On May 9, 2023 Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for cancer, reported its financial results and operational highlights for the first quarter ended March 31, 2023 (Press release, Adicet Bio, MAY 9, 2023, View Source [SID1234631311]).

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 about the continued clinical progress of our lead asset ADI-001," said Chen Schor, President and Chief Executive Officer of Adicet. "In the second quarter, we plan to discuss with the FDA the path forward for a potential pivotal study for ADI-001 in post-CAR T large B-cell lymphoma patients and expect to initiate this study in the fourth quarter of 2023. We plan to report updated efficacy, durability and safety data from ADI-001’s ongoing Phase 1 trial, as well as provide an update on our meeting with the FDA in the second quarter of 2023. Additionally, Adicet is making steady advances in developing our early-stage pipeline candidates, including presenting promising data demonstrating preclinical proof-of-concept for our armored allogeneic gamma delta T cell therapy ADI-270 at ASGCT (Free ASGCT Whitepaper) later this month. Further, we are on track to submit an IND for our novel CAd gamma delta T cell product candidate ADI-925 in the second half of this year."

First Quarter 2023 and Recent Operational Highlights:

Company remains on track to report additional efficacy, durability and safety data and provide a regulatory update and plan for ADI-001 pivotal program in the second quarter of 2023. In December 2022, Adicet reported interim safety and efficacy data from its ongoing Phase 1 study of ADI-001, the Company’s investigational therapy targeting CD20 for the potential treatment of relapsed or refractory B-cell non-Hodgkin’s lymphoma (NHL). The Company is preparing to initiate its first potential pivotal study with ADI-001 in the fourth quarter of 2023.

ADI-270 preclinical data at ASGCT (Free ASGCT Whitepaper). Adicet will present a preclinical data poster for ADI-270, an armored CD70-targeted allogeneic gamma delta chimeric antigen receptor (CAR) T cell development candidate, at the American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) Annual Meeting on May 18, 2023. This encouraging data demonstrates preclinical proof-of-concept for Adicet’s first-in-class development candidate specifically designed to address the needs of solid tumor indications with the addition of TGFb dominant negative receptor armoring and additional protection against host elimination.

Continuing to advance new pipeline programs. In November 2022, Adicet presented preclinical data for four new CAR and CAd (chimeric antigen adaptor) gamma delta T cell programs targeting several hematologic and solid malignancies. The Company continues to advance these new pipeline programs and expects to submit an Investigational New Drug Application (IND) for ADI-925 in the second half of 2023.
Financial Results for First Quarter 2023:

Research and Development (R&D) Expenses: R&D expenses were $26.8 million for the three months ended March 31, 2023, compared to $13.5 million during the same period in 2022. The $13.3 million increase is primarily driven by a $5.0 million increase in contract development manufacturing organization (CDMO) and other externally conducted research and development expense and a $4.1 million increase in payroll and personnel expenses resulting from an increase in overall headcount. There was also a $3.2 million dollar increase in allocated facility expenses and a $1.0 million increase in lab expenses. Payroll and personnel expenses for the three months ended March 31, 2023, includes $2.2 million of non-cash stock-based compensation expense compared to $1.7 million during the same period in 2022.

General and Administrative (G&A) Expenses: G&A expenses were $6.6 million for the three months ended March 31, 2023, compared to $6.8 million during the same period in 2022. The $0.2 million decrease is primarily driven by a $0.9 million decrease in allocated facility and other costs, a $0.1 million decrease in stock-based compensation and a less than $0.1 million decrease in professional fees. The decrease was partially offset by a $0.7 million increase in payroll and personnel expenses. Payroll and personnel expenses for the three months ended March 31, 2023, includes $2.6 million of non-cash stock-based compensation expense compared to $2.6 million during the same period in 2022.

Net Loss/Income: Net loss for the three months ended March 31, 2023 was $30.9 million, or a net loss of $0.72 per basic and diluted share, including non-cash stock-based compensation expense of $4.8 million, as compared to a net income of $4.6 million during the same period in 2022, or a net income of $0.12 per basic share and $0.10 per diluted share, including non-cash stock-based compensation expense of $4.4 million.
Cash Position: Cash and cash equivalents were $231.6 million as of March 31, 2023, compared to $277.9 million during the same period in 2022. The Company expects that current cash and cash equivalents as of March 31, 2023, will be sufficient to fund its operating expenses into the first half of 2025.