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Table of Contents

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 10-Q

 

 

QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended June 30, 2021

or

 

TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from                       to                      

Commission File Number: 001-38822

 

KALEIDO BIOSCIENCES, INC.

(Exact name of registrant as specified in its charter)

 

 

Delaware

47-3048279

(State or other jurisdiction of

incorporation or organization)

(I.R.S. Employer

Identification No.)

 

 

65 Hayden Avenue, Lexington, MA

02421

(Address of principal executive offices)

(Zip Code)

(617) 674-9000

(Registrant’s telephone number, including area code)

 

Not Applicable

(Former name, former address and former fiscal year, if changed since last report)

 

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 (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.    Yes       No  

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).    Yes       No  

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

 

Large accelerated filer

Accelerated filer

Non-accelerated filer

Smaller reporting company

 

 

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.  

Indicate by check mark whether registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).    Yes      No  

 

As of August 9, 2021, there were 42,577,529 shares of registrant’s common stock outstanding.

 

 

 


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FORWARD-LOOKING STATEMENTS

This Quarterly Report on Form 10-Q, or Quarterly Report, contains forward-looking statements, which reflect our current views with respect to, among other things, our operations and financial performance. We make such forward looking statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. All statements other than statements of historical facts contained in this Quarterly Report, including statements regarding our strategy, future operations, future financial position, future revenue, projected costs, prospects, plan, objectives of management and expected market growth are forward-looking statements. You can identify these forward-looking statements by the use of words such as “outlook,” “believes,” “expects,” “potential,” “continues,” “may,” “will,” “should,” “seeks,” “approximately,” “predicts,” “intends,” “plans,” “estimates,” “anticipates” or the negative version of these words or other comparable words. Such forward-looking statements are subject to various risks and uncertainties. Accordingly, there are or will be important factors that could cause actual outcomes or results to differ materially from those indicated in these statements. We believe these factors include but are not limited to those described under “Risk Factors” and include, among other things:

our ability to continue as a going concern, including without limitation our ability to continue to advance the clinical development of our MMT candidates;

the success, cost and timing of our research and development activities, including statements regarding the timing of initiation and completion of clinical studies or clinical trials and related preparatory work, the period during which the results of the clinical studies or clinical trials will become available; 

our ability to advance any product candidate into or successfully complete any clinical trial or identify an alternative commercial pathway for such product candidate; 

our ability or the potential to successfully manufacture our product candidates for clinical studies, clinical trials or for commercial use, if approved; 

our ability to obtain funding for our operations, when needed, including funding necessary to complete further development and commercialization of our product candidates, if approved, and to further expand our propriety product platform;

the accuracy of our estimates regarding expenses, future revenue, capital requirements and needs for additional financing;

the potential for our identified research priorities to advance our product candidates or allow us to identify new product candidates; 

our expectations regarding the timing for proposed submissions of regulatory filings, including but not limited to any Investigational New Drug application filing or any New Drug Applications;

our ability to maintain regulatory approval, if obtained, of any of our current or future product candidates, and any related restrictions, limitations and/or warnings in the label of an approved product candidate; 

our ability to commercialize our products in light of the intellectual property rights of others; 

our plans to research, develop and commercialize our product candidates; 

our ability to attract collaborators with development, regulatory and commercialization expertise; 

the expected results pursuant to collaboration arrangements including the receipts of future payments that may arise pursuant to collaboration agreements;

existing and future agreements with third parties in connection with the research and development or commercialization of our product candidates, if approved;

the size and growth potential of the markets for our product candidates, and our ability to serve those markets either alone or in collaboration with others; 

the rate and degree of market acceptance of our product candidates; 

the success of competing therapies that are or become available to our customers;

our ability to contract with third-party suppliers and manufacturers and their ability to perform their obligations adequately;

our ability to attract and retain key scientific or management personnel;

the impact of changes in existing laws, regulations and guidance or the adoption of new laws, regulations and guidance;

our expectations regarding our ability to obtain and maintain intellectual property protection for our product candidates and other technologies;

the impact of the COVID-19 pandemic on our clinical trial programs and business generally, as well as our plans and expectations with respect to the timing and resumption of any development activities that may be temporarily paused;

the ultimate impact of the current coronavirus pandemic, or any other health epidemic, on our business, our clinical trials, our research programs, healthcare systems or the global economy as a whole; and

other risks and uncertainties, including those discussed in Part II, Item 1A, “Risk Factors” in this Quarterly Report.

 


Table of Contents

 

 

All of our forward-looking statements are as of the date of this Quarterly Report only. In each case, actual results may differ materially from such forward-looking information. We can give no assurance that such expectations or forward-looking statements will prove to be correct. An occurrence of or any material adverse change in one or more of the risk factors or risks and uncertainties referred to in this Quarterly Report or included in our other public disclosures or our other periodic reports or other documents or filings filed with or furnished to the Securities and Exchange Commission, or the SEC, could materially and adversely affect our business, prospects, financial condition and results of operations. Except as required by law, we do not undertake or plan to update or revise any such forward-looking statements to reflect actual results, changes in plans, assumptions, estimates or projections or other circumstances affecting such forward-looking statements occurring after the date of this Quarterly Report, even if such results, changes or circumstances make it clear that any forward-looking information will not be realized. Any public statements or disclosures by us following this Quarterly Report that modify or impact any of the forward-looking statements contained in this Quarterly Report will be deemed to modify or supersede such statements in this Quarterly Report.

We caution readers not to place undue reliance on any forward-looking statements made by us, which speak only as of the date they are made. We disclaim any obligation, except as specifically required by law and the rules of the SEC, to publicly update or revise any such statements to reflect any change in our 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.

 


Table of Contents

 

 

KALEIDO BIOSCIENCES, INC. AND SUBSIDIARIES

TABLE OF CONTENTS

 

 

 

Page Number

PART I: FINANCIAL INFORMATION

 

Item 1.

Condensed Consolidated Financial Statements (Unaudited)

2

 

Condensed Consolidated Balance Sheets

2

 

Condensed Consolidated Statements of Operations

3

 

Condensed Consolidated Statements of Stockholders' Equity

4

 

Condensed Consolidated Statements of Cash Flows

5

 

Notes to Condensed Consolidated Financial Statements

6

Item 2.

Management’s Discussion and Analysis of Financial Condition and Results of Operations

12

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

21

Item 4.

Controls and Procedures

21

PART II: OTHER INFORMATION

 

Item 1.

Legal Proceedings

22

Item 1A.

Risk Factors

22

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

22

Item 3.

Defaults Upon Senior Securities

22

Item 4.

Mine Safety Disclosures

22

Item 5.

Other Information

22

Item 6.

Exhibits

23

Signatures

24

 

 


Table of Contents

 

 

PART I—FINANCIAL INFORMATION

Item 1. Condensed Consolidated Financial Statements (Unaudited)

KALEIDO BIOSCIENCES, INC. AND SUBSIDIARIES

Condensed Consolidated Balance Sheets (Unaudited)

(in thousands, except share and per share data)

 

 

 

As of

 

 

 

June 30, 2021

 

 

December 31, 2020

 

Assets

 

 

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

71,979

 

 

$

46,222

 

Prepaid expenses and other current assets

 

 

2,624

 

 

 

2,499

 

Total current assets

 

 

74,603

 

 

 

48,721

 

Property and equipment, net

 

 

7,526

 

 

 

8,462

 

Restricted cash

 

 

2,161

 

 

 

2,161

 

Total assets

 

$

84,290

 

 

$

59,344

 

Liabilities and Stockholders’ Equity

 

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

 

Accounts payable

 

$

2,695

 

 

$

5,389

 

Accrued expenses and other current liabilities

 

 

5,907

 

 

 

8,636

 

Current term debt, net of unamortized debt discount

 

 

3,667

 

 

 

2,634

 

Total current liabilities

 

 

12,269

 

 

 

16,659

 

Long term debt, net of unamortized debt discount

 

 

17,677

 

 

 

18,375

 

Other liabilities

 

 

4,078

 

 

 

3,814

 

Total liabilities

 

 

34,024

 

 

 

38,848

 

Commitments and contingencies (Note 7)

 

 

 

 

 

 

 

 

Stockholders’ equity:

 

 

 

 

 

 

 

 

Preferred stock, $0.001 par value, 10,000,000 authorized;

   no shares issued or outstanding

 

 

 

 

 

 

Common stock, $0.001 par value, 150,000,000 shares authorized;

   42,571,380 and 36,022,811 shares issued and outstanding at June 30, 2021 and

   December 31, 2020, respectively

 

 

43

 

 

 

36

 

Additional paid-in capital

 

 

371,333

 

 

 

294,639

 

Accumulated deficit

 

 

(321,110

)

 

 

(274,179

)

Total stockholders' equity

 

 

50,266

 

 

 

20,496

 

Total liabilities and stockholders’ equity

 

$

84,290

 

 

$

59,344

 

 

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

2


Table of Contents

 

KALEIDO BIOSCIENCES, INC. AND SUBSIDIARIES

Condensed Consolidated Statements of Operations (Unaudited)

(in thousands, except share and per share data)

 

 

 

Three Months Ended

June 30,

 

 

Six Months Ended

June 30,

 

 

 

2021

 

 

2020

 

 

2021

 

 

2020

 

Revenue:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Collaboration revenue

 

$

211

 

 

$

250

 

 

$

508

 

 

$

250

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

17,633

 

 

 

12,833

 

 

 

34,818

 

 

 

25,970

 

General and administrative

 

 

5,785

 

 

 

5,559

 

 

 

11,245

 

 

 

11,476

 

Total operating expenses

 

 

23,418

 

 

 

18,392

 

 

 

46,063

 

 

 

37,446

 

Loss from operations

 

 

(23,207

)

 

 

(18,142

)

 

 

(45,555

)

 

 

(37,196

)

Other (expense) income:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Interest income

 

 

24

 

 

 

30

 

 

 

45

 

 

 

223

 

Interest expense

 

 

(705

)

 

 

(683

)

 

 

(1,414

)

 

 

(1,371

)

Other expense

 

 

(1

)

 

 

(127

)

 

 

(7

)

 

 

(129

)

Total other (expense) income, net

 

 

(682

)

 

 

(780

)

 

 

(1,376

)

 

 

(1,277

)

Net loss

 

$

(23,889

)

 

$

(18,922

)

 

$

(46,931

)

 

$

(38,473

)

Net loss per share —basic and diluted

 

$

(0.56

)

 

$

(0.59

)

 

$

(1.14

)

 

$

(1.24

)

Weighted-average common shares outstanding —basic and diluted

 

 

42,538,563

 

 

 

31,880,672

 

 

 

41,123,435

 

 

 

31,106,977

 

 

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

3


Table of Contents

 

KALEIDO BIOSCIENCES, INC. AND SUBSIDIARIES

Condensed Consolidated Statements of Stockholders Equity (Unaudited)

(in thousands, except share data)

 

 

 

Common Stock

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Shares

 

 

Amount

 

 

Additional

Paid-In

Capital

 

 

Accumulated

Deficit

 

 

Stockholders’

Equity

 

Balance at January 1, 2021

 

 

36,022,811

 

 

$

36

 

 

$

294,639

 

 

$

(274,179

)

 

 

20,496

 

Issuance of common stock, net of issuance costs $4,512

 

 

6,347,156

 

 

 

6

 

 

 

69,919

 

 

 

 

 

 

69,925

 

Exercise of stock options

 

 

63,331

 

 

 

 

 

 

352

 

 

 

 

 

 

352

 

Stock-based compensation

 

 

 

 

 

 

 

 

4,229

 

 

 

 

 

 

4,229

 

Common stock issued upon vesting of restricted stock units, net of 21,452 shares withheld for employee taxes

 

 

49,873

 

 

 

 

 

 

(186

)

 

 

 

 

 

(186

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

(23,042

)

 

 

(23,042

)

Balance at March 31, 2021

 

 

42,483,171

 

 

$

42

 

 

$

368,953

 

 

$

(297,221

)

 

$

71,774

 

Exercise of stock options

 

 

52,727

 

 

 

1

 

 

 

108

 

 

 

 

 

 

109

 

Stock-based compensation

 

 

 

 

 

 

 

 

2,376

 

 

 

 

 

 

2,376

 

Common stock issued upon vesting of restricted stock units, net of 15,237 shares withheld for employee taxes

 

 

35,482

 

 

 

 

 

 

(104

)

 

 

 

 

 

(104

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

(23,889

)

 

 

(23,889

)

Balance at June 30, 2021

 

 

42,571,380

 

 

$

43

 

 

$

371,333

 

 

$

(321,110

)

 

$

50,266

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Common Stock

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Shares

 

 

Amount

 

 

Additional

Paid-In

Capital

 

 

Accumulated

Deficit

 

 

Stockholders’

Equity

 

Balance at January 1, 2020

 

 

30,127,846

 

 

$

30

 

 

$

241,412

 

 

$

(192,559

)

 

$

48,883

 

Exercise of stock options

 

 

334,444

 

 

 

 

 

 

1,561

 

 

 

 

 

 

1,561

 

Stock-based compensation

 

 

 

 

 

 

 

 

2,725

 

 

 

 

 

 

2,725

 

Vesting of restricted shares

 

 

1,250

 

 

 

 

 

 

3

 

 

 

 

 

 

3

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

(19,551

)

 

 

(19,551

)

Balance at March 31, 2020

 

 

30,463,540

 

 

$

30

 

 

$

245,701

 

 

$

(212,110

)

 

$

33,621

 

Issuance of common stock, net of issuance costs $306

 

 

4,750,000

 

 

 

5

 

 

 

33,182

 

 

 

 

 

 

33,187

 

Exercise of stock options

 

 

143,089

 

 

 

 

 

 

620

 

 

 

 

 

 

620

 

Stock-based compensation

 

 

 

 

 

 

 

 

2,816

 

 

 

 

 

 

2,816

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

(18,922

)

 

 

(18,922

)

Balance at June 30, 2020

 

 

35,356,629

 

 

$

35

 

 

$

282,319

 

 

$

(231,032

)

 

$

51,322

 

 

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

4


Table of Contents

 

KALEIDO BIOSCIENCES, INC. AND SUBSIDIARIES

Condensed Consolidated Statements of Cash Flows (Unaudited)

(in thousands)

 

 

 

Six Months Ended June 30,

 

 

 

2021

 

 

2020

 

Operating activities:

 

 

 

 

 

 

 

 

Net loss

 

$

(46,931

)

 

$

(38,473

)

Reconciliation of net loss to net cash used in operating activities:

 

 

 

 

 

 

 

 

Depreciation and amortization

 

 

1,160

 

 

 

809

 

Stock-based compensation

 

 

6,605

 

 

 

5,541

 

Amortization of debt discount

 

 

356

 

 

 

263

 

Non-cash interest expense

 

 

175

 

 

 

172

 

Loss on disposal of fixed assets

 

 

10

 

 

 

114

 

Changes in:

 

 

 

 

 

 

 

 

Prepaid expenses and other assets

 

 

(125

)

 

 

(4,165

)

Accounts payable

 

 

(2,739

)

 

 

1,274

 

Accrued expense and other liabilities

 

 

(2,568

)

 

 

710

 

Net cash used in operating activities

 

 

(44,057

)

 

 

(33,755

)

Investing activities:

 

 

 

 

 

 

 

 

Purchase of property and equipment

 

 

(262

)

 

 

(1,896

)

Net cash used in investing activities

 

 

(262

)

 

 

(1,896

)

Financing activities:

 

 

 

 

 

 

 

 

Proceeds from exercise of stock options

 

 

461

 

 

 

2,181

 

Payments related to capital lease

 

 

 

 

 

(45

)

Issuance of common stock, net of issuance costs

 

 

69,925

 

 

 

33,182

 

Net settlement of vested restricted stock units to fund related employee statutory tax withholdings

 

 

(290

)

 

 

 

Payments of issuance costs related to debt

 

 

(20

)

 

 

 

Net cash provided by financing activities

 

 

70,076

 

 

 

35,318

 

Net increase (decrease) in cash, cash equivalents, and restricted cash

 

 

25,757

 

 

 

(333

)

Cash, cash equivalents, and restricted cash, beginning of period

 

 

48,383

 

 

 

73,526

 

Cash, cash equivalents, and restricted cash, end of period

 

$

74,140

 

 

$

73,193

 

Supplemental cash flow information

 

 

 

 

 

 

 

 

Interest paid

 

$

1,064

 

 

$

859

 

Supplemental disclosure of non-cash investing and financing activities

 

 

 

 

 

 

 

 

Purchases of property and equipment in accounts payable and accrued expenses

 

$

43

 

 

$

254

 

Offering costs incurred but unpaid at period end

 

$

 

 

$

277

 

Vesting of restricted stock

 

$

 

 

$

3

 

 

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

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KALEIDO BIOSCIENCES, INC. AND SUBSIDIARIES

Notes to Condensed Consolidated Financial Statements (Unaudited)

(Amounts in thousands, except share and per share amounts)

1. Nature of the Business, Basis of Presentation, and Going Concern

Kaleido Biosciences, Inc. and its wholly owned subsidiaries (collectively the “Company”) is a clinical-stage healthcare company that was incorporated in Delaware on January 27, 2015 and has a principal place of business in Lexington, Massachusetts. The Company was formed to use its differentiated, chemistry-driven approach to leverage the potential of the microbiome to treat disease and improve human health.

The Company is subject to risks common to companies in the biotechnology industry, including, but not limited to, successful development of technology, obtaining additional funding, protection of proprietary technology, compliance with government regulations, risks of failure of preclinical studies (including ex vivo assays), clinical studies and clinical trials, the need to obtain marketing approval for its drug candidates and if applicable, its consumer products, fluctuations in operating results, economic pressure impacting therapeutic pricing, dependence on key personnel, risks associated with changes in technologies, development by competitors of technological innovations and the ability to supply sufficient amounts of Microbiome Metabolic Therapies, (“MMT” or “MMTs”) at an acceptable quality level.

On June 4, 2020, the Company completed a public offering (the “Offering”), pursuant to which it issued and sold 4,750,000 shares of the common stock. The aggregate net proceeds received by the Company from the Offering were $33,182. On July 1, 2020, 185,000 shares were exercised under the Underwriters’ overallotment option for net proceeds of $1,260.                   

On August 4, 2020, the Company entered into an Equity Distribution Agreement (the “Sales Agreement”) with a sales agent for the sale of up to $50,000 of the Company’s shares of common stock, from time to time in an at-the-market public offering (the “ATM”). The sales agent is entitled to compensation at a fixed commission rate of 3.0% of the gross proceeds from the sale of the Company’s common stock pursuant to the Sales Agreement. During the year ended December 31, 2020, the Company sold 361,299 shares of its common stock under the ATM which resulted in aggregate net proceeds of $3,432 after payment of related commissions. During the quarter ended March 31, 2021, the Company sold 309,656 shares of its common stock which resulted in aggregate net proceeds of $4,860. No sales or common stock were made under the ATM during the quarter ended June 30, 2021. As of June 30, 2021, there was $41,451 available under the ATM.

On February 8, 2021, the Company completed a public offering (the “2021 Offering”), pursuant to which the Company issued and sold 6,037,500 shares of common stock for net proceeds of $65,265, which included the full exercise of the Underwriters’ overallotment option.

                             

The accompanying condensed consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. As of June 30, 2021, the Company had an accumulated deficit of $321,110. The Company expects to continue to generate operating losses and use cash in operations in the foreseeable future. As of June 30, 2021, the Company had cash and cash equivalents of $71,979, and management expects that the cash and cash equivalents at June 30, 2021 will be sufficient to fund its operating expenses and capital expenditure requirements into the second quarter of 2022. Based on its recurring losses from operations incurred since inception, expectation of continuing operating losses for the foreseeable future, and need to raise additional capital to finance its future operations, the Company has concluded that there is substantial doubt regarding the Company’s ability to continue as a going concern within one year after the date that these consolidated financial statements are issued. These financial statements do not include any adjustments that might result from the outcome of this uncertainty.

The Company will require substantial additional capital to fund its research and development and ongoing operating expenses. These capital requirements are expected to be funded through debt and equity offerings as well as possible strategic collaborations with other companies. If the Company is unable to raise additional funds when needed, it may be required to delay, reduce or eliminate its product development or future commercialization efforts, or grant rights to develop and market product candidates that the Company would otherwise prefer to develop and market itself. While there can be no assurance the Company will be able to successfully reduce operating expenses or raise additional capital, management believes that its historical success in managing cash flows and obtaining capital will continue in the foreseeable future.

 

A novel strain of coronavirus (COVID-19) was first identified in late 2019, and subsequently declared a global pandemic by the World Health Organization on March 11, 2020. As a result of the outbreak, many companies have experienced disruptions in their operations and in markets served. The Company has instituted some and may take additional temporary precautionary measures intended to help minimize the risk of the virus to its employees, including implementing a hybrid work environment, implementing safety measures for those employees currently going into the office to complete their work and limiting business-related travel.

 

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2. Summary of Significant Accounting Policies

Unaudited interim financial information

The condensed consolidated financial statements of the Company included herein have been prepared, without audit, pursuant to the rules and regulations of the Securities and Exchange Commission (the “SEC”). Certain information and footnote disclosures normally included in financial statements prepared in accordance with accounting principles generally accepted in the United States of America ("GAAP") have been condensed or omitted from this report, as is permitted by such rules and regulations. Accordingly, these consolidated financial statements should be read in conjunction with the financial statements and notes thereto included in the annual report on Form 10-K for the year ended December 31, 2020 filed with the SEC on March 3, 2021.

All intercompany transactions and balances of the subsidiaries have been eliminated in consolidation. In the opinion of management, the information furnished reflects all adjustments, all of which are of a normal and recurring nature, necessary for a fair representation of the results for the reported interim periods.

Use of Estimates 

The preparation of the consolidated financial statements in accordance with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the consolidated financial statements and the reported amounts of expenses during the reporting period. Actual results could differ from those estimates.

Collaboration Revenue

The Company analyzes its collaboration arrangements to assess whether they are within the scope of ASC Topic 808, Collaborative Arrangements (ASC 808), to determine whether such arrangements involve joint operating activities performed by parties that are both active participants in the activities and exposed to significant risks and rewards that are dependent on the commercial success of such activities. To the extent the arrangement is within the scope of ASC 808, the Company will assess whether aspects of the arrangement between it and their collaboration partner are within the scope of other accounting literature. If the Company concludes that some or all aspects of the arrangement represent a transaction with a customer, it will account for those aspects of the arrangement within the scope of ASC 606, Revenue from Contracts with Customers, by applying the five-step model described below. If the Company concludes that some or all aspects of the arrangement are within the scope of ASC 808 and do not represent a transaction with a customer, the Company will recognize its allocation of the shared costs incurred with respect to the jointly conducted activities as a component of the related expense in the period incurred.

The Company recognizes revenue after applying the following five steps:

 

 

1)

Identification of the contract, or contracts, with a customer,

 

2)

Identification of the performance obligations in the contract, including whether they are distinct within the context

of the contract

 

3)

Determination of the transaction price, including the constraint on variable consideration

 

4)

Allocation of the transaction price to the performance obligations in the contract

 

5)

Recognition of revenue when, or as, performance obligations are satisfied

 

If a contract is determined to be within the scope of ASC 606 at inception, the Company assesses the goods or services promised within such contract, determines which of those goods and services are performance obligations, and assesses whether each promised good or service is distinct. Promised goods and services are considered distinct provided that: (i) the customer can benefit from the good or service either on its own or together with other resources that are readily available to the customer (that is, the good or service is capable of being distinct) and (ii) the entity’s promise to transfer the good or service to the customer is separately identifiable from other promises in the contract (that is, the promise to transfer the good or service is distinct within the context of the contract). In assessing whether a promised good or service is distinct, the Company considers factors such as the research, manufacturing and commercialization capabilities of the collaboration partner and the availability of the associated expertise in the general marketplace. The Company also considers the intended benefit of the contract in assessing whether a promised good or service is separately identifiable from other promises in the contract. If a promised good or service is not distinct, an entity is required to combine that good or service with other promised goods or services until it identifies a bundle of goods or services that is distinct.

 

The Company may provide options to additional goods or services in such arrangements exercisable at a customer’s discretion. The Company assesses if these options provide a material right to the customer and if so, they are considered performance obligations. The identification of material rights requires judgments related to the determination of the value of the underlying good and services to the option exercise price. 

 

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The Company determines transaction price based on the amount of consideration the Company expects to receive for transferring the promised goods or services in the contract. Consideration may be fixed, variable, or a combination of both. The Company then allocates the transaction price to each performance obligation based on the relative standalone selling prices (“SSP”). SSP is determined at contract inception and is not updated to reflect changes between contract inception and when the performance obligations are satisfied. In developing the SSP for a performance obligation, the Company considers applicable market conditions and relevant entity-specific factors, including factors that were contemplated in negotiating the agreement with the customer and estimated costs.

 

If the consideration promised in a contract includes a variable amount, the Company estimates the amount of consideration to which it will be entitled by using the expected value method or the most likely amount method. The Company includes the unconstrained amount of estimated variable consideration in the transaction price. The amount included in the transaction price is constrained to the amount for which it is probable that a significant reversal of cumulative revenue recognized will not occur. At the end of each subsequent reporting period, the Company re-evaluates the estimated variable consideration included in the transaction price and any related constraint, and if necessary, adjusts its estimate of the overall transaction price.

 

The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied, either at a point in time or over time, and if over time recognition is based on the use of an output or input method.

Amounts received prior to satisfying the revenue recognition criteria are recorded as deferred revenue in the Company’s condensed consolidated balance sheets. If the related performance obligation is expected to be satisfied within the next twelve months this will be classified in current liabilities. Amounts recognized as revenue prior to receipt are recorded as other current assets in the Company's balance sheets. If the Company expects to have an unconditional right to receive the consideration in the next twelve months, this will be classified in other current assets.

 

Recently Issued Accounting Pronouncements

In February 2016, the FASB issued ASU No. 2016-02, Leases (“ASU 2016-02”), which applies to all leases and will require the Company to record most leases on the balance sheet. The Company will use a modified retrospective approach of adoption for ASU 2016-02. As an emerging growth company, this standard is required to be adopted on January 1, 2022, and the Company is evaluating the impact that the adoption of ASU 2016-02 will have on its consolidated financial statements. The Company expects to recognize a significant lease obligation and right to use asset upon adoption.

 

3. Fair Value Measurements

The following tables set forth by level, within the fair value hierarchy, the assets carried at fair value on a recurring basis:

 

 

 

Fair Value Measurements

as of June 30, 2021

 

 

 

Level 1

 

 

Level 2

 

 

Level 3

 

 

Total

 

Assets:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Money market funds included within cash and cash

   equivalents

 

$

25,413

 

 

 

 

 

 

 

 

$

25,413

 

Total

 

$

25,413

 

 

 

 

 

 

 

 

$

25,413

 

 

 

 

Fair Value Measurements

as of December 31, 2020

 

 

 

Level 1

 

 

Level 2

 

 

Level 3

 

 

Total

 

Assets:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Money market funds included within cash and cash

   equivalents

 

$

45,410

 

 

 

 

 

 

 

 

$

45,410

 

Total

 

$

45,410

 

 

 

 

 

 

 

 

$

45,410

 

 

The fair value of money market funds was measured by the Company based on quoted market prices.

Financial Instruments Not Recorded at Fair Value – The carrying value of cash, cash equivalents, restricted cash, accounts payable and accrued expenses that are reported on the condensed consolidated balance sheets approximate their fair value due to the short-term nature of these assets and liabilities. The carrying value of the long-term debt approximates fair value as evidenced by the recent refinancings.

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4. Property and Equipment, net

Property and equipment consist of the following:

 

 

 

As of

 

 

 

June 30, 2021

 

 

December 31, 2020

 

Laboratory equipment

 

$

7,374

 

 

$

6,843

 

Office and computer equipment

 

 

1,590

 

 

 

1,590

 

Leasehold improvements

 

 

1,910

 

 

 

1,910

 

Construction in process

 

 

1,291

 

 

 

1,612

 

Property and equipment – at cost

 

 

12,165

 

 

 

11,955

 

Less accumulated depreciation and amortization

 

 

(4,639

)

 

 

(3,493

)

Property and equipment – net

 

$

7,526

 

 

$

8,462

 

 

Depreciation and amortization expense for the three months ended June 30, 2021 and 2020 was $583 and $388, respectively.  Depreciation and amortization expense for the six months ended June 30, 2021 and 2020 was $1,160 and $809, respectively. During the six months ended June 30, 2021, the Company recorded gross fixed asset disposal of $24 and related accumulated depreciation of $14. During the six months ended June 30, 2020, the Company recorded gross fixed asset disposal of $1,036 and related accumulated depreciation of $922.

5. Accrued Expenses and Other Current Liabilities

Accrued expenses and other current liabilities consisted of the following:

 

 

 

As of

 

 

 

June 30, 2021

 

 

December 31, 2020

 

Payroll and benefits

 

$

1,710

 

 

$

2,943

 

Consulting service

 

 

218

 

 

 

1,049

 

Legal service

 

 

96

 

 

 

173

 

Research and development

 

 

2,815

 

 

 

3,010

 

Interest

 

 

175

 

 

 

181

 

Deferred revenue

 

 

189

 

 

 

498

 

Other

 

 

704

 

 

 

782

 

Accrued expenses and other current liabilities

 

$

5,907

 

 

$

8,636

 

 

6. Debt Financing

On December 31, 2019, the Company entered into a Credit Agreement (the “Credit Agreement”) with Hercules Capital, Inc. (the “Lender”). Under the Credit Agreement, the Company borrowed $22,500, and the Company has the option to draw down an additional $12,500 if certain milestones and conditions are met. The Company incurred fees of $410, which was paid to the Lender on the closing date. These amounts were recorded as a debt discount and are being amortized as interest expense using the effective interest method over the life of the Credit Agreement. The Credit Agreement also includes an end of term charge equal to 7.55% of the aggregate principal amount of all advances. The end of term charge, totaling $1,698 at June 30, 2021, was recognized as a debt discount and is reflected as a reduction in the carrying value of the debt and recorded in other long-term liabilities. The debt discount created by the end of term charge is being accreted and will be recognized as additional interest expense over the term of the Credit Agreement using the effective interest method.

The Credit Agreement contains customary representations and warranties, events of default and affirmative and negative covenants, including, among others, covenants that limit or restrict the Company’s ability to, among other things, incur additional indebtedness, merge or consolidate, make acquisitions, pay dividends or other distributions or repurchase equity, make investments, dispose of assets and enter into certain transactions with affiliates, in each case subject to certain exceptions. As security for its obligations under the Credit Agreement, the Company granted the Lender a first priority security interest on substantially all of the Company’s assets (other than intellectual property), and subject to certain exceptions.

The outstanding principal under the Credit Agreement has a 48-month term with interest only payments for the first 15 months, which period can be extended to up to 24 months, depending on the achievement of certain performance milestones. The principal bears interest at a rate equal to the greater of (i) 8.95% plus the prime rate minus 4.75% and (ii) 8.95%. The Credit Agreement includes mandatory prepayment provisions that require prepayment upon the occurrence of a change in control event.

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On June 15, 2020, the Company entered into a Second Amendment to Loan and Security Agreement (the “Second Amendment”). The Second Amendment was entered into for the primary purpose of amending the Credit Agreement as follows: (i) the second tranche of the term loan (the “Term Loan”) was terminated; (ii) amounts available under Tranche 3 of the Term Loan was increased to $12,500 from the previous $7,500 availability amount and its availability period is extended through December 15, 2021, subject to future approval by the Lender’s investment committee; (iii) the interest-only period was extended through July 31, 2021; (iv) the interest rate on borrowings is increased by 0.4%, such that the per annum interest rate on outstanding borrowings will be the greater of (a) 9.35% and (b) 9.35% plus the Wall Street Journal prime rate minus 3.25%; and (v) the variable amount and duration of a minimum cash covenant in the Agreement were amended. The Second Amendment has been accounted for as a modification and the Company incurred fees of $79, which was paid to the Lender on the closing date and were recorded as a debt discount, which will be amortized as interest expense using the effective interest method.

On April 30, 2021, the Company entered into a Third Amendment to Loan and Security Agreement (the “Third Amendment”). The Third Amendment was entered into for the primary purpose of amending the Credit Agreement as follows: (i) the interest-only period was extended through January 31, 2022; (ii) the second tranche of the term loan (the “Term Loan”) was reinstated and the related $5,000 is available to be drawn at the Company’s option on or before June 1, 2021; and (iii) the Minimum Cash Covenant was reduced from $22,500 to $15,000. The Company incurred fees of $20, which was paid to the Lender on the closing date and were recorded as a debt discount, which will be amortized as interest expense using the effective interest method.

 

Future principal payments under the Credit Agreement as of June 30, 2021 are as follows (in thousands):

 

2021

 

 

 

2022

 

 

9,776

 

2023

 

 

11,671

 

2024

 

 

1,053

 

Total future principal payments

 

 

22,500

 

Less unamortized debt discount

 

 

1,156

 

Total balance

 

$

21,344

 

 

    

 

7. Commitments and contingencies

Facilities Leases

 

In March 2018, the Company entered into a non-cancelable ten-year lease agreement for laboratory and office space in Lexington, Massachusetts. In March 2019, the Company exercised its option to lease additional space in the building. The lease expires in 2029, subject to one option to extend the lease for 10 years.

Rent expense for the three months ended June 30, 2021 and 2020 totaled $1,629 and $1,871, respectively. Rent expense for the six months ended June 30, 2021 and 2020 totaled $3,252 and $3,650. Future minimum lease payments under the non-cancelable operating leases consisted of the following as of June 30, 2021:

 

Year Ending December 31,

 

 

 

 

2021

 

$

3,038

 

2022

 

 

6,207

 

2023

 

 

6,393

 

2024

 

 

6,584

 

2025

 

 

6,782

 

Thereafter

 

 

25,502

 

 

 

$

54,506

 

 

 

8. Stockholders’ Equity

Modification of equity awards

 

On January 20, 2021, the Company entered into a separation agreement with the former Chief Medical Officer and Head of Research and Development of the Company, which amended an existing employment agreement and provided for changes in the term of service and compensation under the agreement. The outstanding options and restricted stock units held by the former Chief Medical Officer were modified to accelerate certain vesting provisions and the period of exercisability. As a result, the Company recorded stock-based compensation expense of $1,968 related to the incremental fair value of the modified awards during the first quarter of 2021. There

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were no award modifications for the quarter ended June 30, 2021.

 

9. Net Loss per Share

Basic and diluted net loss per common share is determined by dividing net loss by the weighted-average common shares outstanding during the period. The Company has computed diluted net loss per common share after giving consideration to all potentially dilutive common shares, including options to purchase common stock and unvested restricted common stock, outstanding during the period determined using the treasury stock method, except where the effect of including such securities would be anti-dilutive. Because the Company has reported net losses since inception, these potential common shares have been anti-dilutive and therefore basic and diluted net loss per share have been equivalent.

The following table presents securities that have been excluded from the computations of diluted weighted-average shares outstanding as they would be anti-dilutive:

 

 

 

As of June 30,

 

 

 

2021

 

 

2020

 

Options to purchase common stock

 

 

6,979,895

 

 

 

6,913,830

 

Restricted stock units

 

 

195,516

 

 

 

235,767

 

 

 

 

7,175,411

 

 

 

7,149,597

 

 

 

 

10. Revenue

In December 2019, the Company entered into a research collaboration agreement with Janssen’s World Without Disease Accelerator (“Janssen”), part of the Janssen Pharmaceutical Companies of Johnson & Johnson, to explore the potential for MMT to prevent the onset of childhood allergy and other atopic, immune and metabolic conditions.

The collaboration includes three milestones of research and development with deliverables due to Janssen at end of the milestone at which point Janssen will have 60 days to decide to proceed with the next milestone.

The Company assessed the Janssen collaboration agreement in accordance with ASC 808 and ASC 606 and concluded that it represents a contract with a customer and is within the scope of ASC 606. The promised goods and services represent one combined performance obligation and the entire transaction price will be allocated to that single combined performance obligation. In addition, the Company concluded the right to proceed with the following milestones does not provide any discounts to Janssen if it decides to proceed with the next milestones. As such, the Company concluded the milestone is not considered to be a material right. Each milestone is considered a separate contract and will reflect applicable standalone selling prices.

Under the Janssen collaboration agreement, Janssen is obligated to reimburse the Company for the costs incurred under an agreed upon research plan. Costs incurred are billed by the Company to Janssen at completion of each milestone. The Company recognizes revenue over the research period and as the performance obligation is satisfied using total estimated hours to be incurred throughout each milestone. For the quarter ended June 30, 2021, the Company recognized $211 as collaboration revenue under the collaboration agreement with Janssen, of which $92 was previously recorded deferred revenue within current liabilities on the Company’s condensed consolidated balance sheets relates to the Janssen collaboration agreement. The June 30, 2021 deferred revenue balance of $189 is comprised of $79 for amounts received prior to satisfying the revenue recognition criteria and $110 for work performed to be recognized upon completion of a milestone. The expected research term of this arrangement is expected to be completed during 2021, and the aggregate consideration to be received by the Company is not expected to be material.

 

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Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

The following discussion and analysis of our financial condition and results of operations should be read in conjunction with (i) our condensed consolidated financial statements and related notes appearing elsewhere in this Quarterly Report and audited financial statements the notes thereto contained in our current report on Form 10-K filed with the Securities and Exchange Commission (the “SEC”), on March 3, 2021. 

Investors and others should note that we announce material financial information to our investors using our investor relations website ( https://investors.kaleido.com/ ), SEC filings, press releases, public conference calls and webcasts. We use these channels as well as social media to communicate with the public about our company, our business, our product candidates, and other matters. It is possible that the information we post on social media could be deemed to be material information. Therefore, we encourage investors, the media, and others interested in our company to review the information we post on the social media channels listed on our investor relations website.

Overview

We are a clinical-stage healthcare company with a differentiated, chemistry-driven approach focused on targeting the microbiome to treat disease and improve human health. We have built a proprietary product platform for discovery and development that we believe will enable the rapid advancement of a broad portfolio of novel product candidates into human clinical studies under regulations supporting research with food. Our product candidates are Microbiome Metabolic Therapies (“MMT” or “MMTs”), which are designed to modulate the metabolic output and profile of the microbiome by driving the function and distribution of the gut’s existing microbes. We have an industrialized approach to the discovery and development of MMTs, and our initial MMTs are targeted glycans. Each targeted glycan is an ensemble of complex carbohydrates that is intended to modulate microbial metabolism and community composition to drive a specific biological response. We believe our MMTs have the potential to be novel treatments across a variety of diseases and conditions.     

The human microbiome is generally a community of more than 30 trillion microbes, organisms that include bacteria, viruses, archaea and fungi, which reside on and inside the human body. By evolving together over thousands of years, microbes and humans have developed an intricate and mutually beneficial relationship. Given the profound impact that microbes have on human health, this highly complex microbial ecosystem has been referred to as a “newly discovered organ.” There is a growing body of research that links a healthy microbiome with overall human health, while dysbiosis, or imbalance, in the microbiome has been correlated with numerous human conditions, including those that can cause significant morbidity and mortality. Some of these conditions include irritable bowel syndrome, Parkinson’s disease, diabetes, metabolic syndrome, cancer, allergies and ulcerative colitis. The gut microbiome remains a largely untapped frontier in healthcare, and we believe that we are uniquely positioned to succeed in translating its promise into solutions for human health.

To date, therapeutic approaches to the microbiome have focused primarily on adding or subtracting bacteria, either through fecal microbiota transplant, the introduction of a consortia of bacteria, single strain approaches or antibiotics. We believe our approach is novel in that we seek to deliver MMTs that drive the function and distribution of the gut microbiome’s existing microbes, enabling an industrialized approach to treat disease and improve human health.

We have developed proprietary synthetic chemistry technologies that allow us to create MMT candidates. We believe the key characteristics of our MMT candidates include that they are orally administered, have limited systemic exposure and are selectively metabolized, structurally diverse, readily scalable, novel and proprietary. We believe that each of our MMT candidates works through one or more mechanisms of action, including decreasing production of metabolites, such as ammonia and trimethylamine generated by bacteria in the microbiome; increasing production of metabolites, such as short chain fatty acids generated by bacteria in the microbiome; and advantaging or disadvantaging certain existing species in the microbiome community (such as decreasing pathogenic bacteria).

Utilizing our proprietary product platform, we have created a library of more than 1,500 MMT candidates to probe the structure-activity relationships of our MMTs. Our MMT library is continuously growing as we continue to invest in techniques and technologies for chemical synthesis. Our MMT candidates and aspects of the proprietary product platform are supported by our expanding intellectual property portfolio, that includes 14 U.S. patents, 4 European Patent Office, or EPO, patents and more than 130 non-provisional applications pending worldwide as of July 23, 2021

Through the use of our proprietary product platform, the effect of MMTs is first tested ex vivo using a highly multiplexed advanced screening platform with microbiome communities from both healthy and patient populations. To establish how MMTs impact therapeutically relevant pathways, a broad range of bioanalytical technologies are used to analyze metabolites, effector molecules and host responses, while sequencing determines key microbial community changes. A candidate MMT may then either undergo further testing in animal models or go straight into clinical evaluation in humans.

Abbreviated development may be possible because in some cases MMTs are synthesized from naturally occurring carbohydrate monomers, are orally administered with limited systemic exposure and can be designated as Generally Recognized as Safe (GRAS).

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This enables us to gain valuable insights into our MMT candidates’ effects on the microbiome and human health before choosing to allocate additional time and capital to proceed to develop a drug product candidate under an IND or regulatory equivalent outside the United States.

In our human clinical studies, we are able to measure safety, tolerability and potential markers of effect, which allows us to assess the potential use of our MMT candidates in humans. Furthermore, we initiated our first Phase 2 clinical trial under an IND approximately two years after conducting our first ex vivo screening. We believe that this provides support for our belief that our approach is more expeditious and cost efficient than traditional drug development.

 

 

Since our inception in 2015, we have devoted substantially all of our resources to building our proprietary product platform, developing our pipeline of MMT candidates, building our intellectual property portfolio and process development and manufacturing function, business planning, raising capital and providing general and administrative support for these operations. To date, we have primarily financed our operations through public offering of our equity securities, private placement of our convertible preferred stock and borrowings of long-term debt.

We have incurred significant net losses since inception and expect to continue to incur net operating losses for the foreseeable future. We expect to continue to incur significant expenses and increasing operating losses for at least the next several years. We expect that our expenses and capital requirements will increase substantially in connection with our ongoing activities, particularly if and as we:

conduct preclinical studies, clinical studies and clinical trials for our product candidates;

advance the development of our product candidate pipeline;

continue to discover and develop additional product candidates;

continue to build out our proprietary pr