On May 11, 2022 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 first quarter ended March 31, 2022 and provided an overview of recent developments (Press release, Atreca, MAY 11, 2022, View Source [SID1234614169]).

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"Atreca has had an exciting start to 2022, with multiple key clinical and preclinical milestones achieved," said John Orwin, Chief Executive Officer of Atreca. "In additional to the clinical data update in March where we reported the first objective responses observed in patients treated with both ATRC-101 monotherapy and pembrolizumab combination therapy, we also provided several updates on our preclinical pipeline at our R&D Day in April, highlighted by the announcement of ATRC-301, an antibody-drug conjugate (ADC) of an Atreca-discovered antibody targeting EphA2, as our next clinical candidate. We look forward to reporting additional data later this year from both the ongoing ATRC-101 Phase 1b clinical trial and the IND-enabling toxicology studies for ATRC-301."

Recent Developments and Highlights

Atreca hosted its first R&D Day in April, focused on the Company’s preclinical pipeline, and provided several updates:
ATRC-301, an ADC that selectively targets a novel, membrane-proximal epitope on erythropoietin-producing hepatocellular receptor A2 (EphA2), was declared as Atreca’s next clinical candidate. EphA2 is a validated and potentially high value target that is widely expressed across several types of cancer, and ATRC-301 has demonstrated potent, dose-dependent in vivo tumor regression in mice with no significant toxicity signals yet observed in murine models. Atreca has initiated IND-enabling studies, including a non-human primate toxicology study which is expected to read out in 2H22, and anticipates submitting an IND application for ATRC-301 in 2H23.
Atreca announced a licensing agreement with Zymeworks Inc. (Zymeworks) to utilize their ZymeLink technology to develop novel ADCs. As part of the licensing agreement with Zymeworks, Atreca’s novel antibodies will be conjugated using ZymeLink, Zymeworks’ suite of proprietary cytotoxins, linkers, and conjugation technologies. The agreement includes a two-year research term, with an option for a third year for Atreca, to evaluate antibodies as ADCs using ZymeLink, during which period Atreca can acquire up to three commercial licenses to develop three unique ADC programs.
Atreca announced multiple additional lead-stage programs in oncology, including ADC leads APN-497444 and APN–959038, CD3-engager lead APN-346958, and IL-15 superagonist (SA) conjugate lead APN-541885. Each program is based on an antibody identified via Atreca’s discovery platform from an active human immune response antibody, and upon further evaluation displayed strong and tumor-selective immunoreactivity against targets present on multiple tumor types across groups of patient samples. In their weaponized formats, each lead has demonstrated anti-tumor activity in in vivo preclinical studies. The targets bound by the antibodies vary in class and include both novel epitopes of known cancer targets as well as entirely novel target antigens in oncology.
To date, 55 total participants have been enrolled in the monotherapy and pembrolizumab-combination cohorts of the Phase 1b trial of ATRC-101, and participant selection based on target expression is expected to commence in 2Q22. Atreca anticipates reporting additional monotherapy and combination data in 2H22.
First Quarter 2022 Financial Results

As of March 31, 2022, cash and cash equivalents and investments totaled $125.8 million.
Research and development expenses for the quarter ended March 31, 2022, were $17.1 million, including non-cash share-based compensation expense of $2.1 million.
General and administrative expenses for the three months ended March 31, 2022, were $8.6 million, including non-cash share-based compensation expense of $2.3 million.
Atreca reported a net loss of $24.9 million, or basic and diluted net loss per share attributable to common stockholders of $0.65, for the three months ended March 31, 2022.