Adicet Bio Files 8-K Report

TL;DR

Adicet Bio filed an 8-K, likely containing updates. Check for details.

AI Summary

On September 19, 2024, Adicet Bio, Inc. filed an 8-K report. The filing primarily serves as a notification of other events and includes financial statements and exhibits. No specific material events or transactions were detailed in the provided excerpt.

Why It Matters

This filing indicates Adicet Bio, Inc. is providing updates or disclosures to the SEC, which could contain material information for investors.

Risk Assessment

Risk Level: low — The provided excerpt is a standard 8-K filing notification without specific material events, making the immediate risk assessment low.

Key Numbers

• 001-38359 — Commission File Number (Identifies the company's SEC filings)
• 81-3305277 — IRS Employer Identification No. (Company's tax identification number)

Key Players & Entities

• Adicet Bio, Inc. (company) — Registrant
• September 19, 2024 (date) — Date of earliest event reported
• Delaware (jurisdiction) — State of Incorporation
• Boston, Massachusetts (location) — Principal Executive Offices

FAQ

Key Financial Figures

• $0.0001 — ch registered Common Stock, par value $0.0001 per share ACET The Nasdaq Global Ma

Filing Documents

• acet-20240919.htm (8-K) — 48KB
• acet-ex99_1.htm (EX-99.1) — 19KB
• img94724212_0.jpg (GRAPHIC) — 2KB
• 0000950170-24-107988.txt ( ) — 190KB
• acet-20240919.xsd (EX-101.SCH) — 24KB
• acet-20240919_htm.xml (XML) — 5KB

01 Regulation FD Disclosure

Item 7.01 Regulation FD Disclosure. On September 19, 2024, Adicet Bio, Inc. (Adicet or the Company) issued a press release titled "ADI-001 Clinical Biomarker Data Demonstrate Robust Tissue Trafficking and Complete B Cell Depletion in Secondary Lymphoid Tissue," a copy of which is furnished herewith as Exhibit 99.1 to this Current Report on Form 8-K. The information in this Item 7.01, including Exhibit 99.1 attached hereto, is intended to be furnished and shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the Exchange Act), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.

01 Other Events

Item 8.01 Other Events. On September 19, 2024, the Company announced ADI-001 clinical biomarker data from the Phase 1 GLEAN trial. Notably, ADI-001 demonstrated robust tissue trafficking resulting in high levels of ADI-001, significant chimeric antigen receptor (CAR) T cell activation, and complete CD19+ B cell depletion in secondary lymphoid tissue. A summary of the results is as follows: ADI-001 demonstrated significant levels of CAR T cell activation and tissue exposure in lymph node biopsies in the GLEAN trial, with a mean exposure of 236,701 CAR T cells per million across all dose levels, representing a range of 27-64% of total cellular material detected by ddPCR in evaluable biopsies at the 1E9 dose, and exceeding levels previously reported for patients who received autologous alpha-beta CAR T therapies. CAR T cells detected in tissues also demonstrated a robust activation profile, based on situ detection of granzyme B. Recent studies have demonstrated depletion of CD19+ plasmablasts, memory B cells and nave B cells in peripheral blood using anti-CD20 targeted antibodies, however, these CD20-targeted antibody modalities failed to deplete B cells within secondary lymphoid tissues. Concurrent with ADI-001 tissue trafficking and activation, complete depletion of CD19+ B cells within analyzed secondary lymphoid tissue was also observed. These results support ADI-001's potential for achieving complete B-cell depletion in peripheral blood and within tissues.

Forward-Looking Statements

Forward-Looking Statements The disclosure under this Item 8.01 contains "forward-looking statements" of Adicet within the meaning of the Private Securities Litigation Reform Act of 1995 relating to the business and operations of Adicet. The words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements include, but are not limited to, express or implied statements regarding the potential safety, tolerability and efficacy of ADI-001 multiple autoimmune indications; the potential for ADI-001 to achieve complete B-cell depletion in peripheral blood and within tissues and differentiation from existing therapies. Any forward-looking statements in this Item 8.01 are based on management's current expectations and beliefs of future events, and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements, including without limitation, the effect of global economic conditions and public health crises on the Company's business and financial results, including with respect to disruptions to its preclinical and clinical studies, business operations, employee hiring and retention, and ability to raise additional capital; Adicet's ability to execute on its strategy including obtaining the requisite regulatory approvals on the expected timeline, if at all; that positive results, including interim results, from a preclinical or clinical study may not necessarily be predictive of the results of future or ongoing studies; that clinical studies may fail to demonstrate adequate safety and efficacy of Adicet's product candidates, which would prevent, delay, or limit the scope of

01 Exhibits

Item 9.01 Exhibits. (d) Exhibits Exhibit No. Description 99.1 Press release issued by Adicet Bio, Inc. on September 19, 2024, furnished herewith. 104 Cover Page Interactive Data File (embedded within the Inline XBRL document).

SIGNATURES

SIGNATURES Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized. ADICET BIO, INC. Date: September 19, 2024 By: /s/ Nick Harvey Name: Nick Harvey Title: Chief Financial Officer

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View this 8-K filing on SEC EDGAR