8-K
false 0001659352 0001659352 2022-08-04 2022-08-04

 

 

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)

August 4, 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 August 4, 2022, Codiak BioSciences, Inc. (the “Company”) issued a press release announcing its financial results for the fiscal quarter ended June 30, 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 August 4, 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: August 4, 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 Second Quarter 2022 Financial Results and

Operational Progress

– Reported platform-validating initial data from Phase 1 studies of exoSTING and exoIL-12;

plans to initiate Phase 2 studies for both programs in 1H 2023 –

– Initiated patient dosing in Phase 1 clinical trial of exoASO-STAT6 in patients with advanced

hepatocellular carcinoma, liver metastases from primary gastric cancer and colorectal cancer –

– Partnered with CEPI to advance pan beta coronavirus candidate –

– Presented positive preclinical data on the Company’s engEx-AAV discovery program –

CAMBRIDGE, Mass., Aug. 4, 2022 — 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 second quarter 2022 financial results and recent operational progress.

“During the second quarter we made strong progress supporting our approach and making advancements across our pipeline. We reported Phase 1 data sets from both our exoSTING and exoIL-12 programs, further validating our engEx® platform, and demonstrating we were able to deliver repeat doses of exoSTING and exoIL-12 to the tumor with a high level of specificity. Importantly, we did so with no observed systemic exposure or associated toxicity, and an enhanced therapeutic index – while demonstrating tumor shrinkage in both injected and uninjected lesions,” said Douglas E. Williams, Ph.D., President and CEO of Codiak. “We also initiated a Phase 1 study of exoASO-STAT6, our third program to enter the clinic, in patients with certain liver, gastric and colorectal cancers. These updates, in combination with preclinical data showing the promise of our engEx-AAV program and a partnership with CEPI to advance our pan Betacoronavirus program, show that Codiak is broadly advancing its portfolio programs in 2022, momentum we aim to carry through this year and into 2023.”

Second Quarter 2022 and Recent Highlights

 

   

Announced platform-validating data from Phase 1 trials of exoSTING and exoIL-12; both candidates demonstrated potential for best-in-class profile; Codiak has identified a recommended Phase 2 dose for each program and intends to finalize study plans with the FDA during the second half of this year to prepare for initiation of Phase 2 trials for both candidates early next year.

 

   

In a Phase 1 trial, exoIL-12 demonstrated a differentiating safety and tolerability profile, with no detectable systemic exposure of IL-12 and no treatment-related adverse events, which has not previously been reported by others with recombinant IL-12. The two patients with cutaneous T cell lymphoma (CTCL) who have been treated each received multiple (>20) injections of exoIL-12 and experienced tumor regressions in both injected and non-injected lesions, including a partial response in one patient.

 

   

In the Phase 1/2 clinical trial evaluating exoSTING as a single agent in patients with late-stage refractory solid tumors, data across all five dose cohorts showed repeat doses of exoSTING were well-tolerated, demonstrated tumor retention with no systemic exposure of the STING agonist, and in a subset of patients, tumor shrinkage was observed in injected and uninjected lesions.

 

   

Initiated patient dosing in the Phase 1 clinical trial of exoASO-STAT6 in patients with advanced hepatocellular carcinoma, liver metastases from primary gastric cancer and colorectal cancer; exoASO-STAT6 is Codiak’s third clinical program and the first to evaluate a systemically administered exosome-based drug candidate.

 

1


   

Partnered with CEPI to continue the advancement of vaccine candidates from the Company’s pan Betacoronavirus program; as part of the partnership, CEPI will provide seed funding of up to $2.5 million, which Codiak anticipates will fund the completion of preclinical development and identification of a clinical candidate.

 

   

Presented preclinical data on the Company’s engEx-AAV discovery program, a novel strategy that aims to leverage exosomes to improve adeno-associated virus (AAV) vector gene therapy, at the 25th Annual Meeting of the American Society of Gene and Cell Therapy (ASGCT); data demonstrated that exosome engineering generates significant increases in AAV yield compared to unmodified exosomes, while retaining the functionality to transduce cells with AAV and resist neutralizing antibodies that impair gene therapy efficacy.

Anticipated Milestones and Events

 

   

Initiate Phase 2 study of exoIL-12 in an expanded group of tumor types in 1H 2023; continue to monitor patients enrolled in Phase 1 study

 

   

Initiate Phase 2 study of exoSTING in bladder cancer in 1H 2023; continue to monitor patients enrolled in ongoing Phase 1/2 study, reporting additional data at an upcoming scientific conference

 

   

Continue enrollment for ongoing Phase 1 trial for exoASO-STAT6, with initial data expected in 1H 2023

 

   

Advance exoVACC pan Betacoronavirus program toward identification of a clinical candidate through new partnership with CEPI

Second Quarter 2022 Financial Results

Total revenues for the quarter ended June 30, 2022, were $13.1 million, compared to $0.9 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 June 30, 2022, was $6.8 million, compared to a net loss of $21.8 million for the same period in 2021. The decrease in net loss for the quarter was driven primarily by an increase in revenues in connection with the Company’s agreement with Jazz Pharmaceuticals.

Research and development expenses were $12.8 million for the quarter ended June 30, 2022, compared to $15.4 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 the Company’s agreement with Lonza.

General and administrative expenses were $7.4 million for the quarter ended June 30, 2022, compared to $6.9 million for the same period in 2021. The increase was due primarily to professional services driven by legal fees for intellectual property rights.

As of June 30, 2022, Codiak had cash, cash equivalents, and marketable securities of approximately $41.8 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 initiation of clinical trials, the release of data from clinical trials and the results of those trials, statements concerning the clinical development of exoASO-STAT6, 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. In particular, the statements regarding the initiation and timing of clinical trials are dependent upon availability of sufficient cash resources, as to which the Company can make no assurance. 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 (SEC), as well as discussions of potential risks, uncertainties and other important factors in Codiak’s subsequent filings with the SEC. 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)

 

     JUNE 30,
2022
    DECEMBER 31,
2021
 

Assets

    

Current assets:

    

Cash and cash equivalents

   $ 41,785     $ 76,938  

Prepaid manufacturing expenses

     9,063       7,315  

Prepaid expenses and other current assets

     5,161       5,918  
  

 

 

   

 

 

 

Total current assets

     56,009       90,171  

Property and equipment, net

     21,557       23,479  

Restricted cash

     4,170       4,170  

Operating right-of-use assets

     21,304       21,957  

Prepaid manufacturing expenses, net of current portion

     29,670       31,893  
  

 

 

   

 

 

 

Total assets

   $ 132,710     $ 171,670  
  

 

 

   

 

 

 

Liabilities and Stockholders’ Equity

    

Current liabilities:

    

Accounts payable

   $ 1,131     $ 1,838  

Accrued expenses

     7,699       9,703  

Deferred revenue

     292       12,963  

Operating lease liabilities

     2,891       2,661  
  

 

 

   

 

 

 

Total current liabilities

     12,013       27,165  

Long-term liabilities:

    

Deferred revenue, net of current portion

     17,341       30,686  

Note payable, net of discount

     25,596       25,430  

Operating lease liabilities, net of current portion

     33,362       34,884  

Other long-term liabilities

     —         —    
  

 

 

   

 

 

 

Total liabilities

     88,312       118,165  
  

 

 

   

 

 

 

Commitments and contingencies

    

Stockholders’ equity:

    

Common stock, $0.0001 par value; 150,000,000 shares authorized as of June 30, 2022 and December 31, 2021; 22,545,531 and 22,383,830 shares issued and outstanding as of June 30, 2022 and December 31, 2021, respectively

     2       2  

Additional paid-in capital

     384,446       378,750  

Accumulated deficit

     (340,050     (325,247
  

 

 

   

 

 

 

Total stockholders’ equity

     44,398       53,505  
  

 

 

   

 

 

 

Total liabilities and stockholders’ equity

   $ 132,710     $ 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
JUNE 30,
    SIX MONTHS ENDED
JUNE 30,
 
     2022     2021     2022     2021  

Revenue:

        

Collaboration revenue

   $ 13,145     $ 890     $ 25,849     $ 14,081  
  

 

 

   

 

 

   

 

 

   

 

 

 

Total revenue

     13,145       890       25,849       14,081  
  

 

 

   

 

 

   

 

 

   

 

 

 

Operating expenses:

        

Research and development

     12,798       15,419       27,045       31,969  

General and administrative

     7,364       6,937       14,071       13,525  
  

 

 

   

 

 

   

 

 

   

 

 

 

Total operating expenses

     20,162       22,356       41,116       45,494  
  

 

 

   

 

 

   

 

 

   

 

 

 

Loss from operations

     (7,017     (21,466     (15,267     (31,413

Other income (expense):

        

Interest expense

     (649     (704     (1,250     (1,401

Interest income

     34       9       38       14  

Other income

     848       352       1,667       683  

Realized gain

     9       —         9       —    
  

 

 

   

 

 

   

 

 

   

 

 

 

Total other income (expense), net

     242       (343     464       (704
  

 

 

   

 

 

   

 

 

   

 

 

 

Net loss

   $ (6,775   $ (21,809   $ (14,803   $ (32,117
  

 

 

   

 

 

   

 

 

   

 

 

 

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

   $ (0.30   $ (0.99   $ (0.66   $ (1.51
  

 

 

   

 

 

   

 

 

   

 

 

 

Weighted average common shares outstanding, basic and diluted

     22,493,879       22,117,593       22,444,799       21,230,424  
  

 

 

   

 

 

   

 

 

   

 

 

 

Investor Contact:

Christopher Taylor

VP, Investor Relations and Corporate Communications

T: 617-949-4220

E: investor@codiakbio.com

Media Contact:

Cory Tromblee

Scient PR

E: media@codiakbio.com

#    #    #