On March 17, 2021 Codiak BioSciences, Inc. (NASDAQ: CDAK), a clinical-stage biopharmaceutical company focused on pioneering the development of exosome-based therapeutics as a new class of medicines,reported fourth quarter and full year 2020 financial results and operational progress (Press release, Codiak Biosciences, MAR 17, 2021, View Source [SID1234576791]).
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"The past year was tremendously productive for Codiak as we brought our first two programs into the clinic, the first ever engineered exosome therapeutic candidates to be tested in humans, and completed a successful initial public offering," said Douglas E. Williams, Ph.D., President and Chief Executive Officer of Codiak. "The early data from our exoIL-12 program have provided validation of our approach and propel us into what we anticipate will be an exciting year ahead, with multiple data read-outs and the initiation of a third clinical program expected."
Fourth Quarter 2020 and Recent Highlights
Reported initial pharmacokinetic/pharmacodynamic and tolerability data from randomized, placebo-controlled healthy volunteer portion of the exoIL-12 Phase 1 clinical trial and selected pharmacological dose and regimen to carry forward into assessment in patients with cutaneous T cell lymphoma (CTCL)
Progressed with subject dosing in the 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
Closed IPO in October 2020, raising $74.4 million in net proceeds
Published manuscript detailing the exoIL-12 preclinical program in Molecular Cancer Therapeutics
Published manuscript highlighting versatility of the engEx Platform in the online edition of Molecular Therapy
Closed follow-on public offering in February 2021, raising $62.0 million in net proceeds
Anticipated Milestones and Events
Late-breaking abstract poster presentation of the full pharmacokinetic/pharmacodynamic and tolerability data from healthy volunteer portion of the exoIL-12 Phase 1 clinical trial at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, to be held April 10-15, 2021
Poster presentation of preclinical data from the exoASO-STAT6 program at the AACR (Free AACR Whitepaper) Annual Meeting, to be held April 10-15, 2021
Safety and preliminary pharmacodynamics and efficacy data from exoSTING Phase 1/2 clinical trial in patients with solid tumors expected mid-2021
Investigational New Drug (IND) application filing for exoASO-STAT6 program to enable initiation of clinical trials anticipated during the second half of 2021
Biomarker, safety and preliminary pharmacodynamics and efficacy data in CTCL patients from exoIL-12 Phase 1 trial expected by year-end 2021
Fourth Quarter and Full Year 2020 Financial Results
Total revenues for the quarter ended December 31, 2020 were $1.6 million, compared to $0.2 million for the same period in 2019. Total revenues for the year ended December 31, 2020 were $2.9 million, compared to $0.4 million for the same period in 2019. These increases were primarily due to revenue recognized in connection with our collaboration with Sarepta Therapeutics.
Net loss for the quarter ended December 31, 2020 was $18.0 million, compared to a net loss of $21.6 million for the same period in 2019. Net loss for the year ended December 31, 2020 was $91.7 million, compared to a net loss of $78.0 million for the same period in 2019. Net loss for the quarter and year was driven primarily by clinical development, general and administrative, and personnel expenses, and ongoing development of the engEx Platform.
Research and development expenses were $13.3 million for the quarter ended December 31, 2020 compared to $17.7 million for the same period in 2019. The decrease in research and development expenses was driven primarily by the timing of external manufacturing expenditures in the prior year.
Research and development expenses were $74.0 million for the year ended December 31, 2020 compared to $59.5 million for the same period in 2019. The year-over-year increase was primarily driven by an increase in license milestones, personnel costs, and clinical development expenses related to the initiation of the exoIL-12 and exoSTING clinical trials in September 2020.
General and administrative expenses were $5.9 million for the quarter ended December 31, 2020 compared to $4.3 million for the same period in 2019. The increase was driven primarily by an increase in personnel costs and costs associated with transitioning to a public company.
General and administrative expenses were $19.9 million for the year ended December 31, 2020 compared to $21.0 million for the same period in 2019. The year-over-year decrease was primarily driven by a decrease in consulting, accounting and legal fees.
As of December 31, 2020, Codiak had cash and cash equivalents of approximately $88.9 million. Subsequent to year end, Codiak closed a public offering in February 2021, raising $62.0 million in net proceeds. Based on our current operating plan, we expect our cash and cash equivalents as of December 31, 2020, together with the net proceeds from our follow-on public offering in February 2021, will enable us to fund our operating expenses and capital expenditure requirements through the end of 2022.