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Adicet Bio, Inc.

For the period ended Sep 30, 2026. Filed Nov 5, 2026.

View on SEC.gov

About this filing

A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.

Sep 30, 2026 · Filed Nov 5, 2026

ACET$3.05+4.5%Stored close · as of Nov 6, 2026

What changed in Management’s Discussion and Analysis?

Read the current filing

Previous report: 10-Q

Period ended 2026-06-30; filed 2026-08-05.

0001720580-26-000050

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

Current report: 10-Q

Period ended 2026-09-30; filed 2026-11-05.

0001720580-26-000066

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

The baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.

Compared 121 previous paragraphs and 120 current paragraphs.

97 unchanged; 18 reworded; 5 added; 6 removed; 0 previous and 0 current paragraphs rearranged.

Tables are not compared: 5 previous and 5 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.

A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.

Added paragraphs (5)

Current report

In September 2026, we announced positive safety and efficacy data from 22 efficacy evaluable patients (16 LN and 6 extra-renal SLE patients) dosed in our Phase 1 trial of prula-cel in autoimmune diseases, as of the August 28, 2026 data cut-off date. All patients had at least 6 months of follow-up, and 13 patients had at least 12 months of follow-up. Based on these findings, 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

Current report

Definition of Remission in Systemic Lupus Erythematosus (DORIS) rates reported in the September 2026 clinical data update, the Company plans to engage with the U.S. Food and Drug Administration (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. In addition, the Company expects to report clinical data evaluating prula-cel in SSc in the second quarter of 2027.

Current report

The Company is developing a differentiated in vivo CAR-T platform designed to achieve highly efficient, selective T-cell transduction through proprietary cell-specific delivery technologies, including novel homing and VSV-G (Vesicular Stomatitis Virus Glycoprotein G) fusogen technologies. The Company’s clinical pipeline includes programs targeting multiple myeloma, non-Hodgkin's lymphoma (NHL) and solid tumors, with differentiated CAR designs and biology-modifying technologies intended to enhance potency, efficacy and durability. The Company plans to initiate the first clinical study from its in-vivo CAR-T program in the second half of 2027.

Current report

Comparison of the Nine Months Ended September 30, 2026 and 2025

Current report

As of September 30, 2026, we had cash, cash equivalents, and short-term investments in treasury securities of $100.9 million. Based on our current operating plan, we believe that substantial doubt exists about our ability to continue as a going concern for at least twelve months following the filing of this Quarterly Report on Form 10-Q, and we will need to obtain additional funding.
Removed paragraphs (6)

Previous report

In October 2025, we announced positive preliminary results from seven SLE and LN patients dosed in our ongoing Phase 1 trial of prula-cel in autoimmune diseases as of the August 31, 2025 data cut-off date. We plan to provide a comprehensive clinical update for this trial in LN and SLE patients in the third quarter of 2026, including data from 22 patients with LN and SLE (16 LN/ 6 SLE), with a minimum of six months follow-up, including 13 patients with at least 12 months of follow-up. Based on recent interactions with the FDA, we are advancing a potential pivotal trial design in LN and supporting planned start-up activities for a pivotal program anticipated to commence in the second half of 2026, subject to regulatory clearance. The Company plans to provide more details on the potential pivotal trial design in the third quarter of 2026. In addition, in the second half of 2026 we expect to report data evaluating prula-cel in patients with SSc.

Previous report

We are also advancing a Phase 1 trial of prula-cel in patients with treatment-refractory rheumatoid arthritis (RA). The study is evaluating prula-cel using two conditioning regimens: cyclophosphamide alone and cyclophosphamide with fludarabine, to explore the potential to reduce the need for conditioning. We plan to provide a clinical update on this trial in the second half of 2026.

Previous report

The Company is developing a differentiated in vivo CAR-T platform and pipeline targeting hematologic malignancies and solid tumors. A comprehensive update on the platform and pipeline is anticipated in the second half of 2026.

Previous report

As of June 30, 2026, we had cash, cash equivalents and short-term investments of $118.2 million and restricted cash of $2.9 million held in cash collateral accounts. We expect that our cash, cash equivalents and short-term investments will be sufficient to fund our forecasted operating expenses, capital expenditure requirements and debt service payments for at least the next twelve months from the issuance of our unaudited consolidated financial statements included in this Quarterly Report on Form 10-Q.

Previous report

As of June 30, 2026, we had cash, cash equivalents, and short-term investments in treasury securities of $118.2 million. We believe that our cash, cash equivalents and short-term investments in treasury securities will be sufficient for us to fund our operations for at least twelve months from the issuance date of our unaudited consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q. We have based these estimates on assumptions that may prove to be wrong, and we could deplete our available capital resources sooner than we expect. Because of the risks and uncertainties associated with research, development, and commercialization of product candidates, we are unable to estimate the exact amount of our working capital requirements.
Reworded paragraphs (18)

Previous wording

We are a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer. We are advancing a pipeline of “off-the-shelf” gamma delta T cells, engineered with chimeric antigen receptors (CARs), to facilitate durable activity in patients.

Current wording

We are a clinical stage biotechnology company discovering and developing a broad pipeline of allogeneic gamma delta T cell therapies, engineered with chimeric antigen receptors (CARs) alongside differentiated in vivo CAR-T therapies with the potential to redefine treatment across autoimmune diseases, hematologic malignancies and solid tumors.

Previous wording

We are advancing patient enrollment in our Phase 1 program of prula-cel across multiple autoimmune diseases. In December 2023, the U.S. Food and Drug Administration (FDA) cleared our IND application for prula-cel in lupus nephritis (LN) and has subsequently authorized the evaluation of prula-cel in systemic lupus erythematosus (SLE), systemic sclerosis (SSc), anti-neutrophil cytoplasmic autoantibody associated vasculitis (AAV), idiopathic inflammatory myopathies (IIM) and stiff person syndrome (SPS) within the Company’s Phase 1 clinical trial. In November 2025, we reached alignment with the FDA to allow LN and SLE patients to be dosed with prula-cel in the outpatient setting in ongoing and future clinical trials. Prula-cel has received Fast Track Designation by the FDA for the potential treatment of relapsed/refractory class III or class IV LN, refractory SLE with extrarenal involvement and for SSc.

Current wording

We are advancing patient enrollment in our Phase 1 program of prula-cel across multiple autoimmune diseases. In December 2023, the U.S. Food and Drug Administration (FDA) cleared our IND application for prula-cel in lupus nephritis (LN) and has subsequently authorized the evaluation of prula-cel in systemic lupus erythematosus (SLE), systemic sclerosis (SSc), anti-neutrophil cytoplasmic autoantibody associated vasculitis (AAV), idiopathic inflammatory myopathies (IIM) and stiff person syndrome (SPS) within the Company’s Phase 1 clinical trial. In November 2025, we reached alignment with the FDA to allow LN and SLE patients to be dosed with prula-cel in the outpatient setting in ongoing and future clinical trials. Prula-cel has received Fast Track Designation by the FDA for the potential treatment of relapsed/refractory class III or class IV LN, refractory SLE with extrarenal involvement and for SSc. In September 2026, the Company prioritized development of prula-cel toward potential pivotal studies in systemic lupus erythematosus (SLE), including both lupus nephritis and extra-renal SLE.

Previous wording

We are advancing ADI-212, a next-generation gene-edited and armored clinical candidate designed to target prostate-specific membrane antigen. ADI-212 is engineered to express a novel CAR binder designed to support enhanced tolerability and tumor-specific recognition. It integrates membrane-tethered IL-12 (mbIL-12) armoring and CRISPR/Cas9 mediated disruption of subunit 12 of the mediator complex (MED12) to enhance potency in solid tumors and deliver multiple anti-tumor mechanisms of action within the tumor microenvironment. We expect to submit a regulatory filing for a clinical trial of ADI-212 for the treatment of metastatic castration-resistant prostate cancer (mCRPC) in the third quarter of 2026. Subject to regulatory clearance to proceed with a clinical trial, we plan to initiate patient enrollment in the fourth quarter of 2026. We believe the potential market opportunity for ADI-212 in mCRPC is significant based on the prevalence in the U.S., EU5, China and Japan of approximately 75,000 patients with second or third line advanced disease.

Current wording

We are advancing ADI-212, a next-generation gene-edited and armored clinical candidate designed to target prostate-specific membrane antigen. ADI-212 is engineered to express a novel CAR binder designed to support enhanced tolerability and tumor-specific recognition. It integrates membrane-tethered IL-12 (mbIL-12) armoring and CRISPR/Cas9 mediated disruption of subunit 12 of the mediator complex (MED12) to enhance potency in solid tumors and deliver multiple anti-tumor mechanisms of action within the tumor microenvironment. In August 2026, the FDA cleared our IND application for ADI-212 in metastatic castration-resistant prostate cancer (mCRPC), followed by the granting of Fast Track Designation in September 2026. Phase 1 startup activities are underway, with patient enrollment in mCRPC anticipated in the first quarter of 2027. We believe the potential market opportunity for ADI-212 in mCRPC is significant based on the prevalence in the U.S., EU5, China and Japan of approximately 75,000 patients with second or third line advanced disease.

Previous wording

Research and development expenses decreased by $15.3 million, or 30%, during the six months ended June 30, 2026 as compared to the same period in 2025. The decrease in research and development expenses was primarily due to a $6.5 million decrease in payroll and personnel expenses due to lower headcount, a $4.5 million decrease related to lower CRO expenses due to no new enrollment of patients, a $2.2 million decrease in expenses related to lab supplies and materials and a $2.4 million decrease in allocated facility-related expenses. The decrease was partially offset by a $0.3 million increase in professional fees.

Current wording

Research and development expenses decreased by $7.2 million, or 32%, during the three months ended September 30, 2026 as compared to the same period in 2025. The decrease in research and development expenses was primarily due to a $3.7 million decrease in payroll and personnel expenses due to lower headcount, a $2.7 million decrease related to lower CRO expenses due to no new enrollment of patients, a $0.4 million decrease in allocated facility-related expenses, and a $0.8 million decrease in expenses related to lab supplies and materials. The decrease was partially offset by a $0.3 million increase in professional fees.

Previous wording

General and administrative expenses decreased by $0.1 million, or 3%, during the three months ended June 30, 2026 as compared to the same period in 2025. The decrease in general and administrative expenses was due to a decrease in payroll and personnel related expenses of $0.9 million primarily related to a decrease in stock-based compensation and lower headcount and a $0.4 million decrease in professional fees. The decrease was partially offset by a $1.2 million increase in allocated facility-related expenses.

Current wording

General and administrative expenses decreased by $0.9 million, or 18%, during the three months ended September 30, 2026 as compared to the same period in 2025. The decrease in general and administrative expenses was due to a decrease in payroll and personnel related expenses of $1.0 million primarily related to a decrease in stock-based compensation and lower headcount. The decrease was partially offset by a $0.1 million increase in professional fees and allocated facility-related expenses.

Previous wording

Interest income decreased by $0.2 million, or 16% during the three months ended June 30, 2026 as compared to the same period in 2025, which was primarily due to lower interest rates and lower cash balances for the period.

Current wording

Interest income decreased by $0.2 million, or 17% during the three months ended September 30, 2026 as compared to the same period in 2025, which was primarily due to lower interest rates and lower cash balances for the period.

Previous wording

Other expense, net decreased by $0.2 million, or 73%, during the three months ended June 30, 2026 as compared to the same period in 2025. This was due to a decrease in state franchise taxes and losses from disposals of property and equipment recognized in 2025.

Current wording

Other expense, net decreased by less than $0.1 million, or 53%, during the three months ended September 30, 2026 as compared to the same period in 2025. This was due to a decrease in realized losses related to foreign exchange rates.

Previous wording

Research and development expenses decreased by $10.0 million, or 35%, during the three months ended June 30, 2026 as compared to the same period in 2025. The decrease in research and development expenses was primarily due to a $4.0 million decrease related to lower CRO expenses due to no new enrollment of patients, a $2.8 million decrease in payroll and personnel expenses due to lower headcount, a $2.3 million decrease in allocated facility-related expenses, a $0.8 million decrease in expenses related to lab supplies and materials, and a $0.1 million decrease in professional fees.

Current wording

Research and development expenses decreased by $22.5 million, or 30%, during the nine months ended September 30, 2026 as compared to the same period in 2025. The decrease in research and development expenses was primarily due to a $10.1 million decrease in payroll and personnel expenses due to lower headcount, a $7.2 million decrease related to lower CRO expenses due to no new enrollment of patients, a $2.9 million decrease in expenses related to lab supplies and materials and a $2.8 million decrease in allocated facility-related expenses. The decrease was partially offset by a $0.5 million increase in professional fees.

Previous wording

General and administrative expenses decreased by $3.1 million, or 28%, during the six months ended June 30, 2026 as compared to the same period in 2025. The decrease in general and administrative expenses was due to a decrease in payroll and personnel related expenses of $2.3 million primarily related to a decrease in stock-based compensation and lower headcount and a $1.0 million decrease in professional fees. The decrease was partially offset by a $0.2 million increase in allocated facility-related expenses.

Current wording

General and administrative expenses decreased by $4.0 million, or 25%, during the nine months ended September 30, 2026 as compared to the same period in 2025. The decrease in general and administrative expenses was due to a decrease in payroll and personnel related expenses of $3.3 million primarily related to a decrease in stock-based compensation and lower headcount and a $0.9 million decrease in professional fees. The decrease was partially offset by a $0.2 million increase in allocated facility-related expenses.

Previous wording

Interest income decreased by $0.6 million, or 19% during the six months ended June 30, 2026 as compared to the same period in 2025, which was primarily due to lower interest rates and lower cash balances for the period.

Current wording

Interest income decreased by $0.8 million, or 18% during the nine months ended September 30, 2026 as compared to the same period in 2025, which was primarily due to lower interest rates and lower cash balances for the period.

Previous wording

Other expense, net decreased by $0.2 million, or 77%, during the six months ended June 30, 2026 as compared to the same period in 2025. This was due to losses from disposals of property and equipment recognized in 2025.

Current wording

Other expense, net decreased by $0.2 million, or 72%, during the nine months ended September 30, 2026 as compared to the same period in 2025. This was due to losses from disposals of property and equipment recognized in 2025.

Previous wording

We have incurred losses since inception and have incurred losses of $41.6 million and $59.4 million for the six months ended June 30, 2026 and 2025, respectively. As of June 30, 2026, we had an accumulated deficit of $656.3 million.

Current wording

We have incurred losses since inception and have incurred losses of $60.5 million and $86.3 million for the nine months ended September 30, 2026 and 2025, respectively. As of September 30, 2026, we had an accumulated deficit of $675.2 million.

Previous wording

Net cash used in operating activities was $41.3 million for the six months ended June 30, 2026. Cash used in operating activities consisted of net loss partially offset by non-cash adjustments of $5.4 million, and a net decrease in operating assets and liabilities of $5.1 million. Non-cash items primarily included depreciation and amortization of $2.5 million, stock-based compensation expense of $2.7 million, non-cash lease expense of $1.5 million and a net amortization of premiums and accretion discounts on investments of $1.4 million. The net change in assets and liabilities was primarily due to a decrease in accounts payable of $1.1 million, a net decrease in accrued and other current and non-current liabilities of $1.9 million, a decrease in operating lease liability of $1.9 million, a decrease in prepaid expenses of $0.2 million and a decrease in other current assets of less than $0.1 million.

Current wording

Net cash used in operating activities was $59.2 million for the nine months ended September 30, 2026. Cash used in operating activities consisted of net loss partially offset by non-cash adjustments of $8.1 million, and a net decrease in operating assets and liabilities of $6.8 million. Non-cash items primarily included depreciation and amortization of $3.6 million, stock-based compensation expense of $4.3 million, non-cash lease expense of $2.2 million and a net amortization of premiums and accretion discounts on investments of $1.9 million. The net change in assets and liabilities was primarily due to a decrease in accounts payable of $2.0 million, a net decrease in accrued and other current and non-current liabilities of $2.0 million, a decrease in operating lease liability of $2.6 million, a decrease in prepaid expenses of $0.1 million and a decrease in other current assets of less than $0.1 million.

Previous wording

Net cash used in operating activities was $52.0 million for the six months ended June 30, 2025. Cash used in operating activities consisted of net loss offset by non-cash adjustments of $50.4 million, and a net decrease in operating assets and liabilities of $1.6 million. Non-cash items primarily included depreciation and amortization of $3.3 million, stock-based compensation expense of $6.1 million, and non-cash lease expense of $1.7 million. The net change in assets and liabilities was primarily due to a net decrease in accrued and other current and non-current liabilities of $0.6 million and a decrease in operating lease liability of $1.9 million, offset by an increase in prepaid expenses and other current assets of $1.1 million.

Current wording

Net cash used in operating activities was $74.3 million for the nine months ended September 30, 2025. Cash used in operating activities consisted of net loss offset by non-cash adjustments of $13.1 million, and a net decrease in operating assets and liabilities of $1.2 million. Non-cash items primarily included depreciation and amortization of $4.9 million, stock-based compensation expense of $8.6 million, non-cash lease expense of $2.4 million and a net amortization of premiums and accretion discounts on investments of $2.9 million. The net change in assets and liabilities was primarily due to a net decrease in accrued and other current and non-current liabilities of less than $0.1 million and a decrease in operating lease liability of $2.7 million, offset by an increase in accounts payable of $0.7 million, an increase in prepaid expenses and other current assets of $0.5 million and an increase in other non-current assets of $0.3 million.

Previous wording

Net cash provided by investing activities was $35.5 million for the six months ended June 30, 2026, which consisted of $80.0 million related to maturities of short-term treasury securities, net of $44.2 million of purchases of short-term treasury securities and $0.2 million of purchases of lab equipment and leasehold improvements for our Good Manufacturing Practice (GMP) cell processing suite at 1000 Bridge Parkway.

Current wording

Net cash provided by investing activities was $47.1 million for the nine months ended September 30, 2026, which consisted of $108 million related to maturities of short-term treasury securities, net of $60.6 million of purchases of short-term treasury securities and $0.3 million of purchases of lab equipment and leasehold improvements for our Good Manufacturing Practice (GMP) cell processing suite at 1000 Bridge Parkway.

Previous wording

Net cash provided by investing activities was $30.1 million for the six months ended June 30, 2025, which consisted of $34.4 million of purchases of short-term treasury securities and $1.5 million of purchases of lab equipment and leasehold improvements for our Good Manufacturing Practice (GMP) cell processing suite at 1000 Bridge Parkway. We received $66.0 million related to the maturities of short-term treasury securities.

Current wording

Net cash provided by investing activities was $46.9 million for the nine months ended September 30, 2025, which consisted of $110 million related to maturities of short-term treasury securities, net of $61.3 million purchases of short-term treasury securities and $1.7 million of purchases of lab equipment and leasehold improvements for our Good Manufacturing Practice (GMP) cell processing suite at 1000 Bridge Parkway.

Previous wording

Net cash used by financing activities was less than $0.1 million for the six months ended June 30, 2026, which was primarily related to net proceeds from the issuance of common stock in connection with our employee stock purchase plan. This was partially offset by cash paid for taxes withheld on the net share settlement of equity awards and issuance costs related to exchange of common stock for pre-funded warrant.

Current wording

Net cash used in financing activities was less than $0.1 million for the nine months ended September 30, 2026, which was primarily related to net proceeds from the issuance of common stock in connection with our employee stock purchase plan. This was partially offset by cash paid for taxes withheld on the net share settlement of equity awards and issuance costs related to exchange of common stock for pre-funded warrant.

Previous wording

Net cash provided by financing activities was $0.2 million for the six months ended June 30, 2025, which was primarily related to net proceeds from the issuance of common stock in connection with our employee stock purchase plan. This was partially offset by cash paid for taxes withheld on the net share settlement of equity awards.

Current wording

Net cash provided by financing activities was less than $0.1 million for the nine months ended September 30, 2025, which included $0.3 million in net proceeds from the issuance of common stock in connection with our employee stock purchase plan. This was partially offset by $0.1 million cash paid for taxes withheld on the net share settlement of equity awards and $0.2 million cash paid for the principal payment on finance leases.