On March 10, 2022 Codiak BioSciences, Inc. (NASDAQ: CDAK), a clinical-stage biopharmaceutical company pioneering the development of exosome-based therapeutics as a new class of medicines, reported fourth quarter and full year 2021 financial results and recent operational progress (Press release, Codiak Biosciences, MAR 10, 2022, View Source [SID1234609889]).
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"We are making a strong start in 2022 thanks to progress with our development programs in 2021 and into this year, and plan to report clinical data for two of our engineered exosome therapeutic candidates and initiate clinical development for a third candidate all in the first half of the year," said Douglas E. Williams, Ph.D., President and CEO of Codiak. "The platform we’ve developed at Codiak allows us to deliver multiple classes of therapeutics with a high degree of precision to specific cells and our clinical data from two programs has already shown promising safety and predictable PK/PD relationships. The emergence of programs in vaccines and gene delivery highlight the breadth of opportunity across multiple therapeutic areas with the engEx platform."
Fourth Quarter 2021 and Recent Highlights
Reported positive initial data from dose cohorts 1-3 in the Phase 1/2 clinical trial of exoSTING (CDK-002) for the treatment of advanced/metastatic, recurrent and injectable solid tumors; progressed subject dosing to cohorts 4 and 5 and follow up in all dose cohorts
Advanced cutaneous T cell lymphoma (CTCL) portion of Phase 1 trial of exoIL-12 (CDK-003)
Filed and received U.S. FDA clearance of Investigational New Drug (IND) application for exoASO-STAT6 (CDK-004) for the intravenous treatment of hepatocellular carcinoma
Presented three abstracts at the 36th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) (SITC 2021), 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
Announced new preclinical data from the exoVACC exosome-based vaccine platform at the World Vaccine & Immunotherapy Congress (WVIC) 2021
Published a manuscript describing the full exoASO-STAT6 preclinical program in the American Association for the Advancement of Science’s journal, Science Advances
Anticipated Milestones and Events
Safety, PK, PD, and objective response rate (ORR) data from dose escalation cohorts 1-5 in the Phase 1/2 trial of exoSTING and recommended Phase 2 dose expected in late 1H 2022
First-in-human dosing for exoASO-STAT6 in a Phase 1 clinical trial in hepatocellular carcinomas anticipated in 1H 2022
Initial safety, PK/PD and efficacy data in CTCL patients in the Phase 1 clinical trial of exoIL-12 anticipated in late 1H 2022. While COVID-related restrictions in the UK that impacted clinical trial sites last year are abating, Codiak continues to work with those sites to explore options to facilitate enrollment.
Poster presentation of 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) (Free AACR Whitepaper) Annual Meeting, to be held April 8-13, 2022
Presentation of 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, to be held April 18-21, 2022
Fourth Quarter and Full Year 2021 Financial Results
Total revenues for the quarter ended December 31, 2021 were $7.7 million, compared to $1.6 million for the same period in 2020. Total revenues for the year ended December 31, 2021 were $22.9 million, compared to $2.9 million for the same period in 2020. These increases were primarily driven by revenue recognized from the Jazz collaboration for $10.9 million as a result of the mutual decision to discontinue work on STAT3 in Q1 2021 and the early termination of the research agreement with Sarepta, for $7.0 million in Q4 2021.
Net income for the quarter ended December 31, 2021 was $16.7 million, compared to a net loss of $18.0 million for the same period in 2020. Net loss for the year ended December 31, 2021, was $37.2 million, compared to a net loss of $91.7 million for the same period in 2020. The decrease in net loss for the fourth quarter and year was driven primarily by a gain on disposition of $33.3 million related to the agreement with Lonza, as well as collaboration revenue recognition in 2021.
Research and development expenses were $17.4 million for the quarter ended December 31, 2021, compared to $13.3 million for the same period in 2020. The increase in research and development expenses for the quarter was driven primarily by an increase in personnel-related costs and ongoing development of the engEx Platform.
Research and development expenses were $64.9 million for the year ended December 31, 2021, compared to $74.0 million for the same period in 2020. The year-over-year decrease was primarily driven by a licensing payment to Kayla Therapeutics in September 2020, offset by increases in clinical development costs for exoIL-12, exoSTING, and exoASO-STAT6 in 2021.
General and administrative expenses were $6.9 million for the quarter ended December 31, 2021, compared to $5.9 million for the same period in 2020. General and administrative expenses were $27.6 million for the year ended December 31, 2021, compared to $19.9 million for the same period in 2020. These increases were driven primarily by an increase in personnel costs and costs associated with transitioning to a public company.
As of December 31, 2021, Codiak had cash and cash equivalents of approximately $76.9 million.