8-K
false 0001659352 0001659352 2021-11-04 2021-11-04

 

 

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 4, 2021

 

 

Codiak BioSciences, Inc.

(Exact name of registrant as specified in its charter)

 

 

 

Delaware   001-39615   47-4926530

(State or other jurisdiction of

incorporation or organization)

 

(Commission

File Number)

 

(I.R.S. Employer

Identification Number)

35 CambridgePark Drive, Suite 500

Cambridge, MA 02140

(Address of principal executive offices and zip code)

(617) 949-4100

(Registrant’s telephone number, including area code)

 

 

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:

 

 

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, par value $0.0001 per share   CDAK   Nasdaq Global 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 4, 2021, Codiak BioSciences, Inc. (the “Company”) issued a press release announcing its financial results for the fiscal quarter ended September 30, 2021. A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated by reference herein.

The information furnished under this Item 2.02 and in the accompanying Exhibit 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 incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act regardless of any general incorporation language in such filing, unless expressly incorporated by specific reference in such filing.

Item 9.01 - Financial Statements and Exhibits

(d) Exhibits

 

Exhibit
Number

  

Description

99.1    Press release, dated November 4, 2021, by Codiak BioSciences, Inc.
104    Cover Page Interactive Data File (embedded within the Inline XBRL document).


SIGNATURE

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.

 

Date: November 4, 2021     Codiak BioSciences, Inc.
    By:  

/s/ Douglas E. Williams

    Name:   Douglas E. Williams, Ph.D.
    Title:   Chief Executive Officer and President
EX-99.1

Exhibit 99.1

 

LOGO

Codiak BioSciences Reports Third Quarter 2021 Financial Results and Recent Operational Progress

– Announced strategic long-term exosome manufacturing collaboration with Lonza –

– Initial data readout from exoSTING clinical trial expected in Q4 2021; initial data from

exoIL-12 trial in CTCL patients now anticipated in H1 2022 –

– Investigational New Drug (IND) application filing for exoASO-STAT6 expected in Q4 2021 –

– Preclinical data showing new potential therapeutic applications for three engineered exosome

candidates to be presented during SITC 2021 next week –

CAMBRIDGE, Mass., November 4, 2021 — Codiak BioSciences, Inc. (NASDAQ: CDAK), a clinical-stage biopharmaceutical company pioneering the development of exosome-based therapeutics as a new class of medicines, today reported third quarter 2021 financial results and recent operational progress.

“We made steady progress in the third quarter toward our goals for Codiak’s pipeline,” said Douglas E. Williams, Ph.D., President and Chief Executive Officer of Codiak. “Patient dosing and follow up in the Phase 1/2 trial of exoSTING has proceeded well, and we anticipate providing preliminary safety and pharmacologic data in patients from the initial dose escalation cohorts shortly. Enrollment in the CTCL portion of our exoIL-12 Phase 1 trial has ramped more slowly than anticipated due predominantly to COVID-related restrictions in the UK, and based on the latest correspondence with our sites, we now estimate that data will be available in the first half of next year. Our recently announced strategic collaboration with Lonza affirms that we are at the forefront of a promising new therapeutic modality. This partnership will expand and accelerate the creation of new exosome production technologies and secures a manufacturing partner for our later-stage clinical and potential commercial material.”

Third Quarter 2021 and Recent Highlights

 

   

Entered into strategic exosome manufacturing collaboration with Lonza, which includes the pending acquisition of Codiak’s manufacturing site in Lexington, MA and the formation of a joint Center of Excellence for exosome manufacturing. Under terms of the agreement, Codiak will receive approximately $65 million of in-kind manufacturing services for its clinical-stage programs, while retaining its core exosome engineering and loading expertise and pipeline. Lonza will assume operation of the Lexington facility.

 

   

Continued to progress subject dosing and follow up in the Phase 1/2 clinical trial of exoSTING (CDK-002) for the treatment of advanced/metastatic, recurrent and injectable solid tumors

 

   

Advanced cutaneous T cell lymphoma (CTCL) portion of Phase 1 trial of exoIL-12 (CDK-003)

 

   

Completed IND-enabling studies for exoASO-STAT6 (CDK-004) for the intravenous treatment of myeloid-rich cancers

 

   

Welcomed Lini Pandite, MBChB, MBA to Board of Directors

Anticipated Milestones and Events

 

   

Three poster presentations at the 36th Annual Meeting of the Society for Immunotherapy of Cancer (SITC 2021) on November 12 and 13, including new preclinical data on exoASO-STAT6 in hepatocellular carcinoma, exoSTING in leptomeningeal disease and the combination of exoSTING and exoIL-12 in solid tumors

 

   

Initial safety, PK, and PD data from dose escalation cohorts 1-3 on the Phase 1/2 trial of exoSTING in patients with advanced/metastatic solid tumors with injectable lesions expected in the fourth quarter of 2021

 

1


   

IND filing for exoASO-STAT6 anticipated during the fourth quarter of 2021

 

   

Initial safety, PK/PD and efficacy data in CTCL patients are now expected in the first half of next year due predominantly to COVID-related restrictions in the U.K. that are impacting the Phase 1 clinical trial sites for exoIL-12 (CDK-003)

Third Quarter 2021 Financial Results

Total revenues for the quarter ended September 30, 2021, were $1.2 million, compared to $1.0 million for the same period in 2020. This increase was due to deferred revenue recognized from ongoing research and development collaborations.

Net loss for the quarter ended September 30, 2021, was $21.7 million, compared to a net loss of $35.3 million for the same period in 2020. Net loss for the quarter was driven primarily by clinical development, general and administrative, and personnel expenses, and ongoing development of the engEx Platform.

Research and development expenses were $15.5 million for the quarter ended September 30, 2021, compared to $30.6 million for the same period in 2020. The decrease in research and development expenses in the third quarter reflects a one-time payment to Kayla Therapeutics S.A.S. under a license agreement in the prior year, partially offset by increases in personnel costs and other engEx platform costs, including manufacturing and preclinical costs as we progressed Codiak’s lead candidates into the clinic.

General and administrative expenses were $7.2 million for the quarter ended September 30, 2021, compared to $5.3 million for the same period in 2020. The increase was driven primarily by an increase in general business expenses, including corporate insurance costs, and additional general and administrative headcount to support our overall growth and our transition to becoming a public company.

As of September 30, 2021, Codiak had cash and cash equivalents of approximately $98.6 million.

About Codiak BioSciences

Codiak is a clinical-stage biopharmaceutical company pioneering the development of exosome-based therapeutics, a new class of medicines with the potential to transform the treatment of a wide spectrum of diseases with high unmet medical need. By leveraging the biology of exosomes as natural intercellular transfer mechanisms, Codiak has developed its proprietary engEx Platform to expand upon the innate properties of exosomes to design, engineer and manufacture novel exosome therapeutic candidates. Codiak has utilized its engEx Platform to generate a deep pipeline of engineered exosomes aimed at treating a broad range of disease areas, spanning oncology, neuro-oncology, neurology, and infectious disease.

Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including, among other things, statements concerning the development and therapeutic potential of exoSTING and exoIL-12, including timing of release of data from clinical trials and the results of those trials, statements concerning the development of exoASO-STAT6, including the timing of IND filing and initiation of clinical trials, and statements regarding the capabilities and potential of Codiak’s engEx Platform and engineered exosomes generally. Any forward-looking statements in this press release are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. For a discussion of these risks and uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the section entitled “Risk Factors” in Codiak’s Annual Report on Form 10-K for the year ended December 31, 2020, and in subsequent filings with the Securities and Exchange Commission, as well as discussions of potential risks, uncertainties and other important factors in Codiak’s subsequent filings with the Securities and Exchange Commission. All information in this press release is current as of the date of this report, and Codiak undertakes no duty to update this information unless required by law.

- financial tables follow –


CODIAK BIOSCIENCES, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

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

 

     SEPTEMBER 30,
2021
    DECEMBER 31,
2020
 

Assets

    

Current assets:

    

Cash and cash equivalents

   $ 98,584     $ 88,915  

Prepaid expenses and other current assets

     5,329       4,843  

Total current assets

     103,913       93,758  

Property and equipment, net

     29,384       31,410  

Restricted cash, net of current portion

     4,170       4,170  

Operating right-of-use assets

     21,258       22,003  
  

 

 

   

 

 

 

Total assets

   $ 158,725     $ 151,341  
  

 

 

   

 

 

 

Liabilities and Stockholders’ Equity

    

Current liabilities:

    

Accounts payable

   $ 1,998     $ 2,018  

Accrued expenses

     9,315       8,870  

Deferred revenue

     9,352       5,281  

Operating lease liabilities

     2,438       1,482  
  

 

 

   

 

 

 

Total current liabilities

     23,103       17,651  

Long-term liabilities:

    

Deferred revenue, net of current portion

     41,393       57,416  

Note payable, net of discount

     25,352       24,960  

Operating lease liabilities, net of current portion

     34,664       36,540  

Other long-term liabilities

     207       207  
  

 

 

   

 

 

 

Total liabilities

     124,719       136,774  
  

 

 

   

 

 

 

Commitments and contingencies (Note 8)

    

Stockholders’ equity:

    

Common stock, $0.0001 par value; 150,000,000 shares authorized as of September 30, 2021 and December 31, 2020; 22,361,305 and 18,787,579 shares issued and outstanding as of September 30, 2021 and December 31, 2020, respectively

     2       2  

Additional paid-in capital

     375,913       302,655  

Accumulated deficit

     (341,909     (288,090
  

 

 

   

 

 

 

Total stockholders’ equity

     34,006       14,567  
  

 

 

   

 

 

 

Total liabilities and stockholders’ equity

   $ 158,725     $ 151,341  
  

 

 

   

 

 

 


CODIAK BIOSCIENCES, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

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

 

     THREE MONTHS ENDED
SEPTEMBER 30,
    NINE MONTHS ENDED
SEPTEMBER 30,
 
     2021     2020     2021     2020  

Revenue:

        

Collaboration revenue

   $ 1,157     $ 954     $ 15,238     $ 1,275  
  

 

 

   

 

 

   

 

 

   

 

 

 

Total revenue

     1,157       954       15,238       1,275  
  

 

 

   

 

 

   

 

 

   

 

 

 

Operating expenses:

        

Research and development

     15,467       30,640       47,436       60,653  

General and administrative

     7,186       5,342       20,711       13,933  
  

 

 

   

 

 

   

 

 

   

 

 

 

Total operating expenses

     22,653       35,982       68,147       74,586  
  

 

 

   

 

 

   

 

 

   

 

 

 

Loss from operations

     (21,496     (35,028     (52,909     (73,311

Other income (expense):

        

Interest expense

     (689     (607     (2,091     (1,196

Interest income

     4       4       18       246  

Other income

     479       338       1,163       553  
  

 

 

   

 

 

   

 

 

   

 

 

 

Total other expense, net

     (206     (265     (910     (397
  

 

 

   

 

 

   

 

 

   

 

 

 

Net loss

   $ (21,702   $ (35,293   $ (53,819   $ (73,708
  

 

 

   

 

 

   

 

 

   

 

 

 

Cumulative dividends on redeemable convertible
preferred stock

     —         (3,457     —         (10,296
  

 

 

   

 

 

   

 

 

   

 

 

 

Net loss attributable to common stockholders

   $ (21,702   $ (38,750   $ (53,819   $ (84,004
  

 

 

   

 

 

   

 

 

   

 

 

 

Net loss per share attributable to common stockholders,
basic and diluted

   $ (0.97   $ (12.83   $ (2.49   $ (27.92
  

 

 

   

 

 

   

 

 

   

 

 

 

Weighted average common shares outstanding, basic and
diluted

     22,325,334       3,020,055       21,599,405       3,008,576  
  

 

 

   

 

 

   

 

 

   

 

 

 

Comprehensive loss:

        

Net loss

   $ (21,702   $ (35,293   $ (53,819   $ (73,708

Other comprehensive loss:

        

Unrealized loss on investments, net of tax of $0

     —         —         —         (43
  

 

 

   

 

 

   

 

 

   

 

 

 

Total other comprehensive loss

     —         —         —         (43
  

 

 

   

 

 

   

 

 

   

 

 

 

Comprehensive loss

   $ (21,702   $ (35,293   $ (53,819   $ (73,751
  

 

 

   

 

 

   

 

 

   

 

 

 

Investor Contact:

Christopher Taylor

VP, Investor Relations and Corporate Communications

T: 617-949-4220

E: investor@codiakbio.com

Media Contact:

Lindy Devereux

Scient PR

T: 646-515-5730

E: media@codiakbio.com

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