Codiak BioSciences Reports Third Quarter 2022 Financial Results and Operational Progress

  • Patient enrollment continuing in Phase 1 clinical trial of exoASO™-STAT6 in patients with advanced hepatocellular carcinoma; preliminary data anticipated during 1H 2023
  • Presented preclinical data showing exoVACC™ pan beta coronavirus vaccine, supported by CEPI, elicits broad protective immunity against variants of SARS-CoV-2 and other potentially human transmissible animal coronaviruses
  • Two preclinical abstracts accepted at SITC 2022 for exoASO-STAT6 and exoASO™-C/EBPβ

CAMBRIDGE, Mass., Nov. 03, 2022 (GLOBE NEWSWIRE) -- 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 2022 financial results and recent operational progress.

“During the third quarter we prioritized our pipeline to focus on the clinical trial underway with exoASO™-STAT6 in patients with certain liver, gastric and colorectal cancers, and on advancing our engEx® Platform and its potential in vaccine development and gene delivery,” said Douglas E. Williams, Ph.D., President and CEO of Codiak. “We are also grateful for the support of our existing shareholders and the new investors who participated in our recent financing, and we remain focused on advancing our priority programs and delivering data from the exoASO-STAT6 clinical trial anticipated in the first half of 2023.”

Third Quarter 2022 and Recent Highlights

  • Continued patient enrollment in the Phase 1 clinical trial of systemically administered exoASO-STAT6 in patients with advanced hepatocellular carcinoma, liver metastases from primary gastric cancer and colorectal cancer.
  • Presented preclinical data at Vaccines Summit 2022 in October demonstrating Codiak’s exoVACC™ pan beta coronavirus vaccine elicits broad protective immunity against known variants of SARS-CoV-2 and seven SARS-related coronaviruses that are currently in bats and may have a high potential to jump into humans.
  • Partnered with CEPI (Coalition for Epidemic Preparedness Innovations) in early Q3 to continue the advancement of vaccine candidates from the Company’s pan beta coronavirus program. 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.
  • Announced financing, restructuring and re-prioritization to focus on delivering data from the ongoing clinical trial of exoASO-STAT6, advancing exoVACC and supporting the engEx-AAV™ discovery program, a novel strategy that aims to enable repeat dosing of gene delivery constructs.

Anticipated Milestones and Events

  • Continue enrollment in Phase 1 trial for exoASO-STAT6, with initial data expected in 1H 2023.
  • Present new preclinical data for macrophage targeting programs exoASO-STAT6 and exoASO™-C/EBPβ at the Society for Immunotherapy of Cancer (SITC) in November 2022.
  • Further validate engEx-AAV gene delivery platform, with in vivo proof of concept data expected later this year, to be presented in 1H 2023.
  • Advance exoVACC pan beta coronavirus program toward identification of a clinical candidate through partnership with CEPI.
  • Pursue partnership opportunities for select programs, the engEx Platform or at the corporate level to continue advancing this new modality of exosome-based therapeutics.

Third Quarter 2022 Financial Results
Total revenues for the quarter ended September 30, 2022 were $0.5 million, compared to $1.2 million for the same period in 2021. Revenues for the third quarter 2022 reflect grant revenue from the Company’s agreement with CEPI.

Net loss for the quarter ended September 30, 2022 was $19.3 million, compared to a net loss of $21.7 million for the same period in 2021. The decrease in net loss for the quarter was driven primarily by decreases in lab expenses and personnel-related costs in connection with the Company’s agreement with Lonza.

Research and development expenses were $10.8 million for the quarter ended September 30, 2022, compared to $15.5 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 $6.6 million for the quarter ended September 30, 2022, compared to $7.2 million for the same period in 2021. The decrease was due primarily to reduced personnel costs, partially offset by an increase in legal fees for intellectual property rights.

As of September 30, 2022, Codiak had cash, cash equivalents, and marketable securities of approximately $51.8 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 the Company’s portfolio, the clinical development of exoASO-STAT6, statements regarding the capabilities and potential of Codiak’s engEx Platform and engineered exosomes generally, and statements regarding the program reprioritization, plans to expand discussions related to potential strategic corporate and program-based partnerships, and the restructuring of operations. 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, and statements regarding the restructuring are dependent on Codiak’s ability to successfully implement the restructuring and the impact of the restructuring on Codiak’s business, as to which the Company can make no assurances. 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)

  SEPTEMBER 30,     DECEMBER 31,  
  2022     2021  
Assets          
Current assets:          
Cash and cash equivalents $ 51,762     $ 76,938  
Prepaid manufacturing services   6,727       7,315  
Prepaid expenses and other current assets   2,744       5,918  
Total current assets   61,233       90,171  
Property and equipment, net of accumulated depreciation of $14,990 and $11,809   20,538       23,479  
Restricted cash   4,170       4,170  
Operating right-of-use assets   20,955       21,957  
Prepaid manufacturing services, net of current portion   27,500       31,893  
Total assets $ 134,396     $ 171,670  
Liabilities and Stockholders’ Equity          
Current liabilities:          
Accounts payable $ 1,956     $ 1,838  
Accrued expenses   8,126       9,703  
Deferred revenue   1,363       12,963  
Operating lease liabilities   3,011       2,661  
Total current liabilities   14,456       27,165  
Long-term liabilities:          
Deferred revenue, net of current portion   17,317       30,686  
Note payable, net of discount   25,693       25,430  
Derivative liability - warrants   5,428        
Operating lease liabilities, net of current portion   32,573       34,884  
Total liabilities   95,467       118,165  
Commitments and contingencies (Note 7)          
Stockholders’ equity:          
Common stock, $0.0001 par value; 150,000,000 shares authorized as of September 30, 2022 and December 31, 2021; 36,829,626 and 22,383,830 shares issued and outstanding as of September 30, 2022 and December 31, 2021, respectively   4       2  
Additional paid-in capital   398,253       378,750  
Accumulated deficit   (359,328 )     (325,247 )
Total stockholders’ equity   38,929       53,505  
Total liabilities and stockholders’ equity $ 134,396     $ 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
SEPTEMBER 30,
    NINE MONTHS ENDED
SEPTEMBER 30,
 
  2022     2021     2022     2021  
Revenue:                      
Collaboration revenue $ 28     $ 1,157     $ 25,877     $ 15,238  
Grant revenue 494           494        
Total revenue   522       1,157       26,371       15,238  
Operating expenses:                      
Research and development   10,847       15,467       37,893       47,436  
General and administrative   6,563       7,186       20,634       20,711  
Impairment of prepaid manufacturing services   4,508             4,508        
Total operating expenses   21,918       22,653       63,035       68,147  
Loss from operations   (21,396 )     (21,496 )     (36,664 )     (52,909 )
Other income (expense):                      
Interest expense   (758 )     (689 )     (2,007 )     (2,091 )
Interest income   119       4       157       18  
Other income   35       479       1,711       1,163  
Change in fair value of derivative liability - warrants   2,722             2,722        
Total other income (expense), net   2,118       (206 )     2,583       (910 )
Net loss $ (19,278 )   $ (21,702 )   $ (34,081 )   $ (53,819 )
Net loss per share attributable to common stockholders, basic and diluted $ (0.77 )   $ (0.97 )   $ (1.46 )   $ (2.49 )
Weighted average common shares outstanding, basic and diluted   25,159,757       22,325,334       23,373,684       21,599,405  
                               

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


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