On August 5, 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 second quarter 2021 financial results and operational progress (Press release, Codiak Biosciences, AUG 5, 2021, View Source [SID1234585869]).
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"We continue to be intensely focused on execution of our two lead clinical programs, with plans to deliver near-term data readouts from both the exoSTING and exoIL-12 trials. We anticipate sharing safety data and a differentiating pharmacologic profile from initial dose escalation cohorts in the Phase 1/2 trial of exoSTING in the fourth quarter of 2021, and we expect to report initial safety, PK/PD and efficacy data from CTCL patients in the exoIL-12 Phase 1 trial by year end," said Douglas E. Williams, Ph.D., President and Chief Executive Officer of Codiak. "We are also prosecuting multiple preclinical programs that together demonstrate the versatility of our platform and we look forward to filing an IND this year for our third engineered exosome therapeutic candidate, exoASO-STAT6 for the treatment of myeloid-rich cancers."
Second Quarter 2021 and Recent Highlights
Presented new preclinical data on exoAAV, exoVACC, exoASO-STAT6, and the ability of engineered exosomes to direct tropism at the American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) 24th Annual Meeting
Published manuscript highlighting the exoSTING preclinical program in Communications Biology, a Nature Research publication
Presented tolerability, pharmacokinetic (PK)/pharmacodynamic (PD) data from healthy volunteer portion of the exoIL-12 Phase 1 clinical trial and preclinical data from the exoASO-STAT6 program at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting
Appointed Jennifer Wheler, M.D., as Chief Medical Officer
Added Anne-Virginie Eggimann, M.Sc., to Board of Directors
Anticipated Milestones and Events
Initial safety, PK, and PD data from dose escalation cohorts 1-3 on the Phase 1/2 trial of exoSTING (CDK-002) in patients with advanced/metastatic solid tumors with injectable lesions expected in the fourth quarter of 2021
IND filing for exoASO-STAT6 (CDK-004) anticipated during the second half of 2021
Initial safety, PK/PD and efficacy data in CTCL patients from the Phase 1 trial of exoIL-12 (CDK-003) expected by year-end 2021
Second Quarter 2021 Financial Results
Total revenues for the quarter ended June 30, 2021, were $0.9 million, compared to $0.2 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 June 30, 2021, was $21.8 million, compared to a net loss of $15.9 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 $15.4 million for the quarter ended June 30, 2021, compared to $11.6 million for the same period in 2020. The increase in research and development expenses was driven by an increase in engEx Platform expenses, partially offset by decreased manufacturing and preclinical costs as Codiak’s lead candidates progressed into the clinic during the second half of 2020.
General and administrative expenses were $6.9 million for the quarter ended June 30, 2021, compared to $4.4 million for the same period in 2020. The increase was driven primarily by an increase in general and administrative headcount to support our overall growth and our transition to becoming a public company.
As of June 30, 2021, Codiak had cash and cash equivalents of approximately $113.7 million.