Adicet Bio, Inc.

Previous wording

Our lead product candidate, ADI-001, a first-in-class allogeneic gamma delta T cell therapy expressing a CAR targeting CD20, is being developed for the potential treatment of autoimmune diseases. We are also pursuing ADI-270, an armored gamma delta CAR T cell product candidate designed to address multiple CD70+ solid tumor and hematological malignancies indications, with renal cell carcinoma (RCC) as the initial indication. Our pipeline has several additional internal gamma delta T cell therapy programs in discovery and preclinical development for both hematological malignancies and solid tumors. We expect to continue to develop product candidates in autoimmune diseases and cancer based on our gamma delta T cell platform using either previously validated antigens or those that we identify and target using CAR and other technology. We plan to file one new Investigational New Drug (IND) application every 12-18 months.

Current wording

Our lead product candidate, ADI-001, a first-in-class allogeneic gamma delta T cell therapy expressing a CAR targeting CD20, is being developed for the potential treatment of autoimmune diseases. We are also pursuing ADI-212, an optimized next-generation gene-edited and armored clinical candidate designed to enhance potency in solid tumors and to deliver multiple anti-tumor mechanisms of action to the tumor microenvironment. We plan to file one new Investigational New Drug (IND) application every 12-18 months.

Previous wording

In December 2023, the U.S. Food and Drug Administration (FDA) cleared our IND application for ADI-001 in lupus nephritis (LN). In August 2024, we expanded our ADI-001 autoimmune clinical development program to include systemic lupus erythematosus (SLE), systemic sclerosis (SSc) and anti-neutrophil cytoplasmic autoantibody associated vasculitis (AAV). In September 2024, we activated sites for our Phase 1 clinical trial of ADI-001 in autoimmune diseases and opened enrollment for patients with LN. In October 2024, we received clearance for our IND amendment to evaluate ADI-001 in idiopathic inflammatory myopathies (IIM) and stiff person syndrome (SPS) as part of our Phase 1 clinical trial in autoimmune diseases. We believe the favorable safety profile, cellular kinetics and B cell depletion in peripheral blood and secondary lymphoid tissue demonstrated with ADI-001 clinical experience to date is favorable for development in autoimmune diseases. We believe the potential market opportunity for ADI-001 in B cell mediated autoimmune diseases is substantial based on the prevalence in the U.S., EU5, China and Japan of greater than 1.7 million patients with autoimmune diseases where CAR-T cell therapy has demonstrated clinical proof-of-concept, including SLE (which includes LN), SSc, IIM and SPS. In June 2024, the FDA granted Fast Track Designation to ADI-001 for the potential treatment of relapsed/refractory class III or class IV LN. In February 2025, the FDA granted Fast Track Designation to ADI-001 for the potential treatment of adult patients with refractory SLE with extrarenal involvement and for SSc. In February 2025, we reported that we have dosed a total of three LN patients, in our Phase 1 clinical trial of ADI-001 in autoimmune diseases. In April 2025, we expanded enrollment to include patients with SLE for our Phase 1 clinical trial evaluating ADI-001 in autoimmune diseases. We expect to initiate enrollment for patients with SSc, IIM, SPS and AAV in the third quarter of 2025. We plan to report preliminary clinical data from this trial, with more than 6 patients with at least 3-month follow up, in the second half of 2025, subject to study site initiation and patient enrollment.

Current wording

In December 2023, the U.S. Food and Drug Administration (FDA) cleared our IND application for ADI-001 in lupus nephritis (LN). In August 2024, we expanded our ADI-001 autoimmune clinical development program to include systemic lupus erythematosus (SLE), systemic sclerosis (SSc) and anti-neutrophil cytoplasmic autoantibody associated vasculitis (AAV). In September 2024, we activated sites for our Phase 1 clinical trial of ADI-001 in autoimmune diseases and opened enrollment for patients with LN. In October 2024, we received clearance for our IND amendment to evaluate ADI-001 in idiopathic inflammatory myopathies (IIM) and stiff person syndrome (SPS) as part of our Phase 1 clinical trial in autoimmune diseases. We believe the favorable safety profile, cellular kinetics and B cell depletion in peripheral blood and secondary lymphoid tissue demonstrated with ADI-001 clinical experience to date is favorable for development in autoimmune diseases. We believe the potential market opportunity for ADI-001 in B cell mediated autoimmune diseases is substantial based on the prevalence in the U.S., EU5, China and Japan of greater than 1.7 million patients with autoimmune diseases where CAR-T cell therapy has demonstrated clinical proof-of-concept, including SLE (which includes LN), SSc, IIM and SPS. In June 2024, the FDA granted Fast Track Designation to ADI-001 for the potential treatment of relapsed/refractory class III or class IV LN. In February 2025, the FDA granted Fast Track Designation to ADI-001 for the potential treatment of adult patients with refractory SLE with extrarenal involvement and for SSc. In April 2025, we expanded enrollment to include patients with SLE for our Phase 1 clinical trial evaluating ADI-001 in autoimmune diseases. In July 2025, we reported that the first systemic sclerosis (SSc) patient has been dosed in the second cohort of the Phase 1 clinical trial evaluating ADI-001 in autoimmune diseases. We have also opened enrollment for patients with IIM, SPS and AAV. We plan to report preliminary clinical data from this trial, with at least 6 patients with at least 3-months' follow up, in the second half of 2025.

Previous wording

Due to the prioritization of ADI-001 in autoimmune indications, patient enrollment in the Phase 1 clinical study of ADI-001 in mantle cell lymphoma has been closed.

Current wording

Due to the prioritization of ADI-001 in autoimmune indications and ADI-212 in prostate cancer, we have discontinued the development of ADI-270 and closed enrollment in the Phase 1 clinical trial in patients with metastatic/advanced clear renal cell carcinoma.

Previous wording

Interest income decreased by $1.2 million, or 42%, during the three months ended March 31, 2025 as compared to the same period in 2024, which was primarily due to lower interest rates and cash balances for the period.

Current wording

Interest income decreased by $1.6 million, or 53%, during the three months ended June 30, 2025 as compared to the same period in 2024, which was primarily due to lower interest rates and lower cash balances for the period.

Previous wording

Other expense, net decreased by less than $0.1 million, or 80%, during the three months ended March 31, 2025 as compared to the same period in 2024. This was due to a decrease in state franchise taxes and realized losses related to foreign exchange rates.

Current wording

Other expense, net increased by less than $0.2 million, or 337%, during the three months ended June 30, 2025 as compared to the same period in 2024. This was due to an increase in franchise taxes and losses from disposals of property and equipment.

Previous wording

Research and development expenses decreased by $1.1 million, or 5%, during the three months ended March 31, 2025 as compared to the same period in 2024. The decrease in research and development expenses was primarily due to a net $1.4 million decrease in expenses related to CDMOs and other externally conducted research and development as well as a $0.4 million decrease in allocated facility expenses. The decrease was partially offset by a $0.5 million increase in lab expenses as well as a $0.2 million increase in professional fees.

Current wording

General and administrative expenses decreased by $2.9 million, or 21%, during the six months ended June 30, 2025 as compared to the same period in 2024. The decrease in general and administrative expenses was due to a decrease in payroll and personnel related expenses of $3.0 million primarily related to a decrease in stock-based compensation and a $0.6 million decrease due to lower travel, recruiting, and other office-related expenses. The decrease was partially offset by a $0.7 million increase in professional fees.

Previous wording

As of March 31, 2025, we had cash, cash equivalents and short-term investments of $150.4 million and restricted cash of $2.9 million. 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.

Current wording

As of June 30, 2025, we had cash, cash equivalents and short-term investments of $125.0 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 wording

We have incurred losses since inception and have incurred losses of $28.2 million and $28.0 million for the three months ended March 31, 2025 and 2024, respectively. As of March 31, 2025, we had an accumulated deficit of $526.1 million.

Current wording

We have incurred losses since inception and have incurred losses of $59.4 million and $57.9 million for the six months ended June 30, 2025 and 2024, respectively. As of June 30, 2025, we had an accumulated deficit of $557.3 million.

Previous wording

As of March 31, 2025, we had cash, cash equivalents, and short-term investments of $150.4 million. We believe that our cash, cash equivalents and short-term investments 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.

Current wording

As of June 30, 2025, we had cash, cash equivalents, and short-term investments in treasury securities of $125.0 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.

Previous wording

Net cash used in operating activities was $25.4 million for the three months ended March 31, 2025. Cash used in operating activities consisted of net loss offset by non-cash adjustments of $4.5 million and a net decrease in operating assets and liabilities of $1.7 million. Non-cash items primarily included depreciation and amortization of $1.7 million, stock-based compensation expense of $3.2 million, non-cash lease expense of $0.8 million and a net amortization of premiums and accretion discounts on investments of $1.2 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 $2.2 million and a decrease in operating lease liability of $1.0 million. The decrease in operating assets and liabilities was partially offset by a $0.8 million increase in prepaid expenses and other current assets and a $0.6 million increase in accounts payable.

Current 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.

Previous wording

Net cash used in operating activities was $22.8 million for the three months ended March 31, 2024. Cash used in operating activities consisted of net loss offset by non-cash adjustments of $8.1 million, and a net decrease in assets and liabilities of $3.0 million. Non-cash items primarily included depreciation and amortization of $1.7 million, stock-based compensation expense of $5.7 million and non-cash lease expense of $0.8 million. The net change in assets and liabilities was primarily due to a net decrease in accrued and other current non-current liabilities of $1.8 million, a decrease in operating lease liability of $0.9 million, a decrease in accounts payable of $0.2 million and a decrease in prepaid expenses and other current assets of $0.2 million. The decrease was partially offset by an increase in other non-current assets of $0.1 million.

Current wording

Net cash used in operating activities was $46.3 million for the six months ended June 30, 2024. Cash used in operating activities consisted of net loss offset by non-cash adjustments of $16.5 million, and a net decrease in operating assets and liabilities of $4.9 million. Non-cash items primarily included depreciation and amortization of $3.3 million, stock-based compensation expense of $11.7 million, and non-cash lease expense of $1.6 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 $0.8 million and a decrease in operating lease liability of $1.8 million. There was also a $1.7 million decrease in prepaid expenses and other current assets and a $0.8 million decrease in accounts payable.

Previous wording

Net cash used in investing activities was $2.9 million for the three months ended March 31, 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 $33.0 million related to the maturities of short-term treasury securities.

Current 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.

Previous wording

Net cash used in investing activities was $0.2 million for the three months ended March 31, 2024, which consisted of purchases of property and equipment of $0.2 million, primarily related to activities at our GMP cell processing suite at 1000 Bridge Parkway.

Current wording

Net cash used in investing activities was $0.5 million for the six months ended June 30, 2024, which consisted of purchases of lab equipment for our GMP cell processing suite at 1000 Bridge Parkway.

Previous wording

Net cash used by financing activities was $0.1 million for the three months ended March 31, 2025, which included approximately $0.1 million of taxes paid in connection with the net share settlement of employee equity awards.

Current 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.

Previous wording

Net cash provided by financing activities was $111.0 million for the three months ended March 31, 2024, which included approximately $91.7 million in net proceeds from the issuance of our common stock and pre-funded warrants in the Offering and approximately $19.3 million in net proceeds from the issuance of our common stock under the JonesTrading ATM Program.

Current wording

Net cash provided by financing activities was $111.2 million for the six months ended June 30, 2024, which included approximately $91.7 million in net proceeds from the issuance of our common stock and pre-funded warrants in the Offering and approximately $19.3 million in net proceeds from the issuance of our common stock under the JonesTrading ATM Program.