Core Insights - Senti Biosciences, Inc. is advancing its lead asset, SENTI-202, a first-in-class off-the-shelf CAR NK cell therapy targeting hematologic malignancies like AML and MDS [2][3] - The company has reported positive preliminary results from a Phase 1 clinical trial, indicating SENTI-202 is well-tolerated with no dose-limiting toxicities [4] - The mechanism of action for SENTI-202 involves a novel gene circuit that selectively kills leukemia cells while sparing healthy hematopoietic stem cells [3][8] 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 [2][6] - The company's pipeline includes engineered cell therapies targeting both liquid and solid tumors, leveraging synthetic biology for enhanced precision and control [6] Clinical Trial Details - SENTI-202 is currently in a Phase 1 trial enrolling adult patients with relapsed/refractory CD33 and/or FLT3-expressing hematologic malignancies [3] - The preliminary recommended Phase 2 dose (RP2D) for SENTI-202 was identified as 1.5 x 10 CAR NK cells administered on Days 0, 7, and 14 in 28-day cycles following lymphodepleting chemotherapy [4] - In the preliminary RP2D cohort, 2 of 3 patients achieved a composite Complete Remission (cCR), and 5 of 7 evaluable patients achieved an overall response rate (ORR) [4] Mechanism of Action - SENTI-202 utilizes a Logic Gated gene circuit to activate CAR targeting CD33 and/or FLT3, which are expressed in approximately 95% of AML patients [8] - The therapy protects healthy hematopoietic stem and progenitor cells (HSC/HSPCs) from off-tumor effects through an inhibitory CAR targeting Endomucin (EMCN) [8]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period from ___to___ Commission File Number 001-40440 Senti Biosciences, Inc. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorp ...

Core Insights - Senti Biosciences, Inc. presented positive Phase 1 data for its lead program SENTI-202 at the AACR Annual Meeting, indicating potential as a treatment for Acute Myeloid Leukemia (AML) with 4 out of 7 patients achieving composite Complete Remission (cCR) [1][3][4] - The company reported financial results for Q1 2025, showing a net loss of $14.1 million, with cash and cash equivalents of approximately $33.8 million as of March 31, 2025 [9][14] Clinical Data Highlights - SENTI-202 was well tolerated with no dose-limiting toxicities, and the preliminary recommended Phase 2 dose (RP2D) was identified as 1.5 x 10 CAR NK cells administered on Days 0, 7, and 14 in 28-day cycles [4] - All 4 patients who achieved cCR were measurable residual disease (MRD) negative, and responses have been maintained for follow-ups ranging from 4+ to 8+ months [1][4] - The ongoing enrollment in the Phase 1 study aims to confirm the RP2D and expand into disease-specific cohorts [1][3] Corporate Developments - The company is advancing its Logic-Gated cell therapy approach, which may have applications in both liquid and solid tumors, providing multiple pipeline expansion opportunities [1][2] - Senti Bio has joined the Webull Corporate Connect Service platform to enhance communication with shareholders and increase market visibility [5] Financial Overview - Research and development expenses for Q1 2025 were $9.3 million, an increase from $8.8 million in Q1 2024, primarily due to higher external services costs [9][14] - General and administrative expenses decreased to $7.1 million in Q1 2025 from $7.5 million in Q1 2024 [9][14] - The total operating expenses for the quarter were $16.4 million, slightly up from $16.3 million in the same period last year [9][14]

Core Viewpoint - Pomerantz LLP is investigating potential securities fraud or unlawful business practices involving Senti Biosciences, Inc. and its officers or directors [1] Group 1: Company Developments - On April 28, 2025, Senti announced the cessation of enrollment in the Investigator Sponsored Trial for its solid tumor pipeline product SN301A due to observed dose limiting toxicities [2] - Following this announcement, Senti's stock price dropped by $1.36 per share, representing a decline of 27.2%, closing at $3.64 per share on the same day [2] Group 2: Legal Context - Pomerantz LLP is recognized as a leading firm in corporate, securities, and antitrust class litigation, with a history of advocating for victims of securities fraud and corporate misconduct [3] - The firm has a track record of recovering significant damages for class members, highlighting its expertise in handling such cases [3]

Core Viewpoint - Pomerantz LLP is investigating potential securities fraud or unlawful business practices involving Senti Biosciences, Inc. and its officers or directors [1] Group 1: Company Developments - On April 28, 2025, Senti announced the cessation of enrollment in the Investigator Sponsored Trial for its solid tumor product SN301A due to observed dose limiting toxicities [3] - Following this announcement, Senti's stock price dropped by $1.36 per share, representing a 27.2% decline, closing at $3.64 per share on the same day [3] Group 2: Legal Actions - Pomerantz LLP is actively seeking claims from investors of Senti Biosciences, indicating a potential class action lawsuit [1][2] - The firm has a long history in corporate, securities, and antitrust class litigation, having recovered significant damages for victims of securities fraud and corporate misconduct [4]

Core Insights - Senti Biosciences, Inc. presented positive preliminary data from the Phase 1 clinical trial of its investigational cell therapy SENTI-202 for treating relapsed/refractory hematologic malignancies, including acute myeloid leukemia (AML) [3][5] - SENTI-202 is designed as a first-in-class off-the-shelf therapy that selectively targets CD33 and/or FLT3 antigens while sparing healthy cells, potentially widening the therapeutic window [5][6] - The company is currently enrolling adult patients with R/R CD33 and/or FLT3-expressing hematologic malignancies in the ongoing Phase 1 clinical trial [5] 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 [2][8] - The company's pipeline includes engineered cell therapies targeting challenging liquid and solid tumor indications, leveraging synthetic biology for enhanced precision and control [8] Industry Context - Acute myeloid leukemia (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% [7] - Current treatment options for R/R AML are limited, with median overall survival typically around five months [7]

Core Insights - Senti Biosciences, Inc. announced positive preliminary clinical results for its lead program, SENTI-202, targeting Relapsed/Refractory AML [1] - The company will present these results at the Citizens JMP Life Sciences Conference on May 8, 2025, in New York [1][2] - Senti Bio is focused on developing next-generation cell and gene therapies using its proprietary Gene Circuit platform [3] Company Overview - Senti Bio is a clinical-stage biotechnology company dedicated to creating innovative cell and gene therapies for patients with incurable diseases [3] - The company utilizes a synthetic biology platform to engineer Gene Circuits that enhance precision and control in targeting cancer cells while sparing healthy cells [3] - 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 NK and T cells [3]

Core Viewpoint - Pomerantz LLP is investigating potential securities fraud or unlawful business practices involving Senti Biosciences, Inc. following a significant drop in stock price due to halted clinical trials [1][3]. Group 1: Company Developments - On April 28, 2025, Senti announced the cessation of enrollment in the Investigator Sponsored Trial for its solid tumor product SN301A due to observed dose limiting toxicities [3]. - Following this announcement, Senti's stock price decreased by $1.36 per share, representing a 27.2% decline, closing at $3.64 per share [3]. Group 2: Legal Investigation - Pomerantz LLP is representing investors of Senti and is looking into claims of securities fraud or other unlawful practices by the company and its officers or directors [1]. - Investors are encouraged to contact Pomerantz LLP for more information regarding the class action investigation [1].

Summary of Senti Biosciences Senti-two zero two Clinical Update Conference Call Company and Industry - **Company**: Senti Biosciences - **Industry**: Biotechnology, specifically focused on cell therapy for hematological malignancies, particularly Acute Myeloid Leukemia (AML) Core Points and Arguments 1. **Introduction of Senti-two zero two**: Senti Biosciences is developing SENTI-two zero two, a logic gated CAR NK cell therapy targeting relapsed/refractory AML and related hematological cancers, with promising preliminary results from a Phase one trial [6][7][40]. 2. **Mechanism of Action**: The therapy utilizes a unique logic gate technology that allows for precise targeting of cancer cells while sparing healthy cells, addressing the challenge of heterogeneous cancer cell populations [8][10][14]. 3. **Patient Demographics**: AML affects approximately 21,000 patients annually in the U.S., with a high relapse rate and poor prognosis, highlighting the urgent need for effective therapies [11][12]. 4. **Trial Design**: The Phase one trial is a multi-center, open-label study enrolling adult patients aged 18-75 with relapsed/refractory AML, focusing on safety, maximum tolerated dose (MTD), and efficacy [19][20]. 5. **Dosing and Administration**: The trial evaluates two dose levels of 1 billion and 1.5 billion CAR NK cells, administered in either three or five doses following lymphodepletion [22][23]. 6. **Safety Profile**: Preliminary safety data indicate that SENTI-two zero two is well tolerated, with no dose-limiting toxicities reported and adverse events primarily being hematologic in nature [26][29][40]. 7. **Efficacy Results**: Five out of seven patients achieved an overall response rate (ORR), with four achieving complete remission (CR), indicating promising efficacy in a heavily treated patient population [30][31][40]. 8. **Durability of Response**: All CR patients were minimal residual disease (MRD) negative, with ongoing responses and a median duration of response not yet reached [31][34][41]. 9. **Future Directions**: The company plans to expand the trial to include more patients and potentially explore other malignancies expressing CD33 or FLT3, such as MDS [49][62]. Other Important but Possibly Overlooked Content 1. **Logic Gate Technology**: The logic gate mechanism allows for the recognition of multiple cancer antigens, enhancing the therapy's ability to target diverse cancer cell populations [9][10]. 2. **Patient Characteristics**: The trial population had multiple adverse prognostic factors, including rapid failure of prior therapies and adverse genetic characteristics, underscoring the high unmet need in this patient group [24][25][34]. 3. **Comparison with Existing Therapies**: Current standard care for relapsed/refractory AML shows low response rates (15-25% for CR), emphasizing the need for innovative therapies like SENTI-two zero two [12][65]. 4. **Potential for Outpatient Use**: Given the favorable safety profile of NK cells, there are plans to develop SENTI-two zero two for outpatient administration [50]. 5. **Broader Applications**: The technology has potential applications beyond AML, including solid tumors, which could significantly expand its therapeutic reach [60][61]. This summary encapsulates the key points discussed during the conference call, highlighting the innovative approach of Senti Biosciences in addressing a critical need in cancer treatment.

Clinical Trial Results - Senti Bio reported that 5 of 7 evaluable patients achieved an overall response rate (ORR) of 71.4%, including 3 complete remissions (CR) and 1 complete remission with partial hematologic recovery (CRh) in the SENTI-202 trial[1] - All complete remission (cCR) patients in the trial were measurable residual disease (MRD) negative, indicating effective treatment[3] - The Phase 1 study of SENTI-202 is ongoing, with continued enrollment to confirm the preliminary RP2D[4] - Senti Bio is collaborating with Celest Therapeutics to evaluate SENTI-301A in a trial in China, although enrollment has been stopped due to observed dose limiting toxicities[11] - The company plans to present additional data on SENTI-202 at the AACR meeting, highlighting its potential as a treatment for AML[6] Financial Performance - As of March 31, 2025, Senti Bio held cash and cash equivalents of approximately $33.8 million[10] - Research and development expenses for Q1 2025 were $9.3 million, an increase of 5.7% from $8.8 million in Q1 2024[10] - General and administrative expenses decreased to $7.1 million in Q1 2025 from $7.5 million in Q1 2024, primarily due to a reduction in personnel-related expenses[14] - The net loss for the quarter ended March 31, 2025, was $14.1 million, equating to $1.41 per basic and diluted share[14] Strategic Outlook - Senti Bio's growth strategy includes ongoing clinical trials and potential future research and development efforts[18] - The company is currently conducting a Phase 1 clinical trial for SENTI-202, with expectations for data availability and patient dosing timelines[17] - Senti Bio's management emphasizes the uncertainty surrounding future results due to various risks and market conditions[18] Risks and Dependencies - The company acknowledges dependence on third parties for clinical trial activities and GMP manufacturing, which may impact timelines[18] - Macroeconomic factors, including inflation and rising interest rates, are noted as potential risks to business operations[18] - Senti Bio's forward-looking statements are subject to change based on subsequent events and developments[18] Communication and Investor Relations - The company encourages stakeholders to review information posted on its website and social media for material updates[19] - Senti Bio's communication strategy includes regular updates through its website and social media platforms[19] - The company has not committed to updating forward-looking statements unless required by law[18] - Investor inquiries can be directed to JTC Team, LLC for further information[20]