ACET 8-K
Adicet Bio, Inc. (ACET)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
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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 2.02 Results of Operations and Financial Condition.
On May 6, 2025, Adicet Bio, Inc. announced its financial results for the quarter ended March 31, 2025. A copy of the press release is being furnished as Exhibit 99.1 to this Current Report on Form 8-K.
The information in this Current Report on Form 8-K and 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.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
Exhibit No. |
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Description |
99.1 |
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Press Release of Adicet Bio, Inc. dated May 6, 2025, furnished herewith. |
104 |
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Cover Page Interactive Data File (embedded within the Inline XBRL document). |
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.
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ADICET BIO, INC. |
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Date: May 6, 2025 |
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By: |
/s/ Nick Harvey |
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Name: |
Nick Harvey |
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Title: |
Chief Financial Officer |
Adicet Bio Reports First Quarter 2025 Financial Results and Provides Business Updates
Two programs with clinical data readouts in 2H/2025
Phase 1 clinical trial of ADI-001 in autoimmune diseases ongoing with preliminary clinical data expected in 2H/2025; Trial now open for enrollment to patients with lupus nephritis (LN) and systemic lupus erythematosus (SLE)
Preliminary data for ongoing ADI-270 Phase 1 clinical trial in patients with metastatic/advanced clear cell renal cell carcinoma (ccRCC) expected in 2H/2025
REDWOOD CITY, Calif. & BOSTON – May 6, 2025 – Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer, today reported financial results and operational highlights for the first quarter ended March 31, 2025.
“We are approaching an exciting inflection point for our pipeline, with significant data milestones on the horizon,” said Chen Schor, President and Chief Executive Officer of Adicet Bio. “In the second half of 2025, we expect to report preliminary Phase 1 data from our two lead programs - ADI-001 in autoimmune diseases and ADI-270 in ccRCC, with more than 6 patients with at least 3-month follow up in both programs. As we progress toward these readouts, we also look to harness the full potential of our allogeneic gamma delta 1 CAR T cell therapy platform, which we believe has key advantages over other cell types. We have identified two promising highly differentiated programs, one targeting PSMA and one follow-on program targeting autoimmune diseases with potential to become best-in-class therapies for patients fighting autoimmune diseases and cancer.”
First Quarter 2025 and Recent Operational Highlights:
Autoimmune diseases
Hematologic malignancies and solid tumor indications
Corporate Update
Financial Results for First Quarter 2025:
About Adicet Bio, Inc.
Adicet Bio, Inc. is a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer. Adicet is advancing a pipeline of “off-the-shelf” gamma delta T cells, engineered with chimeric antigen receptors (CARs), to facilitate durable activity in patients. For more information, please visit our website at https://www.adicetbio.com.
Forward-Looking Statements
This press release 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: clinical development of Adicet’s product candidates, including future plans or expectations for ADI-001 in autoimmune diseases and ADI-270 in ccRCC and the potential safety, tolerability and efficacy for the treatment of autoimmune diseases and cancer; timing and success of the Phase 1 clinical trial of ADI-001 in LN, SLE, SSc, AAV, IIM and SPS, including timing and expectations for enrollment and future data releases; timing and success of the Phase 1 clinical trial of ADI-270 in ccRCC, including expectations for future data releases; expectations regarding the presentation of preclinical data at future scientific conferences; and expectations regarding Adicet’s uses of capital, expenses and financial results, including the expected cash runway.
Any forward-looking statements in this press release 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 emergencies on Adicet’s business and financial results, including with respect to disruptions to our 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; 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 annual report on Form 10-K, as well as discussions of potential risks, uncertainties, and other important factors in Adicet’s other filings with the U.S. Securities and Exchange Commission, including its quarterly report on Form 10-Q. All information in this press release is as of the date of the release, and Adicet undertakes no duty to update this information unless required by law.
ADICET BIO, INC.
Consolidated Statements of Operations and Comprehensive Income
(in thousands, except share and per share amounts)
(Unaudited)
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Three Months Ended March 31, |
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2025 |
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2024 |
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Operating expenses: |
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Research and development |
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$ |
22,814 |
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$ |
23,897 |
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General and administrative |
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7,071 |
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6,974 |
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Total operating expenses |
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29,885 |
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30,871 |
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Loss from operations |
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(29,885 |
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(30,871 |
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Interest income |
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1,683 |
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2,918 |
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Interest expense |
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— |
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(2 |
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Other expense, net |
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(12 |
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(61 |
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Loss before income tax provision |
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(28,214 |
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(28,016 |
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Income tax provision |
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— |
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— |
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Net loss |
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$ |
(28,214 |
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$ |
(28,016 |
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Net loss per share, basic and diluted |
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$ |
(0.31 |
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$ |
(0.35 |
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Weighted-average common shares used in computing net loss per share, basic and diluted |
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91,071,436 |
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79,071,652 |
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Other comprehensive income |
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Unrealized loss on treasury securities, net of tax |
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(25 |
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— |
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Total other comprehensive income |
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(25 |
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— |
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Comprehensive loss |
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$ |
(28,239 |
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$ |
(28,016 |
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ADICET BIO, INC.
Consolidated Balance Sheets Information
(in thousands)
(Unaudited)
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March 31, |
December 31, |
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2025 |
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2024 |
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Cash, cash equivalents, and short term investments in treasury securities |
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$ |
150,439 |
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$ |
176,303 |
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Working capital |
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137,116 |
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160,744 |
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Total assets |
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191,271 |
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220,219 |
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Accumulated deficit |
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(526,108) |
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(497,894) |
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Total stockholders’ equity |
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161,446 |
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186,609 |
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Adicet Bio, Inc.
Investor and Media Contacts
Investors:
Anne Bowdidge
Penelope Belnap
Precision AQ
212-362-1200
Media:
Kerry Beth Daly