Adicet Bio, Inc 8-K, filed Nov 5, 2026
Adicet Bio, Inc. (ACET)
About this 8-K
Adicet Bio, Inc filed this 8-K on November 5, 2026.
Adicet Bio reported that 50% of evaluable lupus nephritis patients achieved a complete renal response at 12 months. Third-quarter net loss was $18.9 million, while cash, cash equivalents and short-term investments totaled $100.9 million as of September 30, 2026. AI summary
Items reported
- Item 2.02: Financial results
- Item 9.01: Financial statements and exhibits
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
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Securities registered pursuant to Section 12(b) of the Act:
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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 November 5, 2026, Adicet Bio, Inc. announced its financial results for the quarter ended September 30, 2026. 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 November 5, 2026, 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: November 5, 2026 |
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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 Third Quarter 2026 Financial Results and Provides Business Updates
Phase 1 data for prulacabtagene leucel (prula-cel, formerly ADI-001) demonstrated durable responses and a favorable safety profile in patients with systemic lupus erythematosus (SLE) with or without lupus nephritis (LN)
Pivotal LN study startup activities underway; FDA engagement planned in 4Q/2026 to discuss pivotal expansion into lupus patients without nephritis
Regulatory update and 12-month follow-up data from ~22 patients expected in 1Q/2027
U.S. Food and Drug Administration (FDA) clears Investigational New Drug (IND) and grants Fast Track Designation (FTD) to ADI-212 for metastatic castration-resistant prostate cancer (mCRPC); Phase 1 startup activities underway
Building next-generation in vivo CAR-T platform and pipeline across hematologic and solid tumors, with first candidate expected to enter clinic in 2H/2027
REDWOOD CITY, Calif. – November 5, 2026 – Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing allogeneic gamma delta CAR-T cell and in vivo CAR-T therapies for autoimmune diseases, hematologic malignancies and solid tumors, today reported financial results and operational highlights for the third quarter ended September 30, 2026.
“The growing body of evidence for prula-cel continues to strengthen our conviction in its potential to generate meaningful, lasting remissions for patients living with SLE, including those with LN and extra renal SLE. The compelling efficacy observed following complete discontinuation of immunosuppressants, together with evidence of a deep immune reset and a favorable safety profile supporting outpatient administration, reinforce the potential for prula-cel to meaningfully change the treatment paradigm for lupus patients," said Chen Schor, President and Chief Executive Officer of Adicet Bio. "With pivotal study startup activities underway in LN and planned FDA discussions regarding potential pivotal expansion to include lupus patients without nephritis, we look forward to providing a regulatory update and additional 12-month follow-up data from approximately 22 patients in the first quarter of 2027 followed by clinical data from our systemic sclerosis cohort in the second quarter. Together with continued progress on ADI-212 and our in vivo CAR-T pipeline, we believe 2027 will be a catalyst-rich year for Adicet.”
Third Quarter 2026 and Recent Operational Highlights:
Autoimmune diseases
Solid tumor indications
In Vivo CAR-T Program and Pipeline
Financial Results for Third Quarter 2026:
About Adicet Bio, Inc.
Adicet Bio, Inc. is a clinical-stage biotechnology company discovering and developing a broad pipeline of allogeneic gamma delta T cell therapies, engineered with chimeric antigen receptors (CARs), alongside differentiated in vivo CAR-T therapies with the potential to redefine treatment across autoimmune diseases, hematologic malignancies and solid tumors. 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 prula-cel in autoimmune diseases and ADI-212 in mCRPC and the potential safety, tolerability and efficacy for prula-cel in the treatment of autoimmune diseases and ADI-212 in mCRPC as well as expectations to achieve a complete immune reset for prula-cel; expectations regarding future alignment with the FDA on regulatory path to approval and discussions to date; timing and success of the Phase 1 clinical trial of prula-cel in multiple autoimmune indications and ADI-212 in mCRPC, including timing and expectations for enrollment and future data releases; expectations regarding the timing and initiation of a pivotal study for prula-cel in SLE patients with or without LN and potential pivotal expansion to include non-renal lupus; expectations regarding FDA engagement in 4Q/2026 regarding expansion into lupus patients without nephritis; expectations regarding prula-cel’s potential to transform treatment for patients with lupus; expectations regarding the suitability of prula-cel for outpatient administration; expectations regarding the scalability of the Company’s off-the-shelf manufacturing platform; expectations regarding the pace of enrollment in the pivotal study for prula-cel in SLE patients with or without LN; estimates for the addressable patient population and commercial opportunity for prula-cel in LN and SLE; the preclinical and clinical development of ADI-212, including the timing of regulatory filings, clinical startup activities, clinical updates and future data releases as well as the potential for 2027 to be a catalyst-rich year; the timing of initiation of enrollment of a Phase 1 trial for ADI-212 in mCRPC; expectations regarding the potential potency of ADI-212; timing of updates to the Company’s in vivo CAR T platform pipeline; ongoing preclinical programs and activities relating to autoimmune diseases, hematological malignancies and solid tumors; 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 September 30, |
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Nine Months Ended September 30, |
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2026 |
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2025 |
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2026 |
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2025 |
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Operating expenses: |
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Research and development |
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$ |
15,626 |
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$ |
22,853 |
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$ |
51,562 |
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$ |
74,091 |
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General and administrative |
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4,170 |
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5,099 |
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12,105 |
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16,137 |
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Total operating expenses |
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19,796 |
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27,952 |
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63,667 |
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90,228 |
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Loss from operations |
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(19,796 |
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(27,952 |
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(63,667 |
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(90,228 |
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Interest income |
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972 |
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1,172 |
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3,482 |
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4,253 |
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Interest expense |
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(23 |
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(12 |
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(68 |
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(12 |
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Other expense, net |
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(30 |
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(64 |
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(83 |
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(300 |
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Loss before income tax provision |
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(18,877 |
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(26,856 |
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(60,336 |
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(86,287 |
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Income tax provision |
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(1 |
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— |
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(144 |
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— |
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Net loss |
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$ |
(18,878 |
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$ |
(26,856 |
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$ |
(60,480 |
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$ |
(86,287 |
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Net loss per share, basic and diluted |
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$ |
(1.76 |
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$ |
(4.72 |
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$ |
(5.62 |
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$ |
(15.10 |
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Weighted-average common shares used in computing net loss per share, basic and diluted |
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10,745,696 |
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5,692,874 |
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10,753,547 |
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5,713,216 |
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Other comprehensive income |
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Unrealized loss on treasury securities, net of tax |
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(70 |
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97 |
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(277 |
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40 |
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Total other comprehensive income |
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(70 |
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97 |
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(277 |
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40 |
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Comprehensive loss |
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$ |
(18,948 |
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$ |
(26,759 |
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$ |
(60,757 |
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$ |
(86,247 |
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ADICET BIO, INC.
Consolidated Balance Sheets
(in thousands, except share and per share amounts)
(Unaudited)
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September 30, |
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December 31, |
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Cash, cash equivalents, and short-term investments in treasury securities |
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$ |
100,945 |
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$ |
158,530 |
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Working capital |
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86,446 |
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139,395 |
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Total assets |
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128,946 |
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192,355 |
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Accumulated deficit |
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(675,177) |
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(614,697) |
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Total stockholders’ equity |
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102,697 |
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159,210 |
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Adicet Bio, Inc.
Investor and Media Contacts
Anne Bowdidge
abowdidge@adicetbio.com
Penelope Belnap
Precision AQ
Penelope.belnap@precisionaq.com