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Calidi Biotherapeutics to Present New Data on Its Lead Asset CLD-401 at the AACR Annual Meeting in April 2026

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Calidi Biotherapeutics (NYSE American: CLDI) will present new preclinical data on its lead candidate CLD-401 at the American Association for Cancer Research (AACR) annual meeting, April 17-22, 2026 in San Diego.

The data will describe tumor-restricted expression of an IL-15 superagonist (IL-15 SA) by CLD-401 and resulting immune changes in the tumor microenvironment; Calidi expects to file an IND for CLD-401 by the end of 2026.

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Negative

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News Market Reaction – CLDI

-2.72%
1 alert
-2.72% Session close to close
$2.64M Market Cap
0.0x Rel. Volume

In the Apr 2 session, CLDI declined 2.72%, reflecting a moderate negative market reaction.

Data tracked by StockTitan Argus on the day of publication.

Market Context

This announcement highlights upcoming CLD-401 data at AACR April 17–22, 2026, emphasizing tumor-loca...
Analysis

This announcement highlights upcoming CLD-401 data at AACR April 17–22, 2026, emphasizing tumor-localized IL-15 superagonist expression and immune remodeling within the TME. It reiterates the goal to file an IND by end of 2026, consistent with prior updates on partnerships and manufacturing. Investors may focus on how AACR findings clarify CLD-401’s pharmacokinetics, safety window, and readiness for first-in-human studies.

Key Figures

AACR meeting dates: April 17–22, 2026 IND timeline: End of 2026 Current share price: $0.24375 +4 more
7 metrics
AACR meeting dates April 17–22, 2026 American Association of Cancer Research annual meeting
IND timeline End of 2026 Expected IND filing for CLD-401
Current share price $0.24375 Pre-news market context
52-week high $19.20 CLDI 52-week trading range
52-week low $0.2088 CLDI 52-week trading range
Market cap $2,267,579 Pre-news valuation snapshot
AACR year 2026 Year of AACR meeting where CLD-401 data presented

Historical Context

5 past events · Latest: Apr 01 (Positive)
Pattern 5 events
Date Event Sentiment 24h Move Catalyst
Apr 01 AACR data preview Positive +1.6% Announced AACR data on RedTail platform and TROP2-targeting candidate.
Mar 27 Earnings and update Neutral -11.7% Reported 2025 results, partnerships, FDA feedback, and $6.5M capital raised.
Mar 24 Clinical partnership Positive -3.6% Partnered with Avance Clinical to expedite Australian approval and Phase I start.
Mar 12 Manufacturing update Positive -4.5% Presented scalable CLD-401 manufacturing with supportive FDA feedback.
Mar 09 Equity offering Negative -1.5% Closed $6.0M underwritten offering with multiple warrant series.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Pattern Detected

CLDI’s news on CLD-401 and platform progress has often coincided with negative or muted price reactions, while dilutive offerings saw declines consistent with their negative tone.

Recent Company History

Over the past month, Calidi has repeatedly highlighted CLD-401 and its RedTail virotherapy platform. Updates have covered strategic partnerships to start a Phase I trial, FDA Type D feedback supporting manufacturing, and presentations on scalable production, all targeting an IND filing by end of 2026. A recent $6.0M public offering and financials showing a $25.6M 2025 net loss and $5.6M cash underscore financing needs alongside scientific progress. Today’s AACR data announcement fits this ongoing CLD-401 narrative.

Key Terms

oncolytic virus, il-15 superagonist, tumor microenvironment, virotherapy, +2 more
6 terms
oncolytic virus medical
"CLD-401, a systemically delivered oncolytic virus that is designed to express"
A virus engineered or selected to infect and destroy cancer cells while leaving healthy tissue largely unharmed, often acting like a guided missile that also alerts the immune system to attack tumors. It matters to investors because oncolytic viruses represent a potential new class of cancer treatments that can command large markets if proven safe and effective, but development is costly and outcome-driven, carrying high regulatory and clinical risk.
il-15 superagonist medical
"express high levels of IL-15 superagonist (“IL-15 SA”) only in the tumor"
An IL-15 superagonist is a lab-engineered therapy that boosts the activity of IL-15, a natural immune signaling protein, effectively stepping on the accelerator for disease-fighting immune cells like natural killer and T cells. Investors pay attention because these agents can change clinical trial results, safety profiles, and regulatory outcomes; success or failure can significantly affect a biotech’s valuation and the commercial potential of immune-based treatments, like upgrading an engine can alter a car’s market value.
tumor microenvironment medical
"only in the tumor microenvironment (“TME”), currently in IND-enabling studies."
The tumor microenvironment is the immediate area surrounding a cancer cell, made up of nearby cells, blood vessels, and support structures that influence how the cancer grows and spreads. It functions like a bustling neighborhood that can either help or hinder the tumor’s development. For investors, understanding changes in this environment can signal the effectiveness of treatments and potential shifts in a cancer-related market.
virotherapy medical
"RedTail platform, a systemically delivered virotherapy platform designed to"
Virotherapy is a medical approach that uses live viruses, often modified, to target and destroy diseased cells or deliver therapeutic genes, most commonly in cancer treatment. For investors, virotherapy matters because results from clinical trials, regulatory approvals, manufacturing scale-up and safety profiles determine whether a therapy can become a viable product; think of it as a precision tool whose clinical success and production challenges drive potential market value and risk.
pharmacokinetic medical
"will characterize the pharmacokinetic pattern of IL-15 SA expression and"
Pharmacokinetic describes how a drug moves through and leaves the body — how it is absorbed, spread to tissues, broken down and excreted — like tracking a package from pickup to delivery and disposal. For investors, these properties determine effective dose, safety risks, how often a medicine must be taken, and how reliably it works, which in turn influence clinical trial success, regulatory approval chances, production complexity and a drug’s commercial value.
cytokine medical
"may dramatically alter the therapeutic window of cytokine treatment.”"
Small proteins produced by cells that act as chemical messengers to coordinate immune and inflammatory responses, like text messages or traffic signals telling cells when to activate, calm down, or move. Investors care because cytokines are common drug targets and biomarkers; changes in cytokine activity can determine a therapy’s effectiveness, safety, regulatory approval, and market potential, so trial results or safety signals tied to cytokines often drive stock moves.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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SAN DIEGO, April 02, 2026 (GLOBE NEWSWIRE) -- Calidi Biotherapeutics, Inc. (NYSE American: CLDI) (“Calidi” or the “Company”), a biotechnology company pioneering the development of targeted genetic medicines, will present new data at the American Association of Cancer Research (AACR) annual meeting in San Diego, California from April 17-22, 2026. The Company will showcase new data on CLD-401, a systemically delivered oncolytic virus that is designed to express high levels of IL-15 superagonist (“IL-15 SA”) only in the tumor microenvironment (“TME”), currently in IND-enabling studies.

CLD-401 is the lead candidate from the Company’s RedTail platform, a systemically delivered virotherapy platform designed to selectively target tumors, remodel the TME, and enable high-level expression of therapeutic genetic payloads directly within the tumor. CLD-401 is engineered to express high levels of IL-15 SA, a known T- and NK-cell activator, in the TME. Data at AACR will detail the pattern of CLD-401 mediated-IL-15 SA expression and the subsequent immune changes in the TME, leading to a robust therapeutic response. The Company expects to file an IND for CLD-401 by the end of 2026.

“We continue to advance the RedTail platform and its breakthrough capabilities through our lead asset, CLD-401,” said Eric Poma, PhD, Chief Executive Officer of Calidi. “We expect to file an IND for CLD-401 by end of 2026 and enter the clinic shortly thereafter.”

“The data we will present at AACR will characterize the pharmacokinetic pattern of IL-15 SA expression and resulting changes in the TME” said Antonio F. Santidrian, PhD, Chief Scientific Officer and Head of Technical Operations at Calidi. “The ability of CLD-401 to induce high levels of IL15-SA expression in the TME but not systemically may dramatically alter the therapeutic window of cytokine treatment.”

The Company continues to expand the functionality of the RedTail platform and is also actively pursuing strategic partnerships to accelerate clinical development and broaden the impact of its RedTail platform.

About Calidi 

Calidi Biotherapeutics (NYSE American: CLDI) is a biotechnology company pioneering the development of targeted therapies with the potential to deliver genetic medicines to distal sites of disease. The company’s proprietary RedTail platform features an engineered enveloped oncolytic virus designed for systemic delivery and targeting of metastatic sites. This advanced enveloped technology is intended to shield the virus from immune clearance, allowing virotherapy to effectively reach tumor sites, induce tumor lysis, and deliver potent genetic medicine(s) to metastatic locations.

CLD-401, the lead candidate from the RedTail platform, currently in IND-enabling studies, targets non-small cell lung cancer, head and neck cancer, and other tumor types with high unmet medical need. Calidi continues to advance its pipeline utilizing the RedTail platform including its novel approach to incorporate in situ T-cell engagers in solid tumors.

Calidi Biotherapeutics is headquartered in San Diego, California. For more information, please visit www.calidibio.com or view Calidi’s Corporate Presentation here.

Forward-Looking Statements

This press release may contain forward-looking statements for purposes of the “safe harbor” provisions under the United States Private Securities Litigation Reform Act of 1995. Terms such as “anticipates,” “believe,” “continue,” “could,” “estimate,” “expect,” “intends,” “may,” “might,” “plan,” “possible,” “potential,” “predicts,” “project,” “should,” “towards,” “would” as well as similar terms, are forward-looking in nature, but the absence of these words does not mean that a statement is not forward-looking. These forward-looking statements include, but are not limited to, statements concerning key milestones, including certain pre-clinical data, planned clinical trials, and statements relating to the safety and efficacy of Calidi’s therapeutic candidates in development. Any forward-looking statements contained in this discussion are based on Calidi’s current expectations and beliefs concerning future developments and their potential effects and are subject to multiple risks and uncertainties that could cause actual results to differ materially and adversely from those set forth or implied in such forward-looking statements. These risks and uncertainties include, but are not limited to, the risk that Calidi is not able to raise sufficient capital to support its current and anticipated clinical trials, the risk that early results of clinical trials do not necessarily predict final results and that one or more of the clinical outcomes may materially change following more comprehensive review of the data, and as more patient data becomes available, the risk that Calidi may not receive FDA approval for some or all of its therapeutic candidates. Other risks and uncertainties are set forth in the section entitled “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements” in the Company’s annual report filed with the SEC on Form 10-K on March 27, 2026, as may be amended or supplemented by other reports we file with the SEC from time to time. We disclaim any obligation to update any forward-looking statement to reflect events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events.

For Investors:

Dave Gentry, CEO
RedChip Companies, Inc.
1-407-644-4256
CLDI@redchip.com


FAQ

What data will Calidi (CLDI) present for CLD-401 at AACR April 2026?

Calidi will present preclinical data showing tumor-restricted expression of IL-15 SA by CLD-401 and associated immune changes in the tumor microenvironment. According to the company, the presentation details the pattern of IL-15 SA expression and subsequent immune activation leading to a robust therapeutic response.

When and where will CLDI present CLD-401 results at the AACR annual meeting in 2026?

Calidi will present at the AACR annual meeting held April 17-22, 2026 in San Diego, California. According to the company, the poster or presentation will focus on pharmacokinetic patterns of IL-15 SA expression and related tumor immune effects.

What is CLD-401 and how does it work according to Calidi (CLDI)?

CLD-401 is a systemically delivered oncolytic virus engineered to express high levels of IL-15 SA selectively in the tumor microenvironment. According to the company, it aims to remodel the TME and activate T and NK cells while limiting systemic cytokine exposure.

When does Calidi (CLDI) expect to file an IND for CLD-401?

Calidi expects to file an IND for CLD-401 by the end of 2026. According to the company, filing follows completion of IND-enabling studies and the company anticipates entering the clinic shortly after IND clearance.

Will the AACR data for CLD-401 address safety or systemic IL-15 exposure concerns for CLDI?

Yes; the AACR data will characterize IL-15 SA expression limited to the tumor microenvironment versus systemic exposure. According to the company, this tumor-restricted expression may improve the therapeutic window by reducing systemic cytokine-related effects.