On May 6, 2025 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, 2025 (Press release, Adicet Bio, MAY 6, 2025, View Source [SID1234652615]).
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"We are approaching an exciting inflection point for our pipeline, with significant data milestones on the horizon," said Chen Schor, President and Chief Executive Officer of Adicet Bio. "In the second half of 2025, we expect to report preliminary Phase 1 data from our two lead programs – ADI-001 in autoimmune diseases and ADI-270 in ccRCC, with more than 6 patients with at least 3-month follow up in both programs. As we progress toward these readouts, we also look to harness the full potential of our allogeneic gamma delta 1 CAR T cell therapy platform, which we believe has key advantages over other cell types. We have identified two promising highly differentiated programs, one targeting PSMA and one follow-on program targeting autoimmune diseases with potential to become best-in-class therapies for patients fighting autoimmune diseases and cancer."
First Quarter 2025 and Recent Operational Highlights:
Autoimmune diseases
Enrollment open for LN and SLE patients in Phase 1 clinical trial of ADI-001 in autoimmune diseases. In April 2025, Adicet expanded enrollment in its Phase 1 trial to include patients with SLE, in addition to ongoing enrollment in LN. The Company expects to initiate enrollment for patients with systemic sclerosis (SSc), idiopathic inflammatory myopathy (IIM), stiff person syndrome (SPS) and anti-neutrophil cytoplasmic autoantibody associated vasculitis (AAV) in the Phase 1 trial in 3Q/2025. Preliminary clinical data from the trial is expected in 2H/2025, subject to study site initiation and patient enrollment.
ADI-001 granted two new Fast Track Designations. In February 2025, the Food and Drug Administration (FDA) granted Fast Track Designation to ADI-001 for the treatment of refractory SLE with extrarenal involvement and for SSc.
Hematologic malignancies and solid tumor indications
Patient enrollment ongoing in Phase 1 trial of ADI-270 in metastatic/advanced ccRCC. Patient enrollment is underway in the Phase 1 clinical trial evaluating ADI-270 in adults with relapsed or refractory metastatic/advanced ccRCC. Adicet expects to share preliminary clinical data from the trial in 2H/2025.
Oral presentation of ADI-270 data at the American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) 28th Annual Meeting. Adicet will present an oral abstract highlighting strong preclinical data demonstrating ADI-270’s anti-tumor activity in hematologic and solid tumor models at the ASGCT (Free ASGCT Whitepaper) Annual Meeting taking place May 13-17, 2025 in New Orleans, LA.
Presented ADI-270 preclinical data at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 2025 Spring Scientific Meeting. In March 2025, Adicet presented posters covering preclinical data of ADI-270 at the SITC (Free SITC Whitepaper) 2025 Spring Scientific Meeting.
Corporate Update
Appointed Michael Grissinger to Board of Directors. In April 2025, Adicet appointed Michael Grissinger to its Board of Directors. Mr. Grissinger brings over four decades of leadership experience in biopharmaceutical business development, strategy, and M&A to Adicet. Mr. Grissinger has an extensive track record of driving commercial success for global pharmaceutical companies, with a strong focus on immunology. He also serves on the board of directors at Aprea Therapeutics (Nasdaq: APRE) and three privately-held biotechnology companies, Envisagenics, Inc., AnaCardio AB, and NephroDI Therapeutics, Inc.
Financial Results for First Quarter 2025:
Research and Development (R&D) Expenses: R&D expenses were $22.8 million for the three months ended March 31, 2025, compared to $23.9 million during the same period in 2024. The decrease in R&D expenses was primarily due to a net $1.4 million decrease in expenses related to contract development manufacturing organizations and other externally conducted research and development.
General and Administrative (G&A) Expenses: G&A expenses were $7.1 and 7.0 million for the three months ended March 31, 2025 and 2024, respectively.
Net Loss: Net loss for the three months ended March 31, 2025 was $28.2 million, or a net loss of $0.31 per basic and diluted share, including non-cash stock-based compensation expense of $3.1 million, as compared to a net loss of $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 during the same period in 2024.
Cash Position: Cash and cash equivalents were $150.4 million as of March 31, 2025, compared to $176.3 million as of December 31, 2024. The Company expects that current cash, cash equivalents and short-term investments as of March 31, 2025, will be sufficient to fund its operating expenses into the second half of 2026.