On August 11, 2021 Kaleido Biosciences, Inc. (Nasdaq: KLDO), a clinical-stage healthcare company with a differentiated, chemistry-driven approach to targeting the microbiome to treat disease and improve human health, reported financial results for the second quarter ended June 30, 2021 (Press release, Kaleido Biosciences, AUG 11, 2021, View Source [SID1234586341]).
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"We have made considerable progress so far this year across our dynamic and diverse clinical pipeline of novel, targeted Microbiome Metabolic TherapyTM (MMT) candidates. We continue to advance KB295 in patients with mild-to-moderate ulcerative colitis and anticipate reporting topline data from the clinical study by the end of the third quarter," said Dan Menichella, President and Chief Executive Officer of Kaleido. "This quarter, we also expect to report data from the observational clinical study evaluating COVID-19 symptoms in ‘Long Hauler’ patients that participated in our prior COVID-19 clinical studies."
Continued Mr. Menichella: "Additionally, we are proud to have announced a strategic collaboration with the COPD Foundation, an organization uniquely qualified to aid us in our mission to improve the lives of patients suffering from COPD. Our KB109 program will be greatly enhanced with support from the COPD Foundation, and we look forward to a productive and mutually beneficial partnership that leverages the strong data from our COVID-19 studies to explore treatment of COPD, the most prevalent chronic respiratory illness, impacting over 250 million people worldwide. While we are prioritizing COPD based on our assessment of the unmet need and commercial opportunity, we will continue to evaluate development opportunities for KB109 in COVID-19 with partners and government agencies."
Recent Program and Corporate Highlights
Topline data from the non-IND clinical study of KB295 in patients with mild-to-moderate ulcerative colitis (UC) are expected by the end of the third quarter.
Additional data from the observational clinical study of KB109 in patients with mild-to-moderate COVID-19 are expected by the end of the third quarter.
In August, Kaleido announced a collaboration with the COPD Foundation that is on track to initiate a Phase 2 clinical study of KB109 in patients with chronic obstructive pulmonary disease (COPD) in the first quarter of 2022.
Second Quarter Financial Results
Kaleido reported a net loss of $23.9 million, or $0.56 per common share, for the second quarter of 2021 compared to $18.9 million, or $0.59 per common share, for the same period in 2020. The second quarter net loss includes non-cash stock-based compensation expenses of $2.4 million, as compared to $2.8 million in the second quarter of 2020.
Research and development (R&D) expenses were $17.6 million and $12.8 million for the three months ended June 30, 2021 and 2020, respectively. The increase was primarily due to an increase in production of material for use in our clinical studies.
General and administrative (G&A) expenses were $5.8 million and $5.6 million for the three months ended June 30, 2021 and 2020, respectively. The increase was primarily due to increased facility operating costs that were attributed to general and administrative functions.
As of June 30, 2021, the Company reported cash and cash equivalents of $72.0 million and has cash runway into the second quarter of 2022.
About Microbiome Metabolic Therapies (MMT)
Kaleido’s Microbiome Metabolic Therapies, or MMTs, are designed to drive the function and distribution of the microbiome’s existing microbes in order to decrease or increase the production of metabolites, or to advantage or disadvantage certain bacteria in the microbiome community. The Company’s initial MMT candidates are targeted, synthetic glycans that are orally administered, have limited systemic exposure, and are selectively metabolized by enzymes in the microbiome. Kaleido utilizes its discovery and development platform to study MMTs in microbiome samples to rapidly advance MMT candidates rapidly into clinical studies in healthy subjects and patients. These human clinical studies are conducted under regulations supporting research with food, evaluating safety, tolerability and potential markers of effect. For MMT candidates that are further developed as therapeutics, the Company conducts clinical trials under an Investigational New Drug (IND) or regulatory equivalent outside the U.S., and in Phase 2 or later development.