Adicet Bio, Inc.

Company focus

• Clinical-stage biotechnology company developing allogeneic gamma delta T cell therapies.
• Developing off-the-shelf gamma delta T cells engineered with CARs and related technologies to treat autoimmune diseases and cancer.
• Cells are sourced from unrelated donors and manufactured for storage and on-demand use to decouple therapy from patient-specific cell collection and reduce the risk of graft-versus-host disease (GvHD).

Lead product and key programs

• Prula-cel (prulacabtagene leucel; formerly ADI-001)

  • Allogeneic Vδ1 gamma delta T cells expressing a CAR targeting CD20.
  • Primary focus on autoimmune diseases.
  • Phase 1 program across multiple autoimmune indications; dosing underway in lupus nephritis (LN), systemic lupus erythematosus (SLE), systemic sclerosis (SSc), idiopathic inflammatory myopathies (IIM), stiff-person spectrum (SPS), ANCA-associated vasculitis (AAV), and rheumatoid arthritis (RA).
  • Clinical updates
    • First LN patient dosed in November 2024; program expanded to include SLE, SSc, IIM, SPS, and AAV.
    • First RA patient dosed in October 2025; the RA study evaluates two conditioning regimens.
    • As of an August 31, 2025 data cut-off, seven SLE/LN patients had been dosed in the autoimmune Phase 1 trial (reported October 2025).
    • FDA Fast Track designations: LN (June 2024); SLE with extrarenal involvement and SSc (February 2025).
    • November 2025 announcement indicated alignment with FDA for outpatient dosing in LN/SLE for ongoing and future trials.
  • Phase 1 design
    • 3+3 dose-escalation starting at 1.0e8 CAR+ cells with escalation up to 1.0e9 CAR+ cells.
    • Lymphodepletion with cyclophosphamide and fludarabine.
    • Safety monitoring through Day 42 and follow-ups at 3, 6, 9, 12, 18, and 24 months.
    • RA expansion measures safety and activity by disease activity scores and pharmacodynamics.

• ADI-212

  • Next-generation, gene-edited and armored gamma delta CAR T candidate targeting PSMA.
  • Engineering features include mbIL-12 armoring and CRISPR/Cas9 disruption of MED12.
  • Regulatory filing planned for metastatic castration-resistant prostate cancer (mCRPC) in 3Q 2026; potential initiation of patient enrollment in 4Q 2026, subject to regulatory clearance.

• ADI-270

  • Program discontinued in July 2025 to prioritize prula-cel and ADI-212.

• Other programs

  • Ongoing preclinical programs and discovery initiatives across autoimmune diseases, hematologic malignancies, and solid tumors, including CAR and related technologies, in vivo approaches, and armored strategies.

Platform, manufacturing and supply

• Cell source and process

  • Gamma delta T cells are isolated from blood of unrelated donors.
  • Activation expands Vδ1 cells; CAR transduction is performed with replication-incompetent vectors, followed by expansion and depletion of residual alpha-beta T cells to reduce GvHD risk.
  • Cells are frozen in single-use vials for post-thaw infusion.

• Manufacturing footprint and sourcing

  • Internal GMP cell processing and vector manufacturing located at 1000 Bridge Parkway, Redwood City, CA.
  • Donor material and critical inputs (activating antibody, viral vectors, guide RNA, etc.) are sourced from third-party CDMOs and suppliers.
  • The current model combines internal processing with external supply for starting materials and vector manufacturing, with plans to expand capability via additional CDMOs and internal improvements.

• Timeline, scale and throughput

  • Manufacturing process is designed to complete in approximately two to three weeks.
  • Bulk manufacturing is intended to enable treatment of multiple patients; large-scale expansion at clinical scale can exceed several thousand-fold (example: >6,000-fold).

• Risks and regulatory considerations

  • Reliance on third-party manufacturers for starting materials and vector production creates exposure to supply disruptions or quality issues.
  • Alpha-beta T cell depletion and overall cell processing are subject to regulatory scrutiny and cGMP compliance.

• Platform differentiators

  • Focus on the tissue-homing Vδ1 subset, potential for multi-mechanistic anti-tumor and immune-reset activity, and MHC-independent targeting.

Intellectual property

• Portfolio components

  • Patents and methods covering gamma delta T cell expansion, engineered gamma delta CAR T cells, manufacturing methods, and methods of treatment.
  • prula-cel (CD20-targeting CAR) and ADI-212 (PSMA CAR with mbIL-12 armoring and MED12 disruption) each have dedicated patent families.
  • Additional assets include companion technologies and engineered constructs (e.g., DAP10-related preclinical work; CRISPR-based gene-editing tools under collaboration).

• Patent horizons and protection

  • Patent expirations for various gamma delta CAR T constructs and related methods are generally in the 2035–2045 range, with certain U.S. patents in core families expiring around 2037–2042.
  • ADI-002 (CRISPR collaboration) and ADI-212 families have expirations around 2039–2044, subject to extensions or adjustments.
  • PCT applications for manufacturing improvements and diagnostic tools are in the 2044–2045 range.
  • Protection is maintained through patents, trade secrets, and know-how.

• Licensing and collaborations

  • Regeneron: license and collaboration for engineered immune-cell therapies including upfront and milestone payments, options to develop and royalties on products; Regeneron has rights to use CAR/TCRs in Regeneron programs outside the collaboration and potential 50/50 cost-and-profit sharing in selected products if Adicet participates.
  • Twist Bioscience: antibody discovery collaboration.
  • CRISPR Therapeutics: CRISPR/Cas technology license for ADI-212 development.
  • City of Hope: non-exclusive license for cytokine expression technologies.

• IP risk posture

  • Patents provide protection through the mid- to late-2030s and 2040s; scope and enforceability depend on prosecution outcomes and potential third-party challenges.

Regulatory trajectory and designations

• U.S. status

  • Prula-cel is in Phase 1 autoimmune trials with INDs cleared for LN and expansion to SLE, SSc, SPS, IIM, AAV; Phase 1 RA initiated.
  • FDA Fast Track designations: LN (2024) and SLE/SSc (2025).
  • The company plans regulatory submissions roughly every 12–18 months and anticipates pivotal study discussions with the FDA in 2026 (LN or LN+SLE).

• International considerations

  • Prepared to pursue trials and marketing approvals outside the U.S. under local regulatory requirements, including the centralized EU pathway for ATMPs (CAT/CHMP and centralized MAA).
  • Data protection and privacy requirements (GDPR/UK GDPR) and cross-border data transfer commitments are part of international operations.

Financial position and key metrics (as of December 31, 2025)

• Employees: 102 full-time employees.
• Net loss: $116.8 million for the year ended December 31, 2025.
• Accumulated deficit: $614.7 million as of December 31, 2025.
• Cash and equivalents: $158.5 million in cash, cash equivalents, restricted cash and short-term investments as of December 31, 2025; runway into the second half of 2027, subject to changes in operating plan and financing.
• Financing activity (illustrative)
  • Approximately $19.3 million net proceeds from an ATM in January 2024.
  • Approximately $91.7 million net from an underwritten public offering in January 2024.
  • Approximately $74.8 million net from an underwritten registered direct offering in October 2025.

Market position and collaborations

• Business model centers on clinical development, collaborations, licensing and potential partner-driven commercialization.
• Strategic collaborations and licenses (Regeneron, Twist, CRISPR Therapeutics, City of Hope) support pipeline advancement, technology access, and external funding; the Regeneron arrangement is a material external funding and development framework.

Geographic footprint

• Principal operations in the San Francisco Bay Area, including Redwood City, CA.
• China-related activities conducted through Adicet Shanghai (PRC subsidiary) and related contractual arrangements.

Business model summary

• Develop allogeneic, off-the-shelf gamma delta T cell therapies (CAR T and related approaches) for autoimmune diseases and cancer.
• Use donor-derived gamma delta T cells engineered ex vivo, with a manufacturing model that combines internal cell processing and external supply of vectors and materials.
• Advance a diversified pipeline (prula-cel; ADI-212; ADI-270 discontinued; additional preclinical programs) and pursue strategic collaborations to fund development, expand capabilities, and support potential commercialization.

Information above reflects disclosures in Adicet Bio’s Form 10-K and related filings as of late 2025 and early 2026.