8-K
false 0001659352 0001659352 2022-05-05 2022-05-05

 

 

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 5, 2022

 

 

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 5, 2022, Codiak BioSciences, Inc. (the “Company”) issued a press release announcing its financial results for the fiscal quarter ended March 31, 2022. 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 5, 2022, 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: May 5, 2022     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 2022 Financial Results and Operational Progress

– Codiak to provide data from ongoing exoSTING and exoIL-12 clinical trials

in late 1H 2022 –

– Anticipate first patients dosed in exoASO-STAT6 Phase 1 clinical trial in 1H 2022 –

– Data from preclinical engEx-AAV program to be presented at ASGCT 2022 showing potential

applications for engineered exosomes in gene delivery –

CAMBRIDGE, Mass., May 5, 2022 — 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 2022 financial results and operational progress.

“We are making exciting progress with our clinical and preclinical programs, which continue to generate further confirmatory evidence that our engEx Platform can harness exosomes for potent and selective delivery of therapeutics, not only in immuno-oncology, but in vaccines and gene therapy as well,” said Douglas E. Williams, Ph.D., President and Chief Executive Officer of Codiak. “We remain on track to deliver on several key milestones by the end of this quarter, including results from all five dose cohorts in our exoSTING trial, initial CTCL patient data from the exoIL-12 program, and commencement of dosing in the Phase 1 study of our third candidate to enter the clinic, exoASO-STAT6.”

First Quarter 2022 and Recent Highlights

 

 

Completed enrollment and dose escalation in cohorts 4 and 5 in the Phase 1/2 clinical trial of exoSTING (CDK-002) for the treatment of advanced/metastatic, recurrent and injectable solid tumors; patient follow-up continues in all dose cohorts, as well as enrollment of enrichment cohorts

 

 

Advanced cutaneous T cell lymphoma (CTCL) portion of Phase 1 trial of exoIL-12 (CDK-003); implemented plans for protocol amendment to include a broader range of CTCL patients, and developed plans to enroll patients with additional cutaneous malignancies responsive to rIL-12

 

 

Opened enrollment in Phase 1 trial of exoASO-STAT6 (CDK-004) for the intravenous treatment of hepatocellular carcinoma in preparation for patient dosing

 

 

Presented new preclinical data from the exoVACC pan-beta coronavirus vaccine program, as part of Codiak’s collaboration with the Ragon Institute, at the World Vaccine Congress 2022

 

 

Presented preclinical data for exoASO-C/EBPß, a proprietary engineered exosome loaded with antisense oligonucleotides targeting C/EBPß, at the American Association for Cancer Research (AACR) Annual Meeting

 

 

Published a manuscript describing the full exoASO-STAT6 preclinical program in the American Association for the Advancement of Science’s journal, Science Advances

 

 

Named industry veteran oncology drug developer David Mauro, M.D., Ph.D. as Chief Medical Officer

Anticipated Milestones and Events

 

 

First patients dosed in exoASO-STAT6 Phase 1 clinical trial in hepatocellular carcinomas anticipated during 1H 2022

 

 

Safety, PK, PD, objective response rate (ORR), and efficacy data in injected and non-injected tumors from dose escalation cohorts 1-5 in the Phase 1/2 trial of exoSTING and recommended Phase 2 dose expected in late 1H 2022

 

1


 

Initial safety, PK/PD and efficacy data from at least the first cohort of CTCL patients in the Phase 1 clinical trial of exoIL-12 anticipated in late 1H 2022

 

 

Presentation of new data from engEx-AAV discovery program describing the generation of potent and high-yield exosome-associated AAV constructs as a strategy for improving gene therapy delivery at the American Society of Gene and Cell Therapy Annual Meeting to be held May 16-19, 2022

Dr. Williams added, “As we have noted in prior quarters, enrollment in the exoIL-12 study at trial sites in the UK has been challenging, and we have worked to pursue options for expediting enrollment. We’re looking forward to the positive impact of protocol enhancements for this trial to include a broader CTCL population (stage IIIa) and the potential to enroll patients with cutaneous malignancies responsive to rIL-12 in past studies – including Kaposi’s sarcoma, Merkel cell carcinoma, and Squamous cell carcinoma – each orphan cutaneous diseases treated by the same physicians, where local treatment is common.”

First Quarter 2022 Financial Results

Total revenues for the quarter ended March 31, 2022, were $12.7 million, compared to $13.2 million for the same period in 2021. These results reflect deferred revenue recognized under the Company’s collaboration with Jazz Pharmaceuticals.

Net loss for the quarter ended March 31, 2022, was $8.0 million, compared to a net loss of $10.3 million for the same period in 2021. The decrease in net loss for the quarter was driven primarily by a reduction in research and development expenses, some of which were in connection with the Company’s agreement with Lonza.

Research and development expenses were $14.2 million for the quarter ended March 31, 2022, compared to $16.6 million for the same period in 2021. The decrease in research and development expenses was driven primarily by decreases in lab expenses and personnel-related costs in connection with our agreement with Lonza.

General and administrative expenses were $6.7 million for the quarter ended March 31, 2022, compared to $6.6 million for the same period in 2021. The increase was driven primarily by an increase in personnel expenses.

As of March 31, 2022, Codiak had cash, cash equivalents, and marketable securities of approximately $56.5 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, infectious disease and rare 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 initiation timing 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 year ended December 31, 2021, 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,
2022
    DECEMBER 31,
2021
 

Assets

    

Current assets:

    

Cash and cash equivalents

   $ 56,494     $ 76,938  

Prepaid manufacturing expenses

     7,308       7,315  

Prepaid expenses and other current assets

     6,111       5,918  
  

 

 

   

 

 

 

Total current assets

     69,913       90,171  

Property and equipment, net

     22,456       23,479  

Restricted cash

     4,170       4,170  

Operating right-of-use assets

     21,638       21,957  

Prepaid manufacturing expenses, net of current portion

     31,893       31,893  
  

 

 

   

 

 

 

Total assets

   $ 150,070     $ 171,670  
  

 

 

   

 

 

 

Liabilities and Stockholders’ Equity

    

Current liabilities:

    

Accounts payable

   $ 1,516     $ 1,838  

Accrued expenses

     6,808       9,703  

Deferred revenue

     442       12,963  

Operating lease liabilities

     2,775       2,661  
  

 

 

   

 

 

 

Total current liabilities

     11,541       27,165  

Long-term liabilities:

    

Deferred revenue, net of current portion

     30,503       30,686  

Note payable, net of discount

     25,514       25,430  

Operating lease liabilities, net of current portion

     34,133       34,884  

Other long-term liabilities

     —         —    
  

 

 

   

 

 

 

Total liabilities

     101,691       118,165  
  

 

 

   

 

 

 

Commitments and contingencies

    

Stockholders’ equity:

    

Common stock, $0.0001 par value; 150,000,000 shares authorized as of March 31, 2022 and December 31, 2021; 22,493,867 and 22,383,830 shares issued and outstanding as of March 31, 2022 and December 31, 2021, respectively

     2       2  

Additional paid-in capital

     381,652       378,750  

Accumulated deficit

     (333,275     (325,247
  

 

 

   

 

 

 

Total stockholders’ equity

     48,379       53,505  
  

 

 

   

 

 

 

Total liabilities and stockholders’ equity

   $ 150,070     $ 171,670  
  

 

 

   

 

 

 


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,
 
     2022     2021  

Revenue:

    

Collaboration revenue

   $ 12,704     $ 13,191  
  

 

 

   

 

 

 

Total revenue

     12,704       13,191  
  

 

 

   

 

 

 

Operating expenses:

    

Research and development

     14,248       16,550  

General and administrative

     6,707       6,588  
  

 

 

   

 

 

 

Total operating expenses

     20,955       23,138  
  

 

 

   

 

 

 

Loss from operations

     (8,251     (9,947

Other income (expense):

    

Interest expense

     819       (698

Interest income

     4       5  

Other income

     (600     332  
  

 

 

   

 

 

 

Total other expense, net

     223       (361
  

 

 

   

 

 

 

Net loss

   $ (8,028   $ (10,308
  

 

 

   

 

 

 

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

   $ (0.36   $ (0.51
  

 

 

   

 

 

 

Weighted average common shares outstanding, basic and diluted

     22,436,938       20,333,398  
  

 

 

   

 

 

 

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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