Every 8-K that Adicet Bio, Inc. (ACET) has filed with the SEC in the last 24 months is listed below, newest first, and each one links through to the document itself with the summary and the scores our analysis gives it.
A 8-K covers material events a company has to report between its quarterly reports, so if you follow ACET and want that one kind of document rather than the whole filing history, this is the page to keep. The company's other filings, of every form, are on the full ACET filings page.
Adicet Bio, Inc. (ACET) reported preliminary Phase 1 prula-cel data in systemic lupus erythematosus (SLE), with or without lupus nephritis (LN), as of August 28, 2026. Among 22 efficacy-evaluable patients, 50% of evaluable LN patients achieved complete renal response at 12 months, and 54% of evaluable patients achieved DORIS remission. All patients discontinued immunosuppressants, and all but one tapered steroids to 5 mg or less of prednisone equivalent.
Of 24 safety-evaluable patients, 25% had Grade 1 or 2 cytokine release syndrome (CRS), with no cases above Grade 2; no dose-limiting toxicities, IEC-HS, ICANS or graft-versus-host disease were reported. Infections were reported in 54%, with Grade 3 or higher in 8.3%. FDA alignment supports outpatient administration. Adicet is aligned with the FDA on a single-arm pivotal LN study for patients with inadequate response to at least two immunosuppressants; expected enrollment is a double-digit number, and the primary endpoint is complete renal response at 12 months. Start-up activities are planned for the fourth quarter of 2026; potential inclusion of non-renal SLE is subject to regulatory alignment.
Adicet Bio, Inc. (ACET) furnished a September 2026 investor presentation outlining an updated strategy focused on off-the-shelf γδ1 CAR‑T and in vivo CAR‑T therapies across autoimmune disease and oncology. The presentation is for information only and is not deemed filed under securities laws.
The lead program, prula‑cel, a CD20‑targeting allogeneic γδ1 CAR‑T, is being advanced for lupus nephritis, systemic lupus erythematosus and systemic sclerosis, with early data in seven patients showing clinical activity and a favorable safety profile with no ICANS, IEC‑HS or Grade >2 CRS as of an August 31, 2025 cutoff. Adicet positions prula‑cel as a potentially first off‑the‑shelf, one‑time CAR‑T option for autoimmune disease, aiming toward a pivotal pathway in LN/SLE.
ADI‑212, a PSMA‑directed, gene‑edited and armored γδ1 CAR‑T for metastatic castration‑resistant prostate cancer, has U.S. IND clearance with first patient dosing planned in the fourth quarter of 2026 and clinical data expected in 2027. Adicet also highlights a preclinical in vivo CAR‑T portfolio for multiple myeloma, non‑Hodgkin lymphoma and solid tumors, with initial clinical data from these programs expected from 2027 onward.
Adicet Bio, Inc. (ACET) reported multiple pipeline milestones, highlighted by completion of the last patient visit for the planned Phase 1 safety and efficacy analysis of prulacabtagene leucel (prula-cel) in systemic lupus erythematosus with or without lupus nephritis. The planned analysis covers 22 SLE patients with at least 6 months of follow-up, including 13 patients with at least 12 months of follow-up. Topline data are expected in September 2026, with an investor webcast planned to review results and outline a potential registrational trial design.
Adicet also announced that the FDA cleared its IND for ADI-212 for metastatic castration-resistant prostate cancer, with a Phase 1 trial expected to begin enrollment in the fourth quarter of 2026. The company is progressing a diversified in vivo CAR-T portfolio for hematologic malignancies and solid tumors and expects its first in vivo CAR-T candidate to enter clinical development in the second half of 2027.
Adicet Bio, Inc. reported second-quarter 2026 results and outlined upcoming milestones for its gamma delta T cell therapy pipeline. For the quarter ended June 30, 2026, research and development expenses were $18.5 million, general and administrative expenses were $3.9 million, and net loss was $21.4 million, or $1.99 per basic and diluted share. Cash, cash equivalents and short-term investments totaled $118.2 million as of June 30, 2026, which the company expects will fund operations into the second half of 2027.
The company plans a Phase 1 clinical update in the third quarter of 2026 for prulacabtagene leucel in lupus nephritis and systemic lupus erythematosus, including data from 22 patients with at least 6 months of follow-up, 13 with at least 12 months. Adicet is advancing a potential pivotal trial design in lupus nephritis anticipated to start in the second half of 2026, subject to regulatory clearance. A regulatory filing for ADI-212 in metastatic castration-resistant prostate cancer is expected in the third quarter of 2026, with Phase 1 enrollment anticipated in the fourth quarter of 2026, and an update on its in vivo CAR-T platform is planned for the second half of 2026. The company appointed board member Lloyd Klickstein, M.D., Ph.D., as Interim Chief Medical Officer.
Adicet Bio, Inc. held its 2026 Annual Meeting of Stockholders on June 17, 2026, where three governance proposals were presented for vote. Stockholders elected Class II directors Jeffrey Chodakewitz, Steve Dubin and Michael Grissinger to three-year terms ending at the 2029 annual meeting.
Support was strong for all three nominees, with votes for ranging from 4,596,116 to 5,257,041 and broker non-votes of 1,384,153. Stockholders also approved, on a non-binding advisory basis, the compensation of the company’s named executive officers, with 4,611,540 votes for and 745,537 against.
In addition, stockholders ratified the appointment of KPMG LLP as independent registered public accounting firm for the fiscal year ending December 31, 2026, with 6,719,352 votes for and 25,206 against. No other matters were submitted to a vote at the meeting.
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.
Adicet Bio, Inc. entered into an exchange agreement with RA Capital under which RA Capital swapped 250,000 shares of Adicet common stock for a pre-funded warrant to acquire 250,000 common shares.
The warrant carries a token exercise price of $0.0001 per share and is exercisable immediately via cashless exercise. It includes a 9.99% cap on both beneficial ownership and voting power, which can be increased on at least 61 days’ prior notice but not above 19.99%. The issuance relied on the Section 3(a)(9) exemption from Securities Act registration.
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.
Adicet Bio reported clinical and regulatory progress for its cell therapy programs. Enrollment in its Phase 1 trial of prulacabtagene leucel (prula-cel, formerly ADI-001) in autoimmune diseases has doubled to over 20 patients as of December 31, 2025. The company has also reached alignment with the U.S. Food and Drug Administration to allow patients with lupus nephritis and systemic lupus erythematosus to be dosed with prula-cel in the outpatient setting in ongoing and future trials. Adicet plans to request a meeting with the FDA in the second quarter of 2026 to inform potential Phase 2 pivotal trial design for prula-cel and expects to submit a regulatory filing for ADI-212 in metastatic castration-resistant prostate cancer in the first half of 2026.
Adicet Bio (ACET) filed an 8-K stating it announced financial results for the quarter ended September 30, 2025.
The detailed results are provided in a press release furnished as Exhibit 99.1. The company specifies that the information in this report and Exhibit 99.1 is being furnished, not filed, under the Exchange Act and is not subject to Section 18 liabilities, nor incorporated by reference except as specifically stated.
Adicet Bio received an additional 180 days from Nasdaq, until April 6, 2026, to regain compliance with the minimum $1.00 bid price requirement. At the same time, its common stock listing will move from the Nasdaq Global Market to the Nasdaq Capital Market, effective October 9, 2025.
The company plans to closely track its share price and may use options such as a reverse stock split to restore compliance. If the stock does not trade at or above $1.00 for at least 10 consecutive business days by the new deadline, the shares could be delisted, though Adicet would be able to appeal.
Adicet Bio, Inc. entered an underwriting agreement for an underwritten registered direct offering of 70,001,000 shares of common stock and pre-funded warrants to purchase 10,000,000 shares, all priced at approximately $1.00 per underlying share.
The company expects to receive approximately $74.8 million in net proceeds after underwriting discounts and expenses. Pre-funded warrants have a nominal exercise price of $0.0001 per share, are exercisable on a cashless basis, and include a beneficial ownership cap of 9.99%, which may be increased up to 19.99% with at least 61 days’ prior notice.
The offering is being conducted under Adicet Bio’s effective Form S-3 shelf registration statement and a final prospectus supplement dated October 7, 2025, with closing expected on October 8, 2025, subject to customary conditions.
Adicet Bio (ACET) reported early clinical results for its cell therapy ADI-001 in seven autoimmune patients (five with lupus nephritis (LN) and two with systemic lupus erythematosus (SLE)) with two- to nine-month follow-up. All five LN patients achieved a renal response—three complete responses and two partial responses—and responses remained ongoing. Patients showed rapid, sustained reductions in disease activity scores (SLEDAI-2K and PGA) and discontinued immunosuppressants while tapering corticosteroids. Biomarker changes described an immune reset with elimination of dominant B cell clones and emergence of naive B cells after a single dose. Through August 31, 2025, ADI-001 was generally well tolerated: no serious adverse events or ICANS, two Grade 1 CRS events, one Grade 1 infection, and no GvHD, HLH-MAS, or prolonged neutropenia. The company plans an FDA meeting in Q1 2026 and anticipates initiating a Phase 2 pivotal study in Q2 2026, while continuing Phase 1 enrollment and expanding Phase 1 into additional autoimmune indications.