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Codiak BioSciences Reports Third Quarter 2020 Financial Results and Operational Progress
[November 19, 2020]

Codiak BioSciences Reports Third Quarter 2020 Financial Results and Operational Progress


– Human clinical testing now underway with Codiak’s first two candidates, exoIL-12™ and exoSTING™ –

– Initial safety results and preliminary systemic exposure/pharmacokinetics of exoIL-12 in healthy volunteers anticipated YE 2020 -

– Biomarker, safety and clinical outcome results in cancer patients anticipated mid-2021 for both exoSTING and exoIL-12 –

CAMBRIDGE, Mass., Nov. 19, 2020 (GLOBE NEWSWIRE) -- Codiak BioSciences, Inc. (NASDAQ: CDAK), a clinical-stage company focused on pioneering the development of exosome-based therapeutics, today reported third quarter 2020 financial results and operational progress.

“Codiak was founded to realize the potential of engineered exosomes as a new and important class of biologic medicines for the treatment of a broad range of diseases,” said Douglas E. Williams, Ph.D., President and Chief Executive Officer of Codiak. “The creativity, expertise, and execution of our team has enabled us to bring the field’s first two engineered exosome candidates into the clinic and we are on track to initiate a third clinical program next year. The recent successful completion of our initial public offering provides additional funding to progress our development programs, invest in our platform and sustain the positive momentum we have built.”

Third Quarter 2020 and Recent Highlights

  • Closed initial public offering (IPO) in October 2020, raising $74.4 million in net proceeds
  • Initiated healthy volunteer dosing of exoIL-12 in a Phase 1 clinical trial designed to transition into patients with cutaneous T cell lymphoma (CTCL)
  • Initiated subject dosing in a 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
  • Presented preclinical data on exoIL-12 and the engEx™ Platform at the 35th Annual Meeting of the Society for Immunotherapy of Cancer (SITC)
  • Expanded executive team with addition of Yalonda Howze as Executive Vice President, Chief Legal Officer
  • Welcomed Jason Haddock to the Board of Directors and as Audit Committee Chairman

Anticipated Milestones and Events

  • Initial safety, tolerability and systemic exposure/pharmacokinetics data from the healthy volunteer portion of the exoIL-12 Phase 1 clinical trial are expected by year-end, with biomarker, safety and preliminary pharmacodynamics and efficacy data in CTCL patients expected by mid-2021
  • Safety and preliminary pharmacodynamics and efficacy data from exoSTING Phase 1/2 clinical trial in patients with solid tumors expected by mid-2021
  • Evercore ISI HEALTHCONx Virtual Conference, December 2, 2020

Third Quarter 2020 Financial Results
Total revenues for the quarter ended September 30, 2020 were $1.0 million, compared to $0.2 million for the same period in 2019. This increase was primarily due to an increase in collaboration revenue driven primarily by activities in connection with the collaboration with Sarepta.

Net loss for the quarter ended September 30, 2020 was $35.3 million, compared to a net loss of $20.7 million for the same period in 2019. Net loss for the quarter ended September 30, 2020 was driven primarily by clinical development, general and administrative, and personnel expenses, and ongoing development of the engEx Platform. The current quarter net loss was inclusive of a $15.0 million milestone payment to Kayla Therapeutics in connection with dosing of the first patient in the Phase 1/2 clinical trial of exoSTING.

Research and development expenses were $30.7 million for the quarter ended September 30, 2020 compared to $16.5 million for the same period in 2019. The increase was primarily driven by an increase in license milestones, personnel costs, and clinical development expenses related to the initiation of the exo-IL12 and exoSTING clinical trials in September 2020.

General and administrative expenses were $5.3 million for the quarter ended September 30, 2020 compared to $4.8 million for the same period in 2019. The increase was primarily driven by an increase in consulting and legal fees, personnel costs, and other administrative expenses in anticipation of operating as a public company.

As of September 30, 2020, Codiak had cash, cash equivalents, and marketable securities of $48.3 million. In October 2020, the completion of the IPO resulted in net proceeds of $74.4 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 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 Quarterly Report on Form 10-Q for the quarter ended September 30, 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. 

Media Contact
Lindy Devereux
Scient PR
T: 646-515-5730
E: media@codiakbio.com

Investor Contact
Christine Labaree
Evergreen Communications
T: 650-600-1697
E: investor@codiakbio.com

CODIAK BIOSCIENCES, INC.
CONDENSED CONSOLIDATED BA
LANCE SHEETS
(In thousands, except share and per share data)
(Unaudited)

  SEPTEMBER 30,
2020
  DECEMBER 31,
2019
 
Assets        
Current assets:        
Cash and cash equivalents $48,339  $10,316 
Investments     73,065 
Restricted cash     367 
Prepaid expenses and other current assets  4,022   10,370 
Total current assets  52,361   94,118 
Property and equipment, net  31,544   17,626 
Restricted cash, net of current portion  4,170   4,170 
Operating lease right-of-use assets  22,226    
Other non-current assets  50   48 
Total assets $110,351  $115,962 
Liabilities, Redeemable Convertible Preferred Stock and Stockholders Deficit        
Current liabilities:        
Accounts payable $2,488  $2,381 
Accrued expenses  23,858   15,818 
Deferred revenue  6,268   742 
Deferred rent     814 
Operating lease liabilities  1,778    
Total current liabilities  34,392   19,755 
Long-term liabilities:        
Deferredrevenue, net of current portion  58,069   54,870 
Note payable, net of discount  24,825   9,572 
Deferred rent, net of current portion     9,814 
Operating lease liabilities, net of current portion  37,102    
Total liabilities  154,388   94,011 
Commitments and contingencies (Note 10)        
Series A redeemable convertible preferred stock, $0.0001 par value; 33,200,000 shares


authorized as of September 30, 2020 and December 31, 2019; 33,200,000 shares issued and
outstanding as of September 30, 2020 and December 31, 2019; liquidation value as of September
30, 2020 and December 31, 2019 of $46,162 and $44,169, respectively
  46,162   44,169 
Series B redeemable convertible preferred stock, $0.0001 par value; 21,400,000 shares
authorized as of September 30, 2020 and December 31, 2019; 20,583,328 and 20,520,828 shares
issued and outstanding as of September 30, 2020 and December 31, 2019, respectively; liquidation
value as of September 30, 2020 and December 31, 2019 of $84,769 and $80,874, respectively
  84,769   81,108 
Series C redeemable convertible preferred stock, $0.0001 par value; 20,204,100 shares
authorized as of September 30, 2020 and December 31, 2019; 20,204,079 shares issued and
outstanding as of September 30, 2020 and December 31, 2019; liquidation value as of September
30, 2020 and December 31, 2019 of $94,102 and $89,507, respectively
  94,102   89,507 
Stockholders’ deficit:        
Common stock, $0.0001 par value; 150,000,000 shares authorized as of September 30, 2020
and 120,000,000 shares authorized as of December 31, 2019; 3,195,355 and 2,997,040 shares
issued and outstanding as of September 30, 2020 and December 31, 2019, respectively
      
Additional paid-in capital  1,063   2 
Accumulated other comprehensive income     43 
Accumulated deficit  (270,133)  (192,878)
Total stockholders’ deficit  (269,070)  (192,833)
Total liabilities, redeemable convertible preferred stock and stockholders’ deficit $110,351  $115,962 
         

CODIAK BIOSCIENCES, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPER
ATIONS AND COMPREHENSIVE LOSS
(In thousands, except share and per share data)
(Unaudited)

  THREE MONTHS ENDED
SEPTEMBER 30,
  NINE MONTHS ENDED
SEPTEMBER 30,
 
  2020  2019  2020  2019 
Revenue:                
Collaboration revenue $954  $151  $1,275  $238 
Total revenue  954   151   1,275   238 
Operating expenses:                
Research and development  30,640   16,546   60,653   41,794 
General and administrative  5,342   4,835   13,933   16,786 
Total operating expenses  35,982   21,381   74,586   58,580 
Loss from operations  (35,028)  (21,230)  (73,311)  (58,342)
Other income (expense):                
Interest income  4   344   246   1,145 
Interest expense  (607)  (3)  (1,196)  (3)
Other income  338   226   553   878 
Total other income (expense), net  (265)  567   (397)  2,020 
Net loss $(35,293) $(20,663) $(73,708) $(56,322)
Cumulative dividends on redeemable convertible
preferred stock
  (3,457)  (3,454)  (10,296)  (10,247)
Net loss attributable to common stockholders $(38,750) $(24,117) $(84,004) $(66,569)
Net loss per share attributable to common stockholders,
basic and diluted
 $(12.83) $(8.05) $(27.92) $(22.29)
Weighted average common shares outstanding, basic and
diluted
  3,020,055   2,995,917   3,008,576   2,986,889 
Comprehensive income (loss):                
Net loss $(35,293) $(20,663) $(73,708) $(56,322)
Other comprehensive income (loss):                
Unrealized gain (loss) on investments, net of tax of $0     (8)  (43)  72 
Total other comprehensive income (loss)     (8)  (43)  72 
Comprehensive loss $(35,293) $(20,671) $(73,751) $(56,250)
                 


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