On November 5, 2026 Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing allogeneic gamma delta CAR-T cell and in vivo CAR-T therapies for autoimmune diseases, hematologic malignancies and solid tumors, reported financial results and operational highlights for the third quarter ended September 30, 2026.

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!

"The growing body of evidence for prula-cel continues to strengthen our conviction in its potential to generate meaningful, lasting remissions for patients living with SLE, including those with LN and extra renal SLE. The compelling efficacy observed following complete discontinuation of immunosuppressants, together with evidence of a deep immune reset and a favorable safety profile supporting outpatient administration, reinforce the potential for prula-cel to meaningfully change the treatment paradigm for lupus patients," said Chen Schor, President and Chief Executive Officer of Adicet Bio. "With pivotal study startup activities underway in LN and planned FDA discussions regarding potential pivotal expansion to include lupus patients without nephritis, we look forward to providing a regulatory update and additional 12-month follow-up data from approximately 22 patients in the first quarter of 2027 followed by clinical data from our systemic sclerosis cohort in the second quarter. Together with continued progress on ADI-212 and our in vivo CAR-T pipeline, we believe 2027 will be a catalyst-rich year for Adicet."

Third Quarter 2026 and Recent Operational Highlights:

Autoimmune diseases

Prula-cel demonstrated positive safety and efficacy data in Phase 1 trial of patients with SLE with or without LN. In September 2026, the Company announced updated safety and efficacy data from its ongoing Phase 1 study evaluating prula-cel in patients with SLE, with or without LN. As of the August 28, 2026 data cutoff, 22 efficacy-evaluable patients (16 with LN and 6 with extra-renal SLE) had 6 to 21 months of follow-up, including 13 patients with at least 12 months of follow-up. Prula-cel continued to demonstrate positive clinical responses and a favorable safety profile in this heavily pretreated population. At 12 months, 50% of evaluable LN patients achieved a complete renal response and 54% of evaluable patients achieved Definition of Remission in Systemic lupus (DORIS) remission. Patients also demonstrated rapid and sustained reductions in mean Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) and the Physician’s Global Assessment (PGA). All patients discontinued immunosuppressants, and all but one tapered background steroids to 5 mg or less of prednisone equivalent. Prula-cel was generally well tolerated, with no Grade > 2 cytokine release syndrome (CRS), no immune effector cell-associated neurotoxicity syndrome (ICANS), no immune effector cell-associated hemophagocytic syndrome (IEC-HS), and no graft-versus-host disease (GvHD) observed, supporting the potential for outpatient administration. Biomarker analyses further demonstrated evidence of immune reset, including complete CD19+ B-cell depletion, naïve-dominant B-cell reconstitution, reductions in anti-dsDNA antibodies, and complement recovery.
Prula-cel pivotal LN study start-up activities underway; FDA meeting planned in 4Q/2026 regarding potential pivotal expansion beyond LN; regulatory update and additional 12-month clinical data expected in 1Q/2027. The Company has initiated start-up activities for a pivotal study in LN. The single-arm study is expected to enroll a double-digit number of patients, with complete renal response at 12 months as the primary efficacy endpoint. Given the high DORIS remission rates reported in the September 2026 clinical data update, the Company plans to engage with the FDA in the fourth quarter of 2026 regarding the potential expansion of its pivotal development program to include lupus patients without nephritis. The Company expects to provide an update on these discussions, as well as additional clinical data from approximately 22 patients with at least 12 months of follow-up, in the first quarter of 2027.
Phase 1 readout of prula-cel in systemic sclerosis (SSc) expected in the second quarter of 2027. The Company expects to report clinical data evaluating prula-cel in SSc in the second quarter of 2027.
Solid tumor indications

Phase 1 startup activities underway for ADI-212 in mCRPC following FDA IND clearance and FTD. In August 2026, the FDA cleared the Company’s IND application for ADI-212 in mCRPC, followed by the granting of FTD in September 2026. Phase 1 startup activities are underway, with patient enrollment in mCRPC anticipated in the first quarter of 2027. ADI-212 is designed as an off-the-shelf therapy, featuring multiple platform enhancements by incorporating gene-editing and expression of novel immune-stimulating molecules intended to strengthen anti-tumor potency, including improved antigen engagement, capacity for durable tumor-killing and active modulation of the tumor microenvironment.
In Vivo CAR-T Program and Pipeline

Progressing a differentiated portfolio of in vivo CAR-T programs designed to address significant unmet needs in both hematologic malignancies and solid tumors. The Company is advancing its in vivo CAR-T platform and pipeline designed to optimize in vivo T-cell transduction and generate highly cytolytic CAR-T therapy. Ongoing preclinical activities include programs targeting multiple myeloma, non-Hodgkin’s lymphoma, and solid tumor indications. Based on progress to date, The Company plans to initiate its first in vivo CAR-T program in the second half of 2027.
Financial Results for Third Quarter 2026:

Research and Development (R&D) Expenses: R&D expenses were $15.6 million for the three months ended September 30, 2026, compared to $22.9 million during the same period in 2025. Non-cash stock-based compensation expense included in R&D expense was $0.8 million for the third quarter of 2026.
General and Administrative (G&A) Expenses: G&A expenses were $4.2 million for the three months ended September 30, 2026, compared to $5.1 million during the same period in 2025. Non-cash stock-based compensation expense included in G&A expense was $0.7 million for the third quarter of 2026.
Net Loss: Net loss was $18.9 million, or a net loss of $1.76 per basic and diluted share for the three months ended September 30, 2026. This net loss includes non-cash charges of $2.7 million that consisted primarily of share-based compensation, depreciation expenses, and noncash lease expense.
Cash Position: Cash, cash equivalents and short-term investments were $100.9 million as of September 30, 2026. The Company expects that current cash, cash equivalents and short-term investments as of September 30, 2026, will be sufficient to fund its operating expenses into the second half of 2027.

(Press release, Adicet Bio, NOV 5, 2026, View Source [SID1234674359])