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Senti Bio Reports Second Quarter 2025 Financial Results and Confirms Next Data Milestone for Phase 1 SENTI-202 Study in Acute Myeloid Leukemia (AML) Expected Q4 2025
Globenewswire· 2025-08-07 12:05
Core Insights - Senti Biosciences, Inc. is advancing its clinical development of SENTI-202, having completed the dose finding phase and confirmed the recommended Phase 2 dose (RP2D) for treating relapsed/refractory AML [2][7] - The company received Orphan Drug Designation from the U.S. FDA for SENTI-202, enhancing its potential market position [7] - Senti Bio aims to grow its pipeline and expects to release additional efficacy and durability data from its ongoing Phase 1 study by the end of the year [2] Recent Pipeline and Corporate Updates - The company has completed the dose finding phase for SENTI-202 and is currently in the dose expansion phase [2][7] - Senti Bio received a $1.0 million tranche from the California Institute for Regenerative Medicine (CIRM) to support the clinical development of SENTI-202 [7] - New appointments to the leadership team include Bryan Baum to the Board of Directors and Dr. James B. Trager to the Scientific Advisory Board [7] Financial Results for Q2 2025 - As of June 30, 2025, Senti Bio reported cash and cash equivalents of approximately $21.6 million, down from $48.3 million as of December 31, 2024 [7][13] - Research and development expenses increased to $10.0 million for Q2 2025, compared to $9.2 million in Q2 2024, primarily due to higher external services and supplies costs [7][15] - General and administrative expenses rose to $6.8 million in Q2 2025 from $4.2 million in Q2 2024, mainly due to increased personnel-related expenses [7][15] - The net loss for Q2 2025 was $14.7 million, or $0.56 per share, compared to a net loss of $11.2 million in Q2 2024 [7][15][16]
Senti Bio Determines Recommended Phase 2 Dose (RP2D) in Phase 1 Study of SENTI-202 for the Treatment of Relapsed/Refractory Hematologic Malignancies, Including Acute Myeloid Leukemia
Globenewswire· 2025-08-05 12:30
Core Insights - Senti Biosciences is progressing towards reporting topline data for its Phase 1 clinical trial of SENTI-202 by year-end, having confirmed the recommended Phase 2 dose (RP2D) for its CAR-NK cell therapy targeting relapsed/refractory hematologic malignancies, including acute myeloid leukemia (AML) [1][2][3] Group 1: Clinical Trial Details - The Phase 1 trial of SENTI-202 is enrolling adult patients with relapsed or refractory CD33 and/or FLT3 expressing hematologic malignancies at multiple sites in the U.S. and Australia [2] - The RP2D has been established as Schedule I, Dose Level 2, with a dosage of 1.5 x 10 CAR+ NK cells administered on Days 0, 7, and 14 of 28-day cycles following lymphodepleting chemotherapy [2] - The company anticipates reporting clinical data, including efficacy and durability, from the expansion cohort before year-end [2] Group 2: Clinical Outcomes - SENTI-202 was well-tolerated with no dose-limiting toxicities, and 2 of 3 patients in the preliminary RP2D cohort achieved a composite Complete Remission (cCR) [4] - Among the 7 best overall response evaluable patients, 5 achieved an overall response rate (ORR), and 4 achieved cCR, with all cCR patients being measurable residual disease negative [4] - The median duration of cCR has not been reached, with the longest durability reported at over 8 months [4] Group 3: Product Overview - SENTI-202 is designed as a first-in-class off-the-shelf therapy targeting CD33 and/or FLT3-expressing hematologic malignancies while sparing healthy bone marrow cells [6] - The therapy incorporates an OR GATE for activating signals, a NOT GATE for protective signals, and calibrated-release IL-15 to enhance cell persistence and activity [6] - The NK cells used in SENTI-202 are sourced from selected healthy adult donors, positioning it as a potential allogeneic off-the-shelf treatment for AML/MDS patients [6] Group 4: Market Context - AML is the most common type of acute leukemia in adults, with an estimated 20,800 new cases in the U.S. in 2024 and a five-year survival rate of approximately 30% [9] - Current treatment options for patients with relapsed/refractory AML are limited, with median overall survival typically around five months [9]
Senti Biosciences Participates in the Virtual Investor “What's Your Story” Summer Spotlight On-Demand Conference
Globenewswire· 2025-07-22 12:45
Core Insights - Senti Biosciences, Inc. is a clinical-stage biotechnology company focused on developing next-generation cell and gene therapies using its proprietary Gene Circuit platform [1][2] - The company aims to create therapies that can precisely target and kill cancer cells while sparing healthy cells, enhancing specificity to target tissues, and allowing for control even after administration [2] Company Overview - Senti Bio is leveraging synthetic biology to engineer Gene Circuits into new medicines aimed at treating patients with incurable diseases [2] - The company's pipeline includes cell therapies designed to target challenging liquid and solid tumor indications, with preclinical evidence supporting the efficacy of Gene Circuits in both NK and T cells [2] - Senti Bio is also exploring the potential applications of Gene Circuits in other modalities and diseases beyond oncology through partnerships [2] Event Participation - Timothy Lu, M.D., Ph.D., Co-Founder and CEO of Senti Bio, participated in the Virtual Investor "What's Your Story" Summer Spotlight On-Demand Conference, sharing insights into his dedication to the company and its programs [1][2]
Senti Bio's Chief Medical Officer, Kanya Rajangam, M.D., Ph.D. to Give Feature Presentation at the BioScience Forum
Globenewswire· 2025-07-21 12:55
Core Insights - Senti Bio is presenting its innovative logic-gated CAR-NK cell therapy, which targets leukemic cells while preserving healthy bone marrow [1] - The presentation will take place at the BioScience Forum on July 23, 2025, featuring Dr. Kanya Rajangam as the speaker [2] Company Overview - Senti Bio is a clinical-stage biotechnology company focused on developing next-generation cell and gene therapies using its proprietary Gene Circuit platform [1][4] - The company aims to create therapies that can precisely kill cancer cells while sparing healthy cells, enhancing specificity to target tissues, and allowing control post-administration [4] - Senti Bio's pipeline includes cell therapies engineered with Gene Circuits targeting both liquid and solid tumors, with preclinical evidence supporting their efficacy in NK and T cells [4]
Senti Bio Appoints Entrepreneurial Leader and Investor, Bryan Baum, to Board of Directors
Globenewswire· 2025-07-18 12:55
Core Insights - Senti Biosciences, Inc. has appointed Bryan Baum to its Board of Directors, enhancing its leadership team with his extensive entrepreneurial and investment experience [1][3][4] - Bryan Baum is recognized for his successful track record in scaling companies and has invested in notable firms such as SpaceX, OpenAI, and Airbnb, which may provide strategic advantages to Senti Bio [2][3] - The company is focused on developing next-generation cell and gene therapies using its proprietary Gene Circuit platform, aiming to address cancer treatments that current drugs cannot [3][5] Company Overview - Senti Bio is a clinical-stage biotechnology company that leverages synthetic biology to engineer Gene Circuits for new medicines, targeting incurable diseases [5] - The company's pipeline includes cell therapies designed to specifically target and kill cancer cells while sparing healthy cells, with preclinical evidence supporting their efficacy in both NK and T cells [5] - Senti Bio is also exploring the potential of Gene Circuits in other disease modalities beyond oncology, indicating a broad scope for future development [5]
Senti Biosciences (SNTI) Earnings Call Presentation
2025-07-04 09:46
SENTI-202 Program Highlights - SENTI-202 is a first-in-class off-the-shelf Logic-Gated selective CD33 OR FLT3 NOT EMCN CAR NK cell therapy targeting AML [4, 5, 52] - The therapy is designed to selectively kill both AML blasts and LSCs while protecting healthy HSPCs [15, 52] - Preliminary Phase 1 trial data shows positive efficacy in R/R AML [5] Clinical Trial & Patient Data - The Phase 1 trial (SENTI-202-101) enrolled heavily pretreated R/R AML patients with poor prognosis [18, 52] - The study identified a preliminary Recommended Phase 2 Dose (RP2D) [20, 22, 52] - The opening dose cohort was anticipated to be biologically active [18, 22] - The median time from AML diagnosis to trial entry was less than 1 year [25] - Patients had received a median of 2 prior lines of therapy [27] Safety & Tolerability - SENTI-202 was generally well-tolerated in R/R AML patients [30, 52] - Most frequent Grade 3+ AEs were hematologic and consistent with R/R AML patients receiving lymphodepletion [29, 52] - The Maximum Tolerated Dose (MTD) was not reached, and the preliminary RP2D was identified as 1.5 x 10^9 cells/dose x 3 weekly doses/28 days [52] Efficacy & Response - Across all patients, the Overall Response Rate (ORR) was 71% (5/7) and the composite Complete Remission (cCR) rate was 57% (4/7) [33, 57] - In the preliminary RP2D cohort, the cCR rate was 67% (2/3) [33, 57] - All cCR patients (4/4) achieved MRD- status as assessed per local standard of care [33, 57] - All cCR patients maintained morphologic remission with the longest follow-up of 8+ months [57]
Senti Bio Participates in Nasdaq Amplify Spotlight Series
Globenewswire· 2025-06-30 13:15
Core Insights - Senti Biosciences, Inc. is a clinical-stage biotechnology company focused on developing next-generation cell and gene therapies using its proprietary Gene Circuit platform [2][3] - The company's lead program, SENTI-202, is a first-in-class CAR NK cell therapy targeting hematologic malignancies, currently in a Phase 1 clinical trial with positive preliminary data [3] - SENTI-202 has received Orphan Drug Designation from the FDA for treating relapsed/refractory hematologic malignancies, including AML [3] Company Overview - Senti Bio aims to create new medicines for patients with incurable diseases by engineering Gene Circuits that can precisely target and kill cancer cells while sparing healthy cells [5] - The company's pipeline includes cell therapies designed to address challenging liquid and solid tumor indications, with Gene Circuits shown to work in both NK and T cells [5] - Senti Bio is also exploring the application of Gene Circuits in other diseases beyond oncology through partnerships [5]
Senti Bio to Present at the 2025 Synthetic Biology: Engineering, Evolution, & Design (SEED) Conference
Globenewswire· 2025-06-24 12:45
Core Insights - Senti Biosciences, Inc. is a clinical-stage biotechnology company focused on developing next-generation cell and gene therapies using its proprietary Gene Circuit platform [1][3] - The company will present at the 2025 Synthetic Biology: Engineering, Evolution, & Design (SEED) Conference, highlighting its innovative approach to tumor-specific therapies [1] Company Overview - Senti Bio is dedicated to creating new cell and gene therapies for patients with incurable diseases, utilizing synthetic biology to engineer Gene Circuits for enhanced precision and control [3] - The company's pipeline includes cell therapies designed to target both liquid and solid tumors, with preclinical evidence supporting the efficacy of Gene Circuits in NK and T cells [3] Conference Details - The SEED Conference, established in 2014, serves as a premier event for synthetic biologists, facilitating networking and collaboration among over 5,000 professionals in the field [1] - Senti Bio's presentation will focus on "Solving the Grand Challenge of Tumor-Specific Therapies with Logic-Gated Cells," showcasing its advancements in the field [1]
Senti Bio Granted U.S. FDA Orphan Drug Designation for Use of First-in-Class Off-the-Shelf Logic Gated Selective CD33 OR FLT3 NOT EMCN CAR NK Cell Therapy, SENTI-202 to Treat Acute Myeloid Leukemia
Globenewswire· 2025-06-18 11:00
Core Insights - Senti Biosciences, Inc. announced progress in the Phase 1 clinical trial of SENTI-202 for treating Acute Myeloid Leukemia (AML), with the FDA granting Orphan Drug Designation for the therapy [1][2] - The company aims to address the significant unmet need in relapsed/refractory AML, which has a median survival rate of only 5.3 months [2] - SENTI-202 is designed to selectively target and eliminate CD33 and/or FLT3-expressing hematologic malignancies while sparing healthy cells [2] Company Overview - Senti Bio is a clinical-stage biotechnology company focused on developing next-generation cell and gene therapies using its proprietary Gene Circuit platform [1][4] - The company’s pipeline includes cell therapies engineered with Gene Circuits targeting challenging liquid and solid tumor indications [4] - Senti Bio's Gene Circuits have shown preclinical efficacy in both NK and T cells, with potential applications beyond oncology [4] Regulatory Milestone - The FDA's Orphan Drug Designation provides Senti Bio with various benefits, including tax credits and exemptions from certain FDA fees, as well as potential market exclusivity for seven years post-approval [3]
Senti Bio to Participate in a Virtual Fireside Chat Hosted by Chardan Capital Markets, LLC
Globenewswire· 2025-06-06 13:05
Core Insights - Senti Biosciences, Inc. is participating in a Virtual Fireside Chat hosted by Chardan Capital Markets on June 9, 2025, featuring key executives discussing the company's advancements in biotechnology [1][2]. 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][3]. - The company aims to create therapies that can precisely target and kill cancer cells while sparing healthy cells, enhancing specificity to target tissues, and allowing for controllability post-administration [3]. - Senti's pipeline includes cell therapies engineered with Gene Circuits targeting both liquid and solid tumors, with preclinical evidence supporting their efficacy in NK and T cells [3]. Additional Information - For further details, Senti Biosciences encourages stakeholders to visit their official website and follow their social media channels for updates and disclosures [4].