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KALEIDO BIOSCIENCES, INC.

(KLDO)
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Kaleido Biosciences Announces New Clinical and Preclinical Data Supporting Advancement of KB295 to a Phase 2 Clinical Study in Mild-to-Moderate Ulcerative Colitis

10/05/2021 | 07:00am EST

Kaleido Biosciences, Inc. announced topline data from the non-IND/CTA clinical study evaluating KB295, a novel Microbiome Metabolic Therapy (MMT™), in mild-to-moderate ulcerative colitis (UC). The primary objective of safety and tolerability was achieved as KB295 was well tolerated and no safety concerns were observed. In the study, subjects receiving KB295 experienced a reduction in three biomarkers, fecal calprotectin (FCP), fecal lactoferrin, and FimH that are known to be associated with UC disease activity. These results are complemented by preclinical studies conducted with Kaleido’s unique translational ex vivo platform using human donor-derived microbiome communities. KB295 was evaluated in an exploratory, open-label, single arm non-IND clinical study in subjects with mild-to-moderate UC. Subjects received KB295 for eight weeks, titrated up to 40g twice daily and then entered a two-week follow-up period. The study was designed to evaluate the safety and tolerability of KB295 with other exploratory assessments including changes in microbiome composition, SCFA levels in stool and biomarkers of inflammation (fecal calprotectin and lactoferrin and FimH). The trial was originally designed to enroll 30 subjects at a single site in Ireland, however, due to COVID-19 related enrollment impacts, 12 subjects were enrolled, primarily from Ireland. Primary pharmacology data were generated with Kaleido’s unique translational ex vivo platform using human donor-derived microbiome communities as well as microbiome and biomarker read-outs on the currently available samples from the first six subjects that entered the study.


ę S&P Capital IQ 2021
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Financials (USD)
Sales 2021 1,61 M - -
Net income 2021 -94,6 M - -
Net cash 2021 5,83 M - -
P/E ratio 2021 -1,60x
Yield 2021 -
Capitalization 153 M 153 M -
EV / Sales 2021 91,8x
EV / Sales 2022 169x
Nbr of Employees 82
Free-Float 91,0%
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Number of Analysts 6
Last Close Price 3,60 $
Average target price 14,80 $
Spread / Average Target 311%
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Managers and Directors
Daniel L. Menichella President, Chief Executive Officer & Director
William E. Duke Chief Financial Officer
Theo Melas-Kyriazi Chairman
Johan van Hylckama Vlieg Chief Scientific Officer
Kimberly Hocknell Senior Vice President-Technical Operations
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