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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 20549

 

FORM 10-Q

 

(Mark One)

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: 001-39615

 

CODIAK BIOSCIENCES, INC.

(Exact Name of Registrant as Specified in its Charter)

 

 

Delaware

47-4926530

(State or other jurisdiction of

incorporation or organization)

(I.R.S. Employer Identification No.)

 

35 CambridgePark Drive, Suite 500

Cambridge, MA

02140

(Address of principal executive offices)

(Zip Code)

Registrant’s telephone number, including area code: (617949-4100

 

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, par value $0.0001 per share

 

CDAK

 

Nasdaq Global 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, smaller reporting company, or an emerging growth company. See the 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 the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).     Yes      No  

As of August 2, 2021, the registrant had 22,331,222 shares of common stock, $0.0001 par value per share, outstanding.

 

 

 

 


 

Table of Contents

 

 

 

Page

PART I.

 

 

Item 1.

Financial Statements (Unaudited)

3

 

Condensed Consolidated Balance Sheets as of June 30, 2021 and December 31, 2020

3

 

Condensed Consolidated Statements of Operations and Comprehensive Loss for the three and six months ended June 30, 2021 and 2020

4

 

Condensed Consolidated Statements of Redeemable Convertible Preferred Stock and Stockholders' Equity (Deficit) for the three and the six months ended June 30, 2021 and 2020

5

 

Condensed Consolidated Statements of Cash Flows for the six months ended June 30, 2021 and 2020

7

 

Notes to Condensed Consolidated Financial Statements

8

Item 2.

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

30

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

44

Item 4.

Controls and Procedures

44

PART II.

 

45

Item 1.

Legal Proceedings

45

Item 1A.

Risk Factors

45

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

45

Item 3.

Defaults Upon Senior Securities

45

Item 4.

Mine Safety Disclosures

45

Item 5.

Other Information

45

Item 6.

Exhibits

46

Signatures

47

 

 

i


 

 

  SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

 

This Quarterly Report on Form 10-Q contains express or implied forward-looking statements that are based on our management’s belief and assumptions and on information currently available to our management. Although we believe that the expectations reflected in these forward-looking statements are reasonable, these statements relate to future events or our future operational or financial performance, and involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by these forward-looking statements. Forward-looking statements contained in this Quarterly Report on Form 10-Q include, but are not limited to, statements about:

 

 

 

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

 

 

 

the design and conduct of our clinical trials of exoSTING and exoIL-12 and planned clinical trial of exoASO-STAT6;

 

 

 

our ability to successfully advance any our engEx product candidates into and through clinical trials, or obtain marketing approval;

 

 

 

the potential and capabilities of our engEx Platform, engEx product candidates and engEx discovery programs;

 

 

 

the potential and capability of our engEx Platform to generate additional engEx product candidates;

 

 

 

our ability to successfully manufacture, or procure from third parties sufficient supply of, our product candidates for preclinical studies, clinical trials or commercial use, if approved;

 

 

 

our ability to establish, operate and maintain our in-house Phase 1/2 clinical manufacturing facility;

 

 

 

our ability to utilize our engEx Platform to engineer exosomes to carry various biologically active drug molecules, target specific cell types or cellular pathways or enhance the value of existing drug modalities;

 

 

 

the potential indications that we may be able to target with engineered exosomes generated from our engEx Platform;

 

 

 

the size, composition and growth potential of the patient populations and markets we intend to target with our engEx product candidates and our ability to develop and commercialize engEx product candidates to address those patient populations and markets;

 

 

 

the ability and willingness of our current and future collaborators to continue research and development activities relating to our engEx exosomes;

 

 

 

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

 

 

 

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

 

 

 

our ability to license intellectual property relating to our product candidates and to comply with our existing license and collaboration agreements;

 

 

 

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

 

 

 

developments relating to the use of exosomes to develop therapeutics;

 

 

 

the success of competing therapies that are or become available;

 

 

 

our ability to obtain funding for our operations, including funding necessary to complete further development and commercialization of our product candidates;

 

 

 

the commercialization of our product candidates, if approved;

 

 

 

our plans to research, develop and commercialize our engEx product candidates and enhance the capabilities of our engEx Platform;

 

 

 

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

1


 

 

 

 

 

future agreements with third parties in connection with the commercialization of our product candidates and any other approved product;

 

 

 

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

 

 

 

regulatory developments in the United States and foreign countries;

 

 

 

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

 

 

 

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

 

 

 

our expectations regarding the time during which we will be an emerging growth company under the JOBS Act;

 

 

 

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

 

 

 

the impact of laws and regulations; and

 

 

 

the direct or indirect impact of the COVID-19 pandemic on our business, operations, development timelines and the markets and communities in which we and our partners, collaborators, vendors and customers operate.

 

In some cases, you can identify forward-looking statements by terminology such as “may,” “should,” “expects,” “intends,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “continue” or the negative of these terms or other comparable terminology. These statements are only predictions. You should not place undue reliance on forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, which are, in some cases, beyond our control and which could materially affect results. Factors that may cause actual results to differ materially from current expectations include, among other things, those listed above under “Summary of the Material Risks Associated with Our Business” and under the section titled “Risk Factors” and elsewhere in this Quarterly Report on Form 10-Q. If one or more of these risks or uncertainties occur, or if our underlying assumptions prove to be incorrect, actual events or results may vary significantly from those implied or projected by the forward-looking statements. No forward-looking statement is a guarantee of future performance. You should read this Quarterly Report on Form 10-Q and the documents that we reference in this Quarterly Report on Form 10-Q and have filed with the Securities and Exchange Commission as exhibits hereto completely and with the understanding that our actual future results may be materially different from any future results expressed or implied by these forward-looking statements.

 

The forward-looking statements in this Quarterly Report on Form 10-Q represent our views as of the date of this Quarterly Report on Form 10-Q. We anticipate that subsequent events and developments will cause our views to change. However, while we may elect to update these forward-looking statements at some point in the future, we have no current intention of doing so except to the extent required by applicable law. You should therefore not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this Quarterly Report on Form 10‑Q.

 

This Quarterly Report on Form 10-Q also contains estimates, projections and other information concerning our industry, our business and the markets for our product candidates. Information that is based on estimates, forecasts, projections, market research or similar methodologies is inherently subject to uncertainties and actual events or circumstances may differ materially from events and circumstances that are assumed in this information. Unless otherwise expressly stated, we obtained this industry, business, market, and other data from our own internal estimates and research as well as from reports, research surveys, studies, and similar data prepared by market research firms and other third parties, industry, medical and general publications, government data and similar sources. While we are not aware of any misstatements regarding any third-party information presented in this Quarterly Report on Form 10-Q, their estimates, in particular as they relate to projections, involve numerous assumptions, are subject to risks and uncertainties and are subject to change based on various factors, including those discussed under the section titled “Risk Factors” and elsewhere in our Annual Report on Form 10-K for the year ended December 31, 2020, or the Annual Report, and this Quarterly Report on Form 10-Q.

 

NOTE REGARDING COMPANY REFERENCES

 

Unless the context otherwise requires, the terms “Codiak,” “the Company,” “we,” “us,” and “our” in this Form 10-Q refer to Codiak BioSciences, Inc. and its consolidated subsidiaries.

2


 

 

Item 1. Financial Statements

 

CODIAK BIOSCIENCES, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(Unaudited, in thousands, except share and per share data)

 

 

 

JUNE 30,

2021

 

 

DECEMBER 31,

2020

 

Assets

 

 

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

113,681

 

 

$

88,915

 

Prepaid expenses and other current assets

 

 

5,641

 

 

 

4,843

 

Total current assets

 

 

119,322

 

 

 

93,758

 

Property and equipment, net

 

 

30,263

 

 

 

31,410

 

Restricted cash, net of current portion

 

 

4,170

 

 

 

4,170

 

Operating right-of-use assets

 

 

21,519

 

 

 

22,003

 

Total assets

 

$

175,274

 

 

$

151,341

 

Liabilities and Stockholders’ Equity

 

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

 

Accounts payable

 

$

1,782

 

 

$

2,018

 

Accrued expenses

 

 

7,689

 

 

 

8,870

 

Deferred revenue

 

 

9,117

 

 

 

5,281

 

Operating lease liabilities

 

 

2,333

 

 

 

1,482

 

Total current liabilities

 

 

20,921

 

 

 

17,651

 

Long-term liabilities:

 

 

 

 

 

 

 

 

Deferred revenue, net of current portion

 

 

41,746

 

 

 

57,416

 

Note payable, net of discount

 

 

25,230

 

 

 

24,960

 

Operating lease liabilities, net of current portion

 

 

35,306

 

 

 

36,540

 

Other long-term liabilities

 

 

207

 

 

207

 

Total liabilities

 

 

123,410

 

 

 

136,774

 

Commitments and contingencies (Note 8)

 

 

 

 

 

 

 

 

Stockholders’ equity:

 

 

 

 

 

 

 

 

Common stock, $0.0001 par value; 150,000,000 shares authorized as of June 30, 2021

   and December 31, 2020; 22,272,975 and 18,787,579 shares issued and outstanding

   as of June 30, 2021 and December 31, 2020, respectively

 

 

2

 

 

 

2

 

Additional paid-in capital

 

 

372,069

 

 

 

302,655

 

Accumulated deficit

 

 

(320,207

)

 

 

(288,090

)

Total stockholders’ equity

 

 

51,864

 

 

 

14,567

 

Total liabilities and stockholders’ equity

 

$

175,274

 

 

$

151,341

 

 

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

3


 

CODIAK BIOSCIENCES, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

(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

 

$

890

 

 

$

187

 

 

$

14,081

 

 

$

321

 

Total revenue

 

 

890

 

 

 

187

 

 

 

14,081

 

 

 

321

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

15,419

 

 

 

11,622

 

 

 

31,969

 

 

 

30,013

 

General and administrative

 

 

6,937

 

 

 

4,358

 

 

 

13,525

 

 

 

8,591

 

Total operating expenses

 

 

22,356

 

 

 

15,980

 

 

 

45,494

 

 

 

38,604

 

Loss from operations

 

 

(21,466

)

 

 

(15,793

)

 

 

(31,413

)

 

 

(38,283

)

Other income (expense):

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Interest expense

 

 

(704

)

 

 

(294

)

 

 

(1,401

)

 

 

(589

)

Interest income

 

 

9

 

 

 

19

 

 

 

14

 

 

 

242

 

Other income

 

 

352

 

 

 

155

 

 

 

683

 

 

 

215

 

Total other expense, net

 

 

(343

)

 

 

(120

)

 

 

(704

)

 

 

(132

)

Net loss

 

$

(21,809

)

 

$

(15,913

)

 

$

(32,117

)

 

$

(38,415

)

Cumulative dividends on redeemable convertible

   preferred stock

 

 

 

 

 

(3,420

)

 

 

 

 

 

(6,839

)

Net loss attributable to common stockholders

 

$

(21,809

)

 

$

(19,333

)

 

$

(32,117

)

 

$

(45,254

)

Net loss per share attributable to common stockholders,

   basic and diluted

 

$

(0.99

)

 

$

(6.44

)

 

$

(1.51

)

 

$

(15.07

)

Weighted average common shares outstanding, basic and

   diluted

 

 

22,117,593

 

 

 

3,003,887

 

 

 

21,230,424

 

 

 

3,002,773

 

Comprehensive loss:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss

 

$

(21,809

)

 

$

(15,913

)

 

$

(32,117

)

 

$

(38,415

)

Other comprehensive loss:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Unrealized loss on investments, net of tax of $0

 

 

 

 

 

(2

)

 

 

 

 

 

(43

)

Total other comprehensive loss

 

 

 

 

 

(2

)

 

 

 

 

 

(43

)

Comprehensive loss

 

$

(21,809

)

 

$

(15,915

)

 

$

(32,117

)

 

$

(38,458

)

 

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

 

4


 

 

CODIAK BIOSCIENCES, INC.

CONDENSED CONSOLIDATED STATEMENTS OF REDEEMABLE CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ EQUITY (DEFICIT)

FOR THE THREE AND SIX MONTHS ENDED JUNE 30, 2021 AND 2020

(Unaudited, in thousands, except share data)

 

 

 

SERIES A

REDEEMABLE

CONVERTIBLE

PREFERRED

STOCK

 

 

SERIES B

REDEEMABLE

CONVERTIBLE

PREFERRED

STOCK

 

 

SERIES C

REDEEMABLE

CONVERTIBLE

PREFERRED

STOCK

 

 

 

COMMON

STOCK

 

 

ADDITIONAL

PAID-IN

 

 

ACCUM-

ULATED

OTHER

COMPRE-

HENSIVE

(LOSS)

 

 

ACCUM-

ULATED

 

 

TOTAL

STOCK-

HOLDERS

EQUITY

 

 

 

SHARES

 

 

AMOUNT

 

 

SHARES

 

 

AMOUNT

 

 

SHARES

 

 

AMOUNT

 

 

 

SHARES

 

 

AMOUNT

 

 

CAPITAL

 

 

INCOME

 

 

DEFICIT

 

 

(DEFICIT)

 

Balance at March 31, 2021

 

 

 

 

$

 

 

 

 

 

$

 

 

 

 

 

$

 

 

 

 

21,996,886

 

 

$

2

 

 

$

367,112

 

 

$

 

 

$

(298,398

)

 

$

68,716

 

Exercise of options to purchase common stock

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

276,089

 

 

 

 

 

 

2,454

 

 

 

 

 

 

 

 

 

2,454

 

Stock-based compensation

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

2,690

 

 

 

 

 

 

 

 

 

2,690

 

Issuance costs related to common stock

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(187

)

 

 

 

 

 

 

 

 

(187

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(21,809

)

 

 

(21,809

)

Balance at June 30, 2021

 

 

 

 

$

 

 

 

 

 

$

 

 

 

 

 

$

 

 

 

 

22,272,975

 

 

$

2

 

 

$

372,069

 

 

$

 

 

$

(320,207

)

 

$

51,864

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance at March 31, 2020

 

 

33,200,000

 

 

$

44,831

 

 

 

20,583,328

 

 

$

82,292

 

 

 

20,204,079

 

 

$

91,033

 

 

 

 

3,002,380

 

 

$

 

 

$

2

 

 

$

2

 

 

$

(216,984

)

 

$

(216,980

)

Issuance of Series B redeemable convertible

   preferred stock in conjunction with sponsored

   research agreement

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Exercise of options to purchase common stock

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

8,472

 

 

 

 

 

 

86

 

 

 

 

 

 

 

 

 

86

 

Accretion of preferred stock to redemption value

 

 

 

 

 

662

 

 

 

 

 

 

1,232

 

 

 

 

 

 

1,526

 

 

 

 

 

 

 

 

 

 

(1,477

)

 

 

 

 

 

(1,943

)

 

 

(3,420

)

Stock-based compensation

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

1,391

 

 

 

 

 

 

 

 

 

1,391

 

Unrealized loss on investments

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(2

)

 

 

 

 

 

(2

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(15,913

)

 

 

(15,913

)

Balance at June 30, 2020

 

 

33,200,000

 

 

$

45,493

 

 

 

20,583,328

 

 

$

83,524

 

 

 

20,204,079

 

 

$

92,559

 

 

 

 

3,010,852

 

 

$

 

 

$

2

 

 

$

 

 

$

(234,840

)

 

$

(234,838

)

 

5


 

 

 

 

SERIES A

REDEEMABLE

CONVERTIBLE

PREFERRED

STOCK

 

 

SERIES B

REDEEMABLE

CONVERTIBLE

PREFERRED

STOCK

 

 

SERIES C

REDEEMABLE

CONVERTIBLE

PREFERRED

STOCK

 

 

 

COMMON

STOCK

 

 

ADDITIONAL

PAID-IN

 

 

ACCUM-

ULATED

OTHER

COMPRE-

HENSIVE

(LOSS)

 

 

ACCUM-

ULATED

 

 

TOTAL

STOCK-

HOLDERS

EQUITY

 

 

 

SHARES

 

 

AMOUNT

 

 

SHARES

 

 

AMOUNT

 

 

SHARES

 

 

AMOUNT

 

 

 

SHARES

 

 

AMOUNT

 

 

CAPITAL

 

 

INCOME

 

 

DEFICIT

 

 

(DEFICIT)

 

Balance at December 31, 2020

 

 

 

 

$

 

 

 

 

 

$

 

 

 

 

 

$

 

 

 

 

18,787,579

 

 

$

2

 

 

$

302,655

 

 

$

 

 

$

(288,090

)

 

$

14,567

 

Exercise of options to purchase common stock

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

322,896

 

 

 

 

 

 

2,770

 

 

 

 

 

 

 

 

 

2,770

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

4,963

 

 

 

 

 

 

 

 

 

4,963

 

Issuance of common stock upon public

   offering, net of issuance costs of $560

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

3,162,500