kldo-8k_20201102.htm
false 0001751299 0001751299 2020-11-02 2020-11-02

 

 

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): November 2, 2020

 

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: (617674-9000

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 2.02. Results of Operations and Financial Condition.

On November 2, 2020, Kaleido Biosciences, Inc. (the “Company”) announced its financial results for the third quarter ended September 30, 2020. The full text of the press release issued in connection with the announcement is furnished as Exhibit 99.1 to this Current Report on Form 8-K.

The information in this Form 8-K (including Exhibits 99.1) 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

 

Press Release issued by Kaleido Biosciences, Inc., dated November 2, 2020, 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: November 2, 2020

By:

 

/s/ Daniel L. Menichella

 

 

 

Daniel L. Menichella

 

 

 

President and Chief Executive Officer

(Principal Executive Officer)

 

 

 

kldo-ex991_6.htm

Exhibit 99.1

Kaleido Biosciences Reports Third Quarter 2020 Financial Results
and Provides Corporate Update

- Topline Data for KB109 for the Treatment of Mild-to-Moderate COVID-19 Expected in the First Quarter of 2021 -

 

LEXINGTON, Mass., November 2, 2020 – Kaleido Biosciences, Inc. (Nasdaq: KLDO) today announced financial results for the third quarter 2020 and provided a corporate update.  

“Kaleido continues to build momentum with the development of interventions based on our Microbiome Metabolic Therapy, or MMT™, platform and evaluate the highly diverse applications of this approach,” commented Dan Menichella, President and Chief Executive Officer of Kaleido. “In the past quarter, we initiated a study of KB295 in patients with ulcerative colitis, representing the fourth application of an MMT approach to enter the clinic. We continue to advance our pipeline and expect to nominate a candidate with potential for the treatment of cardiometabolic and liver diseases in 2021.”

Company Highlights

 

The Company continues to enroll subjects in two non-IND clinical studies that are part of the ongoing COVID-19 development program evaluating KB109 when added to supportive self-care in outpatients with mild-to-moderate COVID-19 disease.

 

 

In September, Kaleido dosed the first patient in a clinical study of KB295 in patients with mild-to-moderate ulcerative colitis.

 

Anticipated Milestones

 

 

Programs KB39 and KB174 will be featured during The Liver Meeting® 2020, the annual meeting of the American Association for the Study of Liver Diseases (AASLD), which is taking place Nov. 13-16, 2020.

 

 

Preclinical data from the immuno-oncology programs are expected in the fourth quarter of 2020.

 

 

Topline data from the multi-center (K031) clinical study of KB109 in outpatients with mild-to-moderate COVID-19 disease and top-line data from the study with Massachusetts General Hospital (K032) are expected in the first quarter of 2021.

 

 

Topline date clinical study of KB295 in approximately 30 patients with mild-to-moderate ulcerative colitis (UC) are expected in mid-2021.

 

 

Topline data from a Phase 2 clinical trial of KB195 in patients with UCD inadequately controlled on standard of care are expected in the second half of 2021.

 

 

Third Quarter 2020 Financial Results

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For the third quarter 2020, Kaleido reported a net loss of $23.1 million, or $0.65 per common share, compared to $22.0 million, or $0.74 per common share, for the third quarter 2019. The 2020 third quarter net loss includes non-cash stock-based compensation expenses of $4.4 million, as compared to $2.9 million in the third quarter of 2019.

 

Research and development (R&D) expenses were $15.7 million for the third quarter 2020, compared to $16.2 million for the third quarter 2019. The third quarter decrease in R&D, as compared to the third quarter of 2019, was primarily driven by decreased external development, manufacturing, and research costs.

 

General and administrative (G&A) expenses were $7.2 million for the third quarter 2020, compared to $5.9 million for the third quarter of 2019. The third quarter 2020 increase in G&A, as compared to the third quarter of 2019, was primarily due to the modification of the vesting provision of stock options and restricted stock units related to the resignation of our former CEO.

 

As of September 30, 2020, the Company reported cash and cash equivalents of $54.5 million and has cash runway into the second half of 2021.

 

About Microbiome Metabolic Therapies (MMT)

 

Kaleido’s Microbiome Metabolic Therapies, or MMTs, are designed to drive the function and distribution of the microbiome’s existing microbes in order to decrease or increase the production of metabolites, or to advantage or disadvantage certain bacteria in the microbiome community. The Company’s initial MMT candidates are targeted, synthetic glycans that are orally administered, have limited systemic exposure, and are selectively metabolized by enzymes in the microbiome. Kaleido utilizes its discovery and development platform to study MMTs in microbiome samples to rapidly advance MMT candidates rapidly into clinical studies in healthy subjects and patients. These human clinical studies are conducted under regulations supporting research with food, evaluating safety, tolerability and potential markers of effect. For MMT candidates that are further developed as therapeutics, the Company conducts clinical trials under an Investigational New Drug (IND) or regulatory equivalent outside the U.S., and in Phase 2 or later development.  

About Kaleido Biosciences

Kaleido Biosciences is a clinical-stage healthcare company with a differentiated, chemistry-driven approach to targeting the microbiome to treat disease and improve human health. The Company has built a proprietary product platform to enable the rapid and cost-efficient discovery and development of novel Microbiome Metabolic Therapies (MMT™). MMTs are designed to modulate the metabolic output and profile of the microbiome by driving the function and distribution of the gut’s existing microbes. Kaleido is advancing a broad pipeline of MMT

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candidates with the potential to address a variety of diseases and conditions with significant unmet patient needs. To learn more, visit https://kaleido.com/.

 

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, statements regarding the therapeutic potential of our MMT candidates, the timing of initiation, completion and reporting of results of clinical studies, and our strategy, business plans and focus. The words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, those related to the breadth of our pipeline of product candidates, the strength of our proprietary product platform, the efficiency of our discovery and development approach, the clinical development and safety profile of our MMT candidates and their therapeutic potential, whether and when, if at all, our MMT candidates will receive approval from the U.S. Food and Drug Administration and for which, if any, indications, competition from other biotechnology companies, and other risks identified in our SEC filings, including our most recent Form 10-Q, and subsequent filings with the SEC. We caution you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. We disclaim any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements.

 

 

 

 

 

 

 

 


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Kaleido Biosciences, Inc. and Subsidiaries

Condensed Consolidated Statement of Operations (Unaudited)

(in thousands, except share and per share data)

 

 

 

Three Months Ended

September 30,

 

 

Nine Months Ended

September 30,

 

 

 

2020

 

 

2019

 

 

2020

 

 

2019

 

Revenue:

 

 

 

 

 

 

Collaboration revenue

 

$

482

 

 

$

 

 

$

732

 

 

$

 

Operating expenses:

 

 

 

 

 

 

Research and development

 

 

15,659

 

 

 

16,188

 

 

 

41,629

 

 

 

50,145

 

General and administrative

 

 

7,201

 

 

 

5,930

 

 

 

18,677

 

 

 

17,544

 

Total operating expenses

 

 

22,860

 

 

 

22,118

 

 

 

60,306

 

 

 

67,689

 

Loss from Operations

 

 

(22,378

)

 

 

(22,118

)

 

 

(59,574

)

 

 

(67,689

)

Other (expense) income

 

 

(753

)

 

 

157

 

 

 

(2,030

)

 

 

870

 

Net loss

 

$

(23,131

)

 

$

(21,961

)

 

$

(61,604

)

 

$

(66,819

)

Net loss per share—basic and diluted

 

$

(0.65

)

 

$

(0.74

)

 

$

(1.89

)

 

$

(2.76

)

Weighted-average common shares outstanding used in net loss—basic and diluted

 

 

35,554,128

 

 

 

29,856,233

 

 

 

32,605,592

 

 

 

24,224,359

 

 

 

 

 

 

 

Kaleido Biosciences, Inc. and Subsidiaries

Condensed Consolidated Balance Sheet Data (Unaudited)

(in thousands)

 

 

 

September 30, 2020

 

 

December 31, 2019

 

Assets:

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

54,532

 

 

$

71,241

 

Other assets

 

 

18,613

 

 

 

11,065

 

Total assets

 

$

73,145

 

 

$

82,306

 

Liabilities and stockholders' equity

 

 

 

 

 

 

 

 

Liabilities

 

$

37,244

 

 

$

33,423

 

Stockholders' equity

 

 

35,901

 

 

 

48,883

 

Total liabilities and stockholders' equity

 

$

73,145

 

 

$

82,306

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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Contacts

Kaleido Biosciences

William Duke, Jr.
Chief Financial Officer

617-890-5772

william.duke@kaleido.com


Investors

Lee M. Stern
Solebury Trout
646-378-2922
lstern@soleburytrout.com

Media

Joshua R. Mansbach
Solebury Trout

646-378-2964

jmansbach@troutgroup.com

 

 

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