Item 8.01 Other Events.
On October 5, 2021, the Company issued a press release announcing results
evaluating Microbiome Metabolic Therapy (MMT™) candidate KB295 in its controlled
non-IND clinical study K030 in subjects with mild-to-moderate ulcerative
colitis, as well as related preclinical data. A copy of the press release is
furnished as Exhibit 99.2 to this Current Report on Form 8-K.
On October 5, 2021, the Company will host a conference call and webcast at 8:00
A.M. to provide an update on the Company's corporate strategy, discuss the data
and clinical development plans for KB295 and discuss the advancement of MMT
KB109 in COPD. 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.
After much consideration, on October 4, 2021, the Company notified clinical
sites of its decision to terminate its Phase 2 clinical trial of KB195 in
subjects with urea cycle disorder with inadequate control on standard of
care. The Company's decision to terminate this clinical trial was based on a
number of factors, including the significant impact of the COVID-19 pandemic on
clinical trial enrollment, timelines and expenditures.
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
Kaleido R&D Day Presentation, dated October 5, 2021, furnished
99.1 herewith
Press release issued by the Company, dated October 5, 2021, furnished
99.2 herewith
Cover Page Interactive Data File (embedded within the Inline XBRL
104 document).
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