ACET

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--(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 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 Phase 1 prula-cel clinical update in LN and SLE patients anticipated in mid-2026. The Company plans to provide its next clinical update in mid-2026 for its ongoing Phase 1 clinical trial evaluating prula-cel across multiple autoimmune conditions. Adicet also intends to meet with the FDA in the second quarter of 2026 to info...

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., March 12, 2026--(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 Phase 1 trial of prula‑cel 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)....

ROCKVILLE, Md., Nov. 12, 2025 (GLOBE NEWSWIRE) -- MaxCyte, Inc., (NASDAQ: MXCT), a leading, cell-engineering focused company providing enabling platform technologies to advance the discovery, development and commercialization of next-generation cell therapeutics, today announced its third quarter ended September 30, 2025 financial results and reiterated its 2025 guidance. Third Quarter and Recent Highlights Core business revenue of $6.4 million in the third quarter of 2025. Strategic Platform License SPL Program-related revenue was $0.4 million for the third quarter of 2025. Total revenue of $6.8 million in the third quarter of 2025. MaxCyte added one new SPL client, Moonlight Bio, in October, in addition to Adicet Bio and Anocca AB in July. The total number of SPL agreements stands at 32. Total cash, cash equivalents and investments were $158.0 million as of September 30, 2025. “We remain on track to achieve our full year 2025 revenue guidance,” said Maher Masoud, President and CEO of MaxCyte. “In the third quarter, we announced an operational restructuring to significantly reduce costs and accelerate our path towards profitability, while strengthening our ability to grow over the long-term. Though the external cell and gene therapy operating environment has rationalized over the last few years, we firmly believe that our value proposition for customers remains strong, as evidenced by recently signing our fourth SPL this year, Moonlight Bio. We remain committed to continued investments in SeQure Dx, product enhancement initiatives, and expanding the breadth of our cell engineering offerings, but will do so with commercial discipline to produce long-term sustainable growth for MaxCyte.” The following tables provide details regarding the sources of the Company’s revenue for the periods presented. In addition to revenue, management regularly reviews key business metrics to evaluate our business, measure performance, identify trends affecting our business, formulate financial projections and make strategic decisions. As of the dates presented, these key metrics were as follows: Third Quarter 2025 Financial Results Total revenue for the third quarter of 2025 was $6.8 million, compared to $8.2 million in the third quarter of 2024, representing a decrease of 16%. Core business revenue (sales of instruments, PAs and consumables, assay services, and licenses to cust...

Announced positive preliminary safety and efficacy data from Phase 1 clinical trial of ADI-001 in patients with lupus nephritis (LN) and systemic lupus erythematosus (SLE); data highlighted rapid and sustained reductions in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI-2K) score and Physician’s Global Assessment (PGA), improved renal function, and favorable safety and tolerability profile as of the August 31, 2025 data cut-off date Company plans to request a meeting with U.S. Food and Drug Administration (FDA) in 1Q/2026 to inform potentially pivotal ADI-001 trial design; study anticipated to commence in 2Q/2026 Ongoing enrollment of patients in Phase 1 study with LN, SLE, systemic sclerosis (SSc), idiopathic inflammatory myopathy (IIM), stiff person syndrome (SPS) and anti-neutrophil cytoplasmic autoantibody associated vasculitis (AAV) On track to share clinical update from Phase 1 study of ADI-001 in LN, SLE, and SSc in 1H/2026 Actively enrolling patients with treatment-refractory rheumatoid arthritis (RA) in Phase 1 study of ADI-001 evaluating potential to reduce the need for conditioning Plan to submit regulatory filing for ADI-212 in metastatic castration-resistant prostate cancer (mCPRC) in 1Q/2026 Completed underwritten registered direct offering to extend projected cash runway into 2H/2027 REDWOOD CITY, Calif., November 05, 2025--(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 third quarter ended September 30, 2025. "We were pleased to announce positive preliminary data last month from seven SLE and LN patients treated in our Phase 1 trial of ADI-001, underscoring its broad potential as a transformative, off-the-shelf, one-time therapy for autoimmune diseases. We are now preparing to discuss the trial design for a potentially pivotal study of ADI-001 with the FDA in the first quarter of 2026, with initiation targeted for the second quarter of 2026," said Chen Schor, President and Chief Executive Officer of Adicet Bio. "As part of our broader clinical strategy, we are also exploring the potential to reduce or eliminate the need for conditioning with a separate Phase 1 trial of ADI-001 in treatment-refractory RA patients. We are a...

Actively enrolling patients with lupus nephritis (LN), systemic lupus erythematosus (SLE) and systemic sclerosis (SSc) in Phase 1 clinical trial of ADI-001 in autoimmune diseases On track to report preliminary clinical data for ADI-001 in 2H/2025 Enrollment now open for patients with idiopathic inflammatory myopathy (IIM), stiff person syndrome (SPS) and anti-neutrophil cytoplasmic autoantibody associated vasculitis (AAV) Advancing development of ADI-212, an optimized next-generation gene-edited and armored clinical candidate designed to enhance potency in solid tumors and to deliver multiple anti-tumor mechanisms of action to the tumor microenvironment REDWOOD CITY, Calif. & BOSTON, August 07, 2025--(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 second quarter ended June 30, 2025. "We continue to make meaningful progress in our ADI-001 autoimmune Phase 1 clinical program. Site activation is progressing well with more than 20 sites currently open for enrollment in multiple territories and additional sites on track to open in the next few months. We see increased interest by investigators and patients in ADI-001 as a well-tolerated, off the shelf, one-time potential therapy for patients with autoimmune diseases. Enrollment is gathering momentum and we remain on track to share preliminary Phase 1 data for the program in the second half of 2025, with at least 6 patients with at least 3 months’ follow-up, which we believe will further validate the differentiated potential of our gamma delta T cell platform," said Chen Schor, President and Chief Executive Officer of Adicet Bio. "In addition, we have recently conducted a strategic review of our pipeline to focus our resources on programs with the greatest potential for long-term clinical and commercial value. As such, we are prioritizing the preclinical development of ADI-212, a gene-edited and armored clinical candidate designed to enhance potency in solid tumors and to deliver multiple anti-tumor mechanisms of action to the tumor microenvironment. Our commitment to executing with focus, operational excellence, and discipline position us to deliver differentiated gamma delta 1 CAR T therapies with the be...

ROCKVILLE, Md., Aug. 06, 2025 (GLOBE NEWSWIRE) -- MaxCyte, Inc., (NASDAQ: MXCT), a leading, cell-engineering focused company providing enabling platform technologies to advance the discovery, development and commercialization of next-generation cell therapeutics, today announced its second quarter ended June 30, 2025 financial results and updated its 2025 guidance. Second Quarter and Recent Highlights Core business revenue of $8.2 million in the second quarter of 2025, an increase of 8% over the second quarter of 2024. Strategic Platform License SPL Program-related revenue was $0.3 million for the second quarter of 2025, compared to $2.9 million in the second quarter of 2024, reflecting the timing variability of SPL Program-related revenue milestones and royalties. Total revenue of $8.5 million in the second quarter of 2025, a decrease of 18% over the second quarter of 2024. MaxCyte added two new SPL clients, Adicet Bio and Anocca AB, in July. Including TG Therapeutics signed in the first quarter, the total number of SPLs agreements stands at 31. Total cash, cash equivalents and investments were $165.2 million as of June 30, 2025. The decrease in cash, cash equivalents and investments since the beginning of the year includes approximately $7.0 million of purchase, transaction, and one-time costs to acquire SeQure Dx. “Despite solid growth in the first half of 2025, the operating environment has evolved since the beginning of the year, impacting our expectations for the second half of 2025. We are lowering our 2025 guidance to account for customer inventory management, as well as some reprioritization and consolidation of customer pipelines. While disappointed with the short-term headwinds, we continue to remain focused on executing in this environment, supporting customers with excellent technology and service,” said Maher Masoud, President and CEO of MaxCyte. “Our pipeline of potential SPLs remains strong, demonstrated by the two new SPLs that we recently announced, Adicet Bio and Anocca AB, bringing our total number of SPL agreements to 31. We continue to be confident about the opportunity in the cell and gene therapy industry and our position in it, remaining committed to spending prudently, and investing in product enhancements and SeQure Dx. We are confident that with improving operational efficiencies, multiple product offerings, and maturing clinical...

Two programs with clinical data readouts in 2H/2025 Phase 1 clinical trial of ADI-001 in autoimmune diseases ongoing with preliminary clinical data expected in 2H/2025; Trial now open for enrollment to patients with lupus nephritis (LN) and systemic lupus erythematosus (SLE) Preliminary data for ongoing ADI-270 Phase 1 clinical trial in patients with metastatic/advanced clear cell renal cell carcinoma (ccRCC) expected in 2H/2025 REDWOOD CITY, Calif. & BOSTON, May 06, 2025--(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 first quarter ended March 31, 2025. "We are approaching an exciting inflection point for our pipeline, with significant data milestones on the horizon," said Chen Schor, President and Chief Executive Officer of Adicet Bio. "In the second half of 2025, we expect to report preliminary Phase 1 data from our two lead programs - ADI-001 in autoimmune diseases and ADI-270 in ccRCC, with more than 6 patients with at least 3-month follow up in both programs. As we progress toward these readouts, we also look to harness the full potential of our allogeneic gamma delta 1 CAR T cell therapy platform, which we believe has key advantages over other cell types. We have identified two promising highly differentiated programs, one targeting PSMA and one follow-on program targeting autoimmune diseases with potential to become best-in-class therapies for patients fighting autoimmune diseases and cancer." First Quarter 2025 and Recent Operational Highlights: Autoimmune diseases Enrollment open for LN and SLE patients in Phase 1 clinical trial of ADI-001 in autoimmune diseases. In April 2025, Adicet expanded enrollment in its Phase 1 trial to include patients with SLE, in addition to ongoing enrollment in LN. The Company expects to initiate enrollment for patients with systemic sclerosis (SSc), idiopathic inflammatory myopathy (IIM), stiff person syndrome (SPS) and anti-neutrophil cytoplasmic autoantibody associated vasculitis (AAV) in the Phase 1 trial in 3Q/2025. Preliminary clinical data from the trial is expected in 2H/2025, subject to study site initiation and patient enrollment. ADI-001 granted two new Fast Track Designations. In February 2025, the...