Core Insights - Senti Biosciences, Inc. announced participation in a Virtual Investor CEO Connect Segment, highlighting its advancements in cell and gene therapies using the Gene Circuit platform [2][3] Group 1: FDA Designation and Clinical Trials - The FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation to SENTI-202, a potential first-in-class CAR-NK investigational cell therapy for relapsed/refractory hematologic malignancies, including AML [3] - SENTI-202 previously received Orphan Drug Designation from the FDA in June [3] - New data from a multinational clinical trial involving 20 patients (18 with evaluable responses) for SENTI-202 was presented at the American Society of Hematology (ASH) Annual Meeting [3] Group 2: Company Overview and Technology - Senti Bio is focused on developing next-generation cell and gene therapies for incurable diseases, utilizing a synthetic biology platform to engineer Gene Circuits [4] - The Gene Circuits are designed to selectively kill cancer cells while sparing healthy cells, enhancing specificity to target tissues, and allowing for post-administration control [4] - The company's pipeline includes cell therapies targeting both liquid and solid tumors, with preclinical evidence supporting the efficacy of Gene Circuits in NK and T cells [4]

Core Insights - Senti Biosciences, Inc. is participating in the Biotech Showcase 2026, highlighting its focus on next-generation cell and gene therapies using its proprietary Gene Circuit platform [1][3] - The panel presentation titled "Engineering the Future: Advances in Cell and Gene Therapies" will take place on January 13, 2026, at 8:00 AM PST [2] Company Overview - Senti Bio is a clinical-stage biotechnology company dedicated to developing innovative cell and gene therapies for patients with incurable diseases [4] - The company utilizes a synthetic biology platform to engineer Gene Circuits aimed at precisely targeting and killing cancer cells while sparing healthy cells [4] - Senti Bio's pipeline includes cell therapies designed to address challenging liquid and solid tumor indications, with preclinical evidence supporting the efficacy of Gene Circuits in both NK and T cells [4] Industry Context - The Biotech Showcase serves as a significant investor and networking conference for biotechnology and life sciences companies, providing a platform for presenting to investors and pharmaceutical executives [3] - This event is recognized for setting the tone for the biotechnology sector in the upcoming year, featuring multiple tracks, plenary sessions, and networking opportunities [3]

Core Viewpoint - Senti Biosciences (SNTI.US) reported promising data from its Phase 1 trial of SENTI-202 in R/R AML, showing a total overall response rate of 50% and a complete response/hematologic response rate of 42%, with most patients achieving minimal residual disease negativity [1] Group 1 - Senti Biosciences opened with a gain of over 7%, reaching a price of $2.54 [1] - The updated data from the Phase 1 trial indicates a significant efficacy in treating R/R AML [1] - The company received Regenerative Medicine Advanced Therapy (RMAT) designation to advance to pivotal studies [1]

Core Viewpoint - Senti Biosciences reported promising data from its Phase 1 trial of SENTI-202 in R/R AML, leading to a significant stock price increase of over 7% [1] Group 1: Clinical Data - The trial showed a total overall response rate (ORR) of 50% [1] - The complete response/complete hematologic response (CR/CRh) rate was 42% [1] - Most patients demonstrated a durable response with minimal residual disease negativity (MRD-Negative) [1] Group 2: Regulatory Support - Senti Biosciences received Regenerative Medicine Advanced Therapy (RMAT) designation to advance the study to pivotal research [1]

Core Viewpoint - Senti Biosciences reported promising data from its Phase 1 trial of SENTI-202 in R/R AML, leading to a significant stock price increase of over 7% [1] Group 1: Clinical Data - The trial showed a total overall response rate (ORR) of 50% [1] - The complete response/complete hematologic response (CR/CRh) rate was reported at 42% [1] - Most patients demonstrated a durable response with minimal residual disease negativity (MRD-Negative) [1] Group 2: Regulatory Support - Senti Biosciences received Regenerative Medicine Advanced Therapy (RMAT) designation to advance the study to pivotal research [1]

Senti Biosciences Conference Call Summary Company Overview - **Company**: Senti Biosciences (NasdaqCM:SNTI) - **Focus**: Development of gene circuit-based therapies for cancer treatment, specifically targeting acute myeloid leukemia (AML) with Senti 202 Key Industry Insights - **Industry**: Oncology, specifically the treatment of relapsed refractory AML - **Current Treatment Landscape**: - Existing therapies yield low complete remission (CR) rates of 12%-25% and CR/CRh rates of 20%-35% [16][17] - Median overall survival for relapsed refractory AML patients is approximately five months [16] Core Points from the Call - **Senti 202 Overview**: - A first-in-class off-the-shelf logic-gated CAR-NK cell therapy targeting CD33 and FLT3 [8] - Achieved a 50% overall response rate and a 42% CR/CRh rate in a phase 1 trial with 20 heavily pretreated relapsed refractory AML patients [8][39] - 100% of complete remission patients were MRD negative, indicating significant clinical benefits [9][40] - **Mechanism of Action**: - Utilizes a logic-gated approach to selectively kill cancer cells while sparing healthy cells [6][7] - Incorporates an OR gate to recognize cancer targets and a NOT gate to protect healthy cells [6][11] - **Clinical Trial Results**: - Phase 1 trial demonstrated durable responses with a median duration of composite CR of 7.6 months [9][39] - High MRD negative rates correlate with better long-term outcomes [9][40] - Safety profile supports outpatient dosing, with most adverse events being low-grade and manageable [21][39] - **Regulatory Designations**: - Received FDA's Regenerative Medicine Advanced Therapy (RMAT) designation and Orphan Drug designation, facilitating closer collaboration with the FDA [9][40] - **Market Potential**: - Addressable market for Senti 202 includes approximately 28,000 relapsed refractory AML patients in the U.S. and EU, with potential expansion into newly diagnosed AML and pediatric AML populations [13][14] Additional Important Insights - **Patient Population**: - The trial enrolled patients with multiple adverse risk characteristics, with a median age of 49 years and a history of multiple prior therapies [26][27] - Senti 202 is not restricted by mutation status, allowing it to benefit a broader range of patients [21] - **Future Directions**: - Plans to initiate pivotal studies in 2026, with ongoing discussions with the FDA regarding trial design [41][43] - Potential for expanding indications to include solid tumors and other hematological malignancies [45] - **Technology Platform**: - Senti's broader gene circuits platform includes various types of genetic circuits that enhance the efficacy and safety of cell and gene therapies [44][45] Conclusion - Senti 202 shows promising efficacy and safety in treating relapsed refractory AML, with a strong potential for market impact and future expansion into other indications. The innovative logic-gated approach may address significant unmet needs in oncology, particularly for patients with limited treatment options.

SENTI-202-101 Promising Results in the Treatment of Relapsed/Refractory Acute Myeloid Leukemia (R/R AML) in Ongoing Phase 1 Trial (SENTI-202-101) December 9, 2025 Conference Call and Webcast NASDAQ: SNTI | sentibio.com Forward Looking Statements This presentation contains forward-looking statements of Senti Biosciences, Inc. ("we," "us," "our") within the meaning of the Private Securities Litigation Reform Act of 1995. Statements we make in this presentation may include statements which are not historical f ...

Core Insights - Senti Biosciences, Inc. announced new data from its clinical trial of SENTI-202, a CAR NK cell therapy for relapsed or refractory Acute Myeloid Leukemia (R/R AML), showing promising efficacy and safety results [1][3][5] Efficacy and Safety Data - The open-label study reported a 50% Overall Response Rate (ORR) and a 42% Complete Remission (CR) or CR with Partial Hematologic Recovery (CRh) among patients, with 100% of CRs and approximately 80% of all responses being minimal residual disease (MRD) negative [2][3][4] - The median duration of composite Complete Remission across all patients was 7.6 months, with some responses lasting over a year [4] - SENTI-202 demonstrated a favorable safety profile, with no dose-limiting toxicities or serious adverse events related to the therapy [4][5] Mechanism of Action - SENTI-202 utilizes a Logic Gate mechanism to selectively target and kill AML blasts and leukemic stem cells while sparing healthy hematopoietic stem and progenitor cells [3][4][12] - The therapy showed potent killing of AML blasts, even in patients with high baseline levels of disease [4] Regulatory Designations - The FDA granted SENTI-202 Regenerative Medicine Advanced Therapy (RMAT) designation, indicating its potential to address serious unmet medical needs [3][5][13] - SENTI-202 also received Orphan Drug Designation, further supporting its development for R/R hematologic malignancies [5][13] Future Development Plans - The positive clinical data and regulatory designations position Senti Biosciences to advance SENTI-202 into pivotal studies and explore its use in broader patient populations, including newly diagnosed AML and pediatric AML [6][9]

Core Insights - The U.S. FDA has granted Regenerative Medicine Advanced Therapy (RMAT) designation to Senti Biosciences' SENTI-202, a potential first-in-class CAR-NK cell therapy for relapsed/refractory hematologic malignancies, including AML [1][2][7] - This designation highlights the urgent need for improved treatments for relapsed/refractory AML and the potential of SENTI-202 to significantly impact the treatment landscape for this aggressive cancer [2][3] Company Overview - Senti Biosciences is a clinical-stage biotechnology company focused on developing next-generation cell and gene therapies using its proprietary Gene Circuit platform [1][10] - The company aims to engineer therapies that can precisely target and kill cancer cells while sparing healthy cells, enhancing specificity and control in treatment [10] Product Development - SENTI-202 is currently in a Phase 1 clinical trial targeting adult patients with relapsed/refractory CD33 and/or FLT3 expressing hematologic malignancies, including AML [2][8] - The therapy utilizes a Logic Gated approach, featuring an OR GATE for activating CAR that targets CD33 and/or FLT3, and a NOT GATE to protect healthy cells [8] - Clinical data presented at the ASH Annual Meeting indicated a 50% Overall Response Rate (ORR) and a 42% Complete Remission (CR) rate at the Recommended Phase 2 Dose (RP2D), with a median duration of composite Complete Remission of 7.6 months [7][8] Regulatory Milestones - The RMAT designation is the second FDA recognition for SENTI-202 in 2025, following the Orphan Drug Designation received in June [2][9] - RMAT designation facilitates closer collaboration with the FDA, providing guidance on data generation to support product approval [4][7] Clinical Progress - Recent presentations at the ASH Annual Meeting showcased updated clinical data, reinforcing SENTI-202's efficacy, safety, and durability in treating relapsed/refractory AML [2][3] - The company is actively enrolling patients for the ongoing Phase 1 trial, which could lead to a first-in-class allogeneic treatment option for AML/MDS patients [8]

Core Viewpoint - Senti Biosciences, Inc. is set to present updated clinical results for its SENTI-202 therapy at the ASH Annual Meeting on December 9, 2025, highlighting its innovative approach in treating hematologic malignancies [1][2]. Group 1: Company Overview - Senti Bio is a clinical-stage biotechnology company focused on developing next-generation cell and gene therapies for patients with incurable diseases, utilizing its proprietary Gene Circuit platform [4]. - The company aims to engineer Gene Circuits that can precisely target and kill cancer cells while sparing healthy cells, enhancing specificity and control in treatment [4]. Group 2: Product Details - SENTI-202 is the first Logic Gated off-the-shelf CAR-NK cell therapy designed to target and eliminate CD33 and/or FLT3 expressing hematologic malignancies, such as acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) [3]. - The therapy includes an OR GATE for activating CAR that targets CD33 and/or FLT3, a NOT GATE to protect healthy cells, and calibrated-release IL-15 to enhance cell persistence and activity [3]. - Currently, Senti Bio is enrolling adult patients with relapsed/refractory CD33 and/or FLT3 expressing hematologic malignancies in a Phase 1 clinical trial for SENTI-202, which could be a first-in-class allogeneic treatment for AML/MDS patients [3]. Group 3: Conference Call Details - The conference call discussing the clinical results will be hosted by key executives including Timothy Lu, MD, PhD, and Kanya Rajangam, MD, PhD, along with a hematologist from the Sarah Cannon Research Institute [2]. - Interested participants can access the call via a domestic or international phone line, and the webcast will be available on the company's website for 90 days post-event [2].