Senti Bio (NASDAQ: SNTI) wins FDA RMAT backing and lines up $40M funding
Filing Impact
Filing Sentiment
Form Type
8-K
Rhea-AI Filing Summary
Senti Biosciences Holdings reported first quarter 2026 results and key progress for its lead program SENTI-202. Net loss narrowed to $4.2 million versus $14.1 million a year earlier as operating expenses declined, helped by a $6.9 million gain from lease modifications and lower R&D and G&A spending. Cash and cash equivalents were $8.9 million on March 31, 2026, with net cash used in operating activities of $7.5 million.
The company highlighted a positive FDA RMAT meeting that supports a single-arm, multi-center pivotal trial of SENTI-202 in relapsed/refractory AML after lymphodepleting chemotherapy. Phase 1 data showed a 50% composite complete remission rate in patients receiving Donor X–derived NK cells versus 12.5% with non–Donor X material, with all complete remissions MRD-negative and durable up to 21+ months. Senti also secured a strategic financing vehicle for up to $40 million in senior secured convertible notes and outlined potential additional $60 million in contingent value rights tied to SENTI-202 milestones.
Positive
- FDA RMAT meeting supports pivotal SENTI-202 trial: Alignment on a single-arm, multi-center registrational strategy in relapsed/refractory AML materially advances the lead program toward potential approval.
- Compelling early SENTI-202 efficacy and durability signals: Donor X–derived product achieved a 50% composite CR rate with all CRs MRD-negative and durable up to 21+ months in the Phase 1 trial.
- Up to $40M strategic financing plus $60M CVR potential: The senior secured convertible note facility and contingent value rights provide a defined pathway to additional capital tied to SENTI-202 milestones.
- Significant improvement in quarterly loss and cash burn: Net loss shrank from $14.1M to $4.2M and operating cash use from $14.1M to $7.5M, reflecting restructuring and cost reductions.
Negative
- Limited cash relative to ongoing losses: Cash and cash equivalents were $8.9M as of March 31, 2026, against continued net losses and operating cash outflows, reinforcing dependence on external financing.
Insights
Positive FDA feedback and strengthened SENTI-202 data advance Senti toward a pivotal AML trial.
Senti Bio secured successful RMAT discussions with the FDA, aligning on a single-arm, multi-center pivotal trial for SENTI-202 in relapsed/refractory AML. This moves the program from early proof-of-concept toward a potential registrational study, an important inflection for a small clinical-stage company.
Phase 1 results appear encouraging: patients receiving Donor X–derived SENTI-202 showed a 50% composite CR rate versus 12.5% with non–Donor X material, and all complete remissions were MRD-negative with durability up to 21+ months. The Donor X phenotype is present in roughly half of adult donors and is independent of HLA or KIR matching, which supports allogeneic, off-the-shelf manufacturing.
While these data come from a small trial, they provide a coherent efficacy and durability story plus a biologically plausible donor-selection strategy. Actual impact will depend on execution of the pivotal trial and whether larger datasets reproduce the response rates and safety profile described here.
Reduced losses and a $40M convertible note facility ease near-term funding pressure.
For Q1 2026, Senti Bio cut net loss to $4.2M from $14.1M, driven by lower R&D and G&A plus a one-time $6.9M lease-modification gain. Operating cash burn improved to $7.5M, and cash stood at $8.9M on March 31, 2026.
A new securities purchase agreement allows issuance of up to $40M in senior secured convertible notes in two tranches, alongside potential $60M in contingent value rights tied to SENTI-202 milestones. This structure provides access to additional capital but adds secured, convertible debt features investors must weigh against existing equity.
Given modest cash and ongoing losses, this financing path and continued cost controls are central to funding the pivotal SENTI-202 program. Subsequent disclosures will be important to see actual drawdown of the facility and resulting balance sheet effects.
8-K Event Classification
3 items: 2.02, 8.01, 9.01
3 items
Item 2.02
Results of Operations and Financial Condition
Financial
Disclosure of earnings results, typically an earnings press release or preliminary financials.
Item 8.01
Other Events
Other
Voluntary disclosure of events the company deems important to shareholders but not covered by other items.
Item 9.01
Financial Statements and Exhibits
Exhibits
Financial statements, pro forma financial information, and exhibit attachments filed with this report.
Key Figures
Cash and cash equivalents: $8.9M
Net loss: $4.2M
Net cash used in operating activities: $7.5M
+5 more
8 metrics
Cash and cash equivalents
$8.9M
As of March 31, 2026
Net loss
$4.2M
Q1 2026 vs $14.1M in Q1 2025
Net cash used in operating activities
$7.5M
Q1 2026 operating cash burn
Strategic financing capacity
$40M
Senior secured convertible notes facility
Potential contingent value rights
$60M
Value tied to SENTI-202 milestones
Gain on lease modification
$6.9M
Recognized in Q1 2026 from lease changes
R&D expenses
$5.3M
Q1 2026 research and development spending
Composite CR rate with Donor X
50%
Phase 1 SENTI-202 patients receiving Donor X-derived NK cells
Key Terms
Regenerative Medicine Advanced Therapy (RMAT), CAR-NK cell therapy, composite CR (cCR), measurable residual disease (MRD), +2 more
6 terms
Regenerative Medicine Advanced Therapy (RMAT) regulatory
"successful completion of a Type B Initial Comprehensive Multidisciplinary Regenerative Medicine Advanced Therapy (RMAT) meeting"
A Regenerative Medicine Advanced Therapy (RMAT) is a U.S. regulatory designation for cell, gene and tissue-based treatments addressing serious or life-threatening conditions that shows early evidence of potential benefit. Think of it as a VIP lane with extra access to the regulator — more interaction, guidance and faster review — which can shorten development time and lower costs, making a program more valuable to investors, though it does not guarantee approval.
CAR-NK cell therapy medical
"first-in-class Logic Gated off-the-shelf CAR-NK cell therapy for relapsed/refractory acute myeloid leukemia"
CAR-NK cell therapy uses a patient's or donor immune cells called natural killer (NK) cells that are genetically equipped with a targeting receptor (CAR) to find and destroy cancer cells. Think of it as giving trained guard dogs a custom scent to track intruders; the approach can be faster to deploy and potentially safer than some other cell therapies. Investors care because successful CAR-NK programs can drive clinical trial milestones, regulatory approvals, and scalable product models that affect company value and future revenue.
composite CR (cCR) medical
"50% (7/14) of the patients achieving a cCR when they received any SENTI-202 doses manufactured from Donor X-characteristic-derived NK cells"
measurable residual disease (MRD) medical
"deep and durable MRD-negative complete remissions"
Measurable residual disease (mrd) is the small number of cancer cells that remain in a patient after treatment and can be detected only with very sensitive laboratory tests. Like finding a few hidden weeds after you think a garden is cleared, MRD signals the risk that disease may return and is used to judge how well a therapy worked, guide follow-up treatment, and influence clinical trial results and regulatory decisions—factors that can affect a drug’s commercial value.
senior secured convertible notes financial
"may issue up to $40 million aggregate principal amount of senior secured convertible notes in up to two tranches"
A senior secured convertible note is a loan a company issues that sits near the top of its repayment order (senior), is backed by specific assets as collateral (secured), and can be swapped into company shares later (convertible). For investors this matters because it combines lower risk of repayment and legal protection from the collateral with the upside of converting into equity—so it affects both the safety of debt holders and potential dilution for shareholders.
contingent value rights financial
"contingent value rights tied to regulatory and commercial milestones for SENTI-202 that could provide up to an aggregate of $60 million"
Contingent value rights are special financial instruments that give their holder the potential to receive additional payments if certain future events or conditions happen, such as the achievement of specific business milestones. They are like a promise of extra rewards that depend on how well a project or company performs later on. Investors care about them because they offer a chance for extra gains but also carry uncertainty, as the extra payments are not guaranteed.
Earnings Snapshot
Revenue - related party: $16K
Q1 2026
Revenue - related party
$16K
Net loss
$4.2M
R&D expenses
$5.3M
G&A expenses
$6.2M
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
___________________________________
FORM 8-K
___________________________________
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): May 14, 2026
___________________________________
(Exact name of Registrant as specified in its charter)
___________________________________
(State or other jurisdiction of incorporation) | (Commission File Number) | (IRS Employer Identification No.) | ||||||||||||
(Address of principal executive offices including zip code)
Registrant’s telephone number, including area code: (650 ) 239-2030
(Former name or former address, if changed since last report)
___________________________________
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) | |||||
| Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) | |||||
| Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) | |||||
| Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) | |||||
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol | Name of each exchange on which registered | ||||||||||||
The | ||||||||||||||
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☒
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☒
Item 2.02 Results of Operations and Financial Condition.
On May 14, 2026 , Senti Biosciences Holdings, Inc. (the “Company”) issued a press release announcing its financial results for the quarter ended March 31, 2026. A copy of the press release is being furnished as Exhibit 99.1 to this Report on Form 8-K.
In accordance with General Instruction B.2. of Form 8-K, the information in this Item 2.02 of Form 8-K and Exhibit 99.1 attached hereto is furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended.
Item 8.01. Other Events
On May 14, the Company issued a press release announcing certain clinical data and regulatory interactions related to its product SENTI-202. A copy of the press release is being furnished as Exhibit 99.2 to this Report on Form 8-K.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
| Exhibit No. | Description | |||||||
| 99.1 | Press Release, dated May 14, 2026 | |||||||
| 99.2 | Press Release, dated May 14, 2026 | |||||||
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) | |||||||
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| SENTI BIOSCIENCES, INC. | |||||||||||||||||
| Date: | By: | /s/ Timothy Lu | |||||||||||||||
| Name: | Timothy Lu, M.D., Ph.D. | ||||||||||||||||
| Title: | Chief Executive Officer | ||||||||||||||||
Exhibit 99.1
Senti Biosciences Holdings Reports First Quarter 2026 Financial Results and Highlights Advancement of SENTI-202 Program into Pivotal Phase
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 (https://investors.sentibio.com/press-releases).
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 uncertainties. Forward-looking statements include, but are not limited to, expectations regarding Senti Bio’s future results. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as and must not be relied on by any investor as, a guarantee, an assurance, a prediction, or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and will differ from assumptions. Many actual events and circumstances are beyond the control of Senti Bio. Many factors could cause actual future results to differ materially from the forward-looking statements in this document, including but not limited to: (i) changes in domestic and foreign business, market, financial, political and legal conditions, (ii) changes in the competitive and highly regulated industries in which Senti Bio operates, variations in operating performance across competitors, changes in laws and regulations affecting Senti Bio’s business, (iii) the ability to implement business plans, forecasts and other expectations, (iv) the risk of downturns and a changing regulatory landscape in Senti Bio’s highly competitive industry, (v) risks relating to the uncertainty of any projected financial information with respect to Senti Bio, (vi) risks related to uncertainty in the timing or results of Senti Bio’s , clinical studies, patient enrollment, and GMP manufacturing startup activities, (vii) Senti Bio’s dependence on third parties in connection with clinical studies, and GMP manufacturing activities, (viii) risks related to delays and other impacts from macroeconomic and geopolitical events, increasing rates of inflation and rising interest rates on business operations, (ix) risks related to the timing and utilization of the grant from CIRM, and (x) the success of any future research and development efforts by Senti Bio. The foregoing list of factors is not exhaustive. You should carefully consider the foregoing factors and the other risks and uncertainties described in the “Risk Factors” section of Senti Bio’s most recent annual report filed with the U.S. Securities and Exchange Commission (“SEC”), and other documents filed by Senti Bio from time to time with the SEC. These filings identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements in this document. There may be additional risks that Senti Bio does not presently know, or that Senti Bio currently believes are immaterial that could also cause actual results to differ from those contained in the forward-looking statements in this document. Forward-looking statements speak only as of the date they are made. Senti Bio anticipates that subsequent events and developments may cause Senti Bio’s assessments to change. Except as required by law, Senti Bio assumes no obligation to
update publicly any forward-looking statements, whether as a result of new information, future events, or otherwise.
Availability of Other Information About Senti Biosciences Holdings, Inc.
For more information, please visit the Senti Bio website at www.sentibio.com or follow Senti Bio on X (@SentiBio) (https://x.com/sentibio) and LinkedIn (Senti Biosciences) (https://www.linkedin.com/company/senti-biosciences). Investors and others should note that we communicate with our investors and the public using our company website (www.sentibio.com), including, but not limited to, company disclosures, investor presentations and FAQs, Securities and Exchange Commission filings, press releases, public conference call transcripts and webcast transcripts, as well as on X (https://x.com/sentibio) and LinkedIn (https://www.linkedin.com/company/senti-biosciences). The information that we post on our website or on X (https://x.com/sentibio) or LinkedIn (https://www.linkedin.com/company/senti-biosciences) could be deemed to be material information. As a result, we encourage investors, the media and others interested to review the information that we post there on a regular basis. The contents of our website or social media shall not be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended.
Investor Contact:
JTC Team, LLC
Jenene Thomas
(908) 824-0775
SNTI@jtcir.com
SENTI BIOSCIENCES HOLDINGS, INC.
Unaudited Selected Consolidated Balance Sheet Data
(In thousands)
| March 31, | December 31, | ||||||||||
| 2026 | 2025 | ||||||||||
| Cash and cash equivalents | $ | 8,935 | $ | 16,420 | |||||||
| Total assets | 38,241 | 51,223 | |||||||||
| Total liabilities | 35,676 | 45,634 | |||||||||
| Accumulated deficit | (362,793) | (358,572) | |||||||||
| Total stockholders’ equity | 2,565 | 5,589 | |||||||||
SENTI BIOSCIENCES HOLDINGS, INC.
Unaudited Condensed Consolidated Statements of Operations and Comprehensive Loss
(In thousands, except share and per share amounts)
| Three Months Ended March 31, | |||||||||||
| 2026 | 2025 | ||||||||||
| Revenue - related party | $ | 16 | $ | — | |||||||
| Operating expenses: | |||||||||||
Research and development (including related party costs of $282 and $4,070 for the three months ended March 31, 2026 and 2025, respectively) | 5,281 | 9,281 | |||||||||
| General and administrative | 6,233 | 7,116 | |||||||||
| Gain on lease modification | (6,882) | — | |||||||||
| Total operating expenses | 4,632 | 16,397 | |||||||||
| Loss from operations | (4,616) | (16,397) | |||||||||
| Other income: | |||||||||||
| Interest income | 101 | 394 | |||||||||
| GeneFab sublease income - related party | 80 | 1,713 | |||||||||
| Other income, net | 214 | 178 | |||||||||
| Total other income, net | 395 | 2,285 | |||||||||
| Net loss | $ | (4,221) | $ | (14,112) | |||||||
| Comprehensive loss | $ | (4,221) | $ | (14,112) | |||||||
| Basic and diluted net loss per share | $ | (0.14) | $ | (1.41) | |||||||
| Basic and diluted weighted-average number of shares used in computing net loss per share | 30,971,573 | 10,012,908 | |||||||||
Exhibit 99.2
Senti Biosciences Holdings Announces Positive FDA RMAT Meeting on Registrational Clinical and CMC Strategy for SENTI-202 in Relapsed/Refractory AML, Along with Important Efficacy and Durability Updates on the SENTI-202 Clinical Program
Following a Type B meeting with FDA, Senti Bio plans to proceed with a single-arm multi-center registrational trial for SENTI-202, building off the strong Phase 1 clinical results demonstrating deep and durable MRD-negative complete remissions
To further optimize SENTI-202 efficacy, the selection criteria for donors for all future manufacturing will include the “Donor X” phenotype
Phase 1 clinical trial patients receiving SENTI-202 from Donor X-derived NK cells achieved a 50% composite CR (cCR) rate
SOUTH SAN FRANCISCO, Calif. — May 14, 2026 — Senti Biosciences Holdings, 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 the successful completion of 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 (see Table below). 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 (see Figure below).
Senti Bio also announced that 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.
“This positive FDA RMAT meeting marks a transformational moment for Senti Bio and significantly advances our path toward potential registration of SENTI-202,” said Tim Lu, M.D., Ph.D., Chief Executive Officer and Co-Founder of Senti Bio. “This news, combined with the compelling clinical responses observed to date that led to refinements in our donor selection strategy, positions us to advance SENTI-202 toward a potential registrational study in relapsed/refractory AML. We believe this milestone further validates both our Gene Circuit platform and the differentiated therapeutic potential of Logic Gated cell therapies.”
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.
“The FDA feedback provides important clarity around our registrational development strategy and further supports our conviction in the SENTI-202 program,” said Kanya Rajangam, M.D., Ph.D., Chief Medical Officer of Senti Bio. “The excellent clinical activity observed thus far, including MRD-negative durable complete remissions alongside a favorable safety profile, gives us confidence as we transition toward later-stage development. We are focused on rapidly implementing the pivotal study while also exploring potential expansion opportunities in newly diagnosed AML and pediatric AML. Since the filing of our IND, Senti has focused on donor selection to minimize variability. We are in a strong position as we prepare for our clinical trials with the identification of a donor phenotype that correlates with increased activity and continues to support SENTI-202’s allogeneic manufacturing.”
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 (N=22) | Any Donor X in Cycle 1 | No Donor X in Cycle 1 | ||||||
| ORR (Overall Response Rate) | 8/14 (57%) | 2/8 (25%) | ||||||
| cCR | 7/14 (50%) | 1/8 (12.5%) | ||||||
Vehicle | Non-engineered NK (NK3) | SENTI-202 (NK3) | Non-engineered NK (NK4) | SENTI-202 (NK4) | |||||||||||||
Median Survival (d) | 56.0 | 64.0 | 86.0 | 112.0 | Not Reached | ||||||||||||
Figure: Retrospective analysis of preclinical MV4-11 NSG mouse model data confirms increased activity and survival with SENTI-202 made from Donor X product. Donor X characteristic was confirmed post-hoc | |||||||||||||||||
About SENTI-202
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.
About the Phase 1 Study
The multinational, multicenter dose-finding study of SENTI-202 (NCT06325748) (https://clinicaltrials.gov/study/NCT06325748?cond=NCT06325748&rank=1) 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. For more information visit clinicaltrials.gov (https://clinicaltrials.gov/)
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 uncertainties. Forward-looking statements include, but are not limited to, expectations regarding Senti Bio’s future results. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as and must not be relied on by any investor as, a guarantee, an assurance, a prediction, or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and will differ from assumptions. Many actual events and circumstances are beyond the control of Senti Bio. Many factors could cause actual future results to differ materially from the forward-looking statements in this document, including but not limited to: (i) changes in domestic and foreign business, market, financial, political and legal conditions, (ii) changes in the competitive and highly regulated industries in which Senti Bio operates, variations in operating performance across competitors, changes in laws and regulations affecting Senti Bio’s business, (iii) the ability to implement business plans, forecasts and other expectations, (iv) the risk of downturns and a changing regulatory landscape in Senti Bio’s highly competitive industry, (v) risks relating to the uncertainty of any projected financial information with respect to Senti Bio, (vi) risks related to uncertainty in the timing or results of Senti Bio’s , clinical studies, patient enrollment, and GMP manufacturing startup activities, (vii) Senti Bio’s dependence on third parties in connection with clinical studies, and GMP manufacturing activities, (viii) risks related to delays and other impacts from macroeconomic and geopolitical events, increasing rates of inflation and rising interest rates on business operations, (ix) risks related to the timing and utilization of the grant from CIRM, and (x) the success of any future research and development efforts by Senti Bio. The foregoing list of factors is not exhaustive. You should carefully consider the foregoing factors and the other risks and uncertainties described in the “Risk Factors” section of Senti Bio’s most recent annual report filed with the U.S. Securities and Exchange Commission (“SEC”), and other documents filed by Senti Bio from time to time with the SEC. These filings identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements in this document. There may be additional risks that Senti Bio does not presently know, or
that Senti Bio currently believes are immaterial that could also cause actual results to differ from those contained in the forward-looking statements in this document. Forward-looking statements speak only as of the date they are made. Senti Bio anticipates that subsequent events and developments may cause Senti Bio’s assessments to change. Except as required by law, Senti Bio assumes no obligation to update publicly any forward-looking statements, whether as a result of new information, future events, or otherwise.
Availability of Other Information About Senti Biosciences Holdings, Inc.
For more information, please visit the Senti Bio website at www.sentibio.com or follow Senti Bio on X (@SentiBio) (https://x.com/sentibio) and LinkedIn (Senti Biosciences) (https://www.linkedin.com/company/senti-biosciences). Investors and others should note that we communicate with our investors and the public using our company website (www.sentibio.com), including, but not limited to, company disclosures, investor presentations and FAQs, Securities and Exchange Commission filings, press releases, public conference call transcripts and webcast transcripts, as well as on X (https://x.com/sentibio) and LinkedIn (https://www.linkedin.com/company/senti-biosciences). The information that we post on our website or on X (https://x.com/sentibio) or LinkedIn (https://www.linkedin.com/company/senti-biosciences) could be deemed to be material information. As a result, we encourage investors, the media and others interested to review the information that we post there on a regular basis. The contents of our website or social media shall not be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended.
Investor Contact:
JTC Team, LLC
Jenene Thomas
(908) 824-0775
SNTI@jtcir.com
FAQ
How did Senti Biosciences Holdings (SNTI) perform financially in Q1 2026?
Senti Bio reduced its Q1 2026 net loss to $4.2 million, down from $14.1 million a year earlier. Operating cash burn improved to $7.5 million, and cash and cash equivalents were $8.9 million as of March 31, 2026, reflecting restructuring and cost controls.
What are the key FDA developments for Senti Biosciences’ SENTI-202 program?
The FDA held a positive RMAT Type B meeting with Senti Bio and aligned on a single-arm, multi-center pivotal trial of SENTI-202 in relapsed/refractory AML. This meeting clarified the registrational clinical and CMC strategy, supporting advancement toward potential registration for this allogeneic CAR-NK therapy.
What efficacy results did Senti Biosciences (SNTI) report for SENTI-202 in AML?
In the Phase 1 trial, patients receiving SENTI-202 from Donor X–derived NK cells achieved a 50% composite CR rate (7/14) versus 12.5% (1/8) with non–Donor X material. At RP2D, overall response rate was 44%, with 37.5% cCR and all complete remissions MRD-negative.
What is the new financing arrangement Senti Biosciences announced?
Senti Bio entered a securities purchase agreement enabling issuance of up to $40 million in senior secured convertible notes in two tranches. It also outlined potential $60 million in contingent value rights linked to SENTI-202 regulatory and commercial milestones, supporting general corporate and development needs.
How is Senti Biosciences (SNTI) managing its operating expenses and cash burn?
Senti Bio lowered Q1 2026 R&D expenses to $5.3 million and G&A to $6.2 million, down from $9.3 million and $7.1 million respectively. A $6.9 million gain from lease modifications and streamlined operations helped cut net cash used in operating activities to $7.5 million.
What is the Donor X phenotype and why is it important for SENTI-202?
Donor X is a specific NK cell phenotype associated with higher SENTI-202 efficacy, found in roughly 50% of adult donors. In the Phase 1 trial, Donor X–derived product produced a 50% composite CR rate. All future SENTI-202 manufacturing for pivotal studies will use Donor X material.