On August 11, 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 second quarter ended June 30, 2021, and provided an overview of recent developments (Press release, Atreca, AUG 11, 2021, View Source [SID1234586316]).
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"We recently announced initial summary data from the dose escalation portion of the Phase 1b trial evaluating ATRC-101 in multiple solid tumors," said John Orwin, Chief Executive Officer. "ATRC-101 was well-tolerated in the study, and we believe that the initial signs of activity, which were associated with expression of ATRC-101’s target, provide strong rationale for further evaluation. Additionally, we believe the data provide validation of the ability of our discovery platform to identify druggable tumor targets shared across broad groups of patients. We look forward to providing an update on our early-stage pipeline in the coming months as well as reporting additional monotherapy in 1H22, pembrolizumab combination data in mid-2022, and chemotherapy combination data in late 2022."
Recent Developments and Highlights
Atreca announced initial summary data from the dose escalation portion of the Phase 1b trial of ATRC-101 in multiple solid tumors. ATRC-101 was well-tolerated with no dose-limiting toxicities observed. Eight of the 20 participants (40%) evaluable prior to the data cut-off in this analysis experienced stable disease (SD) as their best RECIST response, including four with tumor size reduction. The disease control observed in the study was associated with ATRC-101 target expression, and preliminary biomarker analysis was consistent with the proposed mechanism of action for ATRC-101.The peak concentration of ATRC-101 was dose proportional and minimal accumulation was observed following multiple doses.
Phase 1b monotherapy dose expansion of ATRC-101 is ongoing at 30 mg/kg. A combination study evaluating ATRC-101 with pembrolizumab is active and another combination study with pegylated liposomal doxorubicin is expected to begin enrolling patients in 4Q21. Atreca expects to report additional monotherapy data in 1H22, pembrolizumab combination data in mid-2022 and chemotherapy combination data in late 2022.
Supported by data from the dose escalation portion of the trial, Atreca is developing a diagnostic to enable prospective patient selection based on target expression.
Second Quarter 2021 Financial Results
As of June 30, 2021, cash and cash equivalents and short-term investments totaled $182.3 million.
Research and development expenses for the three months ended June 30, 2021 were $19.0 million, including non-cash share-based compensation expense of $1.9 million.
General and administrative expenses for the three months ended June 30, 2021 were $8.0 million, including non-cash share-based compensation expense of $2.0 million.
Atreca reported a net loss of $26.7 million, or basic and diluted net loss per share attributable to common stockholders of $0.72, for the three months ended June 30, 2021.