On November 1, 2021 Kaleido Biosciences, Inc. (Nasdaq: KLDO), a clinical-stage biotech company with a differentiated, small-molecule approach to treating inflammatory conditions and diseases by selectively targeting the resident microbiome to restore gut-immune homeostasis, reported financial results for the third quarter ended September 30, 2021 (Press release, Kaleido Biosciences, NOV 1, 2021, View Source [SID1234594021]).
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"This has been a productive quarter for Kaleido, highlighted by the reporting of positive data from our first-in-human study in mild-to-moderate ulcerative colitis paving a clear path forward to advance KB295 into a Phase 2 clinical trial under an IND next year," said Dan Menichella, President and Chief Executive Officer of Kaleido. "Additionally, we are continuing to work closely with our partners at the COPD Foundation and remain on track to initiate a Phase 2 trial of KB109 in COPD in the first half of 2022. We are excited to initiate clinical trials in these two indications next year and look forward to demonstrating the immunomodulatory effect of our unique, microbiome metabolic therapies."
Recent Program and Corporate Highlights
In October, Kaleido announced the primary objective of safety and tolerability in the non IND/CTA K030 study evaluating KB295 in mild-to-moderate ulcerative colitis (UC) was achieved. Findings from the study revealed KB295 was well tolerated across subjects, including those taking 5-ASA medications and/or biologics, and no product-emergent serious adverse events were reported. In addition, subjects receiving KB295 experienced a reduction in three biomarkers known to be associated with UC disease activity, fecal calprotectin (FCP), fecal lactoferrin, and FimH. These results, together with pre-clinical data from ex vivo studies, support the Company’s plans to initiate a phase 2 trial, under an Investigational New Drug (IND) application and Clinical Trial Application (CTA), of KB295 in mild-to-moderate UC in the first half of 2022.
The Company remains on track to initiate a Phase 2 clinical trial of KB109 in patients with chronic obstructive pulmonary disease (COPD) in the first half of 2022, in collaboration with the COPD Foundation.
Third Quarter Financial Results
Kaleido reported a net loss of $23.1 million, or $0.54 per common share, for the third quarter of 2021 compared to $23.1 million, or $0.65 per common share, for the same period in 2020. The third quarter net loss includes non-cash stock-based compensation expenses of $2.0 million, as compared to $4.4 million for the same period in 2020.
Research and development (R&D) expenses were $17.4 million and $15.7 million for the three months ended September 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 $5.1 million and $7.2 million for the three months ended September 30, 2021 and 2020, respectively. The decrease was primarily due to the modification of the vesting provision of stock options and restricted stock units related to the resignation of our former CEO in July 2020.
As of September 30, 2021, the Company reported cash and cash equivalents of $55.7 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 into clinical studies in healthy subjects and patients. These human clinical studies may be conducted under regulations supporting research with food, evaluating safety and tolerability and impact on the microbiome. For MMT candidates that are developed as therapeutics, the Company currently conducts and will conduct clinical trials under an Investigational New Drug (IND) or regulatory equivalent outside the U.S., often in Phase 2 or later development.