Senti Bio's Phase 1 trial of SENTI-202 shows early promise in treating relapsed/refractory AML patients, with two of three patients achieving complete remission at the lowest dose level. The company also strengthened its financial position with a $47.6 million PIPE financing to advance its innovative gene circuit technology platform.
Two out of three patients with relapsed/refractory acute myeloid leukemia (AML) treated with Senti Bio's novel gene circuit-enabled CAR-NK cell therapy, SENTI-202, have achieved measurable residual disease (MRD) negative complete remission in an ongoing Phase 1 clinical trial. Both patients continue to maintain their remission status, according to the company's latest update.
"With initial data from the clinical trial of SENTI-202, we are getting a glimpse into the potential profile of our gene circuit-enabled CAR-NK therapy for patients with AML. As we look toward 2025, we anticipate sharing additional data from this exciting trial," said Timothy Lu, MD, PhD, Chief Executive Officer and Co-Founder of Senti Bio.
Early Clinical Results Show Promise
The initial data comes from the lowest dose level (1.0 billion CAR+ NK cells per dose) and lowest dose schedule (3 doses per cycle) of the Phase 1 clinical trial (NCT06325748). The two patients who achieved complete remission, confirmed by bone marrow biopsy, showed both blast reduction and recovery of blood cells to normal ranges. Importantly, both were assessed as MRD-negative after treatment, meaning no detectable cancer cells were present in bone marrow samples using the most sensitive locally available detection methods.
Across all three patients included in the initial data, SENTI-202 was generally well-tolerated, with an adverse event profile consistent with the use of lymphodepleting chemotherapy in patients with AML.
Innovative Gene Circuit Technology
SENTI-202 represents a new approach to cell therapy using Senti Bio's proprietary Gene Circuit platform. These Gene Circuits are designed to precisely target and kill cancer cells while sparing healthy cells, increase specificity to target cells, and control the expression of therapeutic proteins even after administration.
The company's lead program, SENTI-202, specifically targets CD33 and/or FLT3, which are commonly expressed on AML cells. The therapy uses logic gates to improve targeting precision, potentially offering advantages over conventional approaches.
Financial Position Strengthened
In December 2024, Senti Bio raised gross proceeds of approximately $47.6 million through a private investment in public equity (PIPE) financing. The financing was led by Celadon Partners, with participation from New Enterprise Associates (NEA), Leaps by Bayer, Nantahala Capital, The Red Hook Fund LP, and other institutional and accredited investors.
The company expects this financing to extend its financial runway into 2026. Net proceeds of $45.1 million will fund continued development of the SENTI-202 program, manufacturing scale-up, other research and development activities, and general corporate purposes.
"We are also grateful to have continued support from our investors, including those who participated in our successful PIPE financing in December 2024, and we look forward to demonstrating the potential of our next-generation cell therapies in oncology," added Dr. Lu.
Additional Funding and Leadership Expansion
In January 2025, Senti Bio received an additional $1.5 million from its $8 million grant from the California Institute for Regenerative Medicines (CIRM), bringing the total CIRM funding received to $6.4 million.
The company has also expanded its leadership team with strategic hires, including Jay Cross as Chief Financial Officer and Faraz Siddiqui as Senior Vice President of Technical Operations. Additionally, Fran Schulz and Feng Hsiung were appointed to the Board of Directors, bringing expertise in finance, strategic planning, operations, and investment management.
Financial Results
As of December 31, 2024, Senti Bio held cash and cash equivalents of $48.3 million. Research and development expenses were $7.8 million for the fourth quarter of 2024, down from $9.1 million for the same period in 2023, primarily due to headcount reductions as the company streamlined operations to prioritize SENTI-202. For the full year of 2024, R&D expenses totaled $34.4 million.
General and administrative expenses were $8.4 million for the fourth quarter of 2024, compared to $9.3 million for the same period in 2023. The company reported a net loss of $0.6 million, or $0.67 per basic and diluted share, for the fourth quarter of 2024. Net loss for the full year 2024 was $52.8 million, or $12.03 per share.
Future Outlook
Senti Bio's pipeline includes off-the-shelf CAR-NK cells equipped with Gene Circuits targeting both liquid and solid tumors. The company has also demonstrated preclinically that its Gene Circuits can function in T cells against solid tumor targets and has shown potential applications in other cell and gene therapy modalities beyond oncology.
As the company continues to advance its SENTI-202 clinical trial, additional data is expected in 2025, which could further validate the potential of its gene circuit technology platform in addressing significant unmet needs in cancer treatment.
