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-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 aim to submit a new regulatory submission, such as an Investigational New Drug (IND) application or equivalent every 12-18 months.

Current wording

Our lead product candidate, prula-cel, 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, a next-generation gene-edited and armored clinical candidate designed to target prostate-specific membrane antigen (PSMA). 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 armoring and CRISPR/Cas9 mediated disruption of subunit 12 of the mediator complex (MED12) to enhance potency in solid tumors and to deliver multiple anti-tumor mechanisms of action to the tumor microenvironment. We aim to submit a new regulatory submission, such as an Investigational New Drug (IND) application or equivalent 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 April 2025, we expanded enrollment to include patients with SLE for our Phase 1 clinical trial evaluating ADI-001 in autoimmune diseases and 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. In October 2025, we announced positive preliminary results from seven SLE and LN patients dosed in our ongoing Phase 1 trial of ADI-001 in autoimmune diseases. . See “Recent Developments - ADI-001 Phase 1 Study Preliminary Data.” Based on these results, we plan to request a meeting with the FDA in the first quarter of 2026 to inform potential Phase 2 pivotal trial design, with the study initiation anticipated to commence in the second quarter of 2026. Enrollment is ongoing in our Phase 1 trial in patients with LN, SLE, SSc, IIM, SPS and AAV, with a clinical update anticipated for LN and SLE as well as an SSc clinical update in the first half of 2026. We also reported in October 2025 that the first patient has been dosed in a Phase 1 clinical trial of ADI-001 in patients with treatment-refractory rheumatoid arthritis (RA). The study will evaluate two conditioning regimens: cyclophosphamide alone and cyclophosphamide with fludarabine, to evaluate how different conditioning regimens may impact the overall therapeutic experience. We expect to provide a clinical update on this tr…

Excerpt shortened here; the source contains the full paragraph.

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.

Previous wording

We are advancing 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. ADI-212, which targets prostate specific membrane antigen (PSMA), has shown enhanced activity in preclinical studies, suggesting the potential for improved potency and tumor-cell killing capacity compared to previous generation alpha-beta and gamma-delta CAR T programs in oncology. 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 ADI-212 for the treatment of metastatic castration-resistant prostate cancer (mCRPC) in the first quarter of 2026. Subject to regulatory clearance to proceed with a clinical trial, we expect to report initial clinical data from this program in the second half 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. We expect to submit a regulatory filing for 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.

Previous wording

Interest income consists primarily of interest earned on our cash, cash equivalents and short-term investments in treasury securities.

Current wording

Interest income consists primarily of interest earned on our cash, cash equivalents, restricted cash and short-term investments in treasury securities.

Previous wording

Other expense, net primarily consists of state franchise and capital taxes not related to income as well as foreign exchange gains and losses.

Current wording

Other expense, net primarily consists of state franchise and capital taxes not related to income.

Previous wording

Research and development expenses decreased by $2.0 million, or 3%, during the nine months ended September 30, 2025 as compared to the same period in 2024. The decrease in research and development expenses was primarily due to a $2.4 million decrease in payroll and personnel expenses due to lower headcount, a $7.1 million decrease related to lower CMO and contracted R&D services due to lower utilization at external CDMOs, and a $1.0 million decrease in R&D consultants partially offset by an increase of $7.7 million of CRO expenses, and a $0.3 million decrease in expenses related to lab supplies and materials. This decrease was partially offset by a $1.0 million increase in allocated facility expenses and a $0.3 million increase in professional fees.

Current wording

Research and development expenses decreased by $5.3 million, or 23%, during the three months ended March 31, 2026 as compared to the same period in 2025. The decrease in research and development expenses was primarily due to a $3.6 million decrease in payroll and personnel expenses due to lower headcount, a $1.4 million decrease in expenses related to lab supplies and materials, a $0.5 million decrease related to lower CRO expenses and a $0.2 million decrease in allocated facility-related expenses. The decrease was partially offset by a $0.4 million increase in professional fees.

Previous wording

General and administrative expenses decreased by $4.7 million, or 23%, during the nine months ended September 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 $4.7 million primarily related to a decrease in stock-based compensation and a $0.7 million decrease in facility-related expenses. The decrease was partially offset by a $0.7 million increase in professional fees.

Current wording

General and administrative expenses decreased by $3.0 million, or 42%, during the three months ended March 31, 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 $1.4 million primarily related to a decrease in stock-based compensation and lower headcount, a $1.0 million decrease in allocated facility-related expenses and a $0.6 million decrease in professional fees.

Previous wording

Interest income decreased by $1.6 million, or 57% during the three months ended September 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.

Current wording

Interest income decreased by $0.3 million, or 20% during the three months ended March 31, 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 increased by less than $0.1 million, or 19%, during the three months ended September 30, 2025 as compared to the same period in 2024. This was primarily due to an increase in realized losses related to foreign exchange rates.

Current wording

Other expense, net decreased by less than $0.1 million, or 158%, during the three months ended March 31, 2026 as compared to the same period in 2025. This was due to a decrease in state franchise taxes and realized losses related to foreign exchange rates.

Previous wording

On January 22, 2024, we entered into an underwriting agreement (the Underwriting Agreement) with Jefferies LLC (Jefferies) and Guggenheim Securities, LLC, as representatives of the underwriters (the Underwriters), related to an underwritten public offering (the Offering) of shares of our common stock and, in lieu of common stock to certain investors, pre-funded warrants to purchase shares of our common stock. We received net proceeds from the Offering, after deducting the underwriting discount and commissions and other estimated offering expenses, of approximately $91.7 million. We may receive nominal proceeds, if any, from the exercise of the pre-funded warrants.

Current wording

On January 22, 2024, we entered into an underwriting agreement (the Underwriting Agreement) with Jefferies LLC (Jefferies) and Guggenheim Securities, LLC (Guggenheim), as representatives of the underwriters, related to an underwritten public offering (the Offering) of shares of our common stock and, in lieu of common stock to certain investors, pre-funded warrants to purchase shares of our common stock. We received net proceeds from the Offering, after deducting the underwriting discount and commissions and other estimated offering expenses, of approximately $91.7 million. We may receive nominal proceeds, if any, from the exercise of the pre-funded warrants.

Previous wording

On October 7, 2025, we entered into the 2025 Underwriting Agreement related to the 2025 Offering of the 2025 Shares and, in lieu of Common Stock to an investor, the 2025 Pre-Funded Warrants to purchase the 2025 Warrant Shares. The 2025 Shares were sold at a price of $1.00 per share and the 2025 Pre-Funded Warrants were sold at a price of $0.9999 per underlying share, which represents the per share offering price of each share of common stock minus the $0.0001 per share exercise price for each pre-funded warrant. The purchase price paid by the Underwriters to us was $0.94 per 2025 Share and $0.93991 per 2025 Pre-Funded Warrant, representing a discount to the Underwriters of 6.0%. We received net proceeds from the 2025 Offering, after deducting the underwriting discount and commissions and other estimated offering expenses, of approximately $74.8 million. We may receive nominal proceeds, if any, from the exercise of the 2025 Pre-Funded Warrants.

Current wording

On October 7, 2025, we entered into an underwriting agreement with Jefferies and Guggenheim, as representatives of the underwriters, related to an underwritten registered direct offering (the 2025 Offering) of shares of our common stock, and, in lieu of our common stock to an investor, pre-funded warrants to purchase shares of our common stock. We received net proceeds from the 2025 Offering, after deducting the underwriting discount and commissions and other estimated offering expenses, of approximately $74.8 million. We may receive nominal proceeds, if any, from the exercise of the 2025 Pre-Funded Warrants.

Previous wording

As of September 30, 2025, we had cash, cash equivalents and short-term investments of $103.1 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.

Current wording

As of March 31, 2026, we had cash, cash equivalents and short-term investments of $137.6 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 $86.3 million and $88.4 million for the nine months ended September 30, 2025 and 2024, respectively. As of September 30, 2025, we had an accumulated deficit of $584.2 million.

Current wording

We have incurred losses since inception and have incurred losses of $20.2 million and $28.2 million for the three months ended March 31, 2026 and 2025, respectively. As of March 31, 2026, we had an accumulated deficit of $634.9 million.

Previous wording

As of the date of this Quarterly Report on Form 10-Q, we believe that with $103.1 million in cash, cash equivalents, and short-term investments in treasury securities as of September 30, 2025, and the additional $74.8 million we received as net proceeds from our 2025 Offering, will enable us to fund our operations into the second half of 2027. 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 March 31, 2026, we had cash, cash equivalents, and short-term investments in treasury securities of $137.6 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 $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 $73.2 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.

Current wording

Net cash used in operating activities was $21.5 million for the three months ended March 31, 2026. Cash used in operating activities consisted of net loss partially offset by non-cash adjustments of $2.6 million, and a net decrease in operating assets and liabilities of $3.8 million. Non-cash items primarily included depreciation and amortization of $1.3 million, stock-based compensation expense of $1.3 million, non-cash lease expense of $0.7 million and a net amortization of premiums and accretion discounts on investments of $0.8 million. The net change in assets and liabilities was primarily due to a decrease in accounts payable of $1.8 million, a net decrease in accrued and other current and non-current liabilities of $1.1 million, a decrease in operating lease liability of $0.8 million and a decrease in prepaid expenses of $0.1 million offset by an increase in other current assets of less than $0.1 million.

Previous wording

Net cash used in operating activities was $68.0 million for the nine months ended September 30, 2024. Cash used in operating activities consisted of net loss offset by non-cash adjustments of $26.2 million, and a net decrease in operating assets and liabilities of $5.5 million. Non-cash items primarily included depreciation and amortization of $4.8 million, stock-based compensation expense of $18.5 million, non-cash lease expense of $2.4 million and a net amortization of premiums and accretion discounts on investments of $0.5 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 $1.2 million and a decrease in operating lease liability of $2.7 million. There was also a $1.7 million decrease in prepaid expenses and other current assets and a $0.2 million decrease in accounts payable.

Current 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 partially 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.

Previous 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 of 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.

Current wording

Net cash provided by investing activities was $18.9 million for the three months ended March 31, 2026, which consisted of $39.0 million related to maturities of short-term treasury securities, net of $20.1 million of purchases of short-term treasury securities and less than $0.1 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 in investing activities was $97.5 million for the nine months ended September 30, 2024, which consisted of $96.6 million of purchases of short-term treasury securities and $0.9 million of purchases of lab equipment for our GMP cell processing suite at 1000 Bridge Parkway.

Current 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.

Previous 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.

Current wording

Net cash used by financing activities was $0.1 million for the three months ended March 31, 2026 and March 31, 2025 and consisted of $0.1 million cash paid for taxes withheld on the net share settlement of equity awards for both years.