ACET
Adicet BioDDocument history
Earnings documents stored for ACET.
Investor releaseQuarter not tagged2026-08-11Adicet Bio Eyes Key Lupus Data This Quarter for Off-the-Shelf Cell Therapy
MarketBeat
Adicet Bio Eyes Key Lupus Data This Quarter for Off-the-Shelf Cell Therapy
Interested in Adicet Bio, Inc.? Here are five stocks we like better. Adicet Bio expects to report lupus data this quarter for its off-the-shelf CAR-T candidate ADI-001, covering 22 patients with at least six months of follow-up and 13 with at least 12 months. The company aims to show 12-month complete-response rates comparable to autologous CAR-T therapies. The company is focusing initially on a potential registrational path in lupus nephritis after recent FDA discussions, while preserving the option to expand into systemic lupus erythematosus. Potential studies could use single-arm designs and assess steroid reduction, quality of life, and other measures beyond standard lupus endpoints. Adicet also plans additional pipeline updates, including systemic-sclerosis data later this year, a prostate-cancer gamma delta cell therapy, and details on an in vivo CAR-T program. Adicet Bio (NASDAQ:ACET) expects to report clinical data this quarter for its lead autoimmune program, ADI-001, also known as prula-cel, including results in lupus nephritis (LN) and systemic lupus erythematosus (SLE), Chief Executive Officer Chen Schor said at the 46th Annual Canaccord Genuity Growth Conference. ADI-001 is an off-the-shelf gamma delta 1 cell therapy targeting CD20. Schor said the company expects its upcoming LN and SLE update to include 22 enrolled patients, all with at least six months of follow-up. Thirteen of those patients are expected to have at least 12 months of follow-up, primarily in lupus nephritis. → SoundHound AI Sends a Loud Signal After Its Q2 Earnings Beat “One year seems to be the benchmark that people are looking at,” Schor said, adding that Adicet’s goal is to demonstrate a complete-response rate at 12 months comparable with rates reported for autologous CAR-T therapies. Schor said CD20 targeting has shown B-cell depletion results that appear comparable to CD19-directed approaches based on the company’s data. He said Adicet has observed complete depletion of CD19-positive B cells in blood and lymph-node biopsy samples, along with what he characterized as an immune-system reset as patients recover. → 3 Dividend Champion Utilities for a Market That Can't Sit Still He emphasized that tissue penetration, particularly B-cell depletion in lymph nodes, is important for evaluating activity in autoimmune disease. The company has not yet completed the data cut for its u…Read full documentShow less
Interested in Adicet Bio, Inc.? Here are five stocks we like better. Adicet Bio expects to report lupus data this quarter for its off-the-shelf CAR-T candidate ADI-001, covering 22 patients with at least six months of follow-up and 13 with at least 12 months. The company aims to show 12-month complete-response rates comparable to autologous CAR-T therapies. The company is focusing initially on a potential registrational path in lupus nephritis after recent FDA discussions, while preserving the option to expand into systemic lupus erythematosus. Potential studies could use single-arm designs and assess steroid reduction, quality of life, and other measures beyond standard lupus endpoints. Adicet also plans additional pipeline updates, including systemic-sclerosis data later this year, a prostate-cancer gamma delta cell therapy, and details on an in vivo CAR-T program. Adicet Bio (NASDAQ:ACET) expects to report clinical data this quarter for its lead autoimmune program, ADI-001, also known as prula-cel, including results in lupus nephritis (LN) and systemic lupus erythematosus (SLE), Chief Executive Officer Chen Schor said at the 46th Annual Canaccord Genuity Growth Conference. ADI-001 is an off-the-shelf gamma delta 1 cell therapy targeting CD20. Schor said the company expects its upcoming LN and SLE update to include 22 enrolled patients, all with at least six months of follow-up. Thirteen of those patients are expected to have at least 12 months of follow-up, primarily in lupus nephritis. → SoundHound AI Sends a Loud Signal After Its Q2 Earnings Beat “One year seems to be the benchmark that people are looking at,” Schor said, adding that Adicet’s goal is to demonstrate a complete-response rate at 12 months comparable with rates reported for autologous CAR-T therapies. Schor said CD20 targeting has shown B-cell depletion results that appear comparable to CD19-directed approaches based on the company’s data. He said Adicet has observed complete depletion of CD19-positive B cells in blood and lymph-node biopsy samples, along with what he characterized as an immune-system reset as patients recover. → 3 Dividend Champion Utilities for a Market That Can't Sit Still He emphasized that tissue penetration, particularly B-cell depletion in lymph nodes, is important for evaluating activity in autoimmune disease. The company has not yet completed the data cut for its upcoming disclosure, he said, but expects to announce the results during the current quarter. Adicet enrolled patients across five countries and was able to recruit at centers that do not necessarily conduct cell-therapy studies, according to Schor. He attributed that enrollment flexibility to the product’s off-the-shelf availability and the lack of a need for leukapheresis, the process used to collect a patient’s cells for autologous therapies. → Is Wingstop's Growth Story Losing Steam? Following a recent meeting with the U.S. Food and Drug Administration, Adicet plans to provide regulatory feedback alongside its data update, Schor said. He indicated that the company’s initial registrational focus is expected to be lupus nephritis, reflecting the composition of its existing clinical data set, while retaining the option to later expand into SLE. According to Schor, registrational studies in LN, SLE, or a combined LN and SLE population could potentially use single-arm designs. He said study sizes in the field have ranged from approximately 35 patients in more heavily pretreated populations to roughly 90 patients in populations that have failed fewer prior therapies. Schor also discussed endpoints beyond conventional lupus measures. He said the company may evaluate factors such as physician global assessment, patient quality of life, reduced use of immunosuppressive drugs, and low or reduced steroid use. He characterized the ability to measure responses without chronic immunosuppression as a potential distinction for cell therapy relative to treatments that require ongoing therapy. Adicet also expects to report data in systemic sclerosis during the second half of the year. Schor said the company enrolled a “reasonable number” of patients in that study but did not provide additional guidance on the expected data set. In rheumatoid arthritis, Adicet is conducting a small study comparing lymphodepletion regimens using cyclophosphamide and fludarabine versus cyclophosphamide alone. Schor said the study is intended to determine whether fludarabine is needed with gamma delta CAR-T cells and could inform conditioning approaches in other indications. The company currently plans to use standard cyclophosphamide/fludarabine conditioning in its pivotal study. Beyond ADI-001, Schor said Adicet has an off-the-shelf gamma delta 1 cell therapy for prostate cancer planned for clinical development. The candidate targets prostate-specific membrane antigen, or PSMA, and incorporates two additional technologies intended to improve potency and address challenges associated with cell therapy in solid tumors. The company also plans to disclose details of an in vivo CAR-T pipeline in the near future. “There’s going to be a lot coming from us in the next few months,” Schor said. Adicet Bio, Inc (NASDAQ: ACET) is a clinical‐stage biotechnology company specializing in the development of off‐the‐shelf, allogeneic gamma delta (γδ) T cell therapies for oncology and autoimmune disorders. The company's proprietary platform enables the genetic engineering of γδ T cells with chimeric antigen receptors (CARs) and other molecular modifications to enhance tumor targeting, expansion, and persistence. By leveraging the innate tumor-recognition properties of γδ T cells, Adicet seeks to overcome the manufacturing and safety challenges associated with autologous cell therapies. Adicet's lead product candidate, ADI-001, is a CAR‐engineered allogeneic γδ T cell therapy directed against CD20 for the treatment of relapsed or refractory B-cell malignancies. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. The article "Adicet Bio Eyes Key Lupus Data This Quarter for Off-the-Shelf Cell Therapy" was originally published by MarketBeat. View MarketBeat's top stocks for August 2026.
Investor releaseQuarter not tagged2026-08-05Adicet Bio Reports Second Quarter 2026 Financial Results and Provides Business Updates
Business Wire
Adicet Bio Reports Second Quarter 2026 Financial Results and Provides Business Updates
Company to provide a comprehensive Phase 1 clinical update for prulacabtagene leucel (prula-cel, formerly ADI-001), featuring data from 22 patients with lupus nephritis (LN) and systemic lupus erythematosus (SLE) with a minimum of 6 months follow-up, including 13 patients with at least 12 months of follow-up; topline results now anticipated in 3Q/2026 Productive interactions with the U.S. Food and Drug Administration (FDA) informing potential pivotal trial design for LN, supporting planned start up activities in 2H/2026 On track for regulatory filing for ADI-212 in metastatic castration-resistant prostate cancer (mCRPC) in 3Q/2026 with enrollment anticipated to begin 4Q/2026, pending regulatory clearance Advancing in vivo CAR-T platform and pipeline REDWOOD CITY, Calif., August 05, 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 second quarter ended June 30, 2026. "At Adicet, we continue to advance prula-cel toward our next important clinical milestone, with a Phase 1 clinical update now expected in the third quarter of 2026. The additional follow-up time will allow us to deliver a more comprehensive and mature dataset, including 22 LN/SLE patients with a minimum of 6 months of follow-up, 13 of whom are expected to have reached at least 12 months of follow-up," said Chen Schor, President and Chief Executive Officer of Adicet Bio. "We also had productive interactions with the FDA to align on overall clinical design for a potential pivotal trial for prula-cel in LN, further supporting a clear regulatory path forward. Furthermore, we anticipate sharing additional clinical updates for prula-cel in the second half of 2026 in patients with systemic sclerosis." Mr. Schor continued, "Beyond prula-cel, we are continuing to advance ADI-212 toward Phase 1 alongside our differentiated in vivo CAR-T platform and pipeline targeting hematologic malignancies and solid tumors. With several planned milestones ahead in 2026, including anticipated clinical data readouts in LN and SLE in the third quarter, clinical data in systemic sclerosis in the second half of the year, and an update on our in vivo CAR T platform and pipeline, we look forward to executing our st…Read full documentShow less
Company to provide a comprehensive Phase 1 clinical update for prulacabtagene leucel (prula-cel, formerly ADI-001), featuring data from 22 patients with lupus nephritis (LN) and systemic lupus erythematosus (SLE) with a minimum of 6 months follow-up, including 13 patients with at least 12 months of follow-up; topline results now anticipated in 3Q/2026 Productive interactions with the U.S. Food and Drug Administration (FDA) informing potential pivotal trial design for LN, supporting planned start up activities in 2H/2026 On track for regulatory filing for ADI-212 in metastatic castration-resistant prostate cancer (mCRPC) in 3Q/2026 with enrollment anticipated to begin 4Q/2026, pending regulatory clearance Advancing in vivo CAR-T platform and pipeline REDWOOD CITY, Calif., August 05, 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 second quarter ended June 30, 2026. "At Adicet, we continue to advance prula-cel toward our next important clinical milestone, with a Phase 1 clinical update now expected in the third quarter of 2026. The additional follow-up time will allow us to deliver a more comprehensive and mature dataset, including 22 LN/SLE patients with a minimum of 6 months of follow-up, 13 of whom are expected to have reached at least 12 months of follow-up," said Chen Schor, President and Chief Executive Officer of Adicet Bio. "We also had productive interactions with the FDA to align on overall clinical design for a potential pivotal trial for prula-cel in LN, further supporting a clear regulatory path forward. Furthermore, we anticipate sharing additional clinical updates for prula-cel in the second half of 2026 in patients with systemic sclerosis." Mr. Schor continued, "Beyond prula-cel, we are continuing to advance ADI-212 toward Phase 1 alongside our differentiated in vivo CAR-T platform and pipeline targeting hematologic malignancies and solid tumors. With several planned milestones ahead in 2026, including anticipated clinical data readouts in LN and SLE in the third quarter, clinical data in systemic sclerosis in the second half of the year, and an update on our in vivo CAR T platform and pipeline, we look forward to executing our strategic priorities and positioning the company for long-term value creation." Second Quarter 2026 and Recent Operational Highlights: Autoimmune diseases Phase 1 prula-cel clinical update in LN and SLE patients expected in 3Q/2026. The Company plans to provide its next clinical update in the third quarter of 2026 for its ongoing Phase 1 clinical trial evaluating prula-cel across multiple autoimmune conditions. The update is expected to include data from 22 patients with LN and SLE (16 LN/ 6 SLE) who will have at least 6 months of follow-up, including 13 patients who are expected to have reached at least 12 months of follow-up. Following alignment with the FDA in November 2025, LN and SLE patients in current and future studies may be dosed with prula-cel in an outpatient setting. Productive FDA interactions to align on overall design for potential pivotal trial design. Based on recent interactions with the FDA, the Company is advancing a potential pivotal trial design in LN and supporting planned start-up activities for a pivotal program anticipated to commence in the second half of 2026, subject to regulatory clearance. The Company plans to provide more details on the potential pivotal trial design as part of its comprehensive clinical update anticipated in the third quarter of 2026. Solid tumor indications Regulatory submission for ADI-212 expected in the third quarter of 2026, with Phase 1 initiation anticipated in the fourth quarter of 2026, pending regulatory clearance. Adicet continues to advance ADI-212, its next-generation gene-edited, armored cell therapy candidate targeting prostate-specific membrane antigen (PSMA), engineered with a novel CAR binder designed to enhance tolerability and tumor specific recognition. The program combines membrane tethered IL-12 armoring and CRISPR/Cas9-mediated disruption of subunit 12 of the mediator complex (MED12) designed to improve potency in solid tumors and enable multiple anti-tumor mechanisms within the tumor microenvironment. Adicet expects to submit a regulatory filing for ADI-212 for the treatment of mCRPC in the third quarter of 2026, with initiation of Phase 1 enrollment anticipated in the fourth quarter of 2026, subject to regulatory clearance. In Vivo CAR-T Program and Pipeline Advancing innovation through a differentiated cell therapy platform. Adicet is developing a differentiated in vivo CAR-T platform and pipeline targeting hematologic malignancies and solid tumors. A comprehensive update on the platform and pipeline is anticipated in the second half of 2026. Corporate Update Lloyd Klickstein, M.D., Ph.D. appointed Interim Chief Medical Officer. Following the departure of Dr. Julie Maltzman, Dr. Klickstein, who currently serves on the board of the Company, has been appointed Interim Chief Medical Officer and will lead all clinical development and medical affairs activities while the Company conducts a search for a permanent Chief Medical Officer. Dr. Klickstein is a physician-scientist and biotechnology executive with more than 20 years of experience in rheumatology, immunology and translational medicine. He completed clinical training in rheumatology and immunology at the Brigham and Women’s Hospital and has held senior leadership roles at Novartis, Versanis Bio, which was acquired by Eli Lilly, Adicet Bio, and currently serves as Board Chair of the Lupus Foundation of New England and CEO of Koslapp Therapeutics. Financial Results for Second Quarter 2026: Research and Development (R&D) expenses were $18.5 million for the three months ended June 30, 2026. Non-cash stock-based compensation expense included in R&D expense was $0.9 million for the second quarter of 2026. General and Administrative (G&A) expenses were $3.9 million for the three months ended June 30, 2026. Non-cash stock-based compensation expense included in G&A expense was $0.6 million for the second quarter of 2026. Net loss was $21.4 million, or a net loss of $1.99 per basic and diluted share for the three months ended June 30, 2026. This net loss includes non-cash charges of $2.8 million that consisted primarily of share-based compensation, depreciation expenses, and noncash lease expense. Cash, cash equivalents and short-term investments were $118.2 million as of June 30, 2026. The Company expects that current cash, cash equivalents and short-term investments as of June 30, 2026, 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; 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, 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 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; 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. View source version on businesswire.com: https://www.businesswire.com/news/home/20260805219525/en/ Contacts Adicet Bio, Inc. Investor and Media Contacts Anne [email protected] Penelope BelnapPrecision [email protected]
Investor releaseQuarter not tagged2026-05-14Adicet Bio Reports First Quarter 2026 Financial Results and Provides Business Updates
Business Wire
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--(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…Read full documentShow less
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 inform potential pivotal trial design. Subject to regulatory clearance to proceed, the Company expects to initiate start up activities for a pivotal program in LN or LN and SLE patients in the second half of 2026. In addition, following alignment with the FDA in November 2025, LN and SLE patients in the ongoing Phase 1 study and future studies may be dosed with prula-cel in the outpatient setting. The Company plans to provide a clinical update in patients with systemic sclerosis in the second half of 2026. Ongoing Phase 1 trial of prula-cel in treatment-refractory rheumatoid arthritis (RA) to assess reduced conditioning regimens. The Phase 1 trial of prula-cel in RA is designed to assess two lymphodepletion approaches, cyclophosphamide alone and in combination with fludarabine. Primary objectives include evaluating safety and tolerability, with secondary assessments focused on cellular kinetics, pharmacodynamic markers, and disease activity measures. The next update on this trial is expected in the second half of 2026. Solid tumor indications Regulatory submission for ADI-212 planned for the third quarter of 2026 with Phase 1 start anticipated in the fourth quarter of 2026 pending regulatory clearance. Adicet continues to advance its next-generation gene-edited, armored cell therapy candidate targeting prostate-specific membrane antigen (PSMA). ADI-212 is engineered to express a novel CAR binder designed to support enhanced tolerability and tumor specific recognition. It integrates membrane tethered IL-12 armoring, and CRISPR/Cas9-mediated disruption of subunit 12 (MED12) to enhance potency in solid tumors and deliver multiple anti-tumor mechanisms of action within the tumor microenvironment. Adicet expects to submit a regulatory filing for ADI-212 for the treatment of mCRPC in the third quarter of 2026, with initiation of Phase 1 enrollment anticipated in the fourth quarter of 2026, subject to regulatory clearance. Additional early-stage programs (CAR and other technologies) Advancing innovation through a differentiated cell therapy platform. Adicet's pipeline also includes additional early-stage gamma delta CAR-T cell therapy programs for autoimmune diseases, hematological malignancies and solid tumors. Additionally, Adicet has ongoing preclinical programs and activities focused on a differentiated in vivo CAR-T platform targeting heme malignancies. Financial Results for First Quarter 2026: Three months ended March 31, 2026 Research and Development (R&D) Expenses: R&D expenses were $17.5 million for the three months ended March 31, 2026, compared to $22.8 million during the same period in 2025. The decrease in R&D expenses was primarily due to a $3.6 million decrease in payroll and personnel expenses due to lower headcount, a $1.4 million decrease in expenses related to lab supplies and materials, a $0.5 million decrease related to lower CRO expenses and a $0.2 million decrease in allocated facility-related expenses. The decrease was partially offset by a $0.4 million increase in professional fees. General and Administrative (G&A) Expenses: G&A expenses were $4.1 million for the three months ended March 31, 2026, compared to $7.1 million during the same period in 2025. The decrease in G&A expenses was due to a $1.4 million decrease in payroll and personnel-related expenses primarily due to a decrease in stock-based compensation and lower headcount, a $1.0 million decrease in allocated facility-related expenses and a $0.6 million decrease in professional fees. Net Loss: Net loss for the three months ended March 31, 2026 was $20.2 million, or a net loss of $1.88 per basic and diluted share, including non-cash stock-based compensation expense of $1.3 million, as compared to a net loss of $28.2 million, or a net loss of $4.96 per basic and diluted share, including non-cash stock-based compensation expense of $3.2 million during the same period in 2025. Cash Position: Cash, cash equivalents and short-term investments were $137.6 million as of March 31, 2026, compared to $158.5 million as of December 31, 2025. The Company expects that current cash, cash equivalents and short-term investments as of March 31, 2026, 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 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. View source version on businesswire.com: https://www.businesswire.com/news/home/20260513189157/en/ Contacts Adicet Bio, Inc. Investor and Media Contacts Anne Bowdidge [email protected] Penelope Belnap Precision AQ [email protected]
Investor releaseQuarter not tagged2026-03-13Adicet Bio Reports Fourth Quarter and Full Year 2025 Financial Results and Highlights Recent Company Progress
Business Wire
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 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).…Read full documentShow less
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). 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 ADI‑212, 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 ADI‑212, a next‑generation gene‑edited and armored cell therapy candidate targeting prostate-specific membrane antigen (PSMA). ADI‑212 is engineered to express a novel CAR binder designed to support enhanced tolerability and tumor‑specific recognition. It integrates membrane‑tethered IL‑12 armoring, and CRISPR/Cas9‑mediated disruption of subunit 12 (MED12) to enhance potency in solid tumors and deliver multiple anti‑tumor 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. ADI‑212 preclinical data presented at scientific meeting. In October 2025, Adicet presented preclinical data from its ADI‑212 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. View source version on businesswire.com: https://www.businesswire.com/news/home/20260312316837/en/ Contacts Adicet Bio, Inc. Investor and Media Contacts Anne Bowdidge [email protected] Penelope Belnap Precision AQ [email protected]
Investor releaseQuarter not tagged2025-11-13MaxCyte Reports Third Quarter 2025 Financial Results and Reiterates Full Year 2025 Revenue Guidance
GlobeNewswire
MaxCyte Reports Third Quarter 2025 Financial Results and Reiterates Full Year 2025 Revenue Guidance
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…Read full documentShow less
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 customers, excluding SPL Program-related revenue) for the third quarter of 2025 was $6.4 million, compared to $8.1 million in the third quarter of 2024, representing a decrease of 21%. SPL Program-related revenue was $0.4 million in the third quarter of 2025, as compared to immaterial in the third quarter of 2024. Gross profit for the third quarter of 2025 was $5.2 million (77% gross margin), compared to $6.2 million (76% gross margin) in the third quarter of 2024. Non-GAAP adjusted gross margin was 81% excluding SPL Program-related revenue and reserves for excess and obsolete inventory, compared to non-GAAP adjusted gross margin of 85% in the third quarter of 2024. Operating expenses for the third quarter of 2025 were $19.4 million, compared to operating expenses of $20.3 million in the third quarter of 2024. Third quarter 2025 net loss was $12.4 million compared to net loss of $11.6 million for the same period in 2024. Adjusted EBITDA, a non-GAAP measure, was a loss of $10.0 million for the third quarter of 2025, compared to a loss of $13.0 million for the third quarter of 2024; stock-based compensation expense was $2.0 million in the third quarter of 2025 compared to $3.4 million in the third quarter of 2024. 2025 Guidance MaxCyte reiterates 2025 revenue guidance for core business revenue and SPL Program-related revenue: Core revenue is expected to be flat to a 10% decline compared to 2024, inclusive of revenue from SeQure Dx. SPL Program-related revenue is expected to be approximately $5 million for the year. SPL-program related revenue guidance includes both expected revenue from pre-commercial milestone payments and commercial royalties/sales-based payments. MaxCyte expects to end 2025 with $152 million to $155 million in total cash, cash equivalents and investments. Our revised guidance reflects near term cash utilization from the operational restructuring announced on September 22, 2025. Webcast and Conference Call Details MaxCyte will host a conference call today, November 12, 2025, at 4:30 p.m. Eastern Time. Investors interested in listening to the conference call are required to register online. A live and archived webcast of the event will be available on the “Events” section of the MaxCyte website at https://investors.maxcyte.com/. About MaxCyte At MaxCyte®, we are committed to building better cells together. As a leading cell-engineering company, we are driving the discovery, development and commercialization of next-generation cell therapies. Our best-in-class Flow Electroporation® technology and SeQure DX™ gene editing risk assessment services enable precise, efficient and scalable cell engineering. Supported by expert scientific, technical and regulatory guidance, our platform empowers researchers from around the world to engineer diverse cell types and payloads, accelerating the development of safe and effective treatments for human health. For more than 25 years, we've been advancing cell engineering, shaping the future of medicine. Learn more at maxcyte.com and follow us on X and LinkedIn. Non-GAAP Financial Measures This press release contains EBITDA, which is a non-GAAP measure defined as earnings before interest income and expense, taxes, depreciation and amortization. This press release also contains Adjusted EBITDA, which is a non-GAAP measure defined as earnings before interest, taxes, depreciation, amortization and one-time restructuring charges. MaxCyte believes that EBITDA and Adjusted EBITDA provide useful information to management and investors relating to its results of operations. The company’s management uses these non-GAAP measures to compare the company’s performance to that of prior periods for trend analyses, and for budgeting and planning purposes. The company believes that the use of EBITDA and Adjusted EBITDA provide an additional tool for investors to use in evaluating ongoing operating results and trends and in comparing the company’s financial measures with other companies, many of which present similar non-GAAP financial measures to investors, and that it allows for greater transparency with respect to key metrics used by management in its financial and operational decision-making. This press release also contains Non-GAAP Gross Margin, which we define as Gross Margin when excluding SPL program related revenue and reserves for excess and obsolete inventory. The Company believes that the use of Non-GAAP Gross Margin provides an additional tool to investors because it provides consistency and comparability with past financial performance, as Non-GAAP Gross Margin excludes non-core revenues and inventory reserves, which can vary significantly between periods and thus affect comparability. Management does not consider these Non-GAAP financial measures in isolation or as an alternative to financial measures determined in accordance with GAAP. The principal limitation of these Non-GAAP financial measures is that they exclude significant revenues and expenses that are required by GAAP to be recorded in the Company’s financial statements. In order to compensate for these limitations, management presents these Non-GAAP financial measures along with GAAP results. Non-GAAP measures should be considered in addition to results prepared in accordance with GAAP, but should not be considered a substitute for, or superior to, GAAP results. Reconciliation tables of net loss, the most comparable GAAP financial measure, to EBITDA and Adjusted EBITDA, and Gross Margin, the most comparable GAAP financial measure, to Non-GAAP Gross Margin, are included at the end of this release. MaxCyte urges investors to review the reconciliation and not to rely on any single financial measure to evaluate the company’s business Forward-Looking Statements This press release contains "forward-looking statements" within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. These statements about us and our industry involve substantial known and unknown risks, uncertainties, and assumptions, including those described in Item 1A under the heading “Risk Factors” and elsewhere in our report on Form 10-K, that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. All statements other than statements of historical facts contained in this press release, including statements regarding our future results of operations or financial condition, business strategy and plans and objectives of management for future operations, are forward-looking statements. Forward-looking statements include, but are not limited to, statements about the Company’s preliminary results of operations, including fourth quarter and full year total revenue, core revenue, and SPL program revenue and statements about possible or future results of operations or financial position. In some cases, you can identify forward-looking statements because they contain words such as "may," “might,” "will," "could," "would," "should," "expect," "plan," "anticipate," "intend," "believe," "estimate," “seek,” "predict," “future,” "project," "potential," "continue," “contemplate,” "target,” the negative of these words and similar words or expressions. These statements are inherently uncertain, and investors are cautioned not to unduly rely on these statements. The forward-looking statements contained in this press release, include, without limitation, statements concerning the following: our expected future growth and success of our business model; the size and growth potential of the markets for our products, and our ability to serve those markets, increase our market share, and achieve and maintain industry leadership; our ability to expand our customer base and enter into additional SPL partnerships; our financial performance and capital requirements; the adequacy of our cash resources and availability of financing on commercially reasonable terms; our expectations regarding general market and economic conditions that may impact investor confidence in the biopharmaceutical industry and affect the amount of capital such investors provide to our current and potential partners; and our use of available capital resources. These and other risks and uncertainties are described in greater detail in Item 1A , entitled "Risk Factors,” in our Annual Report on Form 10-K for the year ended December 31, 2024, filed with the Securities and Exchange Commission on March 11, 2025, as well as in discussions of potential risks, uncertainties, and other important factors in the other filings that we make with the Securities and Exchange Commission from time to time. These documents are available through the Investor Menu, Financials section, under “SEC Filings” on the Investors page of our website at http://investors.maxcyte.com. Any forward-looking statements in this press release are based on our current beliefs and opinions on the relevant subject based on information available to us as of the date of such press release, and you should not rely on forward-looking statements as predictions of future events. We undertake no obligation to update any forward-looking statements made in this press release to reflect events or circumstances after the date of this press release or to reflect new information or the occurrence of unanticipated events, except as required by law. MaxCyte Contacts: Investor Relations Gilmartin Group David Deuchler, CFA +1 415-937-5400 [email protected] Media Contact Oak Street Communications Kristen White [email protected] 415.608.6060 (1) Adjustments include the exclusion of SPL program related revenue from Revenue, and the exclusion of reserves for excess and obsolete inventory from Cost of Goods Sold.
Investor releaseQuarter not tagged2025-11-06Adicet Bio Reports Third Quarter 2025 Financial Results and Provides Business Updates
Business Wire
Adicet Bio Reports Third Quarter 2025 Financial Results and Provides Business Updates
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…Read full documentShow less
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 actively enrolling patients in our Phase 1 trial across LN, SLE, SSc, IIM, SPS and AAV patients, with a clinical update for LN, SLE and SSc expected in the first half of 2026." Mr. Schor continued: "In addition, we are continuing to advance ADI-212, an optimized next-generation gene-edited and armored clinical candidate designed to target prostate specific membrane antigen, and expect to submit a regulatory filing for the mCRPC program in the first quarter of 2026 and share initial clinical data in the second half of 2026, subject to regulatory clearance. ADI-212 is designed to enhance potency in solid tumors and deliver multiple anti-tumor mechanisms of action to the tumor microenvironment. Supported by our recent capital raise in October, which extended our cash runway into the second half of 2027, we are well-positioned to continue clinical execution across our pipeline of differentiated gamma delta 1 CAR T therapies." Third Quarter 2025 and Recent Operational Highlights: Autoimmune diseases Announced positive preliminary data in LN and SLE patients from Phase 1 study of ADI-001 in autoimmune diseases. In October 2025, Adicet announced positive initial safety and efficacy data from seven patients (five LN and two SLE patients) dosed with ADI-001 in the ongoing Phase 1 trial, with follow-up ranging from two to nine months as of the August 31, 2025 data cut-off date. All patients demonstrated rapid and sustained reductions in the SLEDAI-2K score and PGA. All patients in the LN cohort achieved improved renal function, including three complete renal responses and Definition of Remission In Systemic lupus erythematosus (DORIS) remissions, and two partial responses. ADI-001 also demonstrated multiple hallmarks of immune reset with subsequent emergence of naïve and previously undetected B cell repertoire following single dose treatment. ADI-001 was generally well tolerated and demonstrated a favorable safety profile, with no Grade 2 or higher Cytokine Release Syndrome (CRS), and no cases of Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) observed. Based on these results, the Company plans to request a meeting with the FDA in the first quarter of 2026 to inform potential Phase 2 pivotal trial design, with the initiation of the study in LN or LN and SLE patients anticipated to commence in the second quarter of 2026. Enrollment ongoing in ADI-001 Phase 1 program. Adicet is actively enrolling patients in its Phase 1 clinical trial evaluating ADI-001 in autoimmune diseases which include: LN, SLE, SSc, IIM, SPS and AAV. Adicet expects to provide an LN and SLE clinical update as well as an SSc clinical update in the first half of 2026. Actively enrolling patients with treatment-refractory RA in Phase 1 study of ADI-001 evaluating potential to reduce the need for conditioning. The Company is enrolling patients with treatment-refractory RA in a Phase 1 study of ADI-001 evaluating two lymphodepletion regimens: cyclophosphamide alone and cyclophosphamide with fludarabine. Adicet expects to provide a clinical update on the Phase 1 trial in the second half of 2026. Solid tumor indications Presented ADI-212 preclinical data at the 32nd annual Prostate Cancer Foundation Scientific Retreat. Adicet is continuing to advance preclinical development of ADI-212, an optimized next-generation gene-edited and armored clinical candidate designed to target PSMA. ADI-212 is engineered to express a novel CAR binder designed to support enhanced tolerability and tumor-specific recognition. It integrates membrane-tethered IL-12 (mbIL-12) armoring and CRISPR/Cas9 mediated disruption of subunit 12 of the mediator complex (MED12) to enhance potency in solid tumors and deliver multiple anti-tumor mechanisms of action within the tumor microenvironment. In October, Adicet presented preclinical data at the 32nd Annual Prostate Cancer Foundation Scientific Retreat supporting these design elements and functional enhancements in multiple models of disease. Regulatory filing on track for ADI-212 in mCRPC. Adicet plans to submit a regulatory filing for ADI-212 for the treatment of mCRPC in the first quarter of 2026. The Company expects to share initial clinical data from the ADI-212 program in the second half of 2026, subject to regulatory clearance to proceed with a clinical trial. Corporate updates Raised $74.8 million in net proceeds in registered direct offering. In October 2025, Adicet successfully raised $74.8 million in net proceeds through an underwritten registered direct offering of equity securities, extending its cash runway into the second half of 2027. Financial Results for Third Quarter 2025: Research and Development (R&D) Expenses: R&D expenses were $22.9 million for the three months ended September 30, 2025, compared to $26.3 million during the same period in 2024. The decrease in R&D expenses was due to a $1.8 million decrease in payroll and personnel expenses, and a $1.0 million decrease in lab supplies and materials related to lower headcount, a $0.7 million decrease in expenses related to contract development and manufacturing organizations (CDMOs) and contracted R&D services due to lower utilization at external CDMOs, a $0.7 million decrease in expenses related to R&D consultants, partially offset by a $0.8 million of expenses related to contract research organizations; and a $0.1 million decrease in facility-related expenses. General and Administrative (G&A) Expenses: G&A expenses were $5.1 million for the three months ended September 30, 2025, compared to $6.9 million during the same period in 2024. The decrease in G&A expenses was primarily due to a $1.6 million decrease in payroll and personnel expenses primarily related to a decrease in stock-based compensation expense, and a $0.1 million decrease in facility-related expenses. Net Loss: Net loss for the three months ended September 30, 2025 was $26.9 million, or a net loss of $0.29 per basic and diluted share, including non-cash stock-based compensation expense of $2.5 million, as compared to a net loss of $30.5 million, or a net loss of $0.34 per basic and diluted share, including non-cash stock-based compensation expense of $6.8 million during the same period in 2024. Cash Position: Cash, cash equivalents and short-term investments were $103.1 million as of September 30, 2025, compared to $176.3 million as of December 31, 2024. Subsequent to September 30, the Company received approximately $74.8 million of net proceeds from a registered direct offering. The Company expects that its cash and cash equivalents and short-term investments as of September 30, 2025, together with the proceeds raised after quarter end, 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 ADI-001 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 ADI-001 in LN, SLE, SSc, IIM, SPS and AAV, including timing and expectations for enrollment and future data releases; expectations regarding communications with the FDA and a potential pivotal trial for ADI-001; expectations regarding the timing and success of the Phase 1 clinical trial of ADI-001 in treatment-refractory RA; expectations regarding the preclinical and clinical development of ADI-212, including the timing of regulatory filings and future data releases; and expectations regarding Adicet’s uses of capital, expenses and financial results, including the extension of the cash runway into the second half of 2027. 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. View source version on businesswire.com: https://www.businesswire.com/news/home/20251105901973/en/ Contacts Adicet Bio, Inc. Investor and Media Contacts Anne Bowdidge [email protected] Penelope Belnap Precision AQ 212-362-1200 [email protected]
Investor releaseQuarter not tagged2025-08-08Adicet Bio Reports Second Quarter 2025 Financial Results and Provides Business Updates
Business Wire
Adicet Bio Reports Second Quarter 2025 Financial Results and Provides Business Updates
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…Read full documentShow less
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 best potential to address medical need for patients." Second Quarter 2025 and Recent Operational Highlights: Autoimmune diseases First SSc patient dosed in ongoing Phase 1 clinical trial in autoimmune diseases. In July 2025, Adicet announced that the first SSc patient was dosed in the second cohort of the Phase 1 clinical trial evaluating ADI-001 in autoimmune disease, in addition to ongoing enrollment in LN and SLE. The Company recently opened enrollment in the Phase 1 trial to include patients with IIM, SPS and AAV. Adicet remains on track to share preliminary clinical data from the Phase 1 trial in the second half of 2025. Solid tumor indications Prioritizing ADI-212 development for prostate cancer. Adicet is advancing 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. ADI-212, which targets prostate specific membrane antigen (PSMA), has shown enhanced activity in preclinical studies, suggesting the potential for improved potency and tumor-cell killing capacity compared to previous generation alpha-beta and gamma-delta CAR T programs in oncology. The Company expects to submit a regulatory filing for ADI-212 for the treatment of metastatic castration-resistant prostate cancer (mCRPC) in the first quarter of 2026. Subject to regulatory clearance to proceed with a clinical trial, the Company expects to report initial clinical data from this program in the second half of 2026. Corporate updates Recently announced pipeline prioritization with workforce and cost reduction initiatives. In July 2025, the Company announced a strategic prioritization of its pipeline intended to optimize the development of assets with the greatest potential for clinical and commercial success. In connection with this, the Company has made the decision to discontinue the development of ADI-270 for patients with metastatic/advanced clear renal cell carcinoma (ccRCC) and close enrollment in the ADI-270 Phase 1 clinical trial. Adicet also reduced its workforce by approximately 30% in connection with its strategic pipeline prioritization. The workforce reduction and other expense reductions related to the strategic pipeline prioritization are expected to extend the Company’s cash runway into the fourth quarter of 2026. Financial Results for Second Quarter 2025: Research and Development (R&D) Expenses: R&D expenses were $28.4 million for the three months ended June 30, 2025, compared to $25.9 million during the same period in 2024. The increase in R&D expenses was due to a $1.4 million increase in expenses related to contract development and manufacturing organizations and contracted R&D services, a $1.6 million increase in facility-related expenses, and a $0.2 million increase in lab supplies and materials. This increase was partially offset by a $0.7 million decrease in payroll and personnel expenses primarily related to a decrease in stock-based compensation expense. General and Administrative (G&A) Expenses: G&A expenses were $4.0 million for the three months ended June 30, 2025, compared to $6.9 million during the same period in 2024. The decrease in G&A expenses was due to a $1.8 million decrease in payroll and personnel expenses primarily related to a decrease in stock-based compensation expense and a $1.1 million decrease in facility-related expenses. Net Loss: Net loss for the three months ended June 30, 2025 was $31.2 million, or a net loss of $0.34 per basic and diluted share, including non-cash stock-based compensation expense of $2.9 million, as compared to a net loss of $29.9 million, or a net loss of $0.33 per basic and diluted share, including non-cash stock-based compensation expense of $6.0 million during the same period in 2024. Cash Position: Cash, cash equivalents and short-term investments were $125.0 million as of June 30, 2025, compared to $176.3 million as of December 31, 2024. The Company expects that current cash, cash equivalents and short-term investments as of June 30, 2025, will be sufficient to fund its operating expenses into the fourth quarter of 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 ADI-001 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 ADI-001 in LN, SLE, SSc, AAV, IIM and SPS, including timing and expectations for enrollment and future data releases; expectations regarding the preclinical and clinical development of ADI-212, including the timing of regulatory filings and future data releases; expectations regarding the potential potency of ADI-212, as compared to previous generation alpha-beta and gamma-delta CAR T programs in oncology; expectations regarding the pipeline prioritization and workforce reduction, including as it relates to the estimated reduction in expenses and the development of assets with the greatest potential for clinical and commercial success; and expectations regarding Adicet’s uses of capital, expenses and financial results, including the expected extension of the cash runway into the fourth quarter of 2026. 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. View source version on businesswire.com: https://www.businesswire.com/news/home/20250807179442/en/ Contacts Adicet Bio, Inc. Investor and Media Contacts Anne Bowdidge [email protected] Penelope Belnap Precision AQ 212-362-1200 [email protected]
Investor releaseQuarter not tagged2025-08-07MaxCyte Reports Second Quarter 2025 Financial Results and Updates Full Year 2025 Guidance
GlobeNewswire
MaxCyte Reports Second Quarter 2025 Financial Results and Updates Full Year 2025 Guidance
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…Read full documentShow less
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 programs of our customers, we will achieve profitability with our existing capital.” 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: Second Quarter 2025 Financial Results Total revenue for the second quarter of 2025 was $8.5 million, compared to $10.4 million in the second quarter of 2024, representing a decrease of 18%. Core business revenue (sales of instruments, PAs and consumables, assay services, and licenses to customers, excluding SPL Program-related revenue) for the second quarter of 2025 was $8.2 million, compared to $7.6 million in the second quarter of 2024, representing an increase of 8%. SPL Program-related revenue was $0.3 million in the second quarter of 2025, as compared to $2.9 million in the second quarter of 2024. Gross profit for the second quarter of 2025 was $7.0 million (82% gross margin), compared to $8.9 million (86% gross margin) in the second quarter of 2024. Non-GAAP adjusted gross margin was 83% excluding SPL Program-related revenue and reserves for excess and obsolete inventory, compared to non-GAAP adjusted gross margin of 82% in the second quarter of 2024. Operating expenses for the second quarter of 2025 were $21.2 million, compared to operating expenses of $20.9 million in the second quarter of 2024. Second quarter 2025 net loss was $12.4 million compared to net loss of $9.4 million for the same period in 2024. EBITDA, a non-GAAP measure, was a loss of $13.1 million for the second quarter of 2025, compared to a loss of $10.9 million for the second quarter of 2024; stock-based compensation expense was $3.5 million in the second quarter of 2025 compared to $3.6 million in the second quarter of 2024. 2025 Guidance MaxCyte updates 2025 revenue guidance for core business revenue and SPL Program-related revenue: Core revenue is expected to be flat to a 10% decline compared to 2024, inclusive of revenue from SeQure Dx. SPL Program-related revenue is expected to be approximately $5 million for the year. SPL-program related revenue guidance includes both expected revenue from pre-commercial milestone payments and commercial royalties/sales-based payments. MaxCyte now expects to end 2025 with at least $155 million in total cash, cash equivalents and investments. Webcast and Conference Call Details MaxCyte will host a conference call today, August 6, 2025, at 4:30 p.m. Eastern Time. Investors interested in listening to the conference call are required to register online. A live and archived webcast of the event will be available on the “Events” section of the MaxCyte website at https://investors.maxcyte.com/. About MaxCyte At MaxCyte®, we are committed to building better cells together. As a leading cell-engineering company, we are driving the discovery, development and commercialization of next-generation cell therapies. Our best-in-class Flow Electroporation® technology and SeQure DX™ gene editing risk assessment services enable precise, efficient and scalable cell engineering. Supported by expert scientific, technical and regulatory guidance, our platform empowers researchers from around the world to engineer diverse cell types and payloads, accelerating the development of safe and effective treatments for human health. For more than 25 years, we've been advancing cell engineering, shaping the future of medicine. Learn more at maxcyte.com and follow us on X and LinkedIn. Non-GAAP Financial Measures This press release contains EBITDA, which is a non-GAAP measure defined as earnings before interest income and expense, taxes, depreciation and amortization. MaxCyte believes that EBITDA provides useful information to management and investors relating to its results of operations. The company’s management uses this non-GAAP measure to compare the company’s performance to that of prior periods for trend analyses, and for budgeting and planning purposes. The company believes that the use of EBITDA provides an additional tool for investors to use in evaluating ongoing operating results and trends and in comparing the company’s financial measures with other companies, many of which present similar non-GAAP financial measures to investors, and that it allows for greater transparency with respect to key metrics used by management in its financial and operational decision-making. This press release also contains Non-GAAP Gross Margin, which we define as Gross Margin when excluding SPL program related revenue and reserves for excess and obsolete inventory. The Company believes that the use of Non-GAAP Gross Margin provides an additional tool to investors because it provides consistency and comparability with past financial performance, as Non-GAAP Gross Margin excludes non-core revenues and inventory reserves, which can vary significantly between periods and thus affect comparability. Management does not consider these Non-GAAP financial measures in isolation or as an alternative to financial measures determined in accordance with GAAP. The principal limitation of these Non-GAAP financial measures is that they exclude significant revenues and expenses that are required by GAAP to be recorded in the Company’s financial statements. In order to compensate for these limitations, management presents these Non-GAAP financial measures along with GAAP results. Non-GAAP measures should be considered in addition to results prepared in accordance with GAAP, but should not be considered a substitute for, or superior to, GAAP results. Reconciliation tables of net loss, the most comparable GAAP financial measure, to EBITDA, and Gross Margin, the most comparable GAAP financial measure, to Non-GAAP Gross Margin, are included at the end of this release. MaxCyte urges investors to review the reconciliation and not to rely on any single financial measure to evaluate the company’s business Forward-Looking Statements This press release contains "forward-looking statements" within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. These statements about us and our industry involve substantial known and unknown risks, uncertainties, and assumptions, including those described in Item 1A under the heading “Risk Factors” and elsewhere in our report on Form 10-K, that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. All statements other than statements of historical facts contained in this press release, including statements regarding our future results of operations or financial condition, business strategy and plans and objectives of management for future operations, are forward-looking statements. Forward-looking statements include, but are not limited to, statements about the Company’s preliminary results of operations, including fourth quarter and full year total revenue, core revenue, and SPL program revenue and statements about possible or future results of operations or financial position. In some cases, you can identify forward-looking statements because they contain words such as "may," “might,” "will," "could," "would," "should," "expect," "plan," "anticipate," "intend," "believe," “expect,” "estimate," “seek,” "predict," “future,” "project," "potential," "continue," “contemplate,” "target,” the negative of these words and similar words or expressions. These statements are inherently uncertain, and investors are cautioned not to unduly rely on these statements. The forward-looking statements contained in this press release, include, without limitation, statements concerning the following: our expected future growth and success of our business model; the size and growth potential of the markets for our products, and our ability to serve those markets, increase our market share, and achieve and maintain industry leadership; our ability to expand our customer base and enter into additional SPL partnerships; our expectation that our partners will have access to capital markets to develop and commercialize their cell therapy programs; our financial performance and capital requirements; the adequacy of our cash resources and availability of financing on commercially reasonable terms; our expectations regarding our ability to obtain and maintain intellectual property protection for our products, as well as our ability to operate our business without infringing the intellectual property rights of others; our expectations regarding general market and economic conditions that may impact investor confidence in the biopharmaceutical industry and affect the amount of capital such investors provide to our current and potential partners; and our use of available capital resources. These and other risks and uncertainties are described in greater detail in Item 1A , entitled "Risk Factors,” in our Annual Report on Form 10-K for the year ended December 31, 2024, filed with the Securities and Exchange Commission on March 11, 2025, as well as in discussions of potential risks, uncertainties, and other important factors in the other filings that we make with the Securities and Exchange Commission from time to time. These documents are available through the Investor Menu, Financials section, under “SEC Filings” on the Investors page of our website at http://investors.maxcyte.com. Any forward-looking statements in this press release are based on our current beliefs and opinions on the relevant subject based on information available to us as of the date of such press release, and you should not rely on forward-looking statements as predictions of future events. We undertake no obligation to update any forward-looking statements made in this press release to reflect events or circumstances after the date of this press release or to reflect new information or the occurrence of unanticipated events, except as required by law. MaxCyte Contacts: Investor Relations Gilmartin Group David Deuchler, CFA +1 415-937-5400 [email protected] Media Contact Oak Street Communications Kristen White [email protected] 415.608.6060 (1) Adjustments include the exclusion of SPL program related revenue from Revenue, and the exclusion of reserves for excess and obsolete inventory from Cost of Goods Sold.
Investor releaseQuarter not tagged2025-05-07Adicet Bio Reports First Quarter 2025 Financial Results and Provides Business Updates
Business Wire
Adicet Bio Reports First Quarter 2025 Financial Results and Provides Business Updates
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,…Read full documentShow less
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 Food and Drug Administration (FDA) granted Fast Track Designation to ADI-001 for the treatment of refractory SLE with extrarenal involvement and for SSc. Hematologic malignancies and solid tumor indications Patient enrollment ongoing in Phase 1 trial of ADI-270 in metastatic/advanced ccRCC. Patient enrollment is underway in the Phase 1 clinical trial evaluating ADI-270 in adults with relapsed or refractory metastatic/advanced ccRCC. Adicet expects to share preliminary clinical data from the trial in 2H/2025. Oral presentation of ADI-270 data at the American Society of Gene and Cell Therapy (ASGCT) 28th Annual Meeting. Adicet will present an oral abstract highlighting strong preclinical data demonstrating ADI-270’s anti-tumor activity in hematologic and solid tumor models at the ASGCT Annual Meeting taking place May 13-17, 2025 in New Orleans, LA. Presented ADI-270 preclinical data at the Society for Immunotherapy of Cancer (SITC) 2025 Spring Scientific Meeting. In March 2025, Adicet presented posters covering preclinical data of ADI-270 at the SITC 2025 Spring Scientific Meeting. Corporate Update Appointed Michael Grissinger to Board of Directors. In April 2025, Adicet appointed Michael Grissinger to its Board of Directors. Mr. Grissinger brings over four decades of leadership experience in biopharmaceutical business development, strategy, and M&A to Adicet. Mr. Grissinger has an extensive track record of driving commercial success for global pharmaceutical companies, with a strong focus on immunology. He also serves on the board of directors at Aprea Therapeutics (Nasdaq: APRE) and three privately-held biotechnology companies, Envisagenics, Inc., AnaCardio AB, and NephroDI Therapeutics, Inc. Financial Results for First Quarter 2025: Research and Development (R&D) Expenses: R&D expenses were $22.8 million for the three months ended March 31, 2025, compared to $23.9 million during the same period in 2024. The decrease in R&D expenses was primarily due to a net $1.4 million decrease in expenses related to contract development manufacturing organizations and other externally conducted research and development. General and Administrative (G&A) Expenses: G&A expenses were $7.1 and 7.0 million for the three months ended March 31, 2025 and 2024, respectively. Net Loss: Net loss for the three months ended March 31, 2025 was $28.2 million, or a net loss of $0.31 per basic and diluted share, including non-cash stock-based compensation expense of $3.1 million, as compared to a net loss of $28.0 million, or a net loss of $0.35 per basic and diluted share, including non-cash stock-based compensation expense of $5.7 million during the same period in 2024. Cash Position: Cash and cash equivalents were $150.4 million as of March 31, 2025, compared to $176.3 million as of December 31, 2024. The Company expects that current cash, cash equivalents and short-term investments as of March 31, 2025, will be sufficient to fund its operating expenses into the second half of 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 ADI-001 in autoimmune diseases and ADI-270 in ccRCC 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 ADI-001 in LN, SLE, SSc, AAV, IIM and SPS, including timing and expectations for enrollment and future data releases; timing and success of the Phase 1 clinical trial of ADI-270 in ccRCC, including expectations for future data releases; expectations regarding the presentation of preclinical data at future scientific conferences; 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. View source version on businesswire.com: https://www.businesswire.com/news/home/20250506618710/en/ Contacts Adicet Bio, Inc. Investor and Media Contacts Investors: Anne [email protected] Penelope BelnapPrecision [email protected] Media: Kerry Beth [email protected]

