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Adicet Bio (NASDAQ: ACET) outlines 2025 loss and cash runway into 2027

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8-K

Rhea-AI Filing Summary

Adicet Bio reported continued investment in its pipeline alongside steady operating losses for the quarter and year ended December 31, 2025. In the fourth quarter, research and development expenses were $25.0 million and general and administrative costs were $6.9 million, leading to a net loss of $30.5 million, or $2.94 per share.

For full-year 2025, R&D spending was $99.1 million and G&A was $23.0 million, resulting in a net loss of $116.8 million, or $16.95 per share. Cash, cash equivalents and short-term investments totaled $158.5 million at year-end, and the company expects this to fund operations into the second half of 2027.

Operationally, Adicet highlighted strong enrollment in its Phase 1 autoimmune trial of prulacabtagene leucel (prula-cel), with clinical updates planned in the first and second halves of 2026, and FDA alignment enabling outpatient dosing for lupus nephritis and systemic lupus erythematosus. A Phase 1 study in treatment-refractory rheumatoid arthritis is underway, with another update expected in the second half of 2026.

The company is also advancing ADI-212 for metastatic castration-resistant prostate cancer, planning a regulatory filing in the third quarter of 2026 and expecting Phase 1 enrollment to begin in the fourth quarter of 2026, subject to regulatory clearance.

Positive

  • None.

Negative

  • None.

Insights

Adicet maintains a solid cash runway while advancing multiple early-stage cell therapy programs.

Adicet Bio is still pre-revenue and reported a full-year net loss of $116.8 million on operating expenses of $122.1 million. R&D held roughly flat year over year, while G&A fell from $28.3 million to $23.0 million, reflecting tighter overhead control.

The cash position of $158.5 million at December 31, 2025 was bolstered by $74.8 million in net proceeds from an October equity offering. Management states this should fund operating expenses into the second half of 2027, giving several years of runway to generate key clinical data.

On the pipeline, the Phase 1 prula-cel autoimmune trial is progressing with strong enrollment and multiple planned data updates through 2026, while a pivotal study could start in the second half of 2026 pending regulatory discussions. ADI-212 is expected to enter the clinic after a planned regulatory filing in the third quarter of 2026. Subsequent company filings and data releases will show whether these programs can translate into meaningful efficacy and safety signals.

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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): March 12, 2026

 

 

Adicet Bio, Inc.

(Exact name of Registrant as Specified in Its Charter)

 

 

Delaware

001-38359

81-3305277

(State or Other Jurisdiction
of Incorporation)

(Commission File Number)

(IRS Employer
Identification No.)

 

 

 

 

 

131 Dartmouth Street, Floor 3

 

Boston, Massachusetts

 

02116

(Address of Principal Executive Offices)

 

(Zip Code)

 

Registrant’s Telephone Number, Including Area Code: (650) 503-9095

 

Not applicable

(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:

 

 

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Securities registered pursuant to Section 12(b) of the Act:


Title of each class

 

Trading
Symbol(s)

 


Name of each exchange on which registered

Common Stock, par value $0.0001 per share

 

ACET

 

The Nasdaq Capital Market

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 March 12, 2026, Adicet Bio, Inc. announced its financial results for the quarter and year ended December 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.

Description

99.1

Press Release of Adicet Bio, Inc. dated March 12, 2026, 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: March 12, 2026

By:

/s/ Nick Harvey

Name:

Nick Harvey

Title:

Chief Financial Officer

 

 


 

 

img94724212_0.gif

 

 

Adicet Bio Reports Fourth Quarter and Full Year 2025 Financial Results and Highlights Recent Company Progress

 

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 ADI212 in metastatic castrationresistant prostate cancer (mCPRC) planned for 3Q/2026; enrollment expected to begin 4Q/2026 pending regulatory clearance

 

 

REDWOOD CITY, Calif. – March 12, 2026 – 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 prulacel 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, valuedriving milestones in the year ahead.”

 

Fourth Quarter 2025 and Recent Operational Highlights:

 

Autoimmune diseases

 

Phase 1 trial of prulacel demonstrating strong enrollment momentum across multiple autoimmune indications, with next clinical update expected in the first half of 2026. Adicet continues to advance its ongoing Phase 1 clinical trial evaluating prula-cel across multiple autoimmune diseases. Prula-cel has received Fast Track Designation from the FDA for the potential treatment of relapsed/refractory Class III or Class IV LN, refractory SLE with extrarenal involvement, and systemic sclerosis (SSc). The next clinical update is expected in the first half of 2026, with plans to provide an additional clinical update from the study in the second half of 2026. Adicet plans to meet with the FDA in the second quarter of 2026 to inform

 

 

potential pivotal trial design. Subject to regulatory clearance to proceed, the Company expects to initiate a pivotal study in LN or LN and SLE patients in the second half of 2026.

 

Alignment with FDA allows outpatient dosing for LN and SLE patients. In November 2025, the Company reached alignment with the FDA to allow LN and SLE patients to be dosed with prula-cel in the outpatient setting in ongoing and future clinical trials.

 

Phase 1 study underway in treatment-refractory rheumatoid arthritis (RA) patients to evaluate the potential to reduce conditioning requirements. In October 2025, Adicet dosed the first patient in a Phase 1 study of prula-cel in treatment refractory RA. The study is evaluating two lymphodepletion regimens: cyclophosphamide alone and cyclophosphamide in combination with fludarabine. The primary objective of the study is to assess the safety and tolerability of prula-cel, with secondary objectives including evaluation of cellular kinetics, pharmacodynamics, and disease activity scores. The next clinical update on this trial is expected in the second half of 2026.

 

 

Solid tumor indications

 

Preclinical development ongoing for ADI212, with a regulatory filing expected in the third quarter of 2026, which is expected to enable Phase 1 enrollment beginning in the fourth quarter of 2026. Adicet continues to advance preclinical development of ADI212, a nextgeneration geneedited and armored cell therapy candidate targeting prostate-specific membrane antigen (PSMA). ADI212 is engineered to express a novel CAR binder designed to support enhanced tolerability and tumorspecific recognition. It integrates membranetethered IL12 armoring, and CRISPR/Cas9mediated disruption of subunit 12 (MED12) to enhance potency in solid tumors and deliver multiple antitumor mechanisms of action within the tumor microenvironment. Adicet plans to submit a regulatory filing for ADI-212 for the treatment of mCRPC in the third quarter of 2026, with Phase 1 enrollment expected to begin in the fourth quarter of 2026, subject to regulatory clearance.

 

ADI212 preclinical data presented at scientific meeting. In October 2025, Adicet presented preclinical data from its ADI212 program at the 32nd Annual Prostate Cancer Foundation Scientific Retreat. The data supported the rationale for the program’s design features and demonstrated functional enhancements across multiple preclinical models of disease.

 

Financial Results for Fourth Quarter and Full Year 2025:

 

Three months ended December 31, 2025

 

Research and Development (R&D) Expenses: R&D expenses were $25.0 million for the three months ended December 31, 2025, compared to $23.3 million during the same period in 2024. The increase in R&D expenses was primarily due to a $6.1 million increase in expenses related to contract research organizations (CROs) and contract development and manufacturing organizations (CDMOs), partially offset by a $2.7 million decrease in payroll and

 

 

personnel expenses due to lower headcount and a $1.0 million decrease in facilities related expenses.
General and Administrative (G&A) Expenses: G&A expenses were $6.9 million for the three months ended December 31, 2025, compared to $7.5 million during the same period in 2024. The decrease in G&A expenses was primarily due to a $1.3 million decrease in rent and office related expenses and a $0.7 million decrease in professional services and consultants, partially offset by a $1.6 million increase in payroll and personnel expenses primarily related to stock-based compensation.
Net Loss: Net loss for the three months ended December 31, 2025 was $30.5 million, or a net loss of $2.94 per basic and diluted share, including non-cash stock-based compensation expense of $5.7 million, as compared to a net loss of $28.7 million, or a net loss of $5.06 per basic and diluted share, including non-cash stock-based compensation expense of $3.8 million during the same period in 2024.

 

Twelve months ended December 31, 2025

 

Research and Development (R&D) Expenses: R&D expenses were $99.1 million for the year ended December 31, 2025, compared to $99.3 million for the year ended December 31, 2024. The decrease in R&D expenses was primarily due to a $5.1 million decrease in payroll and personnel expenses related to lower headcount and a $0.7 million decrease in lab supplies and materials. The decrease was partially offset by a $5.6 million increase in CRO costs primarily for autoimmune studies.
General and Administrative (G&A) Expenses: G&A expenses were $23.0 million for the year ended December 31, 2025, compared to $28.3 million for the year ended December 31, 2024. The decrease in G&A expenses was primarily due to a decrease in payroll and personnel expenses primarily related to a decrease in stock-based compensation of $3.6 million, a $1.6 million decrease in office related expenses, and a $0.3 million decrease in rent expense.
Net Loss: Net loss for the year ended December 31, 2025 was $116.8 million, or a net loss of $16.95 per basic and diluted share, including non-cash stock-based compensation expense of $14.3 million, as compared to a net loss of $117.1 million, or a net loss of $21.33 per basic and diluted share, including non-cash stock-based compensation expense of $22.2 million during the same period in 2024.
Cash Position: Cash, cash equivalents and short-term investments were $158.5 million as of December 31, 2025, compared to $176.3 million as of December 31, 2024. In October 2025, Adicet successfully raised $74.8 million in net proceeds through an underwritten registered direct offering of equity securities. The Company expects that current cash, cash equivalents and short-term investments as of December 31, 2025, will be sufficient to fund its operating expenses into the second half of 2027.

 

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 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 Ended
December 31,

 

For the Year Ended December 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

 

Anne Bowdidge

abowdidge@adicetbio.com

 

Penelope Belnap

Precision AQ

Penelope.belnap@precisionaq.com

 


FAQ

How did Adicet Bio (ACET) perform financially in Q4 2025?

Adicet Bio reported a Q4 2025 net loss of $30.5 million, or $2.94 per share. Research and development expenses were $25.0 million and general and administrative costs were $6.9 million, reflecting continued investment in its cell therapy pipeline.

What were Adicet Bio’s full-year 2025 results?

For full-year 2025, Adicet Bio recorded a net loss of $116.8 million, or $16.95 per share. Research and development expenses totaled $99.1 million and general and administrative expenses were $23.0 million, broadly in line with the prior year’s R&D spend but lower G&A.

What is Adicet Bio’s cash position and runway as of December 31, 2025?

Adicet Bio held $158.5 million in cash, cash equivalents and short-term investments at December 31, 2025. Management expects this balance to fund operating expenses into the second half of 2027, supported by $74.8 million in net proceeds from an October 2025 equity offering.

What are the key milestones for Adicet Bio’s prula-cel autoimmune program?

The Phase 1 prula-cel trial in autoimmune diseases is showing strong enrollment, with a clinical update planned in the first half of 2026 and an additional update in the second half of 2026. A pivotal study in lupus nephritis, or lupus nephritis and SLE, may begin in the second half of 2026 pending regulatory input.

When will Adicet Bio’s ADI-212 program for prostate cancer enter the clinic?

Adicet Bio plans a regulatory filing for ADI-212 in metastatic castration-resistant prostate cancer in the third quarter of 2026. Subject to regulatory clearance, Phase 1 enrollment is expected to start in the fourth quarter of 2026, following ongoing preclinical development.

What regulatory progress has Adicet Bio made for prula-cel dosing?

In November 2025, Adicet Bio reached alignment with the FDA allowing lupus nephritis and systemic lupus erythematosus patients to receive prula-cel in the outpatient setting in ongoing and future trials. This change may ease trial participation and broaden real-world applicability if results are favorable.

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2 documents
Adicet Bio Inc

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