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Senti Biosciences (NasdaqCM:SNTI) Earnings Call Presentation
2025-12-09 13:00
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 ...
Senti Bio Announces Updated SENTI-202 Clinical Data from Ongoing Phase 1 Trial in Relapsed or Refractory Acute Myeloid Leukemia Patients, Demonstrating Deep, MRD Negative, Durable Complete Remissions and a Favorable Safety Profile
Globenewswire· 2025-12-09 12:00
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]
Senti Bio Receives FDA Regenerative Medicine Advanced Therapy (RMAT) Designation for SENTI-202 in the Treatment of Adults with Relapsed or Refractory Acute Myeloid Leukemia
Globenewswire· 2025-12-09 12:00
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]
Senti Bio to Host Conference Call and Webcast to Discuss SENTI-202 Clinical Data Being Presented at the American Society of Hematology (ASH) Annual Meeting 2025 on Tuesday, December 9th at 8:00 AM ET
Globenewswire· 2025-12-04 13:45
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].
Repare +30%, Nuvalent +9% Lead After-Hours Biotech Gains
RTTNews· 2025-11-17 04:41
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]
Senti Biosciences(SNTI) - 2025 Q3 - Quarterly Report
2025-11-13 22:09
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].
Senti Biosciences(SNTI) - 2025 Q3 - Quarterly Results
2025-11-13 21:38
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].
Senti Bio Reports Third Quarter 2025 Financial Results and Confirms Next Clinical Data Readout for Phase 1 SENTI-202 Study in Acute Myeloid Leukemia (AML) at the American Society of Hematology Annual Meeting in December
Globenewswire· 2025-11-13 21:30
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]
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
Globenewswire· 2025-11-03 14:05
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]
Senti Biosciences (NasdaqCM:SNTI) FY Conference Transcript
2025-10-21 16:37
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]