On February 25, 2021 Atreca, Inc. (Atreca) (NASDAQ: BCEL), a clinical-stage biotechnology company focused on developing novel therapeutics generated through a unique discovery platform based on interrogation of the active human immune response, reported financial results for the fourth quarter and full year ended December 31, 2020, and provided an overview of recent developments (Press release, Atreca, FEB 25, 2021, View Source [SID1234575660]).
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"2020 was a successful year for Atreca marked by several key milestones, including the initiation of our first-in-human study of ATRC-101 and the signing of multiple strategic collaborations to both enhance our discovery platform and build our development pipeline," said John Orwin, Chief Executive Officer. "Preclinical data that we presented on ATRC-101 throughout the year highlighted its novel target and mechanism of action, as well as its potential as a combination therapy both with checkpoint inhibitors targeting the PD-1/PD-L1 axis and with chemotherapy. This year we look forward to reporting initial summary data from our Phase 1b trial, initiating combination studies with a checkpoint inhibitor and chemotherapy, and providing an update on our early-stage pipeline."
Recent Developments and Highlights
To date, 10 clinical trial sites have been initiated in the Phase 1b trial evaluating ATRC-101 in multiple solid tumor cancers. Three patients have been enrolled in the fourth dose cohort (10mg/kg) of the dose escalation portion of the trial. Patient enrollment in the fifth and final dose cohort (30mg/kg) is planned to begin following the protocol-specified dose-limiting toxicity assessment period. Atreca expects to announce initial summary data from the study in 2Q 2021.
As allowed by the study protocol, up to three additional patients are being backfilled into the previously cleared third dose cohort (3mg/kg) due to continued interest in the study and in order to collect supplemental data. The dose expansion portion of the study is also being opened with an additional 3mg/kg cohort expected to enroll up to 12 patients. Further cohorts to evaluate ATRC-101 in combination with a PD-1 inhibitor and in combination with a chemotherapeutic agent are planned to begin in 2Q 2021 and 2H 2021, respectively.
Fourth Quarter and Full Year 2020 Financial Results
As of December 31, 2020, cash and cash equivalents and short-term investments totaled $240.1 million.
Research and development expenses for the year ended December 31, 2020 were $62.0 million, including non-cash share-based compensation expense of $5.9 million. Research and development expenses for the three months ended December 31, 2020 were $16.8 million, including non-cash share-based compensation expense of $1.4 million.
General and administrative expenses for the year ended December 31, 2020 were $26.8 million, including non-cash share-based compensation expense of $6.6 million. General and administrative expenses for the three months ended December 31, 2020 were $6.6 million, including non-cash share-based compensation expense of $1.7 million.
Atreca reported a net loss of $86.3 million, or basic and diluted net loss per share attributable to common stockholders of $2.70, for the year ended December 31, 2020. The Company reported a net loss of $23.0 million, or basic and diluted net loss per share attributable to common stockholders of $0.63, for the three months ended December 31, 2020.