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OFFON

KALEIDO BIOSCIENCES, INC.

(KLDO)
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KALEIDO BIOSCIENCES, INC. : Other Events (form 8-K)

09/03/2021 | 04:09pm EDT

Item 8.01 Other Events.

On August 27, 2021 the Company received a Warning Letter from the U.S. Food and Drug Administration (FDA) for failure to submit an investigational new drug application (IND) prior to conducting two clinical studies, K031 and K032, of the Company's MMT KB109 in subjects with COVID-19. The Warning Letter followed receipt of a Form FDA 483 that was provided to the Company in March 2021 at the conclusion of a clinical inspection. The Form FDA 483 and Warning Letter were each based on a single observation that the Company failed to submit an IND for the conduct of these studies; there were no findings related to the conduct or oversight of these studies or the data that was generated. The Company is coordinating with the FDA and intends to continue with its plans to submit an IND for KB109 in support of future clinical research.

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© Edgar Online, source Glimpses

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Analyst Recommendations on KALEIDO BIOSCIENCES, INC.
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Financials (USD)
Sales 2021 1,80 M - -
Net income 2021 -96,6 M - -
Net cash 2021 38,6 M - -
P/E ratio 2021 -1,96x
Yield 2021 -
Capitalization 182 M 182 M -
EV / Sales 2021 79,4x
EV / Sales 2022 96,2x
Nbr of Employees 82
Free-Float 91,0%
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Mean consensus OUTPERFORM
Number of Analysts 6
Last Close Price 4,27 $
Average target price 14,33 $
Spread / Average Target 236%
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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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