Adicet Bio (Nasdaq: ACET) trims Q1 loss and details prula-cel, ADI-212 plans
Rhea-AI Filing Summary
Adicet Bio reported first quarter 2026 results and highlighted progress across its allogeneic gamma delta T cell pipeline. Net loss narrowed to $20.2 million, or $1.88 per share, from $28.2 million a year earlier, driven by lower research and development and general and administrative costs.
R&D expenses fell to $17.5 million from $22.8 million, while G&A declined to $4.1 million from $7.1 million. Cash, cash equivalents and short-term investments were $137.6 million as of March 31, 2026, which the company expects will fund operations into the second half of 2027.
Adicet plans a mid‑2026 clinical update from its Phase 1 autoimmune trial of prulacabtagene leucel in lupus nephritis and systemic lupus erythematosus, with at least 20 patients and six months’ follow-up. A regulatory interaction to inform potential pivotal trial design is expected in the second quarter of 2026, and a regulatory filing for ADI‑212 in metastatic castration-resistant prostate cancer is planned for the third quarter of 2026.
Positive
- None.
Negative
- None.
Insights
Adicet narrows losses while mapping multiple 2026 clinical milestones.
Adicet Bio reduced its quarterly net loss to $20.2 million as R&D and G&A spending declined meaningfully year over year. Operating expenses dropped to $21.6 million, suggesting tighter cost control while the company continues early-stage development.
Liquidity remains important for a clinical-stage biotech. With $137.6 million in cash, cash equivalents and short-term investments as of March 31, 2026, management expects funding to last into the second half of 2027, giving runway across several planned readouts and filings.
The near-term story centers on execution: a mid‑2026 Phase 1 update for prula‑cel in autoimmune disease, FDA interaction on a potential pivotal trial, and an ADI‑212 regulatory filing for mCRPC in the third quarter of 2026. Subsequent company disclosures will clarify whether early data support advancing to pivotal studies.
8-K Event Classification
Key Figures
Key Terms
prulacabtagene leucel medical
systemic lupus erythematosus medical
metastatic castration-resistant prostate cancer medical
gamma delta T cell therapies medical
Phase 1 clinical trial medical
cash runway financial
Earnings Snapshot
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:
|
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:
|
|
Trading |
|
|
|
|
The |
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 13, 2026, Adicet Bio, Inc. announced its financial results for the quarter ended March 31, 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. |
|
Description |
99.1 |
|
Press Release of Adicet Bio, Inc. dated May 13, 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: May 13, 2026 |
|
By: |
/s/ Nick Harvey |
|
|
Name: |
Nick Harvey |
|
|
Title: |
Chief Financial Officer |
Adicet Bio Reports First Quarter 2026 Financial Results and Provides Business Updates
Clinical update anticipated in mid-2026 for Phase 1 autoimmune program evaluating prulacabtagene leucel (prula-cel, formerly ADI-001) with at least 20 lupus nephritis (LN) and systemic lupus erythematosus (SLE) patients with a minimum of six months follow-up
U.S. Food and Drug Administration (FDA) interaction to inform potential pivotal trial design for prula-cel expected in 2Q/2026
On track to submit regulatory filing for ADI-212 in metastatic castration-resistant prostate cancer (mCRPC) in 3Q/2026; enrollment expected to begin 4Q/2026, pending regulatory clearance
Continued advancement of cell therapy programs and differentiated in vivo CAR-T platform targeting multiple indications
REDWOOD CITY, Calif. – May 13, 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 first quarter ended March 31, 2026.
“Adicet is approaching a key inflection point as we prepare to report Phase 1 data for prula-cel in mid-year 2026, including data from at least 20 LN and SLE patients with a minimum of six months of follow-up,” said Chen Schor, President and Chief Executive Officer of Adicet Bio. “Reaching this important inflection point builds on the collaboration of our employees and a global network of investigators and clinical sites advancing a comprehensive Phase 1 trial of a potential first-in-class gamma delta 1 CAR-T cell therapy in autoimmune diseases.”
Mr. Schor continued, “In parallel, we are continuing to build our portfolio with ADI-212, a gene-edited and armored product candidate designed to enhance clinical activity in solid tumors and deliver multiple anti-tumor mechanisms of action to the tumor microenvironment. We are also advancing our ongoing preclinical programs and activities focused on a differentiated in vivo CAR-T platform targeting heme malignancies.”
First Quarter 2026 and Recent Operational Highlights:
Autoimmune diseases
Solid tumor indications
Additional early-stage programs (CAR and other technologies)
Financial Results for First Quarter 2026:
Three months ended March 31, 2026
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 the timing and initiation of a pivotal study for prula-cel in LN or LN and SLE patients; the ongoing Phase 1 trial of prula-cel in RA; the preclinical and clinical development of ADI-212, including the timing of regulatory filings, clinical startup activities, clinical updates and future data releases; the timing of initiation of enrollment of a Phase 1 trial for ADI-212 in mCRPC; expectations regarding the potential potency of ADI-212; 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)
|
|
For the Three Months Ended March 31, |
|
|||||
|
|
2026 |
|
|
2025 |
|
||
Operating expenses: |
|
|
|
|
|
|
||
Research and development |
|
$ |
17,487 |
|
|
$ |
22,814 |
|
General and administrative |
|
|
4,083 |
|
|
|
7,071 |
|
Total operating expenses |
|
|
21,570 |
|
|
|
29,885 |
|
Loss from operations |
|
|
(21,570 |
) |
|
|
(29,885 |
) |
Interest income |
|
|
1,342 |
|
|
|
1,683 |
|
Interest expense |
|
|
(23 |
) |
|
|
— |
|
Other expense, net |
|
|
7 |
|
|
|
(12 |
) |
Loss before income tax provision |
|
|
(20,244 |
) |
|
|
(28,214 |
) |
Income tax provision |
|
|
— |
|
|
|
— |
|
Net loss |
|
$ |
(20,244 |
) |
|
$ |
(28,214 |
) |
Net loss per share, basic and diluted |
|
$ |
(1.88 |
) |
|
$ |
(4.96 |
) |
Weighted-average common shares used in computing net loss per share, basic and diluted |
|
|
10,744,621 |
|
|
|
5,691,965 |
|
Other comprehensive income |
|
|
|
|
|
|
||
Unrealized loss on treasury securities, net of tax |
|
|
(139 |
) |
|
|
(25 |
) |
Total other comprehensive income |
|
|
(139 |
) |
|
|
(25 |
) |
Comprehensive loss |
|
$ |
(20,383 |
) |
|
$ |
(28,239 |
) |
ADICET BIO, INC.
Consolidated Balance Sheets Information
(in thousands)
(Unaudited)
|
|
March 31, |
December 31, |
|
||||
|
|
2026 |
|
|
2025 |
|
||
Cash, cash equivalents, and short-term investments in treasury securities |
|
$ |
137,592 |
|
|
$ |
158,530 |
|
Working capital |
|
|
121,773 |
|
|
|
139,395 |
|
Total assets |
|
|
169,382 |
|
|
|
192,355 |
|
Accumulated deficit |
|
|
(634,941) |
|
|
|
(614,697) |
|
Total stockholders’ equity |
|
|
140,065 |
|
|
|
159,210 |
|
Adicet Bio, Inc.
Investor and Media Contacts
Anne Bowdidge
abowdidge@adicetbio.com
Penelope Belnap
Precision AQ
Penelope.belnap@precisionaq.com