ACET 8-K
Adicet Bio, Inc. (ACET)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
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 2.02 Results of Operations and Financial Condition.
On August 7, 2025, Adicet Bio, Inc. announced its financial results for the quarter ended June 30, 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. |
|
Description |
99.1 |
|
Press Release of Adicet Bio, Inc. dated August 7, 2025, furnished herewith. |
104 |
|
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.
|
|
ADICET BIO, INC. |
|
|
|
|
|
Date: August 7, 2025 |
|
By: |
/s/ Nick Harvey |
|
|
Name: |
Nick Harvey |
|
|
Title: |
Chief Financial Officer |
Adicet Bio Reports Second Quarter 2025 Financial Results and Provides Business Updates
Actively enrolling patients with lupus nephritis (LN), systemic lupus erythematosus (SLE) and systemic sclerosis (SSc) in Phase 1 clinical trial of ADI-001 in autoimmune diseases
On track to report preliminary clinical data for ADI-001 in 2H/2025
Enrollment now open for patients with idiopathic inflammatory myopathy (IIM), stiff person syndrome (SPS) and anti-neutrophil cytoplasmic autoantibody associated vasculitis (AAV)
Advancing development of ADI-212, an optimized next-generation gene-edited and armored clinical candidate designed to enhance potency in solid tumors and to deliver multiple anti-tumor mechanisms of action to the tumor microenvironment
REDWOOD CITY, Calif. & BOSTON – August 7, 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 second quarter ended June 30, 2025.
“We continue to make meaningful progress in our ADI-001 autoimmune Phase 1 clinical program. Site activation is progressing well with more than 20 sites currently open for enrollment in multiple territories and additional sites on track to open in the next few months. We see increased interest by investigators and patients in ADI-001 as a well-tolerated, off the shelf, one-time potential therapy for patients with autoimmune diseases. Enrollment is gathering momentum and we remain on track to share preliminary Phase 1 data for the program in the second half of 2025, with at least 6 patients with at least 3 months’ follow-up, which we believe will further validate the differentiated potential of our gamma delta T cell platform,” said Chen Schor, President and Chief Executive Officer of Adicet Bio. “In addition, we have recently conducted a strategic review of our pipeline to focus our resources on programs with the greatest potential for long-term clinical and commercial value. As such, we are prioritizing the preclinical development of ADI-212, a gene-edited and armored clinical candidate designed to enhance potency in solid tumors and to deliver multiple anti-tumor mechanisms of action to the tumor microenvironment. Our commitment to executing with focus, operational excellence, and discipline positions us to deliver differentiated gamma delta 1 CAR T therapies with the best potential to address unmet medical need for patients.”
Second Quarter 2025 and Recent Operational Highlights:
Autoimmune diseases
Solid tumor indications
Corporate updates
Financial Results for Second 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 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; expectations regarding the preclinical and clinical development of ADI-212, including the timing of regulatory filings and future data releases; expectations regarding the potential potency of ADI-212, as compared to previous generation alpha-beta and gamma-delta CAR T programs in oncology; expectations regarding the pipeline prioritization and workforce reduction, including as it relates to the estimated reduction in expenses and the development of assets with the greatest potential for clinical and commercial success; and expectations regarding Adicet’s uses of capital, expenses and financial results, including the expected extension of the cash runway into the fourth quarter of 2026.
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)
|
Three Months Ended June 30, |
|
|
Six Months Ended June 30, |
|
||||||||||
|
2025 |
|
|
2024 |
|
|
2025 |
|
|
2024 |
|
||||
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
||||
Research and development |
$ |
28,424 |
|
|
$ |
25,901 |
|
|
$ |
51,238 |
|
|
$ |
49,797 |
|
General and administrative |
|
3,968 |
|
|
|
6,948 |
|
|
|
11,039 |
|
|
|
13,922 |
|
Total operating expenses |
|
32,392 |
|
|
|
32,849 |
|
|
|
62,277 |
|
|
|
63,719 |
|
Loss from operations |
|
(32,392 |
) |
|
|
(32,849 |
) |
|
|
(62,277 |
) |
|
|
(63,719 |
) |
Interest income |
|
1,398 |
|
|
|
2,999 |
|
|
|
3,081 |
|
|
|
5,917 |
|
Interest expense |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(2 |
) |
Other expense, net |
|
(223 |
) |
|
|
(51 |
) |
|
|
(235 |
) |
|
|
(113 |
) |
Loss before income tax provision |
|
(31,217 |
) |
|
|
(29,901 |
) |
|
|
(59,431 |
) |
|
|
(57,917 |
) |
Income tax provision |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
Net loss |
$ |
(31,217 |
) |
|
$ |
(29,901 |
) |
|
$ |
(59,431 |
) |
|
$ |
(57,917 |
) |
Net loss per share, basic and diluted |
$ |
(0.34 |
) |
|
$ |
(0.33 |
) |
|
$ |
(0.65 |
) |
|
$ |
(0.68 |
) |
Weighted-average common shares used in computing net loss per share, basic and diluted |
|
91,085,506 |
|
|
|
90,632,045 |
|
|
|
91,120,502 |
|
|
|
84,848,146 |
|
Other comprehensive loss |
|
|
|
|
|
|
|
|
|
|
|
||||
Unrealized loss on treasury securities, net of tax |
|
(32 |
) |
|
|
— |
|
|
|
(57 |
) |
|
|
— |
|
Total other comprehensive loss |
|
(32 |
) |
|
|
— |
|
|
|
(57 |
) |
|
|
— |
|
Comprehensive loss |
$ |
(31,249 |
) |
|
$ |
(29,901 |
) |
|
$ |
(59,488 |
) |
|
$ |
(57,917 |
) |
ADICET BIO, INC.
Consolidated Balance Sheets Information
(in thousands)
(Unaudited)
|
|
June 30, |
|
|
December 31, |
|
||
Cash and cash equivalents, and short term investments in treasury securities |
|
$ |
124,963 |
|
|
$ |
176,303 |
|
Working Capital |
|
|
110,661 |
|
|
|
160,744 |
|
Total assets |
|
|
162,972 |
|
|
|
220,219 |
|
Accumulated deficit |
|
|
(557,325) |
|
|
|
(497,894) |
|
Total stockholders’ equity |
|
133,372 |
|
|
186,609 |
|
||
Adicet Bio, Inc.
Investor and Media Contacts
Anne Bowdidge
Penelope Belnap
Precision AQ
212-362-1200