Core Insights - Senti Biosciences, Inc. presented positive preliminary data for SENTI-202, a potential first-in-class CAR-NK cell therapy for relapsed/refractory AML, at the AACR Annual Meeting 2025 [1][2][3] Clinical Data Summary - The Phase 1 study of SENTI-202 involved 9 patients with relapsed or refractory AML, with 7 evaluable for overall response [3] - The study identified a preliminary recommended Phase 2 dose (RP2D) of 1.5 x 10 CAR NK cells administered on Days 0, 7, and 14 in 28-day cycles [3] - 5 of 7 evaluable patients achieved an overall response rate (ORR), with 4 achieving composite complete remission (cCR) [3][7] - All cCR patients were measurable residual disease (MRD) negative, indicating a strong efficacy profile [3][7] Safety and Tolerability - SENTI-202 was well-tolerated with no dose-limiting toxicities reported, and a maximum tolerated dose was not reached [3][7] - Adverse events were consistent with other investigational NK cell therapies, with no grade 5 adverse events observed [7] Financial Highlights - As of March 31, 2025, Senti Bio held approximately $33.8 million in cash and cash equivalents [13] - Research and development expenses for Q1 2025 were $9.3 million, an increase from $8.8 million in Q1 2024 [13] - The net loss for the quarter was $14.1 million, or $1.41 per share [13] Pipeline Update - The Phase 1 study of SENTI-202 is ongoing, with plans for disease-specific expansion cohorts [4] - Senti Bio is also evaluating SENTI-301A for HCC, but enrollment has been stopped due to observed dose-limiting toxicities [10] Company Overview - Senti Bio is focused on developing next-generation cell and gene therapies using its proprietary Gene Circuit platform [1][15] - The company aims to engineer therapies that selectively target and eliminate cancer cells while sparing healthy cells [15]

Core Insights - Senti Biosciences, Inc. presented positive preliminary data for SENTI-202, a potential first-in-class CAR-NK cell therapy for relapsed/refractory AML, at the AACR Annual Meeting 2025 [1][2][3] - The Phase 1 study identified a recommended Phase 2 dose (RP2D) of 1.5 x 10^9 CAR NK cells, with no dose limiting toxicities observed [3][4] - The therapy demonstrated a 71% overall response rate (ORR) among evaluable patients, with 4 out of 7 achieving composite complete remission (cCR) [3][5] Clinical Data - The study involved 9 patients treated with SENTI-202, with 7 evaluable for overall response [3] - Efficacy results included 5 of 7 patients achieving ORR, with 3 complete remissions (CR) and 1 CR with partial hematologic recovery (CRh) [3][9] - All cCR patients were found to be measurable residual disease (MRD) negative [3][9] Safety Profile - SENTI-202 was well-tolerated, with an adverse event profile consistent with other investigational NK cell therapies [9] - No grade 5 adverse events were reported, and most grade 3 or higher events were attributed to lymphodepleting chemotherapy rather than SENTI-202 [9] Financial Highlights - As of March 31, 2025, Senti Bio reported cash and cash equivalents of approximately $33.8 million [8] - Research and development expenses for Q1 2025 were $9.3 million, an increase from $8.8 million in Q1 2024 [15] - General and administrative expenses decreased to $7.1 million in Q1 2025 from $7.5 million in Q1 2024 [15] Pipeline Update - The Phase 1 study of SENTI-202 is ongoing, with plans for disease-specific expansion cohorts [4] - Senti Bio is also collaborating on SENTI-301A for hepatocellular carcinoma (HCC), although enrollment has been halted due to dose limiting toxicities observed in a related trial [10]

SOUTH SAN FRANCISCO, Calif., April 24, 2025 (GLOBE NEWSWIRE) -- Senti Biosciences, Inc. (Nasdaq: SNTI) (“Senti Bio” or the “Company”), a clinical-stage biotechnology company developing next-generation cell and gene therapies using its proprietary Gene Circuit platform, today announced that it will host a conference call and webcast to discuss the new SENTI-202 Phase 1 clinical data being presented at the American Association for Cancer Research (AACR) Annual Meeting on Monday, April 28, 2025 at 8:30 AM ET. ...

Company Overview - 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][4] - The company aims to create therapies that enhance precision and control in targeting cancer cells while sparing healthy cells [4] Lead Program - Senti Bio's lead program, SENTI-202, targets hematologic cancers by focusing on CD33 and/or FLT3 [4] - SENTI-202 is currently enrolling patients in a Phase I clinical trial, indicating progress in clinical development [4] Research and Development - The company has demonstrated preclinical success with its Gene Circuits in T cells, enabling selective targeting of solid tumors [4] - Senti Bio is advancing its capabilities through partnerships and exploring applications of Gene Circuits in other cell and gene therapy modalities beyond oncology [4] Industry Context - The discussion in the Virtual Investor KOL segment highlighted the current treatment landscape for acute myeloid leukemia (AML) and areas of unmet need [3] - The insights from respected leukemia researcher Stephen Strickland, MD, emphasize the significance of Senti Bio's innovative approach in addressing these unmet needs [3]

Live moderated webcast with members of the Senti Bio management team on Wednesday, April 23rd at 4:00 PM ETSOUTH SAN FRANCISCO, Calif., April 16, 2025 (GLOBE NEWSWIRE) -- Senti Biosciences, Inc. (Nasdaq: SNTI) (“Senti Bio” or the “Company”), a clinical-stage biotechnology company developing next-generation cell and gene therapies using its proprietary Gene Circuit platform, today announced that will participate in the Virtual Investor Closing Bell Series on Wednesday, April 23, 2025 at 4:00 PM ET. As part o ...

Industry leader in the development and application of cellular therapies, including CAR NK products, for cancer Led development of multiple clinical candidates from conception through IND and early clinical development Vast experience in technology licensing, correlation from “bench to bedside” and back and execution of scientific strategy SOUTH SAN FRANCISCO, Calif., April 10, 2025 (GLOBE NEWSWIRE) -- Senti Biosciences, Inc. (Nasdaq: SNTI) (“Senti Bio” or the “Company”), a clinical-stage biotechnology com ...

Company Overview - 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][7] - The company is advancing off-the-shelf CAR-NK cell therapy programs for oncology, with its lead candidate SENTI-202 targeting acute myeloid leukemia (AML) [1][7] Clinical Development - SENTI-202 has shown promising initial clinical data, achieving minimal residual disease (MRD)-negative complete remissions in 2 out of 3 patients, with a durability of over 6 months as of March 20, 2025 [7] - Senti Bio's Gene Circuits have demonstrated functionality in T cells and the potential for selective targeting of solid tumors in preclinical studies [7] Communication and Investor Relations - The company has joined the Webull Corporate Connect Service platform to enhance communication with shareholders and investors, providing updates on corporate content such as news and earnings reports [3][4] - CEO Timothy Lu emphasized the importance of maintaining effective communication and increasing market awareness among investors [4] Strategic Partnerships and Future Directions - Senti Bio is actively pursuing partnerships to advance its capabilities in cell and gene therapy modalities beyond oncology [7] - The company aims to generate long-term value for stakeholders while continuing to execute on its clinical development plans [4][7]

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 announced that three abstracts related to its SENTI-202 trial have been selected for presentation at the AACR Annual Meeting 2025 [1][2] Company Overview - Senti Bio is leveraging a synthetic biology platform called Gene Circuits to create therapies that enhance precision and control in targeting cancer cells while sparing healthy cells [3] - The lead program, SENTI-202, targets CD33 and/or FLT3 in hematologic cancers and has shown promising initial clinical data, including MRD-negative complete remissions in 2 of 3 patients as of September 19, 2024 [3] - The company has demonstrated the potential of its Gene Circuits in T cells and other cell and gene therapy modalities, indicating a broad application beyond oncology [3] Upcoming Presentations - The first abstract focuses on clinical data from the SENTI-202 trial, scheduled for presentation on April 27, 2025 [2] - The second abstract presents correlative data from the same trial, to be showcased on April 29, 2025 [2] - The third abstract discusses the selective targeting of AML while protecting healthy stem cells from off-tumor toxicity, to be presented on April 30, 2025 [2]

Financial Transactions and Agreements - The company sold purchased assets for a total consideration of $37.8 million in cash, with $18.9 million paid at closing and the remaining $18.9 million waived in connection with a private placement investment[115] - GeneFab was provided an option to purchase up to 1,963,344 shares of common stock, valued at up to $20.0 million, at an exercise price of $10.18670, exercisable by August 7, 2026[116] - The company will receive ten percent of the realized gains from GeneFab's parent company arising from any cash or in-kind distributions in connection with a dividend or sale event[117] - The Celest Agreement includes a potential aggregate amount of $156.0 million in option exercise fees and milestone payments, along with tiered royalty payments[120] - The exclusivity period under the Celest Agreement prohibits the company from exploiting similar CAR-NK cell therapies in mainland China during the option exercise period[121] Intellectual Property - The patent portfolio consists of over 13 issued patents and 214 pending patent applications, with 5 patents and 194 pending applications owned or co-owned by the company[128] - The company has filed trademark applications for "SENTI," "SENTI BIOSCIENCES," and related marks, owning five U.S. trademark registrations and multiple foreign registrations[130] FDA Approval Process - The FDA approval process for biologics involves substantial time and financial resources, including preclinical testing, IND submission, and BLA preparation[134] - The IND submission must become effective within 30 days unless the FDA raises safety concerns, which could delay the start of clinical trials[137] - The FDA released guidance in March 2022 to expedite oncology drug development through seamless trial designs, potentially reducing development costs and time[142] - Human clinical trials typically consist of three phases: Phase 1 focuses on safety and dosage, Phase 2 evaluates efficacy and side effects, and Phase 3 confirms clinical efficacy and safety across a larger population[140][147] - The FDA aims to review standard BLA applications within ten months and priority reviews within six months after filing acceptance[147][154] - A BLA submission requires comprehensive data from preclinical and clinical studies, including both positive and negative results, to establish safety and effectiveness[145] - The FDA may issue a Complete Response Letter (CRL) if the BLA is not approved, detailing deficiencies that must be addressed before resubmission[150] - Products may receive expedited designations such as fast track or breakthrough therapy to facilitate development and review processes[152][153] - Accelerated approval may be granted if a product shows effects on surrogate endpoints likely to predict clinical benefit, with post-marketing studies required to verify this[155] - The FDA requires compliance with cGMP and may inspect manufacturing facilities before approving a BLA[149] - The FDA may condition approval on Risk Evaluation and Mitigation Strategies (REMS) to manage known risks associated with a product[151] - Post-marketing studies may be mandated to monitor safety and effectiveness after commercialization, with the potential for withdrawal of approval if compliance is not maintained[151] - The FDA may grant orphan designation to a biologic intended to treat a rare disease with a patient population of fewer than 200,000 individuals in the U.S.[159] - Orphan drug designation provides financial incentives such as grant funding opportunities, tax advantages, and user-fee waivers[160] - A product with orphan drug designation is entitled to seven years of exclusivity upon receiving the first FDA approval for the specific disease[160] - The FDA may withdraw approval if compliance with regulatory requirements is not maintained, which can lead to product recalls or fines[163] - The FDA requires post-marketing testing and surveillance to monitor the effects of an approved product, which can result in new safety information being added to labeling[164] Legislative and Regulatory Environment - The Affordable Care Act created an abbreviated approval pathway for biosimilars, allowing for a more streamlined process for products similar to FDA-licensed reference biologics[167] - A biosimilar application cannot be submitted until four years after the reference product is licensed, and approval cannot be effective until 12 years post-licensure[169] - The company must ensure adequate coverage and reimbursement for its products from government and private payors to successfully commercialize its product candidates[172] - Legislative and regulatory proposals may lead to more rigorous coverage criteria and downward pressure on drug pricing, impacting revenue generation[175] - The European Union has options for member states to control prices and restrict reimbursement for medicinal products, which may affect the company's product candidates[177] - The statutory minimum rebates for manufacturers under the Medicaid Drug Rebate Program have increased to 23.1% for branded drugs and 13% for generic drugs, with a cap on innovator drugs at 100% of the Average Manufacturer Price[180] - The Inflation Reduction Act of 2022 will reduce the out-of-pocket spending cap for Medicare Part D beneficiaries from $7,050 to $2,000 starting in 2025, effectively eliminating the coverage gap[182] - The American Rescue Plan Act of 2021 eliminated the statutory Medicaid drug rebate cap, previously set at 100% of a drug's average manufacturer price, for certain drugs starting January 1, 2024[182] - Medicare payments to providers will be reduced by 2% per fiscal year through 2031 due to the Budget Control Act of 2011 and subsequent legislation[180] - The Right to Try Act allows certain patients to access investigational new drug products that have completed a Phase 1 clinical trial without enrolling in clinical trials[186] - The implementation of the Inflation Reduction Act is currently subject to ongoing litigation, which may affect its impact on the business and healthcare industry[182] - States are increasingly passing legislation to control pharmaceutical pricing, which may reduce demand for products once approved[185] - The federal Anti-Kickback Statute prohibits remuneration to induce referrals for goods or services reimbursed by federal healthcare programs, with severe penalties for violations[189] - The European Union's Clinical Trials Regulation aims to simplify and streamline the approval of clinical studies across member states[194] - The company must obtain marketing authorization in the European Union before commercializing medicinal products, similar to the BLA process in the United States[195] Company Operations and Workforce - The company had 34 full-time employees as of March 18, 2025, with 67% being people of color and 67% being women[207] - The company occupies approximately 40,000 square feet of office and R&D space in South San Francisco, with a lease expiring in April 2027[211] - A cell therapy manufacturing facility was completed in June 2023, designed to meet cGMP standards, with a sublease agreement for 92,000 square feet expiring in September 2032[211] - The company is classified as a "smaller reporting company," with annual revenues below $100 million and market value of common stock held by non-affiliates below $250 million[213] - The company underwent a merger on June 8, 2022, changing its name to Senti Biosciences, Inc., with common stock trading on Nasdaq under the symbol "SNTI" from June 9, 2022[216] - The company has a good relationship with its employees, with no collective bargaining agreements in place[207] - The company aims to attract and retain employees through equity incentive plans to enhance stockholder value[208] Financial Performance and Projections - The company reported net losses of $52.8 million and $71.1 million for the years ended December 31, 2024, and 2023, respectively, with an accumulated deficit of $297.1 million as of December 31, 2024[225] - The company expects to continue incurring significant operating losses for the foreseeable future due to high costs associated with research and development, clinical trials, and regulatory approval processes[226] - As of December 31, 2024, the company had $48.3 million in cash and cash equivalents, raising substantial doubt about its ability to continue as a going concern for the next twelve months[230] - A strategic plan announced in January 2024 included a workforce reduction of approximately 37% to focus on the development of SENTI-202 and the SENTI-301A program in China[236] - The company has not generated any revenue from product sales to date and does not expect to do so in the foreseeable future[235] - The company is reliant on third parties for conducting clinical trials and preclinical studies, which may not perform satisfactorily[224] - The company has identified a material weakness in its internal control over financial reporting, which could adversely affect investor confidence and the value of its common stock[222] - The company may face challenges in obtaining regulatory approvals for its product candidates, which could delay or prevent commercialization[224] - The biotechnology product development is capital-intensive, and the company will require substantial additional funds to advance its product candidates and gene circuit platform[229] - The company may need to restructure its business or delay its research and development programs if it cannot raise capital on acceptable terms[227] - The company identified a material weakness in its internal control over financial reporting, which could adversely affect investor confidence and the value of its common stock[238] - As of December 31, 2024, the company reported net operating loss carryforwards (NOLs) of approximately $191.8 million for U.S. federal income tax purposes, with a portion expiring beginning in 2036 if not utilized[245] - The company holds a letter of credit with JPMorgan Chase Bank amounting to approximately $2.9 million related to the Alameda facility and $0.5 million related to headquarters facility leases[250] - The company has no products on the market or regulatory approvals, with its lead product candidate, SENTI-202, currently in early clinical development[255] - The company may experience additional turnover in its accounting group, which continues to hinder remediation efforts related to its internal control weaknesses[240] - The company may face limitations on utilizing its NOLs due to potential ownership changes, which could adversely affect future tax liabilities[246] - The company is subject to potential adverse effects from changes in U.S. fiscal, tax, and federal policies that could impact its business operations[247] - The company may incur additional expenses due to limited experience among its management team in handling day-to-day operations of a public company[244] Strategic Collaborations and Risks - The company has agreed to allow Celadon Partners to invest up to approximately $20 million for shares, which could significantly dilute existing shareholders' ownership[249] - The company is exposed to risks from liquidity issues in the financial services industry, which could adversely affect its financial condition and operations[250] - The FDA granted IND clearance for SENTI-202 in December 2023, with initial results from the Phase 1 clinical trial expected in Q4 2024[258] - SENTI-202 and SENTI-301A are the only product candidates tested in humans, with SENTI-202's Phase 1 trial initiated in Q2 2024[271] - The company faces significant risks in clinical development, including potential negative results from preclinical studies or clinical trials[259] - There are uncertainties regarding the efficacy and safety of product candidates, which may impact the ability to submit IND applications on expected timelines[261] - The company has observed dose limiting toxicities in early trials for SN-301A, leading to evaluations of lower dosing levels[262] - The gene circuit platform technologies are based on unproven methods, making it difficult to predict development timelines and costs[263] - The company has not initiated clinical trials for any other product candidates beyond SENTI-202 and SENTI-301A[271] - Regulatory approval processes may be complex and time-consuming due to the novelty of the technologies[264] - The company may not be able to access financial resources necessary for continued development of product candidates[259] - Market acceptance of the product candidates may be hindered by skepticism regarding the novel gene circuit technology[278] - The company may not generate or sustain revenue from sales of approved products, as market acceptance of its gene circuit platform technologies depends on various factors[279] - The company faces challenges in identifying additional therapeutic opportunities and developing suitable product candidates due to limited human and financial resources[279] - The company anticipates that chemistry, manufacturing, and control topics will be a focus of IND reviews, potentially delaying future IND submissions[283] - Clinical trials are expected to be expensive and time-consuming, with significant manufacturing and processing costs due to the new technologies involved[289] - Delays in patient enrollment for clinical trials could adversely affect the company's ability to advance product candidates and may increase costs[290] - The company may experience delays in obtaining regulatory approvals, which could impact the commercialization timeline of its product candidates[292] - The company may seek orphan drug designation for certain product candidates, which could provide financial incentives but does not guarantee expedited development or approval[297] - The company acknowledges that interim, topline, or preliminary data from clinical trials may change as more patient data become available, impacting business prospects[285] - The company may not achieve projected discovery and development milestones, which could adversely affect its stock price[288] - Regulatory changes may require the company to modify clinical development plans, impacting costs and timelines[295] - The company may face challenges in realizing anticipated benefits from the transaction with GeneFab, which could adversely affect its business and financial conditions[301] - The company relies on third parties for clinical trials and preclinical studies, which may lead to less control over timelines and quality[303] - The company has entered into a strategic collaboration with Celest Therapeutics for the clinical development of the SENTI-301A gene circuit to treat solid tumors in China[312] - The company may experience loss of institutional knowledge due to employee transfers to GeneFab, potentially harming its business operations[302] - The company is dependent on maintaining current arrangements and establishing new partnerships for the development and commercialization of its gene circuit platform technology[308] - The company may not be able to conduct animal testing in the future, which could harm its research and development activities[300] - The company faces risks related to regulatory compliance and the potential need to repeat clinical trials if third parties do not meet GCP standards[305] - The company’s marketing exclusivity for orphan drugs may be limited if it seeks broader indications or fails to assure sufficient product availability[299] - The company’s ability to enter into strategic transactions on acceptable terms could be adversely affected, impacting its ability to develop and commercialize product candidates[312] - The company may encounter significant operational and financial risks associated with acquiring new technologies and forming strategic alliances[313]

Financial Performance - Senti Bio reported a net loss of $0.6 million, or $0.67 per share, for Q4 2024, compared to a net loss of $18.7 million, or $4.19 per share, in Q4 2023[11]. - Research and development expenses decreased to $7.8 million in Q4 2024 from $9.1 million in Q4 2023, while total operating expenses for the year were $61.0 million, down from $95.3 million in 2023[11][15]. - The total stockholders' equity decreased to $25.6 million as of December 31, 2024, down from $66.9 million in 2023[14]. Cash and Funding - The company raised gross proceeds of approximately $47.6 million from PIPE financing, which is expected to extend its financial runway into 2026[5]. - As of December 31, 2024, Senti Bio held cash and cash equivalents of $48.3 million, an increase from $35.9 million in 2023[14]. - The company received an additional $1.5 million from its $8 million grant from the California Institute for Regenerative Medicines, bringing the total received to $6.4 million[6][7]. - Senti Bio plans to use the net proceeds of $45.1 million from PIPE financing to fund the continued development of the SENTI-202 program and other R&D activities[5]. Clinical Trials - Initial data from the SENTI-202 clinical trial showed that 2 out of 3 AML patients achieved complete remission, with both being MRD negative[4][10]. Leadership Changes - The company expanded its senior leadership team with the appointment of Jay Cross as CFO and Faraz Siddiqui as SVP of Technical Operations[7]. Operating Expenses - General and administrative expenses for Q4 2024 were $8.4 million, down from $9.3 million in Q4 2023[11][15].