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].

Core Insights - The after-hours trading session on November 14, 2025, saw significant movements in biotech and therapeutics stocks due to various corporate updates and financial results [1] Company Summaries - Repare Therapeutics Inc. (RPTX) experienced a 30.32% increase, closing at $2.15, following the announcement of a definitive agreement for acquisition by XenoTherapeutics, with shareholders set to receive $1.82 per share plus a contingent value right. The company reported cash and cash equivalents of $112.6 million as of September 30, 2025, up from $109.5 million at the end of June [2] - Senti Biosciences, Inc. (SNTI) rose 7.45% to $1.73 after reporting a net loss of $18.1 million, or $0.69 per share, for Q3 2025. Cash and cash equivalents decreased to $12.2 million from $48.3 million at year-end 2024 [3] - Applied Therapeutics, Inc. (APLT) advanced 8.15% to $0.24, reporting a net loss of $19.0 million, or $0.13 per share, for Q3 2025, an improvement from a net loss of $68.6 million, or $0.48 per share, in the same period of 2024. Cash and cash equivalents totaled $11.9 million, down from $79.4 million at the end of 2024 [4] - RenovoRx, Inc. (RNXT) climbed 6.28% to $0.80, reporting revenues of approximately $266,000 for Q3 2025, with a net loss of $2.9 million compared to $2.5 million in the same period of 2024 [5] - Nuvalent, Inc. (NUVL) gained 9.33%, closing at $105.50, and announced plans for a webcast to discuss pivotal data for its investigational ALK-selective inhibitor in patients with advanced ALK-positive non-small cell lung cancer [6]

Financial Performance - For the three months ended September 30, 2025, the company incurred a net loss of $18.1 million, compared to a net loss of $28.9 million for the same period in 2024, representing a 37.5% decrease in losses year-over-year[129]. - For the nine months ended September 30, 2025, the company reported net losses of $47.0 million, down from $52.2 million in the same period of 2024, indicating a 10.0% reduction in losses[129]. - The net loss for Q3 2025 was $18.1 million, a decrease of $10.7 million from a net loss of $28.9 million in Q3 2024[169]. - Net loss decreased to $46.97 million in 2025 from $52.18 million in 2024, showing an improvement of $5.21 million[185]. Cash and Liquidity - As of September 30, 2025, the company had cash and cash equivalents of $12.2 million, a decrease from $48.3 million as of December 31, 2024[129]. - Cash and cash equivalents as of September 30, 2025, were $12.2 million, with an accumulated deficit of $344.1 million[185]. - Net cash used in operating activities was $36.57 million for the nine months ended September 30, 2025, compared to $27.89 million in 2024[194]. - The company anticipates needing substantial additional funding to support ongoing operations and development strategies[186]. Research and Development - The company initiated a clinical trial of SENTI-202 for blood cancers in 2024, with topline data expected before the end of 2025[128][146]. - The FDA granted Orphan Drug Designation to SENTI-202 for the treatment of relapsed/refractory hematologic malignancies, including acute myeloid leukemia[145]. - The company is evaluating next steps for SENTI-301A/SN301A after enrollment was stopped due to dose limiting toxicities observed in the trial[148]. - The company anticipates a substantial increase in expenses and operating losses driven by ongoing clinical and preclinical development activities[130]. - Research and development expenses for Q3 2025 were $10.5 million, an increase of $1.8 million from $8.7 million in Q3 2024, primarily due to higher external services and supplies costs[169]. - Research and development expenses increased to $29.8 million for the nine months ended September 30, 2025, up from $26.6 million in 2024, reflecting a $3.2 million increase primarily due to higher external services and supplies costs[177]. - The company anticipates an increase in research and development expenses and manufacturing costs in connection with planned preclinical and clinical development activities[155]. Operating Expenses - General and administrative expenses for Q3 2025 were $6.4 million, a slight decrease from $6.6 million in Q3 2024, mainly due to reduced external services and supplies costs[170]. - The total operating expenses for Q3 2025 were $16.9 million, compared to $15.2 million in Q3 2024, reflecting an increase of $1.7 million[169]. - General and administrative expenses rose to $20.3 million in 2025 from $18.3 million in 2024, an increase of $2.0 million mainly due to higher personnel-related expenses[178]. Income and Other Financial Metrics - Interest income remained stable at $0.2 million for both Q3 2025 and Q3 2024[171]. - Interest income increased to $0.8 million for the nine months ended September 30, 2025, compared to $0.7 million in 2024, attributed to higher average cash balances[179]. - GeneFab sublease income decreased by $3.2 million in Q3 2025 due to a $3.3 million reversal of previously recognized sublease income[172]. - Other income increased by $0.2 million in Q3 2025, attributed to new sublease agreements that began in October 2024[173]. Shareholder and Financing Activities - The company sold 244,960 shares of common stock under the 2025 ATM Agreement at a weighted average price of $2.82 per share, resulting in gross proceeds of $0.7 million[143]. - The company raised aggregate gross proceeds of $356.9 million from various financing activities since inception, including a merger in 2022 and issuance of common stock[187]. Contractual Obligations and Compliance - As of September 30, 2025, the company is in default on its Alameda lease for nonpayment of rent amounting to approximately $0.4 million[206]. - The company has not reported any material changes in contractual obligations since December 31, 2024[207]. - There are currently no off-balance sheet arrangements as defined by SEC regulations[208]. - No material changes have occurred in critical accounting policies and estimates for the nine months ended September 30, 2025[209]. Company Status and Classification - The company remains classified as an "emerging growth company" and has opted not to take advantage of the extended transition period for new accounting standards[210]. - The company expects to maintain its emerging growth status until it achieves total annual revenue of at least $1.235 billion or meets other specified criteria[211]. - The company operates as a single segment focused on the research and development of its gene circuit platform, with no current revenue generation[215]. - The company qualifies as a "smaller reporting company," allowing it to provide reduced disclosure obligations[214].

Financial Performance - As of September 30, 2025, Senti Bio held cash and cash equivalents of approximately $12.2 million, a decrease from $48.3 million as of December 31, 2024[9]. - Research and development expenses for Q3 2025 were $10.5 million, up from $8.7 million in Q3 2024, reflecting a 20.7% increase primarily due to higher external services and personnel-related costs[9]. - General and administrative expenses decreased slightly to $6.4 million in Q3 2025 from $6.6 million in Q3 2024, a reduction of 3%[9]. - The net loss for Q3 2025 was $18.1 million, or $0.69 per share, compared to a net loss of $28.9 million, or $6.31 per share, in Q3 2024[9][16]. - Total operating expenses for the nine months ended September 30, 2025, were $50.1 million, compared to $44.9 million for the same period in 2024, indicating an increase of 11.5%[16]. - Senti Bio's accumulated deficit as of September 30, 2025, was approximately $344.1 million, up from $297.1 million at the end of 2024[14]. - The total assets of Senti Bio as of September 30, 2025, were $52.7 million, a decrease from $97.8 million as of December 31, 2024[14]. Clinical Development - Senti Bio plans to present updated clinical data for the SENTI-202 study at the American Society of Hematology Annual Meeting in December 2025, highlighting the efficacy and safety of its Logic Gate technology[5][2]. - The company is focused on expanding its clinical development for SENTI-202, particularly in enrolling additional patients with relapsed/refractory acute myeloid leukemia (AML)[2]. Investor Relations - Senti Bio's participation in various investor conferences aims to increase market awareness and visibility among the investor and scientific communities[4].

Core Insights - Senti Biosciences, Inc. is focused on advancing its SENTI-202 clinical development for relapsed/refractory acute myeloid leukemia (AML), with significant milestones achieved in Q3 2025 [2][3] - The company plans to present updated clinical data at the upcoming ASH Annual Meeting, emphasizing the efficacy and safety of its Logic Gate technology [2][7] Financial Results - As of September 30, 2025, Senti Bio reported cash and cash equivalents of approximately $12.2 million, a decrease from $48.3 million as of December 31, 2024 [7][13] - Research and development expenses for Q3 2025 were $10.5 million, up from $8.7 million in Q3 2024, primarily due to increased external services and personnel-related costs [7][14] - General and administrative expenses decreased slightly to $6.4 million in Q3 2025 from $6.6 million in Q3 2024 [7][14] - The net loss for Q3 2025 was $18.1 million, or $0.69 per share, compared to a net loss of $28.9 million in Q3 2024 [7][15] Pipeline and Corporate Highlights - The company is actively enrolling additional patients for the SENTI-202 trial and has achieved important milestones in its dose expansion phase [2][3] - Senti Bio's Gene Circuit platform is designed to enhance precision in targeting cancer cells while sparing healthy tissue, addressing a significant challenge in cancer treatment [6][8] - The company has participated in various investor conferences to increase market awareness and visibility among the scientific community [4][7]

Core Insights - Senti Biosciences, Inc. is set to present its SENTI-202 clinical program at the 67th American Society of Hematology Annual Meeting, showcasing advancements in its Logic Gate technology for treating relapsed/refractory Acute Myeloid Leukemia (AML) [1][4] 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][8] - 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 [8] Product Details - SENTI-202 is the first Logic Gated off-the-shelf CAR-NK cell therapy designed to selectively target and eliminate CD33 and/or FLT3 expressing hematologic malignancies, such as AML and myelodysplastic syndrome (MDS) [3][5] - The therapy incorporates an OR GATE for activating CAR that targets CD33 and FLT3, and a NOT GATE to protect healthy cells expressing EMCN, potentially widening the therapeutic window [5] - SENTI-202 also includes calibrated-release IL-15 to enhance cell persistence and activity [5] Clinical Program - The upcoming presentations will provide updated clinical results, demonstrating deep and durable remission rates and a strong safety profile for SENTI-202 in treating relapsed/refractory AML [4] - The oral session will present promising results from an ongoing Phase I multicenter study, while the poster session will provide correlative data consistent with clinical activity [2][4] Market Context - AML is a prevalent blood cancer with an estimated 22,010 new cases in the U.S. in 2025, and a five-year survival rate of approximately 32.9% at diagnosis [7] - There is a significant unmet need for effective treatments for relapsed/refractory AML, where median overall survival is typically around five months [7]

Summary of Senti Biosciences FY Conference Call Company Overview - **Company**: Senti Biosciences (NasdaqCM:SNTI) - **Lead Program**: Senti 202, an off-the-shelf allogeneic CAR NK cell therapy targeting acute myeloid leukemia (AML) [2][3][31] Industry Context - **Focus Area**: Oncology, specifically targeting cancer cells while sparing healthy cells - **Challenge**: Many cancers lack a single target that is unique to cancer cells, complicating treatment options [2][5][33] Core Technology - **Logic Gate Technology**: Utilizes a NOT gate mechanism to protect healthy cells while targeting cancer cells [4][39] - **Targets**: Senti 202 targets CD33 and FLT3, which are expressed in over 95% of AML patients [9][38] Clinical Development - **Current Phase**: Phase 1 dose expansion study, actively enrolling patients [3][40] - **Patient Population**: Focus on relapsed/refractory AML patients, with a disease burden of approximately 20,000 patients per year in the U.S. [6][34] - **Efficacy Data**: Preliminary data shows an overall response rate (ORR) of 71% in evaluable patients, with 57% achieving a composite complete response (CR) [15][45] Safety Profile - **Adverse Events**: Generally well tolerated with no serious adverse events (SAEs) or dose-limiting toxicities (DLTs) attributed to Senti 202 [43][44] - **Lymphodepletion Effects**: Expected drop in healthy blood cell counts post-lymphodepletion, followed by recovery [14][50] Future Outlook - **Upcoming Data**: Additional phase 1 data expected by the end of the year, with a focus on durability and correlative data using CyTOF analyses [26][59] - **Expansion Potential**: Opportunities to apply logic gate technology to newly diagnosed AML, myelodysplastic syndromes (MDS), and solid tumors [21][52] Key Takeaways - **Unmet Need**: Significant opportunity exists in the relapsed/refractory AML space, especially for patients who do not qualify for existing therapies [35][36] - **Regulatory Pathway**: Potential for FDA breakthrough designation based on precedents set by other therapies in the same space [52] - **Technology Versatility**: Logic gate technology may be adapted for various cancer types, enhancing treatment specificity and efficacy [22][56] Conclusion - Senti Biosciences is positioned to make significant advancements in the treatment of AML through its innovative logic gate technology, with promising early clinical data and a clear path for future development [20][24]

Core Insights - Senti Biosciences, Inc. is set to present at Chardan's 9th Annual Genetic Medicines Conference on October 21, 2025, in New York, NY [1] - The company is focused on developing next-generation cell and gene therapies using its proprietary Gene Circuit platform [1][3] - Management will also engage in one-on-one meetings with qualified investors during the conference [2] Company Overview - Senti Bio is a clinical-stage biotechnology company targeting incurable diseases through innovative cell and gene therapies [3] - The company utilizes a synthetic biology platform to engineer Gene Circuits aimed at precisely targeting and killing cancer cells while sparing healthy cells [3] - Senti Bio's pipeline includes cell therapies designed for challenging liquid and solid tumor indications, with preclinical evidence supporting the efficacy of Gene Circuits in NK and T cells [3] Additional Information - Investors and the public can access more information about Senti Bio through its website and social media platforms [4] - The company emphasizes the importance of its online communications for investor relations and public disclosures [4]