Full Press Release Details
Strong enrollment momentum in Phase 1 autoimmune program evaluating prulacabtagene leucel (prula-cel, formerly ADI-001); clinical update expected in 1H/2026 with an additional update in 2H/2026
Achieved regulatory alignment with the FDA enabling outpatient dosing of prula-cel for lupus nephritis (LN) and systemic lupus erythematosus (SLE) patients in ongoing and future clinical studies
Regulatory filing for ADI‑212 in metastatic castration‑resistant prostate cancer (mCPRC) planned for 3Q/2026; enrollment expected to begin 4Q/2026 pending regulatory clearance
REDWOOD CITY, Calif.--(BUSINESS WIRE)--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 fourth quarter and year ended December 31, 2025.
“Adicet closed the year with solid momentum, driven by strong enrollment progress and the positive data from the prula-cel Phase 1 autoimmune study reported during the fourth quarter. Enrollment in our Phase 1 prula‑cel autoimmune study continues advancing ahead of expectations, supported by significant physician and patient interest in the study and FDA alignment that enables outpatient dosing for LN and SLE patients. We look forward to providing a clinical update in LN, SLE and SSc in the first half of this year,” said Chen Schor, President and Chief Executive Officer of Adicet Bio. “Beyond prula-cel, we expect to submit a regulatory filing for ADI-212 for the treatment of mCPRC in the third quarter of 2026 with enrollment expected to begin in the fourth quarter of 2026. Adicet is well positioned for continued execution and poised to deliver meaningful, value‑driving milestones in the year ahead.”
Fourth Quarter 2025 and Recent Operational Highlights:
Autoimmune diseases
Solid tumor indications
Financial Results for Fourth Quarter and Full Year 2025:
Three months ended December 31, 2025
Twelve months ended December 31, 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 athttps://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 prula-cel 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 prula-cel in multiple autoimmune indications, including timing and expectations for enrollment and future data releases; expectations regarding regulatory alignment with the FDA to allow LN and SLE patients to be dosed with prula-cel in the outpatient setting; expectations regarding the timing and initiation of a pivotal study for prula-cel in LN or LN and SLE patients; expectations regarding the preclinical and clinical development of ADI-212, including the timing of regulatory filings, clinical startup activities, clinical updates and future data releases; expectations regarding the timing of initiation of enrollment of a Phase 1 trial for ADI-212; expectations regarding the potential potency of ADI-212; 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) | ||||||||||||||||
| Three Months EndedDecember 31, | For the Year EndedDecember 31, | |||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | $ | 25,036 | $ | 23,273 | $ | 99,127 | $ | 99,323 | ||||||||
| General and administrative | 6,849 | 7,470 | 22,987 | 28,292 | ||||||||||||
| Total operating expenses | 31,885 | 30,743 | 122,114 | 127,615 | ||||||||||||
| Loss from operations | (31,885 | ) | (30,743 | ) | (122,114 | ) | (127,615 | ) | ||||||||
| Interest income | 1,524 | 2,067 | 5,777 | 10,714 | ||||||||||||
| Interest expense | (24 | ) | (1 | ) | (36 | ) | (4 | ) | ||||||||
| Other expense, net | (131 | ) | (50 | ) | (430 | ) | (217 | ) | ||||||||
| Loss before income tax provision | (30,516 | ) | (28,727 | ) | (116,803 | ) | (117,122 | ) | ||||||||
| Income tax provision | — | — | — | — | ||||||||||||
| Net loss | $ | (30,516 | ) | $ | (28,727 | ) | $ | (116,803 | ) | $ | (117,122 | ) | ||||
| Net loss per share, basic and diluted | $ | (2.94 | ) | $ | (5.06 | ) | $ | (16.95 | ) | $ | (21.33 | ) | ||||
| Weighted-average common shares used in computing net loss per share, basic and diluted | 10,366,936 | 5,678,008 | 6,891,336 | 5,491,652 | ||||||||||||
| Other comprehensive income | ||||||||||||||||
| Unrealized gain on treasury securities, net of tax | 46 | (105 | ) | 86 | 16 | |||||||||||
| Total other comprehensive income | 46 | (105 | ) | 86 | 16 | |||||||||||
| Comprehensive loss | $ | (30,470 | ) | $ | (28,832 | ) | $ | (116,717 | ) | $ | (117,106 | ) | ||||
| ADICET BIO, INC.Consolidated Balance Sheets Information(in thousands)(Unaudited) | ||||||||
| December 31,2025 | December 31,2024 | |||||||
| Cash, cash equivalents, and short term investments in treasury securities | $ | 158,530 | $ | 176,303 | ||||
| Working capital | 139,827 | 160,744 | ||||||
| Total assets | 192,355 | 220,219 | ||||||
| Accumulated deficit | (614,265 | ) | (497,894 | ) | ||||
| Total stockholders' equity | 159,642 | 186,609 |
Adicet Bio, Inc.Investor and Media Contacts
Penelope BelnapPrecision AQPenelope.belnap@precisionaq.com