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REDWOOD CITY, Calif. - Adicet Bio, Inc. (NASDAQ:ACET), a clinical-stage biotechnology company with a market capitalization of $83 million, announced initial safety and efficacy data from seven patients treated with ADI-001, its investigational allogeneic gamma delta T cell therapy for autoimmune diseases. According to InvestingPro data, the company maintains a strong liquidity position with a current ratio of 7.48, though it’s currently experiencing rapid cash burn as it advances its clinical programs.
According to the company’s press release statement, all seven evaluable lupus nephritis (LN) and systemic lupus erythematosus (SLE) patients showed rapid and sustained reductions in disease activity scores following a single treatment. All five LN patients demonstrated improved renal function, with three achieving complete renal responses and two showing partial responses. The market has responded positively to these developments, with InvestingPro data showing a significant 61% price return over the past six months.
The company reported that all patients were able to discontinue immunosuppressant medications and either discontinued or reduced corticosteroids to physiological levels following treatment.
The therapy demonstrated a favorable safety profile with no cases of Immune Effector Cell-Associated Neurotoxicity Syndrome. Only two patients experienced Grade 1 Cytokine Release Syndrome, which manifested as fever.
"ADI-001 has the potential to reset the immune system with a one-time, off-the-shelf therapy," said Chen Schor, President and CEO of Adicet Bio, in the press release. The company noted evidence of immune reset with elimination of dominant B cell clones and emergence of naïve B cells.
Adicet plans to request a meeting with the FDA in the first quarter of 2026 to discuss the design of a potential pivotal Phase 2 trial, which it anticipates initiating in the second quarter of 2026. While analysts maintain a bullish consensus on the stock, with InvestingPro showing price targets ranging from $4 to $8, investors should note that three analysts have recently revised their earnings expectations downward. InvestingPro subscribers have access to 12 additional key insights and comprehensive financial analysis that could help evaluate the company’s long-term potential.
The company has activated more than 25 clinical sites globally for its ongoing Phase 1 study, which has expanded to include patients with systemic sclerosis, idiopathic inflammatory myopathy, stiff person syndrome, anti-neutrophil cytoplasmic autoantibody associated vasculitis, and rheumatoid arthritis.
ADI-001 has received Fast Track Designation from the FDA for several autoimmune conditions including lupus nephritis, systemic lupus erythematosus, systemic sclerosis, and rheumatoid arthritis.
In other recent news, Adicet Bio has announced a strategic pipeline prioritization, which includes halting the development of ADI-270 for clear cell renal cell carcinoma and implementing a 30% workforce reduction. This move is expected to extend the company’s cash runway into the fourth quarter of 2026. In terms of analyst ratings, Citizens JMP has reiterated a Market Perform rating on the company’s stock, maintaining a neutral stance following Adicet Bio’s second-quarter 2025 financial results. Meanwhile, H.C. Wainwright initiated coverage with a Buy rating and a price target of $4.00, highlighting the potential of Adicet’s ADI-270, which is undergoing a Phase 1 trial and has received FDA Fast Track Designation. Additionally, Adicet Bio has dosed the first systemic sclerosis patient in the second cohort of its Phase 1 trial evaluating ADI-001 for autoimmune diseases. The company is enrolling patients with lupus nephritis, systemic lupus erythematosus, and systemic sclerosis, with preliminary clinical data expected in the second half of 2025. These developments reflect Adicet Bio’s ongoing efforts in advancing its clinical trials and strategic positioning in the biotech sector.
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