Item 7.01 Regulation FD Disclosure.

The Company is furnishing a presentation, attached as Exhibit 99.1 to this Current Report on Form 8-K, summarizing the results from its controlled non-IND clinical study K031 evaluating Microbiome Metabolic Therapy (MMT™) candidate KB109 when added to Supportive Self-Care for outpatients with mild-to-moderate COVID-19 disease, which the Company intends to use from time to time in meetings with investors and others. The corporate presentation also includes information on a recently completed Food & Drug Administration (FDA) clinical inspection of the K031 study, as well as K032, a second non-IND clinical study evaluating KB109 for outpatients with mild-to-moderate COVID-19 disease. At the conclusion of the inspection, the FDA issued a Form 483 with a single observation that the Company failed to submit an IND prior to conducting a clinical investigation that the FDA concluded was of an investigational new drug. There were no findings related to the conduct or oversight of the studies.




Item 8.01 Other Events

On March 24, 2021, the Company issued a press release announcing results from its controlled non-IND clinical study K031 evaluating Microbiome Metabolic Therapy (MMT™) candidate KB109 when added to Supportive Self-Care for outpatients with mild-to-moderate COVID-19 disease. A copy of the press release is furnished as Exhibit 99.2 to this Current Report on Form 8-K.

On March 24, 2021, the Company will host a conference call and webcast at 8:30 A.M. to discuss the K031 results. A copy of the deck attached hereto as Exhibit 99.1 will be utilized in the presentation. An updated version of the Company's corporate presentation will also be available in the investor relations section of the Company's website at http://kaleido.com.

The information in this Form 8-K (including Exhibits 99.1, and 99.2) shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.

Item 9.01. Financial Statements and Exhibits.



(d) Exhibits:



Exhibit No.   Description

                K031 Topline Final Data Analysis, dated March 24, 2021, furnished
99.1          herewith
                Press release issued by the Company, dated March 24, 2021, furnished
99.2          herewith
              Cover Page Interactive Data File (embedded within the Inline XBRL
104           document).

--------------------------------------------------------------------------------

© Edgar Online, source Glimpses