Senti Bio's SENTI-202 Shows Promise in AML, Secures FDA Designations

Ticker: SNTI · Form: 10-K · Filed: Mar 27, 2026 · CIK: 0001854270

Sentiment: bullish

Topics: Biotechnology, Cell Therapy, Gene Therapy, Oncology, Acute Myeloid Leukemia, Clinical Stage, FDA Designations

TL;DR

**SNTI's SENTI-202 is a game-changer for AML, with strong Phase 1 data and key FDA designations making it a compelling biotech bet.**

AI Summary

Senti Biosciences, Inc. (SNTI) is a clinical-stage biotechnology company focused on developing next-generation cell and gene therapies using its proprietary gene circuit platform. For the fiscal year ended December 31, 2025, the company's lead product candidate, SENTI-202, a Logic Gated off-the-shelf CAR-NK cell therapy for relapsed/refractory hematological malignancies including Acute Myeloid Leukemia (AML), showed promising Phase 1 clinical trial data. Of twenty AML patients treated, there was a 50% overall response rate, with 42% achieving a CR/CRh and 100% of CRs being MRD negative at the recommended phase 2 dose. The median duration of composite Complete Remission was 7.6 months, and SENTI-202 demonstrated a favorable safety profile. The FDA granted Orphan Drug Designation to SENTI-202 on June 18, 2025, and Regenerative Medicine Advanced Therapy (RMAT) designation on December 9, 2025, based on these Phase 1 results. The company's strategy involves advancing its internal CAR-NK cell therapy pipeline for blood cancers, developing solid tumor cell therapy programs, and leveraging partnerships like the one with BlueRock Therapeutics for regenerative medicines.

Why It Matters

Senti Biosciences' progress with SENTI-202 is critical for investors as it validates their gene circuit platform, potentially de-risking future pipeline assets. The 50% overall response rate and 42% CR/CRh in relapsed/refractory AML patients, a disease with a grim 31.9% five-year survival rate, represent a significant step towards addressing a high unmet medical need. FDA Orphan Drug and RMAT designations could accelerate development and provide market exclusivity, enhancing SNTI's competitive position against other oncology biotechs. Success could offer new hope for AML patients and create substantial value for shareholders, employees, and the broader healthcare market.

Risk Assessment

Risk Level: high — Senti Biosciences is a clinical-stage company with no approved products and relies heavily on the success of its lead candidate, SENTI-202, which is still in Phase 1 clinical trials. The aggregate market value of common stock held by non-affiliates was approximately $53.2 million as of June 30, 2025, indicating a relatively small market capitalization for a biotech, making it susceptible to market volatility and funding challenges. The company also faces inherent risks associated with drug development, including regulatory hurdles and the need for significant additional financing.

Analyst Insight

Investors should closely monitor the ongoing Phase 1 clinical trial results for SENTI-202 and any updates on its path to further clinical development and potential commercialization. Given the high-risk, high-reward nature of clinical-stage biotech, consider SNTI as a speculative investment with potential for significant upside if SENTI-202 continues to demonstrate efficacy and safety in later-stage trials.

Financial Highlights

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Key Numbers

Key Players & Entities

FAQ

What is Senti Biosciences' lead product candidate and its target indication?

Senti Biosciences' lead product candidate is SENTI-202, a Logic Gated off-the-shelf CAR-NK cell therapy. It is designed for the treatment of relapsed/refractory hematological malignancies, specifically Acute Myeloid Leukemia (AML).

What were the key clinical results for SENTI-202 in its Phase 1 trial?

In the Phase 1 clinical trial, SENTI-202 demonstrated a 50% overall response rate among twenty AML patients. Furthermore, 42% of these patients achieved a complete response (CR) or complete response with partial hematologic recovery (CRh), with 100% of CRs being measurable residual disease (MRD) negative at the recommended phase 2 dose.

What FDA designations has Senti Biosciences received for SENTI-202?

Senti Biosciences received Orphan Drug Designation for SENTI-202 from the FDA on June 18, 2025, for relapsed/refractory hematologic malignancies including AML. Additionally, on December 9, 2025, the FDA granted SENTI-202 Regenerative Medicine Advanced Therapy (RMAT) designation.

How does SENTI-202's gene circuit technology work to target cancer cells?

SENTI-202 incorporates a Logic Gated gene circuit with three chimeric proteins. It uses a bivalent CAR as an OR GATE to target CD33 and/or FLT3 on tumor cells, and an inhibitory CAR (iCAR) as a NOT Gate to protect healthy endomucin (EMCN)-expressing cells, even if they also express CD33 and/or FLT3.

What is Senti Biosciences' overall strategic outlook?

Senti Biosciences aims to maintain leadership in cell and gene therapy by advancing its internal CAR-NK cell therapy pipeline for blood cancers, developing solid tumor cell therapy programs, and establishing strategic collaborations for non-oncology programs, such as its partnership with BlueRock Therapeutics for regenerative medicines.

What is the market value of Senti Biosciences' common stock held by non-affiliates?

As of June 30, 2025, the aggregate market value of Senti Biosciences' common stock held by non-affiliates was approximately $53.2 million, based on the closing price on The Nasdaq Capital Market.

What are the key challenges in treating Acute Myeloid Leukemia (AML) that Senti-202 aims to address?

AML has a poor prognosis with a low five-year survival rate of 31.9% due to disease heterogeneity and the insufficiency of therapies targeting single tumor-associated antigens. SENTI-202 aims to overcome this by targeting multiple AML antigens (CD33 and FLT3) and protecting healthy hematopoietic stem cells (HSCs) from on-target/off-tumor toxicity.

How many shares of Senti Biosciences common stock were outstanding as of March 19, 2026?

As of March 19, 2026, there were 31,144,497 shares of Senti Biosciences' common stock, par value $0.0001 per share, issued and outstanding.

What is the significance of the calibrated release interleukin-15 (crIL15) component in SENTI-202?

The crIL15 component in SENTI-202 is an engineered protein designed to express and release cytokines from the cell in a calibrated fashion via a protease. This is believed to stimulate surrounding immune cells and promote CAR-NK cell expansion, persistence, and tumor killing activity.

What are the primary risks for investors in Senti Biosciences?

Primary risks for investors include the company's clinical-stage status with no approved products, reliance on the successful development and regulatory approval of SENTI-202, the need for significant additional financing, and the inherent uncertainties and high failure rates associated with drug development in the biotechnology sector.

Risk Factors

Industry Context

The cell and gene therapy sector is characterized by rapid innovation and significant investment, driven by the potential to offer curative treatments for previously intractable diseases. Key trends include the development of allogeneic ('off-the-shelf') therapies to overcome manufacturing and cost hurdles associated with autologous treatments, and the increasing sophistication of genetic engineering platforms like Senti's gene circuits to enhance therapeutic precision and control. The competitive landscape is intense, with numerous biotech and pharmaceutical companies vying for leadership in oncology and rare diseases.

Regulatory Implications

Senti Biosciences operates in a highly regulated environment. The company's success hinges on navigating complex FDA approval pathways for its novel cell and gene therapies, including demonstrating robust safety and efficacy data for candidates like SENTI-202. Obtaining designations such as Orphan Drug and RMAT is positive but does not guarantee approval, and the company must continue to meet stringent regulatory requirements throughout development and manufacturing.

What Investors Should Do

  1. Monitor clinical trial progress for SENTI-202
  2. Assess the company's cash runway and future financing needs
  3. Evaluate competitive advancements in CAR-NK and gene circuit technologies
  4. Review the terms and progress of strategic partnerships, such as the one with BlueRock Therapeutics

Key Dates

Glossary

Gene Circuit
A synthetic biological system designed to sense inputs, compute decisions, and respond to cellular environments, engineered into cells to control their behavior. (This is the core proprietary technology of Senti Biosciences, enabling the development of 'smarter' cell and gene therapies with enhanced precision and control.)
CAR-NK Cell Therapy
A type of immunotherapy that uses Natural Killer (NK) cells engineered with Chimeric Antigen Receptors (CARs) to target and kill cancer cells. (Senti's lead product candidate, SENTI-202, is a CAR-NK cell therapy, representing a key area of focus for the company's oncology pipeline.)
Off-the-shelf
Refers to cell therapies derived from healthy donor cells that are manufactured in advance and available for immediate use, as opposed to personalized therapies made from a patient's own cells. (Senti's CAR-NK cell therapies, like SENTI-202, are designed as 'off-the-shelf' products, which can potentially reduce manufacturing time and cost compared to autologous therapies.)
Relapsed/Refractory Hematological Malignancies
Blood cancers that have returned after treatment (relapsed) or have not responded to previous therapies (refractory). (This is the target patient population for Senti's lead product candidate, SENTI-202, highlighting a significant unmet medical need.)
Acute Myeloid Leukemia (AML)
A type of cancer of the blood and bone marrow that affects immature white blood cells. (AML is one of the primary indications for which SENTI-202 is being evaluated in clinical trials, with a high unmet medical need as indicated by its low five-year survival rate.)
MRD Negative
Minimal Residual Disease negative, meaning that tests cannot detect any cancer cells remaining in the body after treatment. (Achieving MRD negativity in Complete Remissions for SENTI-202 patients indicates a high level of treatment efficacy and potential for long-term disease control.)
RMAT Designation
Regenerative Medicine Advanced Therapy designation granted by the FDA to expedite the development and review of promising regenerative medicine therapies. (This designation for SENTI-202 suggests strong clinical potential and may lead to faster market access if the therapy proves successful.)

Year-Over-Year Comparison

Information regarding year-over-year comparisons of key financial metrics such as revenue, net income, and margins is not available in the provided text, as this appears to be an initial filing or summary. The filing focuses on the current business operations, pipeline progress, and risk factors. Key developments highlighted include promising Phase 1 data for SENTI-202 and the attainment of Orphan Drug and RMAT designations, which are significant advancements from a clinical and regulatory perspective, rather than financial performance metrics.

Filing Stats: 4,385 words · 18 min read · ~15 pages · Grade level 17.2 · Accepted 2026-03-27 08:06:56

Key Financial Figures

Filing Documents

FORWARD LOOKING STATEMENTS

FORWARD LOOKING STATEMENTS 3 PART I

Risk Factors

Item 1A. Risk Factors 43

Unresolved Staff Comments

Item 1B. Unresolved Staff Comments 120 Item 1C. Cybersecurity 121

Properties

Item 2. Properties 121

Legal Proceedings

Item 3. Legal Proceedings 122

Mine Safety Disclosures

Item 4. Mine Safety Disclosures 122 PART II

Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities

Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 122

[RESERVED]

Item 6. [RESERVED] 122

Management's Discussion and Analysis of Financial Condition and Results of Operations

Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations 123 Item 7A.

Quantitative and Qualitative Disclosures About Market Risk

Quantitative and Qualitative Disclosures About Market Risk 138

Financial Statements and Supplementary Data

Item 8. Financial Statements and Supplementary Data 138

Changes in and Disagreements with Accountants on Accounting and Financial Disclosure

Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure 175

Controls and Procedures

Item 9A. Controls and Procedures 175

Other Information

Item 9B. Other Information 176

Disclosure Regarding Foreign Jurisdictions that Prevent Inspections

Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections 176 PART III

Directors, Executive Officers and Corporate Governance

Item 10. Directors, Executive Officers and Corporate Governance 177

Executive Compensation

Item 11. Executive Compensation 177

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters

Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters 177

Certain Relationships and Related Transactions, and Director Independence

Item 13. Certain Relationships and Related Transactions, and Director Independence 177

Principal Accountant Fees and Services

Item 14. Principal Accountant Fees and Services 177 PART IV

Exhibits and Financial Statement Schedules

Item 15. Exhibits and Financial Statement Schedules 177

Form 10-K Summary

Item 16. Form 10-K Summary 183

SIGNATURES

SIGNATURES 184 2 Table of Contents

FORWARD LOOKING STATEMENTS

FORWARD LOOKING STATEMENTS This Annual Report on Form 10-K ("Annual Report" or "Form 10-K") and some of the information incorporated by reference, includes forward-looking statements regarding, among other things, the plans, strategies, and prospects, both business and financial, of Senti Biosciences, Inc. ("Senti" or the "Company"). These statements are based on the beliefs and assumptions of the management of Senti. Although Senti believes that their respective plans, intentions, and expectations reflected in or suggested by these forward-looking statements are reasonable, it cannot assure you that it will achieve or realize these plans, intentions, or expectations. Forward-looking statements are inherently subject to risks, uncertainties, and assumptions. Generally, statements that are not historical facts, including statements concerning possible or assumed future actions, business strategies, events or results of operations, and any statements that refer to projections, forecasts, or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. These statements may be preceded by, followed by or include the words "believes", "estimates", "expects", "projects", "forecasts", "may", "might", "will", "should", "seeks", "plans", "scheduled", "possible", "anticipates", "intends", "aims", "works", "focuses", "aspires", "strives" or "sets out" or similar expressions. Forward-looking statements are not guarantees of performance. You should not put undue reliance on these statements which speak only as of the date hereof. Forward-looking statements contained in this Annual Report include, for example, statements about: the initiation, cost, timing, progress and results of our clinical trials, preclinical studies or research and development activities with respect to our current and potential future product candidates; the therapeutic potential of our product candidates, and the disease indications for

Business

Item 1. Business Unless the context otherwise requires, for purposes of this section, the terms "we," "us," "our," "our Company," "the Company" or "Senti" refer to Senti Biosciences, Inc. and its subsidiaries. Overview We are a clinical-stage biotechnology company developing next-generation cell and gene therapies engineered with our gene circuit platform technologies for patients living with incurable diseases. Our mission is to create a new generation of smarter medicines that outsmart complex diseases using novel and unprecedented approaches. To accomplish this mission, we have built a synthetic biology platform that we believe may enable us to program next-generation cell and gene therapies with gene circuits. These gene circuits, which we created from novel and proprietary combinations of DNA sequences, are designed to reprogram cells with biological logic to sense inputs, compute decisions and respond to their respective cellular environments. Using gene circuits, our product candidates are designed to precisely kill cancer cells, spare healthy cells, increase specificity to target cells and control the expression of drugs even after administration. We are applying our gene circuit technologies to develop a pipeline of medicines that use chimeric antigen receptor ("CAR") white blood cells with the goal of addressing major challenges and providing potentially lifesaving treatments for people living with cancer. Our lead product candidates utilize off-the-shelf healthy adult donor derived natural killer ("NK") cells to create CAR-NK cells outfitted with gene circuit technologies in several oncology indications with high unmet need. Our Pipeline Our lead product candidate, SENTI-202, is a potentially first-in-class Logic Gated off-the-shelf CAR-NK cell therapy for the treatment of blood cancers currently being studied in an open-label, multi-center Phase 1 clinical trial in the United States and Australia for the treatment of relapsed/refractory hematolog

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