Adicet Bio, Inc 8-K, filed Feb 5, 2025
Adicet Bio, Inc. (ACET)
About this 8-K
Adicet Bio, Inc filed this 8-K on February 5, 2025.
Items reported
- Item 8.01: Other events
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): |
(Exact name of Registrant as Specified in Its Charter)
(State or Other Jurisdiction |
(Commission File Number) |
(IRS Employer |
||
|
|
|
|
|
|
||||
|
||||
(Address of Principal Executive Offices) |
|
(Zip Code) |
||
Registrant’s Telephone Number, Including Area Code: |
(Former Name or Former Address, if Changed Since Last Report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
Securities registered pursuant to Section 12(b) of the Act:
|
|
Trading |
|
|
|
|
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 8.01 Other Events.
Clinical Trial Enrollment Updates
On February 5, 2025, Adicet Bio, Inc. (Adicet or the Company) will participate in the Guggenheim Securities SMID Cap Biotech Conference held in New York City. During the conference, the Company will provide an update on the enrollment status of its clinical programs:
ADI-001 Lupus Nephritis (LN) Program: The Company has enrolled 3 patients in its Phase 1 LN clinical trial for ADI-001, an allogeneic gamma delta chimeric antigen receptor (CAR) T cell therapy targeting B cells via an anti-CD20 CAR. The Company dosed the first patient in the trial in November 2024, and approximately 12 sites have been activated to date, with additional sites anticipated in the near future. Phase 1 patient enrollment is ongoing, and the Company anticipates reporting preliminary results from the Phase 1 LN clinical trial in the first half of 2025.
ADI-001 Additional Autoimmune Indications: The Company continues to expect to initiate Phase 1 patient enrollment in systemic lupus erythematosus, systemic sclerosis, idiopathic inflammatory myopathy and stiff person syndrome in the first quarter of 2025 with preliminary data from these patient cohorts in the second half of 2025. Patient enrollment in anti-neutrophil cytoplasmic autoantibody associated vasculitis is expected to begin in the second half of 2025.
ADI-270 Metastatic/Advanced Clear Cell Renal Cell Carcinoma (ccRCC) Program: The Company has enrolled 3 patients in its Phase 1 ccRCC program for ADI-270, an armored allogeneic gamma delta CAR T cell therapy candidate targeting CD70+ tumors. The Company dosed the first patient in the trial in December 2024, and approximately 7 sites have been activated to date, with additional sites anticipated in the near future. Phase 1 patient enrollment is ongoing, and the Company anticipates reporting preliminary results from the trial in the first half of 2025.
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 Adicet’s expectations regarding its Phase 1 trial of ADI-001 in LN, including plans to report preliminary data from the ongoing Phase 1 LN clinical trial in the first half of 2025 and additional site activation; its Phase 1 trial of ADI-001 in additional autoimmune indications, including plans to initiate patient enrollment in systemic lupus erythematosus, systemic sclerosis, idiopathic inflammatory myopathy and stiff person syndrome in the first quarter of 2025 and plans to report preliminary data from these cohorts in the second half of 2025; the initiation of patient enrollment for ADI-001 in anti-neutrophil cytoplasmic autoantibody associated vasculitis in the second half of 2025; and its Phase 1 trial of ADI-270 in ccRCC, including site activation and plans to report preliminary clinical data in the first half of 2025.
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 regulatory approval and commercialization; and regulatory approval processes of the U.S. Food and Drug Administration and comparable foreign regulatory authorities are lengthy, time-consuming, and inherently unpredictable; and Adicet’s ability to meet production and product release expectations. For a discussion of these and other risks and uncertainties, and other important factors, any of which could cause Adicet's actual results to differ from those contained in the forward-looking statements, see the section titled "Risk Factors" in Adicet's most recent Quarterly Report on Form 10-Q and subsequent filings with the U.S. Securities and Exchange Commission (SEC), as well as discussions of potential risks, uncertainties, and other important factors in Adicet’s other filings with the SEC. All disclosure under this Item 8.01 is as of the date of this Form 8-K, and Adicet undertakes no duty to update this information unless required by law.
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 hereunto duly authorized.
|
|
ADICET BIO, INC. |
|
|
|
|
|
Date: February 5, 2025 |
|
By: |
/s/ Nick Harvey |
|
|
Name: |
Nick Harvey |
|
|
Title: |
Chief Financial Officer |