On August 4, 2020 Kaleido Biosciences, Inc. (Nasdaq: KLDO), a clinical-stage healthcare company with a chemistry-driven approach to targeting the microbiome to treat disease and improve human health, reported financial results for the second quarter 2020 and provided a corporate update (Press release, Kaleido Biosciences, AUG 4, 2020, View Source [SID1234562761]).

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"We have made several important advancements across critical areas of the business, including initiating two clinical studies in our COVID-19 program and strengthening our financial foundation by extending our cash runway into the second half of 2021," said Michael Bonney, Executive Chair of Kaleido. "We anticipate top-line data from the 350-patient, multi-center COVID-19 study in the fourth quarter. We also continue to make progress on our preclinical programs and look forward to reporting data in the fourth quarter from our immuno-oncology, cardiometabolic and liver disease programs."

Company Highlights

Initiated two non-IND clinical studies that are part of the ongoing COVID-19 clinical development program evaluating KB109 when added to Supportive Self-Care in outpatients with mild-to-moderate COVID-19 disease: clinical study K031 is a multi-center study of approximately 350 patients and clinical study K032, in collaboration with Massachusetts General Hospital, aims to include approximately 50 patients.

Completed a $35.6 million offering of common stock.
Anticipated Milestones

Clinical and ex vivo data from KB174, being developed for the treatment of hepatic encephalopathy (HE), to be featured in poster presentations during The Digital International Liver Congress (EASL 2020) August 27-29, 2020.

Topline data from the multi-center (K031) clinical study of KB109 in patients with mild-to-moderate COVID-19 disease expected in Q4 2020 and top-line data from the study with Massachusetts General Hospital (K032) are expected in the first quarter of 2021. A patient may be enrolled in the study if an initial positive COVID-19 test result is received and the patient remains symptomatic.

Initiating a clinical study in Q3 2020 evaluating KB295 in approximately 30 patients with mild-to-moderate ulcerative colitis (UC). Topline results are expected in mid-2021.

Preclinical data from the immuno-oncology, cardiometabolic and liver diseases programs expected in Q4 2020.

Topline data from Phase 2 clinical trial (UNLOCKED) of KB195 in patients with UCD inadequately controlled on standard of care in second half 2021.
Second Quarter 2020 Financial Results

For the second quarter 2020, Kaleido reported a net loss of $18.9 million, or $0.59 per common share, compared to $24.6 million, or $0.83 per common share, for the second quarter 2019. The 2020 second quarter net loss includes non-cash stock-based compensation expenses of $2.8 million, as compared to $2.4 million in the second quarter of 2019.

Research and development (R&D) expenses were $12.8 million for the second quarter 2020, compared to $18.8 million for the second quarter 2019. The second quarter decrease in R&D, as compared to the second quarter of 2019, was primarily driven by decreased external development, manufacturing, and research costs.

General and administrative (G&A) expenses were $5.6 million for the second quarter 2020, compared to $6.2 million for the second quarter of 2019. The second quarter 2020 decrease in G&A, as compared to the second quarter of 2019, was primarily due to decreased personnel-related costs, partially offset by increased facility-related expenses.

As of June 30, 2020, the Company reported cash and cash equivalents of $71.0 million and has cash runway into the second half of 2021.

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.