Kaleido Biosciences, Inc. · OTC:KLDO

Kaleido Biosciences — Investor Presentation (January 2021)

38 slides from Kaleido Biosciences's investor presentation, Jan 20, 2021

  1. Slide 1: Leading a Novel Approach to Targeting the Microbiome

    Leading a Novel Approach to Targeting the Microbiome NASDAQ: KLDO January 2021 Exhibit 99.1 1© 2021 KALEIDO ® Kaleido

  2. 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

  3. 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

  4. Slide 4: The Kaleido Leadership Team

    The Kaleido Leadership Team Daniel Menichella President and Chief Executive Officer Former CEO, CureVac AG Katharine Knobil, M.D. Chief Medical Officer, Head of R&D Former CMO, GlaxoSmithKline Johan van Hylckama Vlieg, Ph.D. Chief Scientific Officer Former VP for Microbiome & Human Health Innovation

  5. 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

  6. 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 …re-engineer the composition of the microbiome… …control production of specific metabolites… The unique abilities of MMTs to… …make them potent polypharmacological therapeutic

  7. Slide 7: COVID-19 (KB109)

    COVID-19 (KB109) KaleidoTM 7 @2021 kaleido

  8. 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 letha

  9. 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

  10. 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 Kaleido TM 10 @2021 kaleido

  11. Slide 11: KB109 in COVID-19 Interim 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 Interim Analysis (IA) High propionate High acetate Multi-center, open label, controlled clinical study* Mild-to-moderate COVID-1

  12. Slide 12: 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 no treatment-related SAEs Hospitalizations: 2 in KB109+SSC vs 3 in SSC alone arm One death due to COVID-19 after withdrawal from study

  13. Slide 13: 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 Kaleido 13 © 2021 KALEIDO ®

  14. Slide 14: Natural History of COVID-19 Infection: SSC Alone Arms

    13 Overall Symptoms8 Cardinal Symptoms 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 Proportion of Patients with Resolution Proportion of Patients with

  15. Slide 15: Time to Resolution of Overall COVID-19 Related Symptoms

    Time to Resolution of Overall 13 COVID-19 Related Symptoms Cough, chills/repeated shaking with chills, muscle pain, fever, headache, anosmia/ageusia, shortness of breath, sore throat, gastrointestinal disturbance/symptoms, diarrhea, fatigue, nasal congestion, and chest tightness Kaleido TM 15 © 2021

  16. Slide 16: Kaplan-Meier Curve: Time to Resolution of Overall 13 Symptoms

    Kaplan-Meier Curve Intake and Follow-up Period Time to Resolution of Overall 13 Symptoms Primary Analysis HR = 1.328 (0.862, 2.047) Hazard ratio (SSC + KB109 / SSC Alone) and 95% CI was estimated based on Cox proportional hazards model with factors for group, study site/center, age group (>=18 to <4

  17. Slide 17: Overall Symptoms Full Analysis Set

    13 Overall Symptoms Full Analysis Set Median time to resolution of symptoms: KB109 + SSC = 18 days SSC alone = 27 days HR = 1.4986 (0.7679, 2.9247) Hazard ratio (SSC + KB109 / SSC Alone) and 95% CI was estimated based on unstratified Cox proportional hazards model. Intake and Follow-up Period: Comor

  18. Slide 18: Time to Resolution of Cardinal COVID-19 Symptoms

    Time to Resolution of 8 Cardinal COVID-19 Symptoms Cough, chills/repeated shaking with chills, muscle pain, fever, headache, anosmia/ageusia, shortness of breath, and sore throat Kaleido TM 18 © 2021 KALEIDO ®

  19. Slide 19: Kaplan-Meier Curve: Time to Resolution of 8 Cardinal Symptoms

    Kaplan-Meier curve Intake and Follow-up Period Time to Resolution of 8 Cardinal Symptoms Full analysis set HR =1.4420 (0.9149, 2.2727) Hazard ratio (SSC + KB109 / SSC Alone) and 95% CI was estimated based on Cox proportional hazards model with factors for group, study site/center, age group (>=18 to

  20. Slide 20: Cardinal Symptoms Full Analysis Set

    8 Cardinal Symptoms Full Analysis Set Median time to resolution of symptoms: KB109 + SSC= 15 days SSC alone = 27 days HR = 2.0384 (1.0279, 4.0422) Hazard ratio (SSC + KB109 / SSC Alone) and 95% CI was estimated based on unstratified Cox proportional hazards model. Intake and Follow-up Period: Comorb

  21. Slide 21: Natural History of COVID-19 Infection: SSC Alone Arms

    13 Overall Symptoms8 Cardinal Symptoms 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 Proportion of Patients with Resolution Median time to resolution of

  22. Slide 22: Potential Clinical Implications

    Full analysis will further elucidate the role KB109 may play in allowing patients with comorbidities to recover more quickly Potential Clinical Implications 13 Overall Symptoms8 Cardinal Symptoms Median time to resolution of symptoms: SSC No comorbidity = 14 days SSC + Comorbidity = 27 days KB109 +

  23. Slide 23: Preliminary Results from Interim Analysis

    Preliminary Results from Interim Analysis Requires confirmation from full dataset Study is now fully enrolled with topline data expected for the full study in Q1 Favorable safety and tolerability profile with no new safety signals in the largest study of MMT No differences seen between KB109+SSC and

  24. Slide 24: Inflammatory Bowel Disease (KB295)

    Inflammatory Bowel Disease (KB295) KaleidoTM 24 © 2021 KALEIDO ®

  25. Slide 25: SCFA producing taxa and 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

  26. Slide 26: 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

  27. Slide 27: Key Expected Upcoming Milestones

    Key Expected Upcoming Milestones – by mid-2021 2020 COVID-19 (K031) study – Q1’2021 COVID-19 (K032) study – Q1’2021 Ulcerative Colitis (K030) study – mid-2021 Clinical Results* *Non-IND clinical studies 27 © 2021 KALEIDO ®

  28. Slide 28: Pre-Clinical Programs, Intellectual Property, Financials

    Pre-Clinical Programs Intellectual Property Financials KaleidoTM 28 © 2021 KALEIDO ®

  29. Slide 29: Poised to Deliver Multiple Clinical-Ready Programs in 2021

    Preclinical Program Collaborator Clinical-Ready Lead MMT Expected in 2021 Prevention of infection by multi-drug resistant pathogens in high risk patients, initially in HSCT Immuno-oncology Cardiometabolic & Liver Diseases Immune-mediated Diseases Prevention of Childhood-Onset Atopic & Immune Conditi

  30. Slide 30: 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

  31. Slide 31: 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 Current Analyst Coverage: Cash and cash equivalents of $54.5 million* $50 million of av

  32. Slide 32: 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

  33. Slide 33: Appendix: COVID-19 Interim Analysis (KB109)

    Appendix: COVID-19 Interim Analysis (KB109) Kaleido TM 33 ©2021 kaleido®

  34. Slide 34: COVID-19 Study Interim Analysis: Baseline Characteristics (1)

    COVID-19 Study Interim Analysis: Baseline Characteristics (1) Demographic SSC + KB109 (N=87) SSC Alone (N=89) Overall (N=176) Age (years) n 87 89 176 Mean 39.9 37.9 38.9 SD 14.40 15.96 15.19 Median 40.0 36.0 38.0 Min, Max 18, 72 18, 76 18, 76 Age Group, n (%) >=18 to <45 years 59 (67.8) 61 (68.5) 12

  35. Slide 35: COVID-19 Study Interim Analysis: Baseline Characteristics (2)

    COVID-19 Study Interim Analysis: Baseline Characteristics (2) Characteristic SSC + KB109 (N=87) SSC Alone (N=89) Overall (N=176) Height (cm) n 86 89 175 Mean 167.6 168.3 167.9 SD 10.48 10.25 10.34 Median 167.0 165.0 167.0 Min, Max 142, 198 152, 191 142, 198 Weight (kg) n 86 89 175 Mean 82.89 82.98 8

  36. Slide 36: COVID-19 Study Interim Analysis: Most Commonly Reported Adverse Events

    COVID-19 Study Interim Analysis: Most Commonly Reported Adverse Events System Organ Class Preferred Term SSC + KB109 (N=90) n (%) SSC Alone (N=116) n (%) Overall (N=206) n (%) Patients with at Least One TEAE 30 (33.3) 20 (17.2) 50 (24.3) Gastrointestinal disorders 17 (18.9) 3 (2.6) 20 (9.7) Diarrhoe

  37. Slide 37: COVID-19 Study Interim Analysis: Most Common Symptoms at Baseline

    COVID-19 Study Interim Analysis: Most Common Symptoms at Baseline COVID-19 Study Interim Analysis: Most Common Symptoms at Baseline Category ssc + kb109 ssc alone n=87 n=89 n (%) n (%) patients who had non-zero fever at baseline 12 (13.8) 16 (18.0) patients who had non-zero chills/repeated shaking w

  38. Slide 38: COVID-19 Study Interim Analysis: Comorbidities Reported at Baseline

    COVID-19 Study Interim Analysis: Comorbidities Reported at Baseline COVID-19 Study Interim Analysis: Comorbidities Reported at Baseline comorbidities full analysis set category ssc + kb109 ssc slone overall (n=87) (n=89) (n=176) n (%) n (%) n (%) patients with at least one comorbidity 39 (44.8) 32 (

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