Adicet Bio — Third Quarter 2026 Earnings Summary

Financial Performance:

• Research and development expenses were $15.6 million for the three months ended September 30, 2026, a decrease from $22.9 million in the same period in 2025.
• General and administrative expenses were $4.2 million for the three months ended September 30, 2026, a decrease from $5.1 million in the same period in 2025.
• Net loss was $18.9 million, or $1.76 per basic and diluted share, for the three months ended September 30, 2026, compared to a net loss of $26.9 million, or $4.72 per share, in the prior year period.
• Cash, cash equivalents, and short-term investments totaled $100.9 million as of September 30, 2026, down from $158.5 million as of December 31, 2025.
• Accumulated deficit increased to $(675.2) million as of September 30, 2026, from $(614.7) million as of December 31, 2025.
• Total operating expenses for the nine months ended September 30, 2026, were $63.7 million, compared to $90.2 million in the same period in 2025.

Guidance and Future Outlook:

• The Company expects current cash resources to fund operating expenses into the second half of 2027.
• Regulatory updates and 12-month follow-up data from approximately 22 patients are expected in the first quarter of 2027.
• Clinical data for the prula-cel systemic sclerosis cohort is expected in the second quarter of 2027.
• The first in vivo CAR-T candidate is expected to enter the clinic in the second half of 2027.
• Management anticipates 2027 to be a catalyst-rich year.

Business Segments and Product Lines:

• Autoimmune Diseases (Prula-cel): Phase 1 data showed 50% of evaluable lupus nephritis (LN) patients achieved complete renal response at 12 months, and 54% achieved DORIS remission. All patients discontinued immunosuppressants, and all but one tapered background steroids to 5 mg or less. No Grade >2 cytokine release syndrome, ICANS, IEC-HS, or GvHD was observed.
• Pivotal Study: Startup activities for a pivotal single-arm LN study are underway, with enrollment of a double-digit number of patients expected. The primary efficacy endpoint is complete renal response at 12 months.
• FDA Engagement: The Company plans to engage with the FDA in the fourth quarter of 2026 regarding the potential expansion of the pivotal program to include lupus patients without nephritis.
• Solid Tumors (ADI-212): The FDA cleared the Investigational New Drug (IND) application and granted Fast Track Designation (FTD) for ADI-212 in metastatic castration-resistant prostate cancer (mCRPC). Phase 1 startup activities are underway, with patient enrollment anticipated in the first quarter of 2027.
• In Vivo CAR-T: The Company is advancing an in vivo CAR-T platform targeting hematologic malignancies and solid tumors, with ongoing preclinical programs for multiple myeloma and non-Hodgkin's lymphoma.

Market and Competitive Landscape:

• The press release does not contain specific market share data, competitor names, or detailed market trend analysis beyond the identification of unmet needs in autoimmune diseases, hematologic malignancies, and solid tumors.

Risks and Challenges:

• Forward-looking statements are subject to risks including global economic conditions, public health emergencies, disruptions to preclinical and clinical studies, and challenges in employee hiring and retention.
• Risks include the inability to obtain regulatory approvals on expected timelines, clinical studies failing to demonstrate adequate safety and efficacy, and the inherently unpredictable nature of FDA regulatory processes.
• Potential risks also include the inability to meet production and product release expectations and the uncertainty of raising additional capital.

Management Commentary and Tone:

• Chen Schor, President and CEO, stated that the evidence for prula-cel strengthens conviction in its potential to generate lasting remissions and change the treatment paradigm for lupus patients.
• Management highlighted the favorable safety profile supporting outpatient administration and the deep immune reset observed in patients.
• The tone is confident regarding the 2027 catalysts, citing upcoming regulatory updates, clinical data releases, and pipeline progress.

Other Key Points:

• Prula-cel demonstrated durable responses and a favorable safety profile in a heavily pretreated population of 22 efficacy-evaluable patients (16 with LN, 6 with extra-renal SLE) with 6 to 21 months of follow-up.
• Biomarker analyses showed complete CD19+ B-cell depletion, naive-dominant B-cell reconstitution, reductions in anti-dsDNA antibodies, and complement recovery.
• ADI-212 is designed as an off-the-shelf therapy incorporating gene-editing and novel immune-stimulating molecules to enhance anti-tumor potency.
• The Company has initiated start-up activities for a pivotal study in LN with a primary endpoint of complete renal response at 12 months.