On August 10, 2023 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, 2023, and announced a corporate reorganization to reduce expenses and extend its cash runway (Press release, Atreca, AUG 10, 2023, View Source [SID1234634180]). As part of the reorganization, Atreca will be undertaking cost-saving measures, including suspending development of ATRC-101 and reducing its workforce by approximately 40%. Going forward operations will focus on advancing current preclinical antibody-drug conjugate (ADC) candidates, including APN-497444, while preserving core discovery capabilities.
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"In order to extend our cash runway and focus on our preclinical ADC development efforts, we are suspending development of ATRC-101," said John Orwin, Chief Executive Officer of Atreca. "We are proud of our work in advancing ATRC-101 into the clinic and are encouraged by the activity and safety profile that we observed, validating the ability of our discovery platform to generate novel, tumor-targeting product candidates. Nevertheless, given both development requirements and financial considerations, we believe that the best path forward for the asset is with a larger partner, and as a result, we are suspending development and evaluating potential out-licensing opportunities. Our preclinical ADC pipeline, led by APN-497444, will continue to advance, and we are working towards declaring a clinical candidate from this program in the coming months."
"We have also made the difficult decision to reduce our headcount by approximately 40%," continued Mr. Orwin. "Given the talent and dedication of our workforce, this decision was not made lightly. We believe, however, that it is a necessary step to ensure we have the capital to execute on our mission to deliver novel therapeutics to patients in need. I’d like to thank those impacted for their important contributions to Atreca, including discovering and advancing both ATRC-101 and APN-497444."
Recent Developments and Highlights
APN-497444 (‘444), an Atreca-discovered antibody targeting a novel, tumor-specific glycan, continues to advance. ‘444 displays uniform and tumor-selective binding with high target prevalence in colorectal cancer and exhibits compelling pre-clinical anti-tumor activity and initial safety when weaponized as an ADC. Atreca expects to nominate a clinical candidate from the program in 2023 and is targeting an IND submission in late 2024/early 2025.
The U.S. Food and Drug Administration (FDA) has cleared an Investigational New Drug (IND) application for MAM01/ATRC-501 submitted by the Gates Medical Research Institute (Gates MRI). Gates MRI plans to initiate its Phase 1 trial based in the US later this year, followed by a trial in Sub-Saharan Africa. Atreca retains commercial rights in the U.S., Europe and parts of Asia, and potential product development opportunities in those regions include prophylaxis for those traveling to malaria endemic regions.
Second Quarter 2023 Financial Results
As of June 30, 2023, cash and cash equivalents and investments totaled $38.5 million.
Research and development expenses for the three months ended June 30, 2023, were $12.9 million, including non-cash stock-based compensation expense of $1.2 million.
General and administrative expenses for the three months ended June 30, 2023, were $6.8 million, including non-cash stock-based compensation expense of $1.7 million.
Atreca reported a net loss of $19.2 million, or basic and diluted net loss per share attributable to common stockholders of $0.49, for the quarter ended June 30, 2023.