On November 2, 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 third quarter ended September 30, 2021, and provided an overview of recent developments (Press release, Atreca, NOV 2, 2021, View Source [SID1234594201]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"In the third quarter, we continued to advance our lead program, ATRC-101, following the release of initial summary data from the dose escalation portion of the Phase 1b trial, which supports the further evaluation of ATRC-101 in multiple solid tumor types," said John Orwin, Chief Executive Officer. "We plan to share additional monotherapy data and initial combination data with pembrolizumab in 2022, and are in a strong position to advance our pipeline with cash runway through mid-2023."
"Our earlier-stage programs are progressing well, highlighted by our recently announced licensing agreement with the Bill & Melinda Gates Medical Research Institute for the development and commercialization of MAM01/ATRC-501, a novel monoclonal antibody entering preclinical development for the prevention of malaria," said Tito Serafini, Ph.D., Chief Strategy Officer. "We look forward to sharing more information on our EphA2 program and other pipeline assets at an R&D day early next year."
Recent Developments and Highlights
Atreca announced a licensing agreement with the Bill & Melinda Gates Medical Research Institute ("Gates MRI") for development and commercialization of MAM01/ATRC-501, a monoclonal antibody for malaria prophylaxis. Under the agreement, Gates MRI will lead the development of MAM01/ATRC-501 and receive commercial rights in GAVI-eligible countries located in malaria-endemic regions of the world, while Atreca will retain commercial rights in the U.S., Europe and parts of Asia. Potential product development opportunities for Atreca include developing MAM01/ATRC-501 for prevention of malaria for those traveling to regions where the infection may be circulating.
Enrollment in the monotherapy portion of the Phase 1b trial of ATRC-101 is ongoing at 30 mg/kg and Atreca plans to report additional monotherapy data in mid-2022.
Enrollment has commenced in a Phase 1b combination cohort evaluating ATRC-101 with pembrolizumab. Another combination cohort with pegylated liposomal doxorubicin ("PLD") is expected to begin enrolling patients following completion of ongoing monotherapy cohorts, including those following a Q2W dosing schedule which better aligns with the standard PLD regimen. Atreca plans to report additional monotherapy data in mid-2022 and pembrolizumab combination data in 3Q22.
Third Quarter 2021 Financial Results
As of September 30, 2021, cash and cash equivalents and short-term investments totaled $152.9 million.
Research and development expenses for the three months ended September 30, 2021 were $18.7 million, including non-cash share-based compensation expense of $1.9 million.
General and administrative expenses for the three months ended September 30, 2021 were $8.8 million, including non-cash share-based compensation expense of $1.9 million.
Atreca reported a net loss of $27.4 million, or basic and diluted net loss per share attributable to common stockholders of $0.74, for the three months ended September 30, 2021