SNTI

Secured strategic financing vehicle for up to $40 million Positive FDA feedback supports single-arm pivotal trial for potential registration of SENTI-202 in initial indication of Relapsed/Refractory Acute Myeloid Leukemia (R/R AML) Continued operational streamlining contributed to substantially reduced quarterly net loss and cash burn SOUTH SAN FRANCISCO, Calif., May 14, 2026 (GLOBE NEWSWIRE) -- Senti Biosciences Holdings, Inc. (Nasdaq: SNTI) (Senti Bio), a clinical-stage biotechnology company developing next-generation cell and gene therapies using its proprietary Gene Circuit platform, today reported financial results for the first quarter ended March 31, 2026, and provided recent business highlights. “We entered 2026 with a clear focus on advancing SENTI-202 and extending our operational runway while positioning the company for its next phase of clinical development,” said Timothy Lu, M.D., Ph.D., Chief Executive Officer and Co-Founder of Senti Bio. “Since the start of the year, we have made meaningful progress across each of these priorities, including a positive regulatory engagement with the FDA on SENTI-202 - a Regenerative Medicine Advanced Therapy (RMAT) designated product - regarding the study design for the planned pivotal trial, execution of a strategic financing agreement that could provide up to $40 million in capital, and continued reductions in operating expenses and cash burn.” Dr. Lu added, “We believe the recent FDA interactions and feedback represent an important milestone for the program and further support the potential of SENTI-202 in relapsed/refractory hematologic malignancies. We remain focused on advancing SENTI-202 efficiently toward the next stage of pivotal development in R/R AML and exploring future combinations with standard of care chemotherapy in newly diagnosed AML patients. We also aim to use our differentiated gene circuit platform to create therapies for additional ex vivo and in vivo CAR therapies.” Recent Business Highlights SENTI-202 Program Update Senti Bio concluded a Type B Initial Comprehensive Multidisciplinary RMAT meeting with FDA. Based on the positive outcome of this meeting, Senti Bio has finalized its pivotal clinical and chemistry, manufacturing and controls (CMC) strategy for SENTI-202, which includes a single-arm, multi-center pivotal trial to support registration in R/R AML with SENTI-202 administered a...

SOUTH SAN FRANCISCO, Calif., March 27, 2026 (GLOBE NEWSWIRE) -- Senti Biosciences, Inc. (Nasdaq: SNTI) (“Senti Bio”), a clinical-stage biotechnology company developing next-generation cell and gene therapies using its proprietary Gene Circuit platform, today reported financial results for the fourth quarter of 2025 and full year 2025 and provided a summary of recent pipeline and corporate highlights. “2025 was a year of important progress for Senti as we continued to advance our mission of developing next-generation cell and gene therapies powered by our synthetic biology platform. Over the past year, we have strengthened the clinical and translational foundation of our pipeline, with SENTI-202 as the lead program generating positive clinical data, while continuing to refine and expand the capabilities of our Gene Circuit platform. We remain focused on disciplined execution, advancing our key programs toward critical development milestones and positioning Senti to deliver smarter, more selective medicines for patients with serious diseases. I am proud of our team’s commitment and believe the progress we made in 2025 positions us well for the opportunities ahead,” commented Timothy Lu, MD, PhD, Co-Founder and CEO of Senti Biosciences. RECENT PIPELINE AND CORPORATE UPDATES Reported updated positive preliminary clinical data from the ongoing Phase 1 trial of SENTI-202 in relapsed/refractory acute myeloid leukemia (AML), demonstrating encouraging response rates, durability, and a favorable safety profile; Received Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration for SENTI-202 for the treatment of adults with relapsed or refractory AML; Continued advancement of the Company’s pipeline and synthetic biology platform, including progress across its Gene Circuit–engineered cell therapy programs; and Maintained focus on disciplined capital management to support pipeline execution and key development milestones. YEAR 2025 FINANCIAL RESULTS Cash and Cash Equivalents: As of December 31, 2025, Senti Bio held cash and cash equivalents of approximately $16.4 million. R&D Expenses: Research and development expenses were $7.8 million for both of the three months ended December 31, 2025 and 2024, respectively. For the full year of 2025, research and development expenses were $37.6 million. G&A Expenses: General and administrat...

SOUTH SAN FRANCISCO, Calif., Nov. 13, 2025 (GLOBE NEWSWIRE) -- Senti Biosciences, Inc. (Nasdaq: SNTI) (“Senti Bio”), a clinical-stage biotechnology company developing next-generation cell and gene therapies using its proprietary Gene Circuit platform, today reported financial results for the third quarter of 2025 and provided a summary of recent pipeline and corporate highlights. “Our team is laser focused on driving SENTI-202 clinical development forward. With important milestones achieved in the third quarter, we continue to execute on our dose expansion phase and on enrolling additional patients with relapsed/refractory AML at the Recommended Phase 2 Dose,” commented Timothy Lu, MD, PhD, Co-Founder and CEO of Senti Biosciences. “At the upcoming ASH Annual Meeting in December, we will be presenting exciting clinical data from additional patients with R/R AML who have received SENTI-202, showcasing continued efficacy, safety, and durability. This data will highlight the ability of our Logic Gate technology to achieve selective cancer killing and healthy tissue sparing, which overcomes a central challenge in the treatment of cancer. We are pleased with the progress made to date and look forward to discussing our expanded dataset next month.” DRIVING TOWARDS NEXT DATA MILESTONE FOR PHASE 1 SENTI-202 STUDY IN AML Recently announced that abstracts detailing certain clinical and correlative results for SENTI-202 were accepted for oral and poster presentations, respectively, at the upcoming American Society of Hematology (ASH) Annual Meeting to be held December 6-9, 2025 in Orlando Florida. At the conference, the Company plans to present updated clinical data from the patients included in the published abstracts, as well as additional patients’ clinical data from a more recent data-cut. Senti will also host a live webcast during the meeting to discuss the results. Additional details to follow. Details for the Company’s ASH abstracts and oral presentation can be found here: Senti Bio to Present Updated Clinical Results of First-in-Class Logic Gated CD33/FLT3 Cell Therapy, SENTI-202, at the American Society of Hematology (ASH) Annual Meeting 2025. CONTINUED ACTIVITIES TO BUILD MARKET AWARENESS AND INCREASE VISIBILITY AMONG THE INVESTOR AND SCIENTIFIC COMMUNITIES Participated in the Webull Financial Corporate Connect Webinar Series Biotech/MedTech event, as well as...

Two presentations, including one oral session, build on existing data and show deep and durable clinical remission rates, combined with a strong safety profile, for SENTI-202 in treating relapsed/refractory Acute Myeloid Leukemia (AML) Pharmacodynamic data further underscore clinical proof-of-mechanism for 'OR/NOT' Logic Gate, showing selective killing of leukemic blasts and leukemic stem cells (LSCs) while sparing healthy hematopoietic stem and progenitor cells (HSPCs) Updated clinical results continue to showcase the potential of Senti Bio’s Logic Gate technology to overcome a central challenge in treating cancers - achieving selective cancer killing and healthy tissue sparing Senti Bio will present data from additional clinical trial participants and longer follow-up at the ASH presentations and in a live webcast during the ASH meeting in December SOUTH SAN FRANCISCO, Calif., Nov. 03, 2025 (GLOBE NEWSWIRE) -- Senti Biosciences, Inc. (Nasdaq: SNTI) (“Senti Bio”), a clinical-stage biotechnology company developing next-generation cell and gene therapies using its proprietary Gene Circuit platform, today announced that it will deliver two presentations, including one oral, on its SENTI-202 clinical program, at the 67th American Society of Hematology (ASH) Annual Meeting and Exposition being held December 6-9, 2025 in Orlando, Florida. Senti Bio will also host a live webcast to discuss the latest data during the annual meeting. “Relapsed/refractory AML is a disease with poor prognosis. There is a tremendous unmet need for effective medicines that can aggressively kill cancer cells while protecting normal cells. With this in mind, we designed our Logic Gate technology to kill AML cells displaying CD33 OR FLT3 cancer targets and to spare normal cells displaying the EMCN healthy target even if they express CD33 and/or FLT3,” commented Timothy Lu, MD, PhD, Co-Founder and CEO of Senti Biosciences. “At ASH, we’re thrilled to present an expanding body of evidence, with more patients and more follow-up data, that continues to demonstrate the potential for the industry's first cell therapy that makes complex, autonomous decisions to transform the relapsed/refractory AML treatment landscape, as well as to open the door to more aggressive, yet safe therapies for other hard-to-treat cancers.” Details of the oral and poster sessions are available on the ASH website and bel...

SOUTH SAN FRANCISCO, Calif., Aug. 07, 2025 (GLOBE NEWSWIRE) -- Senti Biosciences, Inc. (Nasdaq: SNTI) (“Senti Bio”), a clinical-stage biotechnology company developing next-generation cell and gene therapies using its proprietary Gene Circuit platform, today reported financial results for the second quarter of 2025 and provided a summary of recent pipeline and corporate highlights. “Our team has continued to advance SENTI-202’s clinical development. We have now completed dose finding and have confirmed the recommended Phase 2 dose (RP2D), which is an important step in our Phase 1 study. We are currently in the dose expansion phase, enrolling additional patients with relapsed/refractory AML at the RP2D. Additionally, we recently received Orphan Drug Designation for SENTI-202 and bolstered the leadership and expertise of our team, welcoming new key members to our Scientific Advisory Board and our Board of Directors,” commented Timothy Lu, MD, PhD, Co-Founder and CEO of Senti Biosciences. “Looking ahead, we are focused on growing our pipeline opportunities to deliver transformative therapies to patients with currently limited options and, importantly, expect to release additional efficacy and durability data from our ongoing Phase 1 study before the end of the year, representing a significant milestone for our lead program.” RECENT PIPELINE AND CORPORATE UPDATES Completed dose finding phase and confirmed the recommended Phase 2 dose (RP2D) in its ongoing Phase 1 clinical trial of SENTI-202 (NCT06325748) for the treatment of relapsed/refractory hematologic malignancies including AML; Granted U.S. FDA Orphan Drug Designation for use of SENTI-202 to treat AML; Received an additional $1.0 Million tranche from California Institute for Regenerative Medicines (CIRM) grant for advancing clinical development of SENTI-202; and Bolstered expertise of leadership team with the appointment of Bryan Baum to the Board of Directors and Dr. James B. Trager to the Scientific Advisory Board. CONTINUED ACTIVITIES TO BUILD MARKET AWARENESS AND INCREASE VISIBILITY AMONG THE INVESTOR AND SCIENTIFIC COMMUNITIES Participated in Nasdaq's Amplify Spotlight Series to provide a corporate overview and highlight how Senti is leveraging its proprietary Gene Circuit platform to develop next-generation cell and gene therapies for the treatment of challenging liquid and solid tumor indications. Wa...

Positive Phase 1 data from lead program, SENTI-202, recently presented at the AACR Annual Meeting: SENTI-202 was generally well tolerated, preliminary RP2D identified; 4 of 7 patients achieved composite Complete Remission (cCR) (3 CR, 1CRh), all 4 cCR patients were measurable residual disease (MRD) negative as assessed by local standard of care; All cCR patients maintaining responses, from 4+ to 8+ months ongoing Ongoing enrollment in Phase 1 SENTI-202 study to confirm the preliminary recommended Phase 2 dose (RP2D) followed by disease specific expansion cohorts Logic-Gated cell therapy approach may have the potential for broad liquid and solid tumor applications, providing multiple pipeline expansion opportunities SOUTH SAN FRANCISCO, Calif., May 06, 2025 (GLOBE NEWSWIRE) -- Senti Biosciences, Inc. (Nasdaq: SNTI) (“Senti Bio” or the “Company”), a clinical-stage biotechnology company developing next-generation cell and gene therapies using its proprietary Gene Circuit platform, today reported financial results for the first quarter of 2025 and provided a summary of recent pipeline and corporate highlights. “We continue to be encouraged by our SENTI-202 data and strongly believe in its potential to provide a much-needed treatment option for patients with AML. Notably, our recent data at AACR showed early deep responses seen with SENTI-202 across dose levels, with 4+ to 8+ months of durability noted and growing. We are pleased with the progress made to date, with our team remaining focused on the successful execution of this trial and further SENTI-202 development,” commented Timothy Lu, MD, PhD, Co-Founder and CEO of Senti Biosciences. “Beyond our prioritized SENTI-202 program in AML, we are continuing to advance our potential best-in-class Logic-Gated programs with additional discovery efforts for solid tumors, in order to continue building value in the near and long-term.” RECENT PIPELINE AND CORPORATE UPDATES New Positive Data for Lead Program SENTI-202 Drives Confidence as a Potential Treatment Option for Acute Myeloid Leukemia (AML): The Company presented positive data from its ongoing Phase 1 clinical trial of SENTI-202 (NCT06325748) for the treatment of relapsed/refractory hematologic malignancies including AML at the recently held American Association for Cancer Research (AACR) Annual Meeting 2025. The presented data also included correlative data fro...

Data presented at the American Association for Cancer Research (AACR) Annual Meeting 2025 Dose Finding completed with no dose limiting toxicities and preliminary recommended Phase 2 dose (RP2D) identified 5 of 7 best overall response evaluable patients achieved ORR (3 CR, 1 CRh and 1 morphologic leukemia-free state) across all dose cohorts, including 1 CR and 1 CRh in 3 patients in preliminary RP2D cohort 4 of 4 cCR patients were measurable residual disease (MRD) negative as assessed by local standard of care Early deep responses with SENTI-202 noted across dose levels with all cCRs ongoing as of the data cut and longest durability of 8+ months Company to host webcast to discuss the new Phase 1 SENTI-202 data today, April 28th at 8:30 AM ET; Register Here Announces certain preliminary first quarter 2025 financial results and provides pipeline update SOUTH SAN FRANCISCO, Calif., April 28, 2025 (GLOBE NEWSWIRE) -- Senti Biosciences, Inc. (Nasdaq: SNTI) (“Senti Bio” or the “Company”), a clinical-stage biotechnology company developing next-generation cell and gene therapies using its proprietary Gene Circuit platform, today reported additional positive preliminary data from a Phase 1 clinical trial of SENTI-202, a potential first-in-class off-the-shelf Logic Gated selective CD33 OR FLT3 NOT EMCN chimeric antigen receptor natural killer (CAR-NK) investigational cell therapy, for the treatment of relapsed/refractory (R/R) hematologic malignancies including acute myeloid leukemia (“AML”). As previously announced, the Company will host a conference call and webcast to discuss the presented data today, April 28, 2025, at 8:30 AM ET (details below). SENTI-202 CLINICAL DATA UPDATE The positive preliminary SENTI-202 clinical data was presented on April 27 in a Clinical Trials Oral Minisymposium at the American Association for Cancer Research (AACR) Annual Meeting 2025 in an abstract titled, “First-in-human, multicenter study of SENTI-202, a CD33/FLT3 selective off-the-shelf logic gated CAR NK cell therapy in hematologic malignancies including AML: Clinical data.” Timothy Lu, MD, PhD, Co-Founder and CEO of Senti Biosciences, commented, “Senti was founded on engineering Logic Gated cell therapies with the enhanced ability to selectively kill cancer cells and protect healthy cells for cancer indications not addressable by existing drugs. Building upon these exciting result...

– Previously reported MRD negative CR in 2 of 3 relapsed/refractory AML patients enrolled in first dose level and schedule of Phase 1 clinical trial of SENTI-202 maintaining remission – – Strengthened balance sheet with gross proceeds of approximately $47.6 million from private investment in public equity (PIPE) financing – SOUTH SAN FRANCISCO, Calif., March 20, 2025 (GLOBE NEWSWIRE) -- Senti Biosciences, Inc. (Nasdaq: SNTI) (“Senti Bio” or the “Company”), a clinical-stage biotechnology company developing next-generation cell and gene therapies using its proprietary Gene Circuit platform, today reported financial results for the fourth quarter of 2024 and provided a summary of recent pipeline and corporate highlights. “With initial data from the clinical trial of SENTI-202, we are getting a glimpse into the potential profile of our gene circuit-enabled CAR-NK therapy for patients with AML. As we look toward 2025, we anticipate sharing additional data from this exciting trial," said Timothy Lu, MD, PhD, Chief Executive Officer and Co-Founder of Senti Bio. “We are also grateful to have continued support from our investors, including those who participated in our successful PIPE financing in December 2024, and we look forward to demonstrating the potential of our next-generation cell therapies in oncology.” PIPELINE AND CORPORATE HIGHLIGHTS SENTI-202 for AML: The Company previously announced initial data from its ongoing Phase 1 clinical trial of SENTI-202 (NCT06325748) for the treatment of relapsed/refractory hematologic malignancies including acute myeloid leukemia ("AML"). As announced in December 2024, three AML patients had been treated at the lowest dose level (1.0 billion CAR+ NK cells per dose) and lowest dose schedule (3 doses per cycle) and two achieved complete remission ("CR"), confirmed by bone marrow biopsy, which includes blast reduction and recovery of blood cells to normal ranges. In addition, both patients were assessed as measurable residual disease ("MRD") negative after treatment, which is defined as no detectable cancer cells present in a bone marrow sample by the most sensitive locally available method. As of this month, both patients remain in remission. Across all three patients for which data was announced, SENTI-202 was generally well-tolerated, with an adverse event profile consistent with the use of lymphodepleting chemotherapy in p...