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., Nov. 04, 2021 (GLOBE NEWSWIRE) -- Codiak BioSciences (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
  • 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

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 –


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

    DECEMBER 31,
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  



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

    2021     2020     2021     2020  
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
    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

Media Contact:
Lindy Devereux
Scient PR
T: 646-515-5730

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