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On Friday, H.C. Wainwright reaffirmed a Neutral stock rating for Adicet Bio Inc. (NASDAQ:ACET), a biotechnology company focused on the development of therapies for cancer and other diseases. The company’s stock, currently trading at $0.85, has experienced significant volatility, declining 65% over the past year. According to InvestingPro analysis, the stock appears undervalued based on its Fair Value metrics. Analyst Edward White provided insights into Adicet’s progress with its leading product candidate, ADI-001, which is an allogeneic gamma delta T cell therapy featuring an anti-CD20 CAR.
Adicet Bio, with a market capitalization of approximately $70 million, is exploring ADI-001’s effectiveness across multiple autoimmune diseases. While the company maintains a strong liquidity position with a current ratio of 10.64, InvestingPro data reveals it is quickly burning through cash. Notably, ADI-001 has received Fast Track Designation from the FDA for the potential treatment of various conditions including refractory systemic lupus erythematosus with extrarenal involvement, systemic sclerosis, and relapsed or refractory lupus nephritis.
The company began its Phase 1 clinical trial for ADI-001 in autoimmune diseases and administered the first dose to a lupus nephritis patient on November 18, 2024. The trial encompasses several autoimmune disorders such as lupus nephritis, systemic lupus erythematosus, systemic sclerosis, vasculitis, idiopathic inflammatory myopathy, and stiff person syndrome, divided into four study arms.
The primary goals of this study are to assess the incidence of treatment-emergent adverse events, including their severity and relation to the treatment, as well as the incidence of dose-limiting toxicities. Participants receive a single dose of ADI-001, with a 28-day window to monitor for dose-limiting toxicities. Follow-up assessments are scheduled for specific intervals up to 24 months post-treatment.
Adicet Bio expects to share preliminary results for the lupus nephritis cohort in the first half of 2025. The company plans to commence enrollment for additional autoimmune disease cohorts, with systemic lupus erythematosus, systemic sclerosis, idiopathic inflammatory myopathy, and stiff person syndrome patients starting in the second quarter of 2025, and those with vasculitis in the second half of the year. Further data from the lupus nephritis group and initial data from other autoimmune disease cohorts are anticipated in the latter half of 2025, contingent on the initiation of study sites and patient enrollment. For deeper insights into Adicet Bio’s financial health and growth prospects, including 8 additional ProTips and comprehensive valuation metrics, visit InvestingPro to access the detailed Pro Research Report.
In other recent news, Adicet Bio, Inc. has received Fast Track Designation from the FDA for its investigational treatment, ADI-001, targeting systemic sclerosis in adults. This designation is aimed at expediting the development of drugs addressing serious conditions with unmet medical needs. The company is actively enrolling patients in several trials, including ADI-001 for Lupus Nephritis and ADI-270 for renal cell carcinoma, with preliminary results expected in the first half of 2025. Adicet Bio has also initiated a Phase 1 clinical trial for ADI-270, targeting metastatic/advanced clear cell renal cell carcinoma, with the first patient dosed.
Additionally, Adicet Bio announced the appointment of Julie Maltzman, M.D., as its new Chief Medical (TASE:BLWV) Officer, effective January 13, 2025. Dr. Maltzman brings over two decades of experience in drug development, having previously worked at IconOVir Bio and Roche/Genentech. Her leadership is expected to advance the company’s clinical development strategy, particularly for the ADI-001 and ADI-270 programs. These developments highlight Adicet Bio’s ongoing efforts to advance its pipeline of therapies for cancer and autoimmune diseases.
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