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Adicet Bio (ACET)

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Earnings summaries and quarterly performance for Adicet Bio.

Recent press releases and 8-K filings for ACET.

Adicet Bio Provides Corporate Update and Outlines 2026 Milestones
ACET
Guidance Update
New Projects/Investments
  • Adicet Bio has extended its cash runway into the second half of 2027 after successfully raising approximately $74.8 million in net proceeds through an underwritten registered direct offering in October 2025.
  • The company received FDA alignment for outpatient dosing of prula-cel in systemic lupus erythematosus (SLE) and lupus nephritis (LN) patients and anticipates providing multiple clinical updates for its prula-cel Phase 1 autoimmune disease program in 1H 2026 and 2H 2026.
  • Adicet plans to submit a regulatory filing for ADI-212 in metastatic castration-resistant prostate cancer (mCRPC) in 1H 2026 and expects to initiate clinical startup activities in Q2 2026, subject to regulatory clearance.
  • The company intends to request a meeting with the FDA in Q2 2026 to discuss pivotal trial design for prula-cel and aims to initiate a pivotal study in LN or LN and SLE patients in 2H 2026.
Jan 7, 2026, 12:00 PM
Adicet Bio Announces Reverse Stock Split
ACET
Delisting/Listing Issues
  • Adicet Bio's board of directors has approved a one-for-16 reverse stock split of its common stock.
  • The reverse stock split will become effective at 12:01 a.m. Eastern Time on December 30, 2025, with split-adjusted trading beginning the same day on The Nasdaq Capital Market.
  • This action is intended to help Adicet Bio regain compliance with the minimum bid price requirement for continued listing on the Nasdaq Capital Market.
  • The split will reduce the number of outstanding shares from approximately 153.3 million to approximately 9.6 million.
  • Stockholders who would otherwise receive fractional shares will automatically receive cash in lieu of such shares.
Dec 26, 2025, 1:30 PM
Adicet Provides Clinical and Financial Update at Guggenheim Conference
ACET
Guidance Update
New Projects/Investments
  • Adicet, a leader in gamma delta CAR T cell therapies, reported positive safety and efficacy data from the first seven patients in its Lupus Nephritis (LN) and Systemic Lupus Erythematosus (SLE) program, with responses ongoing and immune reset observed.
  • The company plans to meet with the FDA in Q1 next year and initiate a pivotal study for LN and SLE in Q2 next year, with an expected size of 30-90 patients.
  • Adicet anticipates reporting initial data for Systemic Sclerosis (SSC) in the first half of next year, with additional data potentially in the second half.
  • Manufacturing for their off-the-shelf therapy takes approximately 14 days, and the cost of manufacturing is projected to be less than 10% of pricing.
  • As of September 30, Adicet held almost $180 million in cash, providing a financial runway into the second half of 2027, covering significant clinical and regulatory milestones planned for next year.
Nov 11, 2025, 8:00 PM
Adicet Bio Reports Q3 2025 Results and Positive ADI-001 Clinical Data
ACET
Earnings
Guidance Update
New Projects/Investments
  • Adicet Bio reported a net loss of $26.9 million, or $0.29 per basic and diluted share, for the third quarter ended September 30, 2025.
  • As of September 30, 2025, the company's cash, cash equivalents, and short-term investments totaled $103.1 million.
  • Following the quarter end, Adicet successfully raised $74.8 million in net proceeds from a registered direct offering in October 2025, which is expected to extend its cash runway into the second half of 2027.
  • The company announced positive preliminary safety and efficacy data from its Phase 1 clinical trial of ADI-001 in lupus nephritis and systemic lupus erythematosus patients as of August 31, 2025.
  • Adicet plans to request a meeting with the FDA in Q1 2026 to discuss the design for a potentially pivotal ADI-001 trial, with the study anticipated to commence in Q2 2026.
Nov 5, 2025, 9:02 PM
Adicet Bio Provides Positive ADI-001 Phase 1 Autoimmune Study Update
ACET
New Projects/Investments
Guidance Update
  • Adicet Bio's ADI-001 Phase 1 autoimmune study demonstrated a well-tolerated safety profile suitable for outpatient administration, with no Grade 2 or higher Cytokine Release Syndrome (CRS) and no Immune effector Cell-Associated Neurotoxicity Syndrome (ICANS).
  • The study reported rapid and sustained reductions in SLEDAI-2K and PGA across all patients (five LN and two SLE), with all five LN patients achieving renal responses, including three complete responses.
  • ADI-001 treatment showed clear evidence of immune reset, characterized by deep and broad B cell depletion and reconstitution by naive B cells, leading to all patients discontinuing immunosuppressants and tapering corticosteroids.
  • Adicet Bio anticipates key milestones in 2026, including clinical updates for SLE and LN, alignment with the FDA on pivotal study design, and initiation of a pivotal study in LN or LN/SLE.
Oct 7, 2025, 12:00 PM
Adicet Bio Reports Positive Phase I Study Results for ADI-one
ACET
New Projects/Investments
  • Adicet Bio announced promising safety and efficacy results from its ongoing Phase I study of ADI-one in patients with Lupus Nephritis (LN) and Systemic Lupus Erythematosus (SLE).
  • The study demonstrated rapid and sustained reductions in SLEDAI-2K and Physician Global Assessment (PGA) scores across all seven patients (five LN and two SLE).
  • Kidney function improved in all five LN patients, with three achieving complete renal responses (CRR) and two partial renal responses, representing a 60% CRR rate.
  • ADI-one was very well tolerated, with no serious adverse events (SAEs), no ICANS, and no CRS events greater than Grade 1. All patients discontinued immunosuppressants and tapered steroids to zero or below physiological levels.
  • The company plans to request a meeting with the FDA in Q1 2026 to inform the Phase II pivotal trial design for LN or LN and SLE, with the study anticipated to commence in Q2 2026.
Oct 7, 2025, 12:00 PM