On November 8, 2022 Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for cancer, reported financial results and operational highlights for the third quarter ended September 30, 2022 (Press release, Adicet Bio, NOV 8, 2022, View Source [SID1234623446]).

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"We have continued to make very encouraging clinical progress in 2022, reporting promising safety and efficacy data for our lead candidate ADI-001 for the potential treatment of relapsed or refractory B-cell non-Hodgkin’s lymphoma," said Chen Schor, President and Chief Executive Officer at Adicet Bio. "We’re currently enrolling patients in dose level 4 and expect to initiate a potentially pivotal program with the recommended Phase 2 dose for ADI-001 in the first half of 2023. We look forward to providing additional clinical data on ADI-001 at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December as well as promising preclinical data on our emerging pipeline programs at the upcoming Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s Annual Meeting and our upcoming R&D event."

Third Quarter 2022 and Recent Operational Highlights:

Preclinical Data for Four New Pipeline Programs at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 37th Annual Meeting. Preclinical data from four new pipeline programs will be presented at the SITC (Free SITC Whitepaper) 37th Annual Meeting on November 10-11, 2022.
Company to Host R&D Webcast Event to Outline Pipeline Updates. Adicet is hosting an R&D webcast event on Thursday, November 10, 2022, at 9:00 a.m. ET to provide additional preclinical data from its newly disclosed pipeline and upcoming milestones.
Updated Data from Ongoing Phase 1 Study of ADI-001 at the 2022 American Society of Hematology (ASH) (Free ASH Whitepaper) 64th Annual Meeting. In November, Adicet announced that as of the July 15, 2022 data-cut date for the ASH (Free ASH Whitepaper) abstract, ADI-001 demonstrated a 78% overall response rate (ORR) and complete response rate (CR) (7/9) and sustained durability in adults with relapsed or refractory B-cell non-Hodgkin’s lymphoma (NHL). For the four patients who had prior autologous CD19 CAR T therapies, the ORR and CR rate was 100% (4/4). ADI-001 continued to demonstrate a favorable safety and tolerability profile. Based on data collected on ADI-001, Adicet expects to establish the recommended Phase 2 dose for ADI-001 in the second half of 2022.

In December 2022, the Company plans to provide data from a more recent data-cut date from the ongoing Phase 1 study of ADI-001 in adults with relapsed or refractory B-cell NHL during the upcoming 2022 ASH (Free ASH Whitepaper) Annual Meeting. The Company will host an ADI-001 webcast on Sunday, December 11, 2022, at 8:00 a.m. CT / 9:00 a.m. ET to discuss data from the ongoing study.
Establishing In-House Manufacturing Capacity in Redwood City Facility. Adicet’s new in-house manufacturing capabilities in the Redwood City facility, which is designed to enable manufacturing for early clinical development of its pipeline candidates, is expected to be operational in the fourth quarter of 2022.
Financial Results for Third Quarter 2022:

Research and Development (R&D) Expenses: R&D expenses were $16.6 million for the three months ended September 30, 2022, compared to $11.9 million during the same period in 2021. The $4.6 million increase is primarily driven by a $3.2 million increase in payroll and personnel expenses resulting from an increase in overall headcount and a $1.2 million increase in contract manufacturing organizations and other externally conducted research and development expense. Payroll and personnel expenses for the three months ended September 30, 2022 includes $1.7 million of non-cash stock-based compensation expense compared to $0.8 million during the same period in 2021.
General and Administrative (G&A) Expenses: G&A expenses were $6.4 million for the three months ended September 30, 2022, compared to $5.2 million during the same period in 2021. The $1.2 million increase is primarily driven by an increase of $1.3 million of payroll and personnel expenses. Payroll and personnel expenses for the three months ended September 30, 2022 includes $2.4 million of non-cash stock-based compensation expense compared to $1.7 million during the same period in 2021.
Net Loss: Net loss for the three months ended September 30, 2022 was $22.0 million, or a net loss of $0.53 per basic and diluted share, including non-cash stock-based compensation expense of $4.2 million, as compared to a net loss of $14.0 million during the same period in 2021, or a net loss of $0.44 per basic and diluted share, including non-cash stock-based compensation expense of $2.5 million.
Cash Position: Cash and cash equivalents were $282.7 million as of September 30, 2022, compared to $277.5 million as of December 31, 2021. The Company expects that current cash and cash equivalents as of September 30, 2022, will be sufficient to fund its operating expenses into the first half of 2025.