Senti Biosciences Participates in Virtual Investor CEO Connect Segment to Discuss the Company’s Groundbreaking AML Data at the American Society of Hematology Annual Meeting and Recently Granted RMAT Designation

Rhea-AI Summary

Senti Biosciences (Nasdaq: SNTI) participated in a Virtual Investor CEO Connect segment on Jan 14, 2026, where CEO Timothy Lu discussed two regulatory milestones and new clinical data. The U.S. FDA granted RMAT designation to SENTI-202, a potential first-in-class logic gated off-the-shelf CAR-NK investigational therapy for relapsed/refractory hematologic malignancies including AML, building on an Orphan Drug designation awarded in June. Dr. Lu also reviewed data from 20 patients (18 with evaluable responses) in the ongoing multinational SENTI-202 trial, with results presented at the American Society of Hematology (ASH) Annual Meeting.

Positive

• RMAT designation granted for SENTI-202 by FDA
• Orphan Drug designation previously awarded in June
• Clinical data from 20 patients (18 evaluable) presented at ASH

Negative

• Dataset limited to 20 patients (only 18 evaluable), limiting statistical confidence
• SENTI-202 remains in ongoing development, not approved or commercially available

News Market Reaction

+3.77%

1 alert

+3.77% News Effect

On the day this news was published, SNTI gained 3.77%, reflecting a moderate positive market reaction.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

Patients enrolled: 20 patients Evaluable patients: 18 patients

2 metrics

Patients enrolled 20 patients Ongoing multinational SENTI-202 clinical trial in relapsed/refractory AML

Evaluable patients 18 patients Patients with evaluable responses in SENTI-202 AML trial

Market Reality Check

Price: $1.08 Vol: Volume 250,433 is below 2...

low vol

$1.08 Last Close

Volume Volume 250,433 is below 20-day average of 444,667 (relative volume 0.56). low

Technical Shares at $1.06 are trading below the 200-day MA of $2.16, near the 52-week low of $1.04 and well below the 52-week high of $5.10.

Peers on Argus

SNTI is down 5.36% while peers show mixed moves: LSB down 20.62%, LVTX down 3.87...

SNTI is down 5.36% while peers show mixed moves: LSB down 20.62%, LVTX down 3.87%, MRSN up 0.62%, IPSC up 5.39%, and MURA flat. This points to a stock-specific move rather than a sector-wide pattern.

Historical Context

5 past events · Latest: Jan 09 (Positive)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Jan 09	Conference participation	Positive	+2.8%	CEO panel appearance on advances in cell and gene therapies.
Dec 18	Equity compensation	Neutral	+2.6%	Inducement stock options granted to a new employee.
Dec 09	Regulatory designation	Positive	-35.6%	FDA RMAT designation for SENTI-202 in R/R AML.
Dec 09	Clinical data update	Positive	-35.6%	Updated Phase 1 SENTI-202 data showing favorable efficacy and safety.
Dec 04	Conference call	Neutral	+0.9%	Announcement of webcast to discuss upcoming ASH SENTI-202 data.

Pattern Detected

Recent high-impact SENTI-202 clinical and RMAT updates with positive framing were followed by a sharp -35.56% selloff, suggesting a pattern of negative price reactions to positive clinical/regulatory news.

Recent Company History

Over the last six weeks, Senti Bio has focused investor attention on SENTI-202 and its gene circuit platform. A December 2025 conference call highlighted upcoming ASH data, followed by updated Phase 1 results in 20 AML patients and an FDA RMAT designation; despite positive data, shares fell 35.56%. Subsequent routine items, including inducement grants and participation in the Biotech Showcase panel, saw modest gains. Today’s CEO discussion of ASH data and RMAT at a Virtual Investor segment fits this ongoing SENTI-202 narrative.

Market Pulse Summary

This announcement reiterates key elements of Senti Bio’s story: SENTI-202’s RMAT and Orphan Drug des...

Analysis

This announcement reiterates key elements of Senti Bio’s story: SENTI-202’s RMAT and Orphan Drug designations and updated ASH data from 20 relapsed/refractory AML patients, including 18 with evaluable responses. It extends the sequence of SENTI-202-focused updates seen in December 2025. Investors following the narrative may watch for future clinical updates, financing developments from recent SEC filings, and how management addresses previously disclosed going-concern risks.

Key Terms

regenerative medicine advanced therapy (rmat) designation, orphan drug designation, chimeric antigen receptor, car-nk, +2 more

6 terms

regenerative medicine advanced therapy (rmat) designation regulatory

"the U.S. Food and Drug Administration (FDA) granted Regenerative Medicine Advanced Therapy (RMAT) designation"

A Regenerative Medicine Advanced Therapy (RMAT) designation is a U.S. regulatory status given to certain cell, gene, or tissue-based treatments that show promise for serious conditions and early clinical evidence of benefit. It signals that regulators will provide extra guidance and expedited review steps—like giving a promising project a “fast pass” through some development checkpoints—which can shorten time to market and reduce regulatory risk, making the program more valuable and noteworthy to investors.

orphan drug designation regulatory

"The RMAT designation builds on the Orphan Drug Designation that the FDA granted SENTI-202 in June."

Orphan drug designation is a special status given to medicines developed to treat rare diseases affecting only a small number of people. This status often provides benefits like faster approval processes and financial incentives, making it more attractive for companies to develop these drugs. For investors, it signals potential for exclusive market rights and reduced competition, which can impact the drug’s profitability.

chimeric antigen receptor medical

"Logic Gated off-the-shelf chimeric antigen receptor natural killer (CAR-NK) investigational cell therapy"

A chimeric antigen receptor is an engineered protein added to a patient’s immune cells that gives them a new, specific ability to recognize and attack cells carrying a particular marker (antigen) — like equipping police with a facial‑recognition app to find a suspect. For investors, CARs are the core technology behind targeted cell therapies: their clinical success, manufacturing complexity, safety profile, and regulatory approval determine treatment market potential, development costs, and company value.

car-nk medical

"off-the-shelf chimeric antigen receptor natural killer (CAR-NK) investigational cell therapy"

CAR‑NK are immune cells (natural killer cells) that have been genetically given a chimeric antigen receptor so they can home in on and destroy specific diseased cells, typically cancer. Think of it like equipping a guard with GPS coordinates for a target: it makes the cell better at finding and killing the enemy. Investors watch CAR‑NK programs because they offer potential for powerful, off‑the‑shelf therapies with different safety and manufacturing profiles than traditional drugs, which can drive company value but also carry clinical and regulatory risk.

hematologic malignancies medical

"for the treatment of relapsed/refractory hematologic malignancies, including AML."

Hematologic malignancies are types of cancers that start in the blood or the organs responsible for blood production, like the bone marrow and lymph nodes. They matter because they can disrupt normal blood functions, leading to issues like weakness, infections, or abnormal growths, and often require specialized treatments.

acute myeloid leukemia (aml) medical

"including AML. The RMAT designation builds on the Orphan Drug Designation"

A fast‑growing cancer of the blood and bone marrow in which abnormal cells crowd out healthy blood cells, leading to infections, bleeding and fatigue; think of it as aggressive weeds rapidly taking over a garden. It matters to investors because the size, severity and unmet need of this condition drive demand for new drugs, influence clinical trial and regulatory outcomes, and determine revenue and risk for companies developing therapies.

AI-generated analysis. Not financial advice.

Access the segment here

SOUTH SAN FRANCISCO, Calif., Jan. 14, 2026 (GLOBE NEWSWIRE) -- Senti Biosciences, Inc. (Nasdaq: SNTI) (“Senti Bio”), a clinical-stage biotechnology company developing next-generation cell and gene therapies using its proprietary Gene Circuit platform, today announced that it participated in a Virtual Investor CEO Connect Segment.

As part of the segment, Timothy Lu, MD, PhD, CEO of Senti, discussed its recent news release announcing that the U.S. Food and Drug Administration (FDA) granted Regenerative Medicine Advanced Therapy (RMAT) designation to SENTI-202, the Company’s potential first-in-class Logic Gated off-the-shelf chimeric antigen receptor natural killer (CAR-NK) investigational cell therapy, that is currently in development for the treatment of relapsed/refractory hematologic malignancies, including AML. The RMAT designation builds on the Orphan Drug Designation that the FDA granted SENTI-202 in June. Dr. Lu also discussed the new data from 20 patients (18 with evaluable responses) in its ongoing multinational, multicenter clinical trial of SENTI-202 in patients with relapsed or refractory AML that were recently presented at the American Society of Hematology (ASH) Annual Meeting in Orlando.

About Senti Bio
Senti Bio is a 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’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.

Availability of Other Information About Senti Bio
For more information, please visit the Senti Bio website at https://www.sentibio.com or follow Senti Bio on X (formerly Twitter) (@SentiBio) and LinkedIn (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 and LinkedIn. The information that we post on our website or on X or LinkedIn 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.

Senti Bio Contacts:
Investors: investors@sentibio.com
Media: media@sentibio.com

Investor Contact:
Jenene Thomas
Chief Executive Officer
JTC Team, LLC
T: 908.824.0775
snti@jtcir.com  

FAQ

What did Senti Biosciences (SNTI) announce about SENTI-202 on January 14, 2026?

Senti announced the FDA granted RMAT designation to SENTI-202 and discussed clinical data from 20 patients presented at ASH.

What does RMAT designation for SENTI-202 mean for SNTI investors?

RMAT designation signals regulatory recognition of potential for expedited development and review for SENTI-202.

How many patients were included in the SENTI-202 data presented at ASH for SNTI?

The presentation covered data from 20 patients, with 18 having evaluable responses.

Was SENTI-202 already granted any other FDA designations before the RMAT for SNTI?

Yes, SENTI-202 had previously received Orphan Drug designation from the FDA in June.

Where were the SENTI-202 clinical results presented that Senti referenced on Jan 14, 2026?

The results were presented at the American Society of Hematology (ASH) Annual Meeting in Orlando.