On May 14, 2024 Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer, reported financial results and operational highlights for the first quarter ended March 31, 2024 (Press release, Adicet Bio, MAY 14, 2024, View Source [SID1234643276]).

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"We are poised for a transformational year in 2024 as we advance our gamma delta T cell platform in autoimmune diseases and prepare to initiate a Phase 1 study evaluating our lead candidate ADI-001 in lupus nephritis in the second quarter of this year," said Chen Schor, President and Chief Executive Officer at Adicet Bio. "We recently shared encouraging preclinical data on ADI-270 at the ASGCT (Free ASGCT Whitepaper) annual meeting highlighting its highly differentiated profile and illustrating ADI-270’s robust anti-tumor activity in multiple CD70+ solid and hematological cancer indications and supporting ADI-270’s clinical development. In parallel, we are continuing to enroll mantle cell lymphoma patients in our ongoing Phase 1 study of ADI-001 in relapsed or refractory non-Hodgkin’s lymphoma and expect to share a clinical update in the second half of this year."

First Quarter 2024 and Recent Operational Highlights:

Autoimmune diseases

On track to initiate Phase 1 study of ADI-001 in lupus nephritis in 2Q 2024. In December 2023, the FDA granted clearance for Adicet’s IND application to evaluate ADI-001 in lupus nephritis. The Company plans to commence a Phase 1 clinical trial to assess the safety and efficacy of ADI-001 in lupus nephritis in the second quarter of 2024. Preliminary data from the study are anticipated during the fourth quarter of 2024 or first quarter of 2025, depending on patient enrollment and study site activation.
Continuing to expand ADI-001 into additional autoimmune diseases. Adicet plans to continue broadening the clinical applications of ADI-001 to include additional autoimmune indications. The Company expects to share preliminary clinical data in the fourth quarter of 2024 or first half of 2025, subject to regulatory clearances and contingent upon successful site initiation and patient enrollment in the relevant clinical protocols.
Hematologic malignancies and solid tumor indications

Presentation of preclinical data from ADI-270 at the ASGCT (Free ASGCT Whitepaper) Annual Meeting. In May 2024, Adicet presented promising preclinical data in an oral presentation at the ASGCT (Free ASGCT Whitepaper) annual meeting demonstrating robust anti-tumor activity of ADI-270, an armored allogeneic "off-the-shelf" gamma delta CAR T cell therapy candidate targeting CD70+ cancers, in multiple CD70+ solid and hematological tumor indications. Based on ADI-270’s promising profile in preclinical studies to date, Adicet expects to submit an IND for ADI-270 in renal cell carcinoma in the second quarter of 2024. Following regulatory clearance and contingent upon study initiation progress, the Company intends to present clinical data from a Phase 1 study in the first half of 2025.
Enrollment of mantle cell lymphoma (MCL) patients in ongoing ADI-001 Phase 1 GLEAN study. Adicet is continuing to enroll MCL patients in the Phase 1 trial evaluating ADI-001 in relapsed or refractory non-Hodgkin’s Lymphoma (NHL). The Company remains on track to provide a clinical update on safety, efficacy and 6-month complete response data in MCL patients in the second half of 2024.
Financial Results for First Quarter 2024:

Research and Development (R&D) Expenses: R&D expenses were $23.9 million for the three months ended March 31, 2024, compared to $26.8 million during the same period in 2023. The decrease in R&D expenses was primarily due to a net $3.1 million decrease in expenses related to contract development manufacturing organizations (CDMOs) and other externally conducted research and development.
General and Administrative (G&A) Expenses: G&A expenses were $7.0 million for the three months ended March 31, 2024, compared to $6.6 million during the same period in 2023. The $0.4 million increase was primarily driven by an increase in personnel expenses. The increase was partially offset by a $0.2 million decrease in contractor fees as well as a $0.1 million decrease in professional fees.
Net Loss: Net loss for the three months ended March 31, 2024 was $28.0 million, or a net loss of $0.35 per basic and diluted share, including non-cash stock-based compensation expense of $5.7 million, as compared to a net loss of $30.9 million, or a net loss of $0.72 per basic and diluted share, including non-cash stock-based compensation expense of $4.8 million during the same period in 2023.
Cash Position: Cash and cash equivalents were $247.6 million as of March 31, 2024, compared to $231.6 million during the same period in 2023. The Company expects that current cash and cash equivalents as of March 31, 2024, will be sufficient to fund its operating expenses into the second half of 2026.