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

Rhea-AI Summary

Senti Bio (Nasdaq: SNTI) will present updated clinical results for SENTI-202, a first‑in‑class CD33/FLT3 & not EMCN logic‑gated off‑the‑shelf CAR NK cell therapy, at the ASH Annual Meeting, Dec 6–9, 2025.

The company announced two presentations on Dec 8, including an oral session (abs25-10130) at 5:45–6:00 PM and a poster (abs25-2711) at 6:00–8:00 PM. Reported highlights include deep, durable clinical remissions, a strong safety profile, and pharmacodynamic data showing selective killing of leukemic blasts and leukemic stem cells while sparing healthy hematopoietic stem and progenitor cells. A live webcast will accompany the ASH presentations.

Insights

Clinical Translational Immuno‑Oncology Expert

SENTI-202 data show encouraging remission durability and a favorable safety signal; ASH presentations provide a clearer efficacy and mechanism readout by December 8, 2025.

Senti Biosciences reports expanded clinical follow-up for SENTI-202, describing "deep and durable clinical remission rates" and a "strong safety profile" in relapsed/refractory acute myeloid leukemia, plus pharmacodynamic evidence of an "OR/NOT" logic gate that selectively kills leukemic blasts and leukemic stem cells while sparing healthy hematopoietic stem and progenitor cells. The company will present an oral session and a poster at ASH and host a live webcast, which should provide patient-level outcomes, follow-up duration, and mechanistic correlative data.

The business mechanism is straightforward: the program aims to combine target selectivity (CD33 and/or FLT3) with a healthy‑cell exclusion signal (EMCN) to widen the therapeutic window for cell therapy. The claim of selective killing plus sparing of HSPCs, if supported by the upcoming data, strengthens the case for a differentiated safety/efficacy profile for this first‑in‑class approach. Key dependencies remain expanded patient numbers and longer follow-up to confirm durability and to quantify safety across sites.

Watch the oral presentation on December 8, 2025 and the live webcast for concrete metrics: objective response rates, duration of remission, numbers of evaluable patients, adverse event rates, and the pharmacodynamic assays linking EMCN expression to selective sparing. These specific data elements and extended follow-up will determine whether the early positive signals translate into a robust clinical benefit profile.

• 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 67^th 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 below:

Session Type: Oral
Session Number: abs25-10130
Abstract Title: Promising results from an ongoing Phase I multicenter study of senti-202, a first-in-class, CD33 and/or FLT3 & not endomucin (EMCN), selective off-the-shelf logic gated CAR NK cell therapy in adults with Relapsed/Refractory Acute Myeloid Leukemia (R/R AML)
Session Date: December 8, 2025
Session Time: 4:30 PM - 6:00 PM
Presentation Time: 5:45 PM - 6:00 PM
Room: OCCC - Valencia Room W415BC

Session Type: Poster
Abstract Number: abs25-2711
Abstract Title: Correlative data from an ongoing Phase 1, multicenter study of senti-202, a first-in-class, CD33 and/or FLT3 & not endomucin (EMCN), selective off-the-shelf CAR NK cell therapy for Acute Myeloid Leukemia (AML) is consistent with its clinical activity and unique logic gated mechanism of action
Session Date: December 8, 2025
Session Time: 6:00 PM - 8:00 PM
Presentation Time: 6:00 PM - 8:00 PM
Room: OCCC - West Halls B3-B4
Session: 704

About SENTI-202

SENTI-202 is the first Logic Gated off-the-shelf CAR-NK cell therapy product candidate designed to selectively target and eliminate CD33 and/or FLT3 expressing hematologic malignancies, such as AML and myelodysplastic syndrome (“MDS”), while sparing healthy bone marrow cells. SENTI-202 has three main components. First, SENTI-202 contains an OR GATE, which is an activating CAR that recognizes and kills CD33 and FLT3 expressing cells. By targeting either or both of these antigens, SENTI-202 is designed to effectively kill both leukemic blasts (that largely express CD33) and leukemic stem cells (that predominantly express FLT3), which constitute a difficult-to-eradicate reservoir of AML disease. Second, SENTI-202 contains a NOT GATE, which is an inhibitory CAR that is designed to recognize EMCN selectively expressed on healthy hematopoietic stem and progenitor cells and protect those healthy cells from being killed even if they express CD33 and/or FLT3, thus potentially widening the therapeutic window. Third, SENTI-202 contains calibrated-release IL-15, which is designed to significantly increase cell persistence, expansion and activity of both the CAR-NK cells and host immune cells. The NK cells used to construct SENTI-202 are sourced from selected healthy adult donors, manufactured, cryopreserved and available off-the-shelf for use as needed. Senti Bio is currently enrolling adult patients with R/R CD33 and/or FLT3 expressing heme malignancies in a Phase 1 clinical trial for SENTI-202, which can be a potential first-in-class allogeneic treatment for AML/MDS patients.

Earlier this year, the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation to SENTI-202 for the treatment of relapsed/refractory hematologic malignancies including AML.

About AML^1,2

AML is a cancer of the blood and bone marrow and is one of the most common types of acute leukemia in adults. It is estimated there will be 22,010 new cases of AML in the United States in 2025. At diagnosis, the five-year survival rate for these patients is approximately 32.9%. Newly diagnosed AML is currently treated with chemotherapy, targeted therapies, and/or allogeneic or autologous stem cell transplant. For patients with R/R AML, there are few treatment options and median overall survival is typically approximately five months.

About Senti Bio

Senti Bio is a biotechnology company developing a new generation of cell and gene therapies for patients living with incurable diseases. To achieve this, Senti Bio is leveraging its synthetic biology platform to engineer Gene Circuits into new medicines with enhanced precision and control. These Gene Circuits are designed to precisely kill cancer cells, to spare healthy cells, to increase specificity to target tissues, and/or to be controllable even after administration. The Company’s wholly-owned pipeline is comprised of cell therapies engineered with Gene Circuits to target challenging liquid and solid tumor indications. Senti’s Gene Circuits have been shown preclinically to work in both NK and T cells. Senti Bio has also preclinically demonstrated the potential breadth of Gene Circuits in other modalities and diseases outside of oncology, and continues to advance these capabilities through partnerships.

Forward-Looking Statements

This press release and document contain certain statements that are not historical facts and are considered forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements generally are identified by the words “believe,” “could,” “predict,” “continue,” “ongoing,” “project,” “expect,” “anticipate,” “estimate,” “intend,” “strategy,” “future,” “opportunity,” “plan,” “may,” “should,” “will,” “would,” “will be,” “will continue,” “will likely result,” “forecast,” “seek,” “target” and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. Forward-looking statements are predictions, projections, and other statements about future events that are based on current expectations of Senti Bio’s management and assumptions, whether or not identified in this document, and, as a result, are subject to risks and uncertainties. Forward-looking statements include, but are not limited to, expectations regarding Senti Bio’s future results. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as and must not be relied on by any investor as, a guarantee, an assurance, a prediction, or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and will differ from assumptions. Many actual events and circumstances are beyond the control of Senti Bio. Many factors could cause actual future results to differ materially from the forward-looking statements in this document, including but not limited to: (i) changes in domestic and foreign business, market, financial, political and legal conditions, (ii) changes in the competitive and highly regulated industries in which Senti Bio operates, variations in operating performance across competitors, changes in laws and regulations affecting Senti Bio’s business, (iii) the ability to implement business plans, forecasts and other expectations, (iv) the risk of downturns and a changing regulatory landscape in Senti Bio’s highly competitive industry, (v) risks relating to the uncertainty of any projected financial information with respect to Senti Bio, (vi) risks related to uncertainty in the timing or results of Senti Bio’s , clinical studies, patient enrollment, and GMP manufacturing startup activities, (vii) Senti Bio’s dependence on third parties in connection with clinical studies, and GMP manufacturing activities, (viii) risks related to delays and other impacts from macroeconomic and geopolitical events, increasing rates of inflation and rising interest rates on business operations, (ix) risks related to the timing and utilization of the grant from CIRM, and (x) the success of any future research and development efforts by Senti Bio. The foregoing list of factors is not exhaustive. You should carefully consider the foregoing factors and the other risks and uncertainties described in the “Risk Factors” section of Senti Bio’s most recent periodic report filed with the U.S. Securities and Exchange Commission (“SEC”), and other documents filed by Senti Bio from time to time with the SEC. These filings identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements in this document. There may be additional risks that Senti Bio does not presently know, or that Senti Bio currently believes are immaterial that could also cause actual results to differ from those contained in the forward-looking statements in this document. Forward-looking statements speak only as of the date they are made. Senti Bio anticipates that subsequent events and developments may cause Senti Bio’s assessments to change. Except as required by law, Senti Bio assumes no obligation to update publicly any forward-looking statements, whether as a result of new information, future events, or otherwise.

Availability of Other Information About Senti Biosciences, Inc.

For more information, please visit the Senti Bio website at www.sentibio.com or follow Senti Bio on X (@SentiBio) and LinkedIn (Senti Biosciences). Investors and others should note that we communicate with our investors and the public using our company website (www.sentibio.com), including, but not limited to, company disclosures, investor presentations and FAQs, Securities and Exchange Commission filings, press releases, public conference call transcripts and webcast transcripts, as well as on X and LinkedIn. The information that we post on our website or on X or LinkedIn could be deemed to be material information. As a result, we encourage investors, the media and others interested to review the information that we post there on a regular basis. The contents of our website or social media shall not be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended.

Investor Contact:
JTC Team, LLC
Jenene Thomas
(908) 824-0775
SNTI@jtcir.com

Press Contact:
Shira Derasmo
Cuttlefish Communications
+1 917-280-2497
shira@cuttlefishpr.com

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1}National Cancer Institute. “Acute Myeloid Leukemia - Cancer Stat Facts.” SEER, 2025, seer.cancer.gov/statfacts/html/amyl.html.
²Brandwein, Joseph M, et al. “Outcomes of Patients with Relapsed or Refractory Acute Myeloid Leukemia: A Population-Based Real-World Study.” American Journal of Blood Research, vol. 10, no. 4, 2020, pp. 124–133, pubmed.ncbi.nlm.nih.gov/32923092/.

FAQ

When will Senti Bio (SNTI) present SENTI-202 data at ASH 2025?

Senti Bio will present on December 8, 2025, with an oral session at 5:45–6:00 PM ET and a poster session 6:00–8:00 PM ET.

What clinical outcomes for SENTI-202 did Senti Bio report for ASH 2025?

Updated results report deep, durable clinical remissions and a strong safety profile in relapsed/refractory AML participants.

What mechanism did Senti Bio highlight for SENTI-202 at ASH 2025?

Pharmacodynamic data support an OR/NOT logic gate that selectively kills CD33/FLT3‑positive leukemic cells while sparing EMCN‑positive healthy HSPCs.

Will Senti Bio provide a webcast of the SENTI-202 ASH presentation?

Yes. Senti Bio will host a live webcast during the ASH meeting to discuss the latest SENTI-202 data.

Which ASH abstracts cover SENTI-202 clinical and correlative data?

The oral session is abs25-10130 and the poster is abs25-2711, both presented on December 8, 2025.