On March 19, 2024 Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer, reported financial results and operational highlights for the fourth quarter and year ended December 31, 2023 (Press release, Adicet Bio, MAR 19, 2024, View Source [SID1234641280]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We are excited to explore the potential of our gamma delta T cell platform in autoimmune diseases following the FDA’s IND clearance of ADI-001 in lupus nephritis," said Chen Schor, President and Chief Executive Officer at Adicet Bio. "We believe ADI-001 is ideally suited for the treatment of autoimmune diseases given its robust B-cell depletion consistent with other autologous CAR T therapies tested in autoimmune diseases, its tissue tropism potential in autoimmune diseases, and the safety and efficacy data observed in our Phase 1 study. In addition, ADI-001’s off-the-shelf availability and safety profile has the potential to make cell therapy for autoimmune diseases available to patients in community setting. We look forward to initiating the Phase 1 study in lupus nephritis in the second quarter of 2024 and are on track to expand the program to additional autoimmune indications."

Mr. Schor continued: "In addition, we are continuing to enroll MCL patients in our ongoing Phase 1 study of ADI-001 in relapsed or refractory non-Hodgkin’s lymphoma. With the completion of the successful capital raise and other net proceeds from stock sales under the at-the-market program in January, extending our cash runway into the second half of 2026, we are well-positioned to continue clinical execution across our pipeline through multiple upcoming milestones."

Fourth Quarter 2023 and Recent Operational Highlights:

Autoimmune diseases

IND clearance for ADI-001 in lupus nephritis. In December 2023, the FDA cleared the Company’s IND application for ADI-001 in lupus nephritis. Adicet plans to initiate a Phase 1 study to evaluate the safety and efficacy of ADI-001 in lupus nephritis during the second quarter of 2024. Preliminary clinical data from the trial are expected in the fourth quarter of 2024 or first quarter of 2025, pending study site activation progression and patient enrollment.
Expansion of ADI-001 development in autoimmune diseases. Adicet expects to expand into additional autoimmune indications in the near future. The Company anticipates providing preliminary clinical data in the fourth quarter of 2024 or first half of 2025, subject to clearance of INDs in those indications as well as successful site initiation and patient enrollment in the relevant clinical protocols.
Hematologic malignancies and solid tumor indications

Continuing to advance ADI-001 in Phase 1 GLEAN study in mantle cell lymphoma (MCL). The Phase 1 study of ADI-001 in relapsed or refractory non-Hodgkin’s lymphoma (NHL) is ongoing, with enrollment focused on the MCL patient population, which demonstrated the greatest clinical benefit in the June 2023 clinical update. Adicet expects to provide a clinical update on safety, efficacy and 6-month complete response data in MCL patients in the second half of 2024.
Advancing ADI-270 preclinical development in solid tumors. ADI-270 is designed to home to solid tumors, with a highly specific targeting moiety for CD70 and an armoring technology of dominant negative TGF beta receptor to address immunosuppressive factors in the tumor microenvironment. Adicet remains on track to file an IND for ADI-270 in renal cell carcinoma in the second quarter of 2024 and expects to provide clinical data from a Phase 1 study in the first half of 2025, following regulatory clearance and subject to study initiation progress.
Presented persistence and pharmacodynamic data from ADI-001 Phase 1 study at the 65th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting. In December 2023, Adicet presented new pharmacokinetic and pharmacodynamic data from the Phase 1 study of ADI-001 at the ASH (Free ASH Whitepaper) Annual Meeting. The data demonstrated robust dose-dependent expansion and persistence in patients with relapsed or refractory aggressive B-cell NHL. ADI-001’s strong exposure and persistence profile observed in the study to date further validates Adicet’s gamma delta T cell technology.
Corporate updates

Hired Benjamin Hsu, M.D., Ph.D., as Vice President Clinical Development – Autoimmune. In March 2024, Adicet appointed Dr. Benjamin Hsu, M.D., Ph.D., as Vice President Clinical Development. Dr. Hsu brings over 20 years of experience in the biotech and pharmaceutical industry with extensive expertise in immunology and rheumatology clinical development. Dr. Hsu will lead the clinical design and execution of the clinical development plan for Adicet’s gamma delta T cell therapies for autoimmune diseases.
Extended projected cash runway into 2H 2026. In January 2024, Adicet successfully raised $91.8 million in net proceeds through an underwritten public offering and received $19.3 million in net proceeds under its at-the-market (ATM) program.
Financial Results for Fourth Quarter and Full Year 2023:

Three months Ended December 31, 2023

Research and Development (R&D) Expenses: R&D expenses were $24.8 million for the three months ended December 31, 2023, compared to $25.0 million during the same period in 2022. The $0.2 million decrease was primarily driven by a $2.7 million decrease in expenses related to contract development manufacturing organizations (CDMOs), contract research organizations (CROs) and consultant costs related to our lead product candidate ADI-001. This decrease was partially offset by an increase of $1.3 million in payroll and personnel expenses, an increase of $0.7 million in lab expenses and an increase of $0.6 million in facility and other expenses.
General and Administrative (G&A) Expenses: G&A expenses were $6.8 million for the three months ended December 31, 2023, compared to $6.6 million during the same period in 2022. The $0.2 million increase was primarily driven by an increase of $0.9 million in payroll and personnel expenses. This increase was partially offset by a $0.4 million decrease in professional fees and a $0.4 million decrease in facility and other expenses.
Net Loss: Net loss for the three months ended December 31, 2023 was $29.5 million, or a net loss of $0.69 per basic and diluted share, including non-cash stock-based compensation expense of $4.9 million, as compared to a net loss of $29.9 million, or a net loss of $0.72 per basic and diluted share, including non-cash stock-based compensation expense of $4.3 million during the same period in 2022.
Twelve Months Ended December 31, 2023

Research and Development (R&D) Expenses: R&D expenses were $106.0 million for the year ended December 31, 2023, compared to $71.2 million for the year ended December 31, 2022. The $34.8 million increase was primarily driven by an $11.5 million increase in payroll and personnel expenses resulting from an increase in overall headcount, a net $10.7 million increase in expenses related to CDMOs, CROs and consultant costs related to our lead product candidate ADI-001, a $8.5 million increase in facility and other expenses and a $4.1 million increase in lab expenses.
General and Administrative (G&A) Expenses: G&A expenses were $26.5 million for the year ended December 31, 2023, compared to $26.3 million for the year ended December 31, 2022. The $0.2 million increase was primarily driven by a $3.3 million increase in payroll and personnel expenses, which includes an increase in stock-based compensation of $1.2 million, salaries and benefits of $1.0 million and contractor fees of $0.9 million and an increase in recruiting fees of $0.3 million. These increases were primarily due to increased headcount for the period. The overall increase was partially offset by a $2.6 million decrease in facilities and other related expenses.
Goodwill Impairment: Goodwill was impaired by $19.5 million during the year ended December 31, 2023 following the results of an interim impairment test conducted during the period. This represented the entire remaining balance of goodwill.

Net Loss: Net loss for the year ended December 31, 2023 was $142.7 million, or a net loss of $3.31 per basic and diluted share, including non-cash stock-based compensation expense of $20.3 million, as compared to a net loss of $69.8 million, or a net loss of $1.70 per basic and diluted share, including non-cash stock-based compensation expense of $17.1 million during the same period in 2022.

Cash Position: Cash and cash equivalents were $159.7 million as of December 31, 2023, compared to $257.7 million as of December 31, 2022. Subsequent to December 31, 2023, the Company received $91.8 million of net proceeds from an underwritten public offering and $19.3 million of net proceeds under its ATM program. The Company expects that its cash and cash equivalents as of December 31, 2023, together with the proceeds raised subsequent to year end, will be sufficient to fund its operating expenses into the second half of 2026.