On November 3, 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 third quarter 2022 financial results and recent operational progress (Press release, Codiak Biosciences, NOV 3, 2022, View Source [SID1234622974]).

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"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/EBPß at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 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.