Adicet Bio Inc. (NASDAQ:ACET) shares fell Tuesday after the biotechnology company priced an $80 million direct offering, even as early safety and efficacy data from its Phase 1 trial of ADI-001 in autoimmune diseases showed encouraging signs.
The company priced a registered direct offering of 70 million shares and pre-funded warrants to purchase 10 million shares at $1.00 per share and $0.9999 per warrant, respectively, for expected gross proceeds of approximately $80 million.
The stock climbed as high as $1.30 in premarket trading after Adicet shared initial safety and efficacy data from the first seven patients dosed with ADI-001 in the ongoing study evaluating the therapy for autoimmune diseases.
As of August 31, 2025, the data cut includes seven patients (five with lupus nephritis and two with systemic lupus erythematosus), with two to nine months of follow-up.
Based on these results, Adicet will request a meeting with the FDA to inform the design of a potentially pivotal Phase 2 trial for lupus nephritis or for lupus nephritis and systemic lupus erythematosus.
One hundred percent of patients in the lupus nephritis cohort achieved a renal response, including three complete responses, DORIS remissions, and two partial responses, with all responses ongoing.
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100% of patients experienced rapid and sustained reductions in SLEDAI-2K and PGA scores, highlighting ADI-001’s potential for a durable effect on a broad range of lupus symptoms.
ADI-001 demonstrated multiple hallmarks of an immune reset with elimination of dominant B cell clones and subsequent emergence of naïve B cells and new B cell repertoire following single dose treatment.
ADI-001 was generally well-tolerated and showed a favorable safety profile, which could enable dosing in an outpatient setting.
Across all seven patients dosed with ADI-001, no serious adverse events were reported, and no cases of ICANS were observed.
Anticipated development plans
Adicet plans to request a meeting with the FDA in the first quarter of 2026 to inform the Phase 2 pivotal trial design, with a study anticipated to commence in the second quarter of 2026.
Lupus nephritis and systemic lupus erythematosus patient enrollment in the ongoing Phase 1 is expected to continue until the Phase 2 pivotal study is open for enrollment.
ACET Price Action: Adicet Bio shares were down 15.00% at $0.85 at the time of publication on Tuesday, according to Benzinga Pro data.
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