8-K

 

 

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) May 6, 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 May 6, 2021, Codiak BioSciences, Inc. (the “Company”) issued a press release announcing its financial results for the fiscal quarter ended March 31, 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 May 6, 2021, by Codiak BioSciences, Inc.


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: May 6, 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 First Quarter 2021 Financial Results and Operational Progress

– Key clinical data from first in-human studies of engineered exosome therapeutic candidates, exoIL-12 and exoSTING, expected this year –

– Data from multiple preclinical programs to be presented at ASGCT 2021 showing broad potential applications for engineered exosomes –

CAMBRIDGE, Mass., May 6, 2021 — Codiak BioSciences, Inc. (NASDAQ: CDAK), a clinical-stage biopharmaceutical company focused on pioneering the development of exosome-based therapeutics as a new class of medicines, today reported first quarter 2021 financial results and operational progress.

“We are making excellent progress with our clinical and preclinical programs, which continue to generate further confirmatory evidence that our engEx exosome engineering and manufacturing platform can harness exosomes as delivery vehicles for potent and selective therapeutics, not only in immuno-oncology, but potentially in vaccines, gene therapy and neuro-oncology/neurology as well,” said Douglas E. Williams, Ph.D., President and Chief Executive Officer of Codiak. “We remain on track to deliver safety, biomarker and preliminary efficacy data from our exoIL-12 and exoSTING clinical programs in oncology and file an IND for our third program, exoASO-STAT6, later this year.”

First Quarter 2021 and Recent Highlights

 

   

Reported positive Phase 1 results for exoIL-12 confirming local pharmacology and dose selection for safety and efficacy trial in patients with early-stage cutaneous T cell lymphoma (CTCL)

 

   

Progressed with subject dosing in the Phase 1/2 clinical trial of exoSTING for the treatment of advanced/metastatic, recurrent and injectable solid tumors

 

   

Continued to advance exoASO-STAT6 for the intravenous treatment of myeloid-rich cancers through IND-enabling studies

 

   

Detailed versatility of Codiak’s engEx Platform in manuscript published in Molecular Therapeutics, a Cell partner journal

 

   

Presented pharmacokinetic/pharmacodynamic and tolerability data from healthy volunteer portion of the exoIL-12 Phase 1 clinical trial and preclinical data from the exoASO-STAT6 program at the American Association for Cancer Research (AACR) Annual Meeting, April 10-15

 

   

Published manuscript highlighting the exoSTING preclinical program in Communications Biology, a Nature Research publication

Anticipated Milestones and Events

 

   

Four poster presentations at the American Society of Gene and Cell Therapy (ASGCT) 24th Annual Meeting on May 11, including new preclinical data on exoAAV, exoVACC, exoASO-STAT6, and the ability of engineered exosomes to direct tropism to neuronal cells of interest

 

   

Safety, biomarker and preliminary pharmacodynamics and efficacy data from the exoSTING Phase 1/2 clinical trial in patients with solid tumors continue to be expected mid-2021, within the third quarter

 

   

Investigational New Drug (IND) application filing for exoASO-STAT6 anticipated during the second half of 2021 to enable initiation of clinical trials

 

   

Safety, biomarker and preliminary pharmacodynamics and efficacy data in CTCL patients from the exoIL-12 Phase 1 trial expected by year-end 2021


First Quarter 2021 Financial Results

Total revenues for the quarter ended March 31, 2021 were $13.2 million, compared to $0.1 million for the same period in 2020. This increase was primarily due to the mutual agreement between the Company and Jazz Pharmaceuticals to discontinue their work on exoASO-STAT3, one of five oncogene targets subject to the Collaboration and License Agreement by and between Codiak and Jazz Pharmaceuticals. The Company recognized the remaining $10.9 million in deferred revenue allocated to this target as revenue during the three months ended March 31, 2021.

Net loss for the quarter ended March 31, 2021 was $10.3 million, compared to a net loss of $22.5 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, offset in part by the $10.9 million in deferred revenue described above.

Research and development expenses were $16.6 million for the quarter ended March 31, 2021 compared to $18.4 million for the same period in 2020. The decrease in research and development expenses was driven primarily by lower manufacturing and preclinical costs as our lead assets progressed into the clinic during the second half of 2020.

General and administrative expenses were $6.6 million for the quarter ended March 31, 2021 compared to $4.2 million for the same period in 2020. The increase was driven primarily by an increase in personnel costs and costs associated with transitioning to a public company.

As of March 31, 2021, Codiak had cash, cash equivalents, and marketable securities of approximately $130.3 million.

About Codiak BioSciences

Codiak is a clinical-stage biopharmaceutical company focused on 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, neuromuscular disease 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, statements concerning the development of exoASO-STAT6, including the timing of IND filing and initiation of its clinical program, 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 quarter 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

(In thousands, except share and per share data)

(unaudited)

 

     MARCH 31,
2021
    DECEMBER 31,
2020
 

Assets

    

Current assets:

    

Cash and cash equivalents

   $ 130,272     $ 88,915  

Prepaid expenses and other current assets

     4,405       4,843  

Total current assets

     134,677       93,758  

Property and equipment, net

     30,885       31,410  

Restricted cash, net of current portion

     4,170       4,170  

Operating right-of-use assets

     21,767       22,003  
  

 

 

   

 

 

 

Total assets

   $ 191,499     $ 151,341  
  

 

 

   

 

 

 

Liabilities and Stockholders’ Equity

    

Current liabilities:

    

Accounts payable

   $ 2,162     $ 2,018  

Accrued expenses

     6,805       8,870  

Deferred revenue

     4,345       5,281  

Operating lease liabilities

     2,230       1,482  
  

 

 

   

 

 

 

Total current liabilities

     15,542       17,651  
  

 

 

   

 

 

 

Long-term liabilities:

    

Deferred revenue, net of current portion

     46,008       57,416  

Note payable, net of discount

     25,095       24,960  

Operating lease liabilities, net of current portion

     35,931       36,540  

Other long-term liabilities

     207       207  
  

 

 

   

 

 

 

Total liabilities

     122,783       136,774  
  

 

 

   

 

 

 

Commitments and contingencies

    

Stockholders’ equity:

    

Common stock, $0.0001 par value; 150,000,000 shares authorized as of March 31, 2021 and December 31, 2020; 21,996,886 and 18,787,579 shares issued and outstanding as of March 31, 2021 and December 31, 2020, respectively

     2       2  

Additional paid-in capital

     367,112       302,655  

Accumulated deficit

     (298,398     (288,090
  

 

 

   

 

 

 

Total stockholders’ equity

     68,716       14,567  
  

 

 

   

 

 

 

Total liabilities and stockholders’ equity

   $ 191,499     $ 151,341  
  

 

 

   

 

 

 


CODIAK BIOSCIENCES, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

(In thousands, except share and per share data)

(unaudited)

 

     THREE MONTHS ENDED
MARCH 31,
 
     2021     2020  

Revenue:

    

Collaboration revenue

   $ 13,191     $ 134  

Total revenue

     13,191       134  
  

 

 

   

 

 

 

Operating expenses:

    

Research and development

     16,550       18,391  

General and administrative

     6,588       4,233  
  

 

 

   

 

 

 

Total operating expenses

     23,138       22,624  
  

 

 

   

 

 

 

Loss from operations

     (9,947     (22,490

Other income (expense):

    

Interest expense

     (698     (295

Interest income

     5       223  

Other income

     332       60  

Total other expense, net

     (361     (12
  

 

 

   

 

 

 

Net loss

   $ (10,308   $ (22,502

Cumulative dividends on redeemable convertible preferred stock

     —         (3,419
  

 

 

   

 

 

 

Net loss attributable to common stockholders

   $ (10,308   $ (25,921

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

   $ (0.51   $ (8.64
  

 

 

   

 

 

 

Weighted average common shares outstanding, basic and diluted

     20,333,398       3,001,660  
  

 

 

   

 

 

 

Comprehensive loss:

    

Net loss

   $ (10,308   $ (22,502

Other comprehensive loss:

    

Unrealized loss on investments, net of tax of $0

     —         (41

Total other comprehensive loss

     —         (41
  

 

 

   

 

 

 

Comprehensive loss

   $ (10,308   $ (22,543
  

 

 

   

 

 

 

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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