UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 OR 15(d)

of The Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): ~~August~~October 274, 2021

KALEIDO BIOSCIENCES, INC.

(Exact name of registrant as specified in its charter)

Delaware

001-38822

47-3048279

(State or other jurisdiction

of incorporation)

(Commission

File Number)

(IRS Employer

Identification No.)

65 Hayden Avenue Lexington, MA	02421
(Address of principal executive offices)	(Zip Code)

Registrant's telephone number, including area code: (617) 674-9000

Not Applicable

(Former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

☐	Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐	Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐	Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐	Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class

Trading

Symbol(s)

Name of each exchange on which registered

Common Stock, $0.001 Par Value

KLDO

NASDAQ Global Select Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ☒

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item 8.01 Other Events.

On ~~August~~October 275, 2021, the Company ~~received~~issued a ~~Warning~~press ~~Letter~~release ~~from~~announcing ~~the~~results ~~U.S.~~evaluating ~~Food~~Microbiome ~~and~~Metabolic ~~Drug~~Therapy ~~Administration~~ (~~FDA~~MMT™) ~~for~~candidate ~~failure~~KB295 toin ~~submit~~its ancontrolled ~~investigational new drug application (~~non-IND) ~~prior to conducting two~~ clinical ~~studies,~~study ~~K031~~K030 ~~and K032, of the Company’s MMT KB109~~ in subjects with ~~COVID~~mild-~~19. The Warning Letter followed receipt of a Form FDA 483 that was provided~~ to-moderate ~~the~~ulcerative ~~Company~~colitis, inas ~~March~~well ~~2021~~as atrelated ~~the~~preclinical ~~conclusion of a clinical inspection~~data. ~~The~~ ~~Form~~A ~~FDA~~copy ~~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~~press orrelease ~~oversight~~is offurnished ~~these~~as ~~studies~~Exhibit ~~or the data that was generated~~99. ~~The~~2 ~~Company is coordinating with the FDA and intends~~ to ~~continue~~this ~~with~~Current ~~its~~Report ~~plans~~on toForm ~~submit an IND for KB109 in support of future clinical research~~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

99.1		Kaleido R&D Day Presentation, dated October 5, 2021, furnished herewith
99.2		Press release issued by the Company, dated October 5, 2021, furnished herewith
104		Cover Page Interactive Data File (embedded within the Inline XBRL document).

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

	KALEIDO BIOSCIENCES, INC.
Date: September 3, 2021	By:	/s/ Daniel L. Menichella
Date: October 5, 2021	By:	/s/ Daniel Menichella
		Daniel L. Menichella
		Daniel Menichella
		President and Chief Executive Officer (Principal Executive Officer)
		Chief Executive Officer, President and Director

Filing Compare · Kaleido Biosciences, Inc.