On November 2, 2020 Kaleido Biosciences, Inc. (Nasdaq: KLDO) reported financial results for the third quarter 2020 and provided a corporate update (Press release, Kaleido Biosciences, NOV 2, 2020, View Source [SID1234569698]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Kaleido continues to build momentum with the development of interventions based on our Microbiome Metabolic Therapy, or MMT, platform and evaluate the highly diverse applications of this approach," commented Dan Menichella, President and Chief Executive Officer of Kaleido. "In the past quarter, we initiated a study of KB295 in patients with ulcerative colitis, representing the fourth application of an MMT approach to enter the clinic. We continue to advance our pipeline and expect to nominate a candidate with potential for the treatment of cardiometabolic and liver diseases in 2021."

Company Highlights

The Company continues to enroll subjects in two non-IND clinical studies that are part of the ongoing COVID-19 development program evaluating KB109 when added to supportive self-care in outpatients with mild-to-moderate COVID-19 disease.

In September, Kaleido dosed the first patient in a clinical study of KB295 in patients with mild-to-moderate ulcerative colitis.
Anticipated Milestones

Programs KB39 and KB174 will be featured during The Liver Meeting 2020, the annual meeting of the American Association for the Study of Liver Diseases (AASLD), which is taking place Nov. 13-16, 2020.

Preclinical data from the immuno-oncology programs are expected in the fourth quarter of 2020.

Topline data from the multi-center (K031) clinical study of KB109 in outpatients with mild-to-moderate COVID-19 disease and top-line data from the study with Massachusetts General Hospital (K032) are expected in the first quarter of 2021.

Topline date clinical study of KB295 in approximately 30 patients with mild-to-moderate ulcerative colitis (UC) are expected in mid-2021.

Topline data from a Phase 2 clinical trial of KB195 in patients with UCD inadequately controlled on standard of care are expected in the second half of 2021.
Third Quarter 2020 Financial Results

For the third quarter 2020, Kaleido reported a net loss of $23.1 million, or $0.65 per common share, compared to $22.0 million, or $0.74 per common share, for the third quarter 2019. The 2020 third quarter net loss includes non-cash stock-based compensation expenses of $4.4 million, as compared to $2.9 million in the third quarter of 2019.

Research and development (R&D) expenses were $15.7 million for the third quarter 2020, compared to $16.2 million for the third quarter 2019. The third quarter decrease in R&D, as compared to the third quarter of 2019, was primarily driven by decreased external development, manufacturing, and research costs.

General and administrative (G&A) expenses were $7.2 million for the third quarter 2020, compared to $5.9 million for the third quarter of 2019. The third quarter 2020 increase in G&A, as compared to the third quarter of 2019, 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.

As of September 30, 2020, the Company reported cash and cash equivalents of $54.5 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.