ADDED
As of March 19, 2026 there were 31,144,497 shares of the registrant s common stock, par value $0.0001 per share, issued and outstanding.
Management's Discussion and Analysis of Financial Condition and Results of Operations 123 Item 7A.
Our pipeline also includes additional preclinical programs: (i) a solid tumor cell therapy program, (ii) our partnered programs related to cell therapies for regenerative medicines with BlueRock Therapeutics, Inc.
Our most advanced program, SENTI-202, originates from our internal pipeline of programs.
SENTI-202 for the Potential Treatment of Hematologic Malignancies including Acute Myeloid Leukemia Overview Our lead product candidate SENTI-202 is a potentially 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, while sparing healthy bone marrow cells, even if they express CD33 and/or FLT3 due to our unique NOT gate design.
We reported clinical data for this trial in 2024 and 2025, which included twenty AML patients treated in our Phase 1 clinical trial protocol (the Phase 1 Patients ).
The initial clinical data showed that of the Phase 1 Patients, there was a 50% overall response rate during our Phase 1 clinical trial, 42% of the Phase 1 Patients achieved a CR/CRh (with 100% of the CRs and 83% of all responses being assessed as measurable residual disease ( MRD ) negative at the recommended phase 2 dose ( RP2D ), with a 7.6 months median duration of composite Complete Remission across all patients.
All patients treated with SENTI-202 showed a favorable safety profile.
On June 18, 2025, we announced that the FDA has granted Orphan Drug Designation to SENTI-202 for the treatment of relapsed/refractory hematologic malignancies including acute myeloid leukemia.
Also, on December 9, 2025, we announced that the FDA has granted SENTI-202 Regenerative Medicine Advanced Therapy ( RMAT ) designation.
REMOVED
As of March 18, 2025 there were 26,004,366 shares of the registrant s common stock, par value $0.0001 per share, issued and outstanding.
Management's Discussion and Analysis of Financial Condition and Results of Operations 122 Item 7A.
In 2024, we initiated a clinical trial of SENTI-202 for blood cancers and our partner, Celest Therapeutics, initiated a clinical trial for SN301A for solid tumors.
The second product candidate SN301A, is a multi-armed, off-the-shelf CAR-NK cell therapy for the treatment of solid tumors currently being studied in an investigator-initiated open-label single-center study for the treatment of hepatocellular carcinoma ( HCC ) in mainland China, in collaboration with Celest Therapeutics.
SN301A utilizes the SENTI-301A gene circuit developed by Senti and refers to the CAR-NK product candidate manufactured by Celest Therapeutics in China.
Our pipeline also includes additional preclinical programs: (i) a solid tumor cell therapy program, (ii) our partnered programs related to gene therapies for tissue-directed targets with Spark Therapeutics, Inc.
Our most advanced programs, SENTI-202 and SENTI-301A, originate from our internal pipeline of programs.
We are pursuing this goal by leveraging our unique approach to programming gene circuits, which we believe may be broadly applicable toward engineering optimal efficacy, precision and control into cell or gene-based medicines, rapidly advancing our pipeline of cell therapies for oncology indications and establishing strategic collaborations/partnerships to support our non-oncology programs and manufacturing.
We reported initial clinical data for this trial on December 2, 2024, which included three AML patients treated at the lowest dose level approved in our Phase 1 clinical trial protocol (the Initial 3 AML Patients ).
The initial clinical data showed that two of the first three AML patients treated achieved complete remission, and both patients in complete remission were also assessed as measurable residual disease ( MRD ) negative after treatment.