Price Target Changed • Jun 18
Price target increased by 18% to US$13.00 Up from US$11.00, the current price target is an average from 3 analysts. New target price is 1,290% above last closing price of US$0.94. Stock is down 59% over the past year. The company is forecast to post a net loss per share of US$1.05 next year compared to a net loss per share of US$2.73 last year. New Risk • May 17
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 12% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$44m free cash flow). Earnings are forecast to decline by an average of 12% per year for the foreseeable future. Revenue is less than US$1m (US$38k revenue). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$113m net loss in 3 years). Shareholders have been diluted in the past year (19% increase in shares outstanding). Market cap is less than US$100m (US$31.5m market cap). Announcement • May 16
Senti Biosciences Holdings, Inc. Announces Positive FDA RMAT Meeting And Provides Updates On SENTI-202 Clinical Program Senti Biosciences Holdings, Inc. completed a Type B Initial Comprehensive Multidisciplinary Regenerative Medicine Advanced Therapy (RMAT) meeting with the U.S. Food and Drug Administration (FDA) regarding SENTI-202, the Company’s first-in-class Logic Gated off-the-shelf CAR-NK cell therapy for relapsed/refractory acute myeloid leukemia (R/R AML) and updated Phase 1 clinical data. Following the RMAT meeting, the Company has finalized its pivotal clinical and chemistry, manufacturing and controls (CMC) strategy for SENTI-202. The Company plans to implement a single-arm, multi-center pivotal trial intended to support potential SENTI-202 registration in patients with R/R AML. This study is expected to evaluate SENTI-202 administered following lymphodepletion (LD) chemotherapy in a patient population consistent with the Phase 1 trial population. In addition to the positive RMAT meeting, after conducting exploratory efficacy covariate analysis of the Phase 1 trial results, Senti has identified a specific Donor X attribute that correlates with efficacy of SENTI-202, with 50% (7/14) of the patients achieving a cCR when they received any SENTI-202 doses manufactured from Donor X-characteristic-derived NK cells in Cycle 1 versus 12.5% (1/8) achieving a cCR when they received SENTI-202 manufactured from non-Donor X NK cells. As a result of this discovery, all future SENTI-202 manufacturing, including for pivotal study use, will use Donor X material?. The Donor X attribute is found in ~50% of adult donors, and published literature supports increased NK cell cytotoxicity in donors with this phenotype. The Donor X NK phenotype is independent of HLA or KIR matching, thus supporting SENTI-202’s allogeneic off-the-shelf usage. Retrospective analysis of preclinical MV4-11 NSG mouse model data confirmed increased activity and survival with Donor X product. SENTI-202 continues to exhibit durable MRD-negative responses in the full 22 patient Phase 1 trial, which compares favorably with current FDA approved therapies for R/R AML. At RP2D, across all patients receiving a mix of Donor X and non-Donor X material, an ORR of 44% and cCR of 37.5% was observed with 100% of CRs being MRD negative. The complete remissions continue to be durable, with all the CR/CRh responders who were in remission as of the data-cut supporting the oral presentation at the 2025 ASH annual meeting continuing to maintain remission with an additional 7 months of follow up, the longest duration being 21+ months. FDA previously granted RMAT designation to SENTI-202. This program is intended to facilitate the expedited development and review of regenerative medicine therapies addressing serious or life-threatening diseases. Relapsed/refractory AML remains an aggressive hematologic malignancy with limited therapeutic options and poor long-term survival outcomes. Senti Bio believes SENTI-202’s differentiated mechanism, off-the-shelf availability, and encouraging early clinical profile position the program as a potentially important next-generation treatment option for AML patients. Table: Phase 1 SENTI-202-101 Trial R/R AML Patient Efficacy Data Based on Donor Phenotype All Patients? Any Donor X in Cycle 1? No Donor X in Cycle 1? (N=22)? ORR? (Overall Response Rate) 8/14 (57%)? 2/8 (25%)? cCR? 7/14 (50%)? 1/8 (12.5%)?. Vehicle Non-engineered SENTI-202 (NK3) Non-engineered SENTI-202 (NK4) NK (NK3) NK (NK4) Median Survival (d) 56.0 64.0 86.0 112.0 Not Reached. SENTI-202 is a first-in-class Logic Gated off-the-shelf CAR-NK cell therapy designed to selectively target and eliminate CD33 and/or FLT3 expressing hematologic malignancies, including AML and myelodysplastic syndrome (MDS), while sparing healthy bone marrow cells. SENTI-202 incorporates multiple engineered Gene Circuits, including OR GATE and NOT GATE logic systems and calibrated-release IL-15, to improve tumor specificity, persistence, and therapeutic activity. SENTI-202 has received Regenerative Medicine Advanced Therapy (RMAT) designation and Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration. The multinational, multicenter dose-finding study of SENTI-202 (NCT06325748) comprised an initial dose finding using a modified "3+3" study design to determine the maximum tolerated dose (MTD) and/or recommended phase two dose (RP2D) of SENTI-202 when administered after lymphodepleting chemotherapy (Part 1) followed by disease-specific expansion cohorts at the RP2D (Part 2). The primary objectives were to evaluate safety, determine the MTD and RP2D, and assess efficacy in expansion cohorts using ELN 2022 consensus criteria for AML, with key secondary objectives including measurable residual disease assessment, pharmacokinetics, and pharmacodynamics using CyTOF on serial bone marrow samples.