Secured strategic financing vehicle for up to $40 million
Positive FDA feedback supports single-arm pivotal trial for potential registration of SENTI-202 in initial indication of Relapsed/Refractory Acute Myeloid Leukemia (R/R AML)
Continued operational streamlining contributed to substantially reduced quarterly net loss and cash burn
SOUTH SAN FRANCISCO, Calif., May 14, 2026 (GLOBE NEWSWIRE) -- Senti Biosciences Holdings, Inc. (Nasdaq: SNTI) (Senti Bio), a clinical-stage biotechnology company developing next-generation cell and gene therapies using its proprietary Gene Circuit platform, today reported financial results for the first quarter ended March 31, 2026, and provided recent business highlights.
"We entered 2026 with a clear focus on advancing SENTI-202 and extending our operational runway while positioning the company for its next phase of clinical development," said Timothy Lu, M.D., Ph.D., Chief Executive Officer and Co-Founder of Senti Bio. "Since the start of the year, we have made meaningful progress across each of these priorities, including a positive regulatory engagement with the FDA on SENTI-202 - a Regenerative Medicine Advanced Therapy (RMAT) designated product - regarding the study design for the planned pivotal trial, execution of a strategic financing agreement that could provide up to $40 million in capital, and continued reductions in operating expenses and cash burn."
Dr. Lu added, "We believe the recent FDA interactions and feedback represent an important milestone for the program and further support the potential of SENTI-202 in relapsed/refractory hematologic malignancies. We remain focused on advancing SENTI-202 efficiently toward the next stage of pivotal development in R/R AML and exploring future combinations with standard of care chemotherapy in newly diagnosed AML patients. We also aim to use our differentiated gene circuit platform to create therapies for additional ex vivo and in vivo CAR therapies."
Recent Business Highlights
SENTI-202 Program Update
Senti Bio concluded a Type B Initial Comprehensive Multidisciplinary RMAT meeting with FDA. Based on the positive outcome of this meeting, Senti Bio has finalized its pivotal clinical and chemistry, manufacturing and controls $(CMC)$ strategy for SENTI-202, which includes a single-arm, multi-center pivotal trial to support registration in R/R AML with SENTI-202 administered after LD chemotherapy. The Company believes the FDA interaction supports continued advancement of SENTI-202 and provides important clarity around a potential registrational development strategy.
In addition, Senti announced that it identified a specific Donor X attribute that correlates with efficacy of SENTI-202, with 50% (7/14) of the patients achieving a composite CR (cCR) when they received any SENTI-202 doses manufactured from Donor X-characteristic derived NK cells in Cycle 1. The Donor X attribute is found in 50% of adult donors, is independent of HLA or KIR matching, and will be used in all future SENTI-202 manufacturing, thus supporting SENTI-202's allogeneic off-the-shelf usage. Senti Bio also announced that SENTI-202 continues to achieve durable MRD-negative responses in the full 22 patient Phase 1 trial that compares favorably with current FDA approved therapies for R/R AML.
Additional details can be found on Senti Bio's website.
Strategic Financing Agreement
In April 2026, Senti Bio entered into a securities purchase agreement with an affiliate of Celadon Partners SPV 24, pursuant to which Senti Biosciences, Inc., the Company's wholly owned subsidiary, may issue up to $40 million aggregate principal amount of senior secured convertible notes in up to two tranches.
The financing includes:
-- An initial $10 million tranche, expected to close in May subject to
specified closing conditions;
-- An additional tranche of up to $30 million, subject to investor election
and additional conditions; and
-- Future potential contingent value rights tied to regulatory and
commercial milestones for SENTI-202 that could provide up to an aggregate
of $60 million in additional value to stockholders.
The Company expects to use proceeds from the financing to support general corporate purposes and advance clinical and manufacturing activities for SENTI-202.
Operational and Financial Restructuring Progress
During the first quarter, Senti Bio completed amendments to its Alameda lease and related GeneFab sublease arrangements, significantly reducing future lease obligations and streamlining operations.
These actions contributed to a $6.9 million gain from lease modification during the quarter and are expected to further reduce the Company's ongoing operating expense profile.
First Quarter 2026 Financial Results
-- Cash Position: Cash and cash equivalents were $8.9 million as of March
31, 2026, compared to $16.4 million as of December 31, 2025.
-- Research and Development Expenses: Research and development expenses were
$5.3 million for the first quarter of 2026, compared to $9.3 million for
the same period in 2025. The decrease was primarily driven by lower
external services and supplies costs.
-- General and Administrative Expenses: General and administrative expenses
were $6.2 million for the first quarter of 2026, compared to $7.1 million
for the same period in 2025. The decrease was primarily driven by lower
external services and supplies costs.
-- Net Loss: Net loss was $4.2 million, or $0.14 per basic and diluted share,
for the first quarter of 2026, compared to a net loss of $14.1 million,
or $1.41 per basic and diluted share, for the first quarter of 2025. Net
loss for the three months ended March 31, 2026 included non-cash
stock-based compensation expense of $1.3 million, offset by a
non-recurring $6.9 million gain on lease modification.
-- Cash Burn: Net cash used in operating activities was $7.5 million during
the first quarter of 2026, compared to $14.1 million during the same
period in 2025, reflecting continued operational discipline and
restructuring actions.
About SENTI-202
SENTI-202 is the first Logic Gated off-the-shelf CAR-NK cell therapy product candidate designed to selectively target and eliminate CD33 and/or FLT3 expressing hematologic malignancies, such as AML and myelodysplastic syndrome (MDS), while sparing healthy bone marrow cells. SENTI-202 has three main components. First, SENTI-202 contains an OR GATE, which is an activating CAR that recognizes and kills CD33 and FLT3 expressing cells. By targeting either or both of these antigens, SENTI-202 is designed to effectively kill both leukemic blasts (that largely express CD33) and leukemic stem cells (that predominantly express FLT3), which constitute a difficult-to-eradicate reservoir of AML disease. Second, SENTI-202 contains a NOT GATE, which is an inhibitory CAR that is designed to recognize EMCN selectively expressed on healthy hematopoietic stem and progenitor cells and protect those healthy cells from being killed even if they express CD33 and/or FLT3, thus potentially widening the therapeutic window. Third, SENTI-202 contains calibrated-release IL-15, which is designed to significantly increase cell persistence, expansion and activity of both the CAR-NK cells and host immune cells. The NK cells used to construct SENTI-202 are sourced from selected healthy adult donors, manufactured, cryopreserved and available off-the-shelf for use as needed. Senti Bio is currently enrolling adult patients with R/R CD33 and/or FLT3 expressing heme malignancies in a Phase 1 clinical trial for SENTI-202, which can be a potential first-in-class allogeneic treatment for AML/MDS patients.
The U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation $(ODD)$ and Regenerative Medicine Advanced Therapy (RMAT) designation to SENTI-202 for the treatment of relapsed/refractory hematologic malignancies including AML.
About Senti Bio
Senti Bio is a clinical stage biotechnology company developing a new generation of cell and gene therapies for patients living with incurable diseases. To achieve this, Senti Bio is leveraging its synthetic biology platform to engineer Gene Circuits into new medicines with enhanced precision and control. These Gene Circuits are designed to precisely kill cancer cells, to spare healthy cells, to increase specificity to target tissues, and/or to be controllable even after administration. The Company's wholly-owned pipeline comprises cell therapies engineered with Gene Circuits to target challenging liquid and solid tumor indications. Senti Bio's Gene Circuits have been shown preclinically to work in both NK and T cells. Senti Bio has also preclinically demonstrated the potential breadth of Gene Circuits in other modalities and diseases outside of oncology, and continues to advance these capabilities through partnerships.
Forward-Looking Statements
This press release and document contain certain statements that are not historical facts and are considered forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements generally are identified by the words "believe," "could," "predict," "continue," "ongoing," "project," "expect, " "anticipate," "estimate," "intend," "strategy," "future," "opportunity, " "plan," "may," "should," "will," "would," "will be," "will continue," "will likely result," "forecast," "seek," "target" and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. Forward-looking statements are predictions, projections, and other statements about future events that are based on current expectations of Senti Bio's management and assumptions, whether or not identified in this document, and, as a result, are subject to risks and
(MORE TO FOLLOW) Dow Jones Newswires
May 14, 2026 08:45 ET (12:45 GMT)
Comments