Kaleido Biosciences, Inc. · OTC:KLDO
Kaleido Biosciences — Investor Presentation (June 2021)
38 slides from Kaleido Biosciences's investor presentation, Jun 17, 2021
Slide 1: Leading a Novel Approach to Targeting the Microbiome
Leading a Novel Approach to Targeting the Microbiome NASDAQ: KLDO June 2021 Exhibit 99.1
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: Kaleido Biosciences in Brief
Kaleido Biosciences in Brief Unique approach using synthetic glycans as modulators of the microbiome Act by targeting the resident microbiome as opposed to adding/subtracting micro-organisms Ability to induce large compound-specific microbial shifts to more favorable composition and metabolic output
Slide 4: The Kaleido Leadership Team
The Kaleido Leadership Team Daniel Menichella President and Chief Executive Officer Former CEO, CureVac AG Johan van Hylckama Vlieg, Ph.D.Chief Scientific Officer Former VP for Microbiome & Human Health Innovation, Chr. Hansen William Duke Chief Financial Officer Former CFO, Pulmatrix and Valeritas
Slide 5: Synthetic glycan chemistry enables an extensive array of MMTs
Synthetic glycan chemistry enables an 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), enabling rapid a
Slide 6: MMTs can act via multiple specific mechanisms in indications with strong clinical rationale
MMTs can act via multiple specific mechanisms in indications with strong clinical rationale for a microbiome-based approach The unique abilities of MMTs to… …make MMTs potent polypharmacological therapeutic candidates Urea cycle disorders Hepatic encephalopathy MDR pathogen infection HSCT Immuno-onc
Slide 7: COVID-19 (KB109)
@kKaleido COVID-19 (KB109)
Slide 8: Glycans change Microbiome and SCFA Profiles associated with reduced severity of respiratory viral infections
Glycans change Microbiome and SCFA* Profiles, which are associated with Reduced Severity of Respiratory Viral Infections High butyrate associated with lower clinical respiratory tract infection, including coronavirus Haak et al, 2018 Blood. Trompette et al, 2018 Immunity Glycans protect against leth
Slide 9: KB109 enriches SCFA and microbiome profiles associated with improved viral infection outcomes
KB109 enriches SCFA and microbiome profiles associated with improved viral infection outcomes KB109 consistently depleted pathogens (Enterobacteriaceae and Enterococcaceae) and enriched commensal Parabacteroides across compositionally diverse fecal communities KB109 consistently increased the produc
Slide 10: Randomized, open label study of KB109 in mild-to-moderate COVID-19
A Randomized, Open Label, Prospective, Parallel Group Study to Assess the Natural History of COVID-19 and Effects of KB109 in Addition to Supportive Self Care (SSC) Compared to SSC Alone on Measures of Health in Non-hospitalized Patients with Mild-to-Moderate COVID-19
Slide 11: KB109 in COVID-19 Final Analysis
*Non-IND Clinical Study conducted under regulations supporting research with food, evaluating safety, tolerability and potential markers of human effect. KB109 in COVID-19 Final Analysis High propionate High acetate Multi-center, open label, controlled clinical study* Mild-to-moderate COVID-19 Two w
Slide 12: K031 Study Objectives
K031 Study Objectives Primary Objective: Evaluate the safety of KB109 in addition to Supportive Self Care (SSC + KB109) compared to SSC alone in outpatients with mild-to-moderate COVID‑19. Secondary Objective: Evaluate selected measures of health in outpatients with mild-to-moderate COVID-19. Explor
Slide 13: Results: Favorable Safety and Tolerability Profile
Results: Favorable Safety and Tolerability Profile Largest study of MMTs conducted so far, leading to most comprehensive safety data set to date Well tolerated with similar number of treatment emergent SAEs in both arms (2 in KB109 vs. 3 in SSC alone) Hospitalizations: 3 in KB109+SSC vs 3 in SSC alo
Slide 14: KB109 – Healthcare Utilization Data
COVID-19 related Hospitalization, Emergency room, or Urgent Care visits (Safety Analysis Set) KB109 – Healthcare Utilization Data Comorbidity Patient Subgroup Overall Study Population Statistics SSC + KB109 (N=169) SSC alone (N=181) Overall (N=350) % change (SSC + KB109 vs SSC alone) N (%) 7 (4.1%)
Slide 15: Natural History of Mild to Moderate COVID-19: Time to Resolution of Symptoms
Natural History of Mild to Moderate COVID-19: Time to Resolution of Symptoms
Slide 16: Natural History of COVID-19 Infection: SSC Alone Arms
Proportion of Patients with Resolution Natural History of COVID-19 Infection: SSC Alone Arms Comparing patients with and without comorbidities shows extended duration of symptoms, especially in patients with at least one comorbidity 13 Overall Symptoms 8 Cardinal Symptoms Proportion of Patients with
Slide 17: Time to Resolution of COVID-19 Related Symptoms
Time to Resolution of COVID-19 Related Symptoms
Slide 18: Additional studies will further elucidate the role KB109 may play in patients with comorbidities
Additional studies will further elucidate the role KB109 may play in allowing patients with comorbidities to recover more quickly Potential Clinical Implications Median time to resolution of symptoms: SSC No comorbidity = 15 days SSC + Comorbidity = 21 days KB109 + SSC + Comorbidity = 17 days Median
Slide 19: Exploratory Analysis of Time to Resolution of Covid-19 Symptoms
13 Symptoms Exploratory Analysis of Time to Resolution of Covid-19 Symptoms ≥45 years or with Comorbidity KB109 + SSC vs. SSC alone 13 Covid-related symptoms: Cough, chills/repeated shaking with chills, muscle pain, fever, headache, anosmia/ageusia, shortness of breath, sore throat, gastrointestinal
Slide 20: Inflammatory Bowel Disease (KB295)
Inflammatory Bowel Disease (KB295)
Slide 21: Reduced SCFA producing taxa and increased pathobionts are a key signature of UC-dysbiosis
↓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 p = 0.02 p = 0.02 p = 0.03 p = 0.51 Clinic
Slide 22: KB295 Restores Gut-immune Homeostasis
KB295 Restores Gut-immune Homeostasis – Disrupted Gut Microbiome in UC is Driving Inflammation KB295 address the key microbiome dysbiosis thought to drive UC disease pathology: Restores remission associated taxa known to play a role in immunohomeostasis and appropriate Treg function Disadvantage the
Slide 23: KB295 Rationale and Study in Ulcerative Colitis
KB295 Rationale and Study in Ulcerative Colitis Increases SCFA production (ex vivo) Ongoing Clinical Study (Single Arm) Evaluate safety and tolerability Exploratory: Simple Clinical Colitis Activity Index (SCCAI) composite score, changes in microbiome taxa, SCFA levels in stool and biomarkers of inf
Slide 24: KB295 could be impactful across the continuum of disease severity
KB295 could be impactful across the continuum of disease severity Dysbiotic microbiomes seen in IBD disease pathogenesis are not addressed by current treatments 1. EvaluatePharma 2020 Worldwide Sales by Indication – Ulcerative Colitis. Accessed June 2021. 2. Xavier, R.J et al. Unravelling the pathog
Slide 25: Pre-Clinical Programs, Intellectual Property, Financials
Pre-Clinical Programs Intellectual Property Financials
Slide 26: Advancing Our MMTs for Lead Identification
Advancing Our MMTs for Lead Identification Poised to Deliver Multiple Clinical-Ready Programs in 2021 Jeffrey Gordon, MD Glycan chemistry & utilization Gnotobiotic preclinical models combined with computational methods to further identify molecular pathways of how MMTs can modify functional configur
Slide 27: Robust Global IP Portfolio
Robust Global IP Portfolio 14 U.S. and European Patents Issued and 150+ Pending Applications Worldwide 12 U.S. Patents + 2 EPO Patents: Glycan pharmaceutical compositions (U.S. and Europe) Methods to treat cancer (U.S.) Methods to treat pathogen infection (U.S.) Methods to treat obesity (U.S.) Metho
Slide 28: Corporate Information
Corporate Information John Newman, Ph.D. Canaccord Genuity Gbola Amusa, M.D., CFA Chardan Terence Flynn, Ph.D. Goldman Sachs Gobind Singh JMP Securities LLC Jessica Fye J.P. Morgan Matthew Harrison Morgan Stanley Ted Tenthoff Piper | Sandler Current Analyst Coverage: Cash and cash equivalents of $92
Slide 29: Kaleido in Brief
Kaleido in Brief Highly differentiated approach Unique within the microbiome space Highly unique as a therapeutic modality overall Broad set of portfolio assets Platform makes use of compounds generally recognized as safe (GRAS) Ability to execute on near-term milestones Promising safety profile ben
Slide 30: Appendix: COVID-19 Final Topline Analysis (KB109)
Appendix: COVID-19 Final Topline Analysis (KB109)
Slide 31: K031 Study Population: Most Prevalent, Yet Understudied
Symptom Duration and Risk Factors for Delayed Return to Usual Health Among Outpatients with COVID-19 in a Multistate Health Care Systems Network — United States, March–June 2020. Available at: https://www.cdc.gov/mmwr/volumes/69/wr/mm6930e1.htm Estimated Disease Burden of COVID-19. Available at: htt
Slide 32: K031 Study Design
K031 Study Design Enrollment Period rs eons) oy i2 ays bay 514 bay 1898 pis Pays Eh wane Epis ‘n catia toi easy star ane oe Wa aoytre ers feeeeretane 3 Sappoive Se care ) car on bays by? ayo obs oy Cy Baty Baty Brean Rae Ba [ “A. As needed telemedicine visit(s) nioniaton A. = Webess Vato hone
Slide 33: Treatment Emergent AEs by SOC and Preferred Term
Treatment Emergent AEs by SOC (≥ 2%) and Preferred Term System Organ Class Preferred Term SSC + KB109 (N=169) n (%) SSC Alone (N=181) n (%) Overall (N=350) n (%) Patients with at Least One TEAE 61 (36.1) 48 (26.5) 109 (31.1) Gastrointestinal disorders 35 (20.7) 9 (5.0) 44 (12.6) Diarrhoea 18 (10.7)
Slide 34: Subgroup Analysis of Time to Resolution of Overall Symptoms
Subgroup Analysis of Time to Resolution of Overall 13 Symptoms Table of Time to resolution - FAS Intake Period and Follow-up Period SSC + KB109 (N=169) SSC Alone (N=172) SSC + KB109 vs. SSC Alone Subgroup N1 Patients with Event n (%) Median Time (95% CI) (day)[1] N1 Patients with Event n (%) Median
Slide 35: Subgroup Analysis of Time to Resolution of 8 Cardinal Symptoms
Table of Time to resolution - FAS Subgroup Analysis of Time to Resolution of 8 Cardinal Symptoms Intake Period and Follow-up Period SSC + KB109 (N=169) SSC Alone (N=172) SSC + KB109 vs. SSC Alone Subgroup N1 Patients with Event n (%) Median Time (95% CI) (day)[1] N1 Patients with Event n (%) Median
Slide 36: Recent Antibody Data Provides Useful Context for K031
Recent Antibody Data Provides Useful Context for K031 Data from broad population in the mAb studies did not show strong results for symptoms or outcomes, leading to conditions of FDA EUA requiring a population of patients with higher risk; comorbidities and advanced age: High risk is defined as pati
Slide 37: Ulcerative Colitis Prevalence and Unmet Need
Ulcerative Colitis Prevalence and Unmet Need
Slide 38: Leading a Novel Approach to Targeting the Microbiome
Leading a Novel Approach to Targeting the Microbiome NASDAQ: KLDO June 2021
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