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 and relapsed or refractory aggressive B cell non-Hodgkin's lymphoma (NHL). 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-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.

Previous wording

In December 2023, the U.S. Food and Drug Administration (FDA) cleared our IND applications for ADI-001 in lupus nephritis (LN) and we recently expanded clinical development beyond LN to include systemic lupus erythematosus (SLE), systemic sclerosis (SSc) and anti-neutrophil cytoplasmic autoantibody associated vasculitis (AAV). We have initiated startup activities at multiple clinical sites and plan to commence enrollment in our Phase 1 clinical trial of ADI-001 in LN in the third quarter of 2024, and in SLE, SSc and AAV patients in the second half of 2024. 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 and idiopathic inflammatory myopathies. In June 2024, the FDA granted us Fast Track Designation to ADI-001 for the potential treatment of relapsed/refractory class III or class IV LN. We anticipate providing preliminary clinical data from our Phase 1 clinical trial of ADI-001 in LN as well as in SLE, SSc and AAV in the first 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 applications for ADI-001 in lupus nephritis (LN) and 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 myopathy (IIM) and stiff person syndrome (SPS) as part of our Phase 1 clinical trial in autoimmune diseases. We expect to initiate enrollment for patients with SLE, SSc, IIM and SPS in the first quarter of 2025, and for patients with AAV in the second half of 2025. 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 us Fast Track Designation to ADI-001 for the potential treatment of relapsed/refractory class III or class IV LN. We plan to report preliminary clinical data from our Phase 1 clinical study of ADI-001 in LN in the first half of 2025, and for other autoimmune diseases in the second half of 2025, subject to study site initiation and patient enrollment.

Previous wording

Interest income consists primarily of interest earned on our cash and cash equivalents.

Current wording

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

Previous wording

Research and development expenses decreased by $2.5 million, or 9%, during the three months ended June 30, 2024 as compared to the same period in 2023. The decrease in research and development expenses was primarily due to a net $1.9 million decrease in expenses related to CDMOs and other externally conducted research and development as well as a $0.6 million decrease in payroll and personnel expenses resulting from a decrease in overall headcount.

Current wording

Research and development expenses increased by less than $0.1 million, or 0%, during the three months ended September 30, 2024 as compared to the same period in 2023. The increase in research and development expenses was primarily due to a $0.9 million increase in laboratory expenses, a $0.8 million increase in payroll and personnel expenses as well as a less than $0.1 million increase in professional fees for the period. This increase was partially offset by a $1.3 million decrease in expenses related to CDMOs and other externally conducted research and development and a $0.4 million decrease in allocated facility expenses.

Previous wording

General and administrative expenses increased by $0.4 million, or 6%, during the three months ended June 30, 2024 as compared to the same period in 2023. The increase in general and administrative expenses was primarily due to an increase in stock-based compensation of $0.7 million. The increase was partially offset by a $0.2 million decrease in recruiting fees and a $0.1 million decrease in consultant fees.

Current wording

General and administrative expenses increased by $0.3 million, or 4%, during the three months ended September 30, 2024 as compared to the same period in 2023. The increase in general and administrative expenses was primarily due to a $0.3 million increase in payroll and personnel expenses which includes a $0.1 million increase in stock-based compensation, $0.1 million increase in salaries and benefits, and $0.1 million in recruiting and consulting fees.

Previous wording

Other expense, net decreased by less than $0.1 million, or 59%, during the three months ended June 30, 2024 as compared to the same period in 2023. This was due to a decrease in franchise taxes and realized losses related to foreign exchange rates.

Current wording

Other expense, net decreased by less than $0.1 million, or 62%, during the three months ended September 30, 2024 as compared to the same period in 2023. This was due to a decrease in franchise taxes and realized losses related to foreign exchange rates.

Previous wording

Comparison of the Six Months Ended June 30, 2024 and 2023

Current wording

Comparison of the Nine Months Ended September 30, 2024 and 2023

Previous wording

Research and development expenses decreased by $5.3 million, or 10%, during the six months ended June 30, 2024 as compared to the same period in 2023. The decrease in research and development expenses was primarily due to a $5.1 million decrease in expenses related to CDMOs and other externally conducted research and development and a $0.6 million decrease in payroll and personnel expenses resulting from an decrease in overall headcount. This decrease was partially offset by a $0.3 million increase in professional fees.

Current wording

Research and development expenses decreased by $5.2 million, or 7%, during the nine months ended September 30, 2024 as compared to the same period in 2023. The decrease in research and development expenses was primarily due to a $6.4 million decrease in expenses related to CDMOs and other externally conducted research and development. This decrease was partially offset by a $0.9 million increase in laboratory expenses and $0.3 million increase in professional fees.

Previous wording

General and administrative expenses increased by $0.8 million, or 6%, during the six months ended June 30, 2024 as compared to the same period in 2023. The increase in general and administrative expenses was primarily due to an increase in stock-based compensation of $1.3 million as well as an increase in professional fees of $0.2 million. The increase was partially offset by a $0.3 million decrease in recruiting fees and a $0.3 million decrease in consultant fees.

Current wording

General and administrative expenses increased by $1.1 million, or 6%, during the nine months ended September 30, 2024 as compared to the same period in 2023. The increase in general and administrative expenses was primarily due to an increase in stock-based compensation of $1.4 million as well as an increase in legal and other professional fees of $0.4 million. The increase was partially offset by a $0.6 million decrease in recruiting fees and other payroll expenses.

Previous wording

Interest income increased by $0.4 million, or 15%, during the three months ended June 30, 2024 as compared to the same period in 2023, which was primarily due to higher interest rates as well as our investments in treasury securities.

Current wording

Interest income increased by $0.4 million, or 6%, during the nine months ended September 30, 2024 as compared to the same period in 2023, which was primarily due to higher cash balances and higher interest rates for the first six months of the period as well as our investments in treasury securities.

Previous wording

Other expense, net decreased by $0.2 million, or 66%, during the six months ended June 30, 2024 as compared to the same period in 2023. This was due to a decrease in franchise taxes and realized losses related to foreign exchange rates.

Current wording

Other expense, net decreased by $0.3 million, or 65%, during the nine months ended September 30, 2024 as compared to the same period in 2023. This was due to a decrease in franchise taxes and realized losses related to foreign exchange rates.

Previous wording

As of June 30, 2024, we had cash and cash equivalents of $224.1 million. We expect that the cash and cash equivalents 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 September 30, 2024, we had cash, cash equivalents and short-term investments in treasury securities of $202.1 million. We expect that our cash, cash equivalents and short-term investments in treasury securities 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 recorded net loss of $29.9 million for the three months ended June 30, 2024. Prior to this period, we have recorded net losses since inception. As of June 30, 2024, we had an accumulated deficit of $438.7 million.

Current wording

We recorded net loss of $30.5 million for the three months ended September 30, 2024. Prior to this period, we have recorded net losses since inception. As of September 30, 2024, we had an accumulated deficit of $469.2 million.

Previous wording

As of June 30, 2024, we had cash and cash equivalents of $224.1 million. We believe that our cash and cash equivalents will be sufficient for us to continue as a going concern 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 September 30, 2024, we had cash, cash equivalents and short-term investments in treasury securities of $202.1 million. We believe that our cash, cash equivalents and short-term investments in treasury securities will be sufficient for us to continue as a going concern 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

All of our revenue to date has been generated from the our License and Collaboration Agreement (the Regeneron Agreement) with Regeneron Pharmaceuticals, Inc. (Regeneron). We do not expect to generate any significant product revenue until we obtain regulatory approval of and commercialize any of our product candidates or enter into additional collaborative agreements with third parties, and we do not know when, or if, either will occur. We expect to continue to incur significant losses for the foreseeable future, and we expect the losses to increase as we continue the development of, and seek regulatory approvals for, our product candidates and begin to commercialize any approved products. We are subject to all of the risks typically related to the development of new product candidates, and we may encounter unforeseen expenses, difficulties, complications, delays and other unknown factors that may adversely affect our business.

Current wording

All of our revenue to date has been generated from our License and Collaboration Agreement (the Regeneron Agreement) with Regeneron Pharmaceuticals, Inc. (Regeneron). We do not expect to generate any significant product revenue until we obtain regulatory approval of and commercialize any of our product candidates or enter into additional collaborative agreements with third parties, and we do not know when, or if, either will occur. We expect to continue to incur significant losses for the foreseeable future, and we expect the losses to increase as we continue the development of, and seek regulatory approvals for, our product candidates and begin to commercialize any approved products. We are subject to all of the risks typically related to the development of new product candidates, and we may encounter unforeseen expenses, difficulties, complications, delays and other unknown factors that may adversely affect our business.

Previous 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.

Current 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.

Previous wording

Net cash used in operating activities was $49.0 million for the six months ended June 30, 2023. Cash used in operating activities consisted of net loss offset by non-cash adjustments of $13.9 million, and a net increase in operating assets and liabilities of $0.4 million. Non-cash items primarily included depreciation and amortization of $2.8 million, stock-based compensation expense of $9.8 million, and non-cash lease expense of $1.3 million. The net change in assets and liabilities was primarily due to a net increase in operating lease liability of $1.6 million related to the additional tenant improvement allowance as part of the Third Amendment to the lease at 1000 Bridge Parkway as well as an increase of $0.2 million in prepaid expenses and other current assets and an increase of $0.2 million in other non-current assets. This increase was offset by a decrease in accounts payable of $1.6 million.

Current wording

Net cash used in operating activities was $70.2 million for the nine months ended September 30, 2023. Cash used in operating activities consisted of net loss offset by non-cash adjustments of $41.3 million, and a net increase in operating assets and liabilities of $1.6 million. Non-cash items primarily included goodwill impairment of $19.5 million, stock-based compensation expense of $15.3 million, depreciation and amortization of $4.4 million and non-cash lease expense of $2.0 million. The net change in assets and liabilities was primarily due to an increase in operating lease liability of $0.8 million related to the additional tenant improvement allowance as part of the Third Amendment to the lease at 1000 Bridge Parkway as well as an increase of $0.8 million in prepaid expenses and other current assets and an increase of $0.3 million in other non-current assets. This increase was offset by a decrease in accounts payable of $0.2 million.

Previous 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.

Current 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.

Previous wording

Net cash used in investing activities was $3.4 million for the six months ended June 30, 2023, which consisted of purchases of lab equipment of $3.4 million, primarily related to our GMP cell processing suite at 1000 Bridge Parkway.

Current wording

Net cash used in investing activities was $4.3 million for the nine months ended September 30, 2023, which consisted of purchases of lab equipment primarily related to our GMP cell processing suite at 1000 Bridge Parkway.

Previous 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.

Current wording

Net cash provided by financing activities was $111.2 million for the nine months ended September 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.

Previous wording

Net cash provided by financing activities was $0.2 million for the six months ended June 30, 2023, 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 $0.2 million for the nine months ended September 30, 2023, which was primarily related to $0.2 million in net proceeds from the issuance of common stock with our employee stock purchase plan. This was partially offset by less than $0.1 million of cash paid for taxes withheld on the net share settlement of equity awards.

Previous wording

On October 28, 2018, Adicet Therapeutics executed a non-cancelable lease agreement for an office and laboratory facility at 1000 Bridge Parkway (the Redwood City Lease), with an expiration date of February 28, 2030. The initial annual base rent for the Redwood City Lease is an aggregate of $1.3 million, and such amount will increase 3% annually. On June 16, 2022, Adicet Therapeutics entered into a second amendment to the Redwood City Lease (the Second Amendment), which expands the space lease by 12,204 square feet (the Expansion Space). Adicet Therapeutics will pay a monthly fee for the Expansion Space increasing annually from approximately $73,000 to $78,000 over the thirty-six (36) month term of the Second Amendment. The Second Amendment also provides Adicet Therapeutics with an allowance to construct improvements to the Expansion Space. On January 9, 2023, Adicet Therapeutics entered into a third amendment of the Redwood City Lease (the Third Amendment). The Third Amendment increases the tenant improvement allowance as of

Current wording

On October 28, 2018, Adicet Therapeutics executed a non-cancelable lease agreement for an office and laboratory facility at 1000 Bridge Parkway (the Redwood City Lease), with an expiration date of February 28, 2030. The initial annual base rent for the Redwood City Lease is an aggregate of $1.3 million, and such amount will increase 3% annually. On June 16, 2022, Adicet Therapeutics entered into a second amendment to the Redwood City Lease (the Second Amendment), which expands the space lease by 12,204 square feet (the Expansion Space). Adicet Therapeutics will pay a monthly fee for the Expansion Space increasing annually from approximately $73,000 to $78,000 over the thirty-six (36) month term of the Second Amendment. The Second Amendment also provides Adicet Therapeutics with an allowance to construct improvements to the Expansion Space. On January 9, 2023, Adicet Therapeutics entered into a third amendment of the Redwood City Lease (the Third Amendment). The Third Amendment increases the tenant improvement allowance as of January 1, 2023 by an additional $3.0 million. The additional allowance will be repaid through equal monthly payments of principal amortization and interest on a monthly basis over the term of the lease at an interest rate of eight percent (8%) per annum. On August 7, 2023, Adicet Therapeutics entered into the Fourth Amendment, which amends the period over which the tenant improvement allowance received in the Third Amendment will be amortized and identifies the monthly amortization payable by us.