Senti Bio Completes FDA RMAT Meeting, Advances SENTI-202 Clinical Trial
Written by Emily J. Thompson, Senior Investment Analyst
Updated: May 14 2026
0mins
Senti Bio announced the successful completion of a Type B Initial Comprehensive Multidisciplinary Regenerative Medicine Advanced Therapy, or RMAT, meeting with the FDA regarding SENTI-202, the company's Logic Gated off-the-shelf CAR-NK cell therapy for relapsed/refractory acute myeloid leukemia and updated Phase 1 clinical data. Following the RMAT meeting, the company has finalized its pivotal clinical and chemistry, manufacturing and controls strategy for SENTI-202. The company plans to implement a single-arm, multi-center pivotal trial intended to support potential SENTI-202 registration in patients with R/R AML. This study is expected to evaluate SENTI-202 administered following lymphodepletion chemotherapy in a patient population consistent with the Phase 1 trial population. In addition to the RMAT meeting, after conducting exploratory efficacy covariate analysis of the Phase 1 trial results, Senti has identified a specific Donor X attribute that correlates with efficacy of SENTI-202, with 50% of the patients achieving a cCR when they received any SENTI-202 doses manufactured from Donor X-characteristic-derived NK cells in Cycle 1 versus 12.5% achieving a cCR when they received SENTI-202 manufactured from non-Donor X NK cells. As a result of this discovery, all future SENTI-202 manufacturing, including for pivotal study use, will use Donor X material. The Donor X attribute is found in ~50% of adult donors, and published literature supports increased NK cell cytotoxicity in donors with this phenotype. The Donor X NK phenotype is independent of HLA or KIR matching, thus supporting SENTI-202's allogeneic off-the-shelf usage. Retrospective analysis of preclinical MV4-11 NSG mouse model data confirmed increased activity and survival with Donor X product. Senti Bio also announced that SENTI-202 continues to exhibit durable MRD-negative responses in the full 22 patient Phase 1 trial, which compares favorably with current FDA approved therapies for R/R AML. At RP2D, across all patients receiving a mix of Donor X and non-Donor X material, an ORR of 44% and cCR of 37.5% was observed with 100% of CRs being MRD negative. The complete remissions continue to be durable, with all the CR/CRh responders who were in remission as of the data-cut supporting the oral presentation at the 2025 ASH annual meeting continuing to maintain remission with an additional 7 months of follow up, the longest duration being 21+ months.
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About SNTI
Senti Biosciences, Inc. and its subsidiaries is a clinical-stage biotechnology company developing next-generation cell and gene therapies engineered with its gene circuit platform technologies for patients living with incurable diseases. The Company is leveraging its synthetic biology platform to engineer gene circuits into new medicines with enhanced precision and control. These gene circuits are designed to kill cancer cells, to spare healthy cells, to increase specificity to target tissues, and/or to be controllable even after administration. Its product candidates include SENTI-202 and SENTI-301A. SENTI-202 is a potential first-in-class Logic Gated off-the-shelf chimeric antigen receptor natural killer (CAR-NK) investigational cell therapy. SENTI-301A is a multi-armed off-the-shelf healthy donor-derived chimeric antigen receptor natural killer (CAR-NK) cell therapy product candidate designed for the treatment of GPC3 positive tumors.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Senti Biosciences Reports Q1 2026 Financial Results
- Financial Performance: Senti Biosciences reported a GAAP EPS of -$0.14 for Q1 2026, with revenue at only $0.01 million, indicating significant challenges in revenue growth that could undermine investor confidence.
- Cash Position: As of March 31, 2026, the company had $8.9 million in cash and cash equivalents, down from $16.4 million as of December 31, 2025, reflecting pressure on cash management that may limit future operational and investment capabilities.
- Operational Spending Control: The net cash used in operating activities for Q1 2026 was $7.5 million, a decrease from $14.1 million in the same period of 2025, indicating some success in implementing restructuring measures and operational discipline, although the overall financial situation remains precarious.
- Market Outlook: Despite improvements in cost control, ongoing losses and low revenue levels may negatively impact the company's future financing capabilities and market competitiveness, necessitating close monitoring of subsequent developments.
See More
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- FDA Meeting Outcome: Senti Bio successfully completed a Type B meeting with the FDA, clarifying the registrational development strategy for SENTI-202, marking a significant advancement in the treatment of acute myeloid leukemia (AML) and expected to expedite clinical trial implementation.
- Clinical Trial Data: In the Phase 1 trial, patients receiving NK cells from Donor X exhibited a 50% composite complete remission (cCR) rate (7/14), compared to only 12.5% (1/8) for non-Donor X patients, highlighting the significant impact of the Donor X attribute on efficacy.
- Manufacturing Strategy Optimization: All future manufacturing of SENTI-202 will utilize Donor X material, a choice that not only enhances NK cell cytotoxicity but also supports the allogeneic off-the-shelf usage of SENTI-202, strengthening its market competitiveness.
- Long-term Efficacy Observation: Among the 22 patients in the Phase 1 trial, SENTI-202 demonstrated durable MRD-negative responses, with all complete remission patients maintaining remission during follow-up, with the longest duration reaching over 21 months, further validating its potential as a treatment option for AML patients.
See More
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- Earnings Miss: Senti Biosciences reported a Q4 non-GAAP EPS of -$0.53, missing estimates by $0.06, indicating challenges in profitability that could undermine investor confidence.
- Cash Position: As of December 31, 2025, Senti Bio held approximately $16.4 million in cash and cash equivalents, which, while providing some liquidity, raises concerns about capital efficiency and future funding needs.
- Market Reaction: The earnings miss may negatively impact Seeking Alpha’s Quant Rating on Senti Biosciences, prompting investors to reassess the company's growth potential in light of recent performance.
- Historical Financial Data: Historical earnings data for Senti Biosciences suggests that ongoing losses could exert pressure on its long-term strategic development, particularly in the highly competitive biotech sector.
See More
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Quarterly Revenue Overview: The report highlights that the revenue for Q4 reached $22,000, indicating a significant financial performance.
Sector Performance: The analysis suggests that various sectors contributed to the overall revenue, showcasing diverse growth areas within the company.
See More
Senti Bio to Present at Global Healthcare Conference
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- Platform Advantages: Leveraging its proprietary Gene Circuit platform, Senti Bio is developing next-generation cell and gene therapies aimed at precisely killing cancer cells while sparing healthy ones, thereby enhancing treatment safety and efficacy, which holds significant market potential.
- Clinical Stage Progress: The company's pipeline includes cell therapies targeting challenging liquid and solid tumors, with preclinical studies demonstrating the effectiveness of its Gene Circuits in both NK and T cells, indicating broad applicability and potential clinical value of its technology.
- Information Transparency: Senti Bio emphasizes communication with investors through its website and social media, ensuring timely updates and transparency of information, which enhances investor confidence and promotes public understanding of its technology.
See More
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- Technology Sharing: Senti Bio participated in the Cell & Gene Live virtual event on February 19, 2026, where it showcased its Gene Circuit-based cell therapy technology, emphasizing its advantages in precision and functionality aimed at advancing the design and development of cell therapies.
- Product Introduction: SENTI-202 is the first Logic Gated CAR-NK cell therapy product designed to target CD33 and FLT3 expressing hematologic malignancies, effectively eliminating leukemic cells while sparing healthy bone marrow cells, demonstrating significant therapeutic potential.
- Clinical Trial Progress: Senti Bio is currently enrolling adult patients for a Phase 1 clinical trial of SENTI-202 targeting relapsed/refractory hematologic malignancies, which, if successful, could become the first allogeneic treatment for AML/MDS, presenting substantial market opportunities.
- FDA Designation: SENTI-202 has received Orphan Drug and Regenerative Medicine Advanced Therapy designations from the FDA, indicating its potential in treating relapsed hematologic malignancies, thereby enhancing investor and market confidence.
See More
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- Financial Performance: Senti Biosciences reported a GAAP EPS of -$0.14 for Q1 2026, with revenue at only $0.01 million, indicating significant challenges in revenue growth that could undermine investor confidence.
- Cash Position: As of March 31, 2026, the company had $8.9 million in cash and cash equivalents, down from $16.4 million as of December 31, 2025, reflecting pressure on cash management that may limit future operational and investment capabilities.
- Operational Spending Control: The net cash used in operating activities for Q1 2026 was $7.5 million, a decrease from $14.1 million in the same period of 2025, indicating some success in implementing restructuring measures and operational discipline, although the overall financial situation remains precarious.
- Market Outlook: Despite improvements in cost control, ongoing losses and low revenue levels may negatively impact the company's future financing capabilities and market competitiveness, necessitating close monitoring of subsequent developments.
See More
Senti Bio Advances SENTI-202 Registrational Trial Following FDA Meeting
- FDA Meeting Outcome: Senti Bio successfully completed a Type B meeting with the FDA, clarifying the registrational development strategy for SENTI-202, marking a significant advancement in the treatment of acute myeloid leukemia (AML) and expected to expedite clinical trial implementation.
- Clinical Trial Data: In the Phase 1 trial, patients receiving NK cells from Donor X exhibited a 50% composite complete remission (cCR) rate (7/14), compared to only 12.5% (1/8) for non-Donor X patients, highlighting the significant impact of the Donor X attribute on efficacy.
- Manufacturing Strategy Optimization: All future manufacturing of SENTI-202 will utilize Donor X material, a choice that not only enhances NK cell cytotoxicity but also supports the allogeneic off-the-shelf usage of SENTI-202, strengthening its market competitiveness.
- Long-term Efficacy Observation: Among the 22 patients in the Phase 1 trial, SENTI-202 demonstrated durable MRD-negative responses, with all complete remission patients maintaining remission during follow-up, with the longest duration reaching over 21 months, further validating its potential as a treatment option for AML patients.
See More
Senti Biosciences Reports Q4 Losses, Misses EPS Estimates
- Earnings Miss: Senti Biosciences reported a Q4 non-GAAP EPS of -$0.53, missing estimates by $0.06, indicating challenges in profitability that could undermine investor confidence.
- Cash Position: As of December 31, 2025, Senti Bio held approximately $16.4 million in cash and cash equivalents, which, while providing some liquidity, raises concerns about capital efficiency and future funding needs.
- Market Reaction: The earnings miss may negatively impact Seeking Alpha’s Quant Rating on Senti Biosciences, prompting investors to reassess the company's growth potential in light of recent performance.
- Historical Financial Data: Historical earnings data for Senti Biosciences suggests that ongoing losses could exert pressure on its long-term strategic development, particularly in the highly competitive biotech sector.
See More
SENTI BIOSCIENCES REPORTS Q4 REVENUE OF $22,000
Quarterly Revenue Overview: The report highlights that the revenue for Q4 reached $22,000, indicating a significant financial performance.
Sector Performance: The analysis suggests that various sectors contributed to the overall revenue, showcasing diverse growth areas within the company.
See More
Senti Bio to Present at Global Healthcare Conference
- Conference Presentation: Senti Biosciences' CEO Timothy Lu is set to present at the Leerink Partners Global Healthcare Conference in Miami on March 9, 2026, showcasing the company's advancements in cell and gene therapies, which is expected to attract investor and industry attention.
- Platform Advantages: Leveraging its proprietary Gene Circuit platform, Senti Bio is developing next-generation cell and gene therapies aimed at precisely killing cancer cells while sparing healthy ones, thereby enhancing treatment safety and efficacy, which holds significant market potential.
- Clinical Stage Progress: The company's pipeline includes cell therapies targeting challenging liquid and solid tumors, with preclinical studies demonstrating the effectiveness of its Gene Circuits in both NK and T cells, indicating broad applicability and potential clinical value of its technology.
- Information Transparency: Senti Bio emphasizes communication with investors through its website and social media, ensuring timely updates and transparency of information, which enhances investor confidence and promotes public understanding of its technology.
See More
Senti Bio Participates in Cell & Gene Live Event on Innovative Therapies
- Technology Sharing: Senti Bio participated in the Cell & Gene Live virtual event on February 19, 2026, where it showcased its Gene Circuit-based cell therapy technology, emphasizing its advantages in precision and functionality aimed at advancing the design and development of cell therapies.
- Product Introduction: SENTI-202 is the first Logic Gated CAR-NK cell therapy product designed to target CD33 and FLT3 expressing hematologic malignancies, effectively eliminating leukemic cells while sparing healthy bone marrow cells, demonstrating significant therapeutic potential.
- Clinical Trial Progress: Senti Bio is currently enrolling adult patients for a Phase 1 clinical trial of SENTI-202 targeting relapsed/refractory hematologic malignancies, which, if successful, could become the first allogeneic treatment for AML/MDS, presenting substantial market opportunities.
- FDA Designation: SENTI-202 has received Orphan Drug and Regenerative Medicine Advanced Therapy designations from the FDA, indicating its potential in treating relapsed hematologic malignancies, thereby enhancing investor and market confidence.
See More
