Slide 1: K031 Topline Final Data Analysis
K031 Topline Final Data Analysis March 24, 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: 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 4: 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 5: KB109 – Healthcare Utilization Data
COVID-19 related Hospitalization, Emergency room, or Urgent Care visits (Safety Analysis Set) KB109 – Healthcare Utilization Data Statistics SSC + KB109 (N=69) SSC alone (N=66) Overall (N=135) % change (SSC + KB109 vs SSC alone) N (%) 4 (5.8%) 10 (15.2%) 14 (10.4%) -61.8% Comorbidity Patient Subgrou
Slide 6: 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 Symptoms8 Cardinal Symptoms Proportion of Patients with
Slide 7: Time to Resolution of Covid-19 Symptoms for Patients with Comorbidity
13 Symptoms Time to Resolution of Covid-19 Symptoms for Patients with Comorbidity KB109 + SSC vs. SSC alone 21 vs 30 days, HR=1.4217 (0.8982, 2.2501); p=NS 13 Covid-related symptoms: Cough, chills/repeated shaking with chills, muscle pain, fever, headache, anosmia/ageusia, shortness of breath, sore
Slide 8: Potential Clinical Implications for 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 9: Exploratory Analysis of Time to Resolution ≥45 Years or with Comorbidity
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 10: KB109: Regulatory Interactions and Next Steps
KB109: Regulatory Interactions and Next Steps Engaging with FDA and other regulatory agencies with the goal of opening an IND and CTAs in Q4 2021 Pre-IND discussions with FDA Gained alignment on nonclinical toxicology program to support IND filing Ongoing discussions to seek alignment in support of
Slide 11: Population at Risk for Hospitalization Needs Respiratory Viral Therapeutics
Population at risk for hospitalization is in great need of respiratory viral therapeutics during this current pandemic and beyond The 45% COVID-19 infected adults with comorbidities1 The 40%+ of cases that occur in adults ≥45 years old2 The 10%+ of addressable patients with “long-COVID” published lo
Slide 12: Live Q&A Session
Live Q&A Session 121 KALEIDO®
Slide 13: Back-up Slides
Back-up Slides 121 KALEIDO®
Slide 14: 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 15: K031 Study Design
K031 Study Design Enrollment Period Up to 12 Days If symptomatic: Must not report significant improvement in cardinal symptoms in 48 hrs immediately prior to randomization If pre-symptomatic: symptom development within 7 days of a positive test and randomization within 5 days of the symptoms showing
Slide 16: 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 17: 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 18: Subgroup Analysis of Time to Resolution of Overall Symptoms
Subgroup Analysis of Time to Resolution of Overall 13 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 Time (95% CI) (day)[1] Hazard Rati
Slide 19: 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 20: 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 21: K031 Topline Final Data Analysis
K031 Topline Final Data Analysis March 24, 2021