reduction of biomarker of microbiome ammonia pr
Slide 32: Urea Cycle Disorders: Rare Inborn Errors of Metabolism
32 ©2020 KALEIDO™ GUT Ammonia Production LIVER Main Site of Ammonia Clearance Sources: Batshaw , M. L., et. al. (2014). Molecular Genetics and Metabolism , 113(0), 127 - 130; Häberle, J, et al. Journal of Inherited Metabolic Disorders , 2019;1 - 39; Company reports Urea Cycle Disorders: Rare Inborn
Slide 33: UCD Clinical Program with KB195
33 ©2020 KALEIDO™ UCD Patients UCD Clinical Program with KB195: 2 Positive Clinical Studies, Phase 2 Enrollment Delayed Due to COVID - 19 Clinical study (completed) • Enrollment delayed due to impacts of COVID - 19; modifications being made to enrollment and operations: . Expand eligibility to age 1
Slide 34: Hepatic Encephalopathy: Cognitive Dysfunction as a Result of Liver Disease
34 ©2020 KALEIDO™ Hepatic Encephalopathy: Cognitive Dysfunction as a Result of Liver Disease, including Cirrhosis GUT Ammonia Production LIVER Main Site of Ammonia Clearance A close up of a logo Description automatically generated A picture containing computer, drawing Description automatically gene
Slide 35: KB174 Clinical Study in Cirrhotic Patients: Positive Top-Line Data
35 ©2020 KALEIDO™ KB174 Clinical Study in Cirrhotic Patients: Positive Top - Line Data Show Reduction in a Biomarker of Ammonia Production • KB174 chosen as lead in HE based on its ability to reduce ammonia & MDR pathogens ex vivo • Patients treated with KB174 had a 26% median reduction in urinary 1
Slide 36: Cardiometabolic & Liver Diseases Program
36 ©2020 KALEIDO™ Cardiometabolic & Liver Diseases Program: Multiple Microbiome - Derived Factors are Involved in Development, Progression or Prevention Fig. 1 CVD Tang et al., Nature Reviews Cardiology, 2019 • Lead MMTs identified in ex vivo testing • Mechanistic work ongoing to evaluate MMTs in va
Slide 37: Appendix
37 ©2020 KALEIDO™ ©2020 KALEIDO™ Appendix
Slide 38: Discovery & Development Model Enables Rapid Advancement into Human Clinical Studies
38 ©2020 KALEIDO™ Discovery & Development Model Enables Rapid Advancement into Human Clinical Studies EX VIVO SCREENING IN HEALTHY MICROBIOME SAMPLES EX VIVO TESTING IN PATIENT MICROBIOME SAMPLES RAPID ADVANCEMENT INTO HUMAN CLINICAL STUDIES 1,2 Patients Healthy Volunteers & Image Image VALIDATED AN
Slide 39: Platform Enables Rapid, Cost-Efficient Discovery & Development
39 ©2020 KALEIDO™ Year 1 Year 2 Year 3 Year 4 Year 5 Year 6 Year 7 Kaleido’s Human - Centric Discovery and Development 2 - 3 Years Traditional Pharmaceutical R&D 1 5 - 7 Years Source: 1. DiMasi, Joseph, et al., Journal of Health Economics, 2016, 47, 20 - 23. Platform Enables Rapid, Cost - Efficient
Slide 40: Manufacturing is a Core Strategic Advantage
40 ©2020 KALEIDO™ Manufacturing is a Core Strategic Advantage: Small - molecule like, Efficient and Scalable Cost - Effective Process Internal Manufacturing Production for ex vivo , toxicology, and human clinical studies 3 rd Party Manufacturers Large scale production for clinical trials and future
Slide 41: Robust Global IP Portfolio
41 ©2020 KALEIDO™ Robust Global IP Portfolio 11 Patents Issued and 100+ Pending Worldwide 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
Slide 42: World-Class Leadership Team
42 ©2020 KALEIDO™ World - Class Leadership Team Alison Lawton President & Chief Executive Officer Former GM, Genzyme Biosurgery, COO Aura & OvaScience Katharine Knobil, M.D. Chief Medical Officer, Head of R&D Former CMO, GlaxoSmithKline Johan van Hylckama Vlieg , Ph.D. Chief Scientific Officer Forme
Slide 43: ©2020 KALEIDO™ ©2020 KALEIDO™
43 ©2020 KALEIDO™ ©2020 KALEIDO™
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