Calidi Biotherapeutics To Present on its New Approach to Bispecific T-Cell Engagers (BiTEs) Using its RedTail Platform in a Late-Breaking Abstract at the 2026 AACR-IO Conference

Rhea-AI Summary

Calidi Biotherapeutics (NYSE American: CLDI) will present a late‑breaking abstract at the AACR Immuno‑Oncology (AACR‑IO) conference in Los Angeles, Feb 18–21, 2026, on its RedTail virotherapy platform and a novel approach to tumor‑localized BiTEs.

Calidi will discuss preclinical data for lead candidate CLD‑401, which expresses an IL‑15 superagonist in the tumor microenvironment, and reports IND‑enabling studies with an expected IND submission by end of 2026. The company is pursuing strategic partnerships to accelerate clinical development.

Key Figures

AACR-IO conference dates: February 18-21, 2026 Planned IND timing: End of 2026

2 metrics

AACR-IO conference dates February 18-21, 2026 Timing of RedTail/BiTEs data presentation

Planned IND timing End of 2026 Target Investigational New Drug application for CLD-401

Market Reality Check

Price: $0.8162 Vol: Volume 32,077 is 60% belo...

low vol

$0.8162 Last Close

Volume Volume 32,077 is 60% below the 80,099 share 20-day average. low

Technical Shares at 0.8162 are trading below the 200-day MA of 2.96 and 95.75% under the 52-week high.

Peers on Argus

CLDI was down 1.6% pre-announcement while peers were mixed: APRE -6.61%, CELZ +2...

CLDI was down 1.6% pre-announcement while peers were mixed: APRE -6.61%, CELZ +2.16%, GNPX +0.46%, INAB +3.65%, NLSP -1.05%. Moves are dispersed, pointing to stock-specific dynamics rather than a coordinated sector reaction.

Historical Context

5 past events · Latest: Jan 28 (Positive)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Jan 28	Corporate update	Positive	+3.0%	Outlined 2026 value drivers and reiterated CLD-401 IND timing and platform goals.
Nov 17	Investor webinar	Positive	+0.0%	Announced investor webinar covering RedTail data, IND progress, and financial trends.
Nov 13	Earnings and update	Neutral	+0.7%	Reported Q3 2025 results, capital raises, and SITC preclinical RedTail data.
Nov 10	Clinical data update	Positive	-2.8%	Presented new CLD-401 preclinical data and reiterated IND-enabling work and partnerships.
Nov 04	Investor event	Positive	-2.0%	Announced SITC investor event focused on RedTail and CLD-401 IND-enabling studies.

Pattern Detected

Preclinical and corporate updates around the RedTail/CLD-401 program have generally produced modest price moves, with some positive news met by negative reactions.

Recent Company History

Over the last few months, Calidi has repeatedly highlighted its RedTail platform and lead candidate CLD-401. Events on Nov 4-17, 2025 and the Jan 28, 2026 corporate update all emphasized systemic tumor targeting, IL-15 superagonist expression, and an intended IND by end of 2026. Price reactions to these updates ranged from modest gains to declines, suggesting that similar preclinical and investor-relations news has not consistently driven strong upside despite a clear strategic focus on RedTail.

Market Pulse Summary

This announcement highlights further positioning of Calidi’s RedTail platform, focusing on bispecifi...

Analysis

This announcement highlights further positioning of Calidi’s RedTail platform, focusing on bispecific T-cell engagers in solid tumors and reinforcing plans to file an IND by end of 2026 for CLD-401. It extends a series of RedTail-centric updates from late 2025 and early 2026. Investors may monitor progress of IND-enabling studies, additional preclinical data at forums like AACR-IO, and any strategic partnerships that could support clinical development and funding needs.

Key Terms

bispecific t-cell engagers (bites), virotherapy, tumor microenvironment (tme), investigational new drug (ind)

4 terms

bispecific t-cell engagers (bites) medical

"its New Approach to Bispecific T-Cell Engagers (BiTEs) Using its RedTail Platform"

Bispecific T‑cell engagers (BiTEs) are engineered proteins that act like a molecular matchmaker, simultaneously attaching to a specific marker on a diseased cell (often a cancer cell) and to an immune T cell so the immune cell can recognize and kill the target. They matter to investors because successful BiTE therapies can create significant, ongoing revenue and rapidly change a biotech company’s valuation, while clinical trial setbacks or safety concerns can cause large, sudden downside moves.

virotherapy medical

"RedTail is Calidi’s systemically delivered virotherapy platform designed to selectively target tumors"

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.

tumor microenvironment (tme) medical

"designed to selectively target tumors, remodel the tumor microenvironment (TME), and enable high‑level expression"

The tumor microenvironment (TME) is the immediate surrounding area of a tumor, including nearby cells, blood vessels, and supporting tissues that interact with the cancer cells. It plays a crucial role in how a tumor grows and spreads, much like how the environment around a plant influences its health and development. For investors, understanding the TME is important because it affects the success of treatments and innovations in cancer therapies, impacting the potential value of related biotech companies.

investigational new drug (ind) regulatory

"anticipates submitting an Investigational New Drug (IND) application for CLD-401 by the end of 2026"

An investigational new drug (IND) is a drug or biologic that is being tested but has not yet been approved for general use; it is the application and formal status that allows a company to begin human clinical trials under regulator oversight. Investors care because an IND marks the transition from lab work to human testing — like getting a permit to run real-world experiments — which creates important milestones, costs, timelines and regulatory risk that drive a development-stage company's value.

AI-generated analysis. Not financial advice.

SAN DIEGO, Feb. 12, 2026 (GLOBE NEWSWIRE) -- Calidi Biotherapeutics, Inc. (NYSE American: CLDI) (“Calidi” or the “Company”), a biotechnology company pioneering the development of targeted genetic medicines, today announced that it will present data on its novel approach to the use of BiTEs in solid tumors by utilizing its systemically delivered RedTail platform at the AACR Immuno-Oncology (AACR-IO) conference being held in Los Angeles, California, from February 18-21, 2026.

RedTail is Calidi’s systemically delivered virotherapy platform designed to selectively target tumors, remodel the tumor microenvironment (TME), and enable high‑level expression of therapeutic genetic payloads directly within the tumor. CLD‑401, the lead candidate derived from the RedTail platform, is engineered to express high levels of IL‑15 superagonist, a known T-cell activator, in the TME.

BiTEs have shown exceptional efficacy in hematological malignancies but have failed to show efficacy in solid tumors where the TME inhibits T-cell activity. In immunocompetent models of metastatic disease, the RedTail platform has demonstrated that it can alter the TME and induce T-cell activation through its ability to convert tumors into local producers of IL-15 superagonist. Given the high capacity for genetic payloads with RedTail, it is possible to have simultaneous high levels of expression of multiple tumor‑localized payloads, such as an IL-15 superagonist, along with a tumor-specific BiTE.

“RedTail is a major leap forward in the delivery of genetic medicine via an engineered virus,” said Eric Poma, PhD, Chief Executive Officer of Calidi. “It is able to avoid immune clearance allowing for systemic delivery but can only replicate and express payload in tumor cells.”

“Our work with RedTail continues to highlight the flexibility of the platform to deliver complex biologics directly within the tumor microenvironment” said Antonio F. Santidrian, PhD, Chief Scientific Officer and Head of Technical Operations at Calidi. “We believe simultaneous tumor-localized expression of a T-cell activator and BiTE via RedTail can remodel the TME to enable for T-cell engagement precisely where it is needed.”

Calidi is currently conducting IND-enabling studies with CLD-401, the first lead candidate from its RedTail platform. The company anticipates submitting an Investigational New Drug (IND) application for CLD-401 by the end of 2026. The Company continues to expand the functionality of the RedTail platform 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 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 BiTEs 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 31, 2025, 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 will Calidi (CLDI) present at AACR‑IO on Feb 18–21, 2026?

Calidi will present a late‑breaking abstract on RedTail delivering tumor‑localized BiTEs and IL‑15 expression. According to the company, the presentation covers preclinical data for CLD‑401 and RedTail’s ability to remodel the tumor microenvironment in immunocompetent models.

What is CLD‑401 and why is it significant for CLDI shareholders?

CLD‑401 is Calidi’s lead RedTail candidate engineered to express an IL‑15 superagonist in tumors. According to the company, CLD‑401 aims to activate T cells locally and enable tumor‑targeted BiTE expression, potentially addressing solid‑tumor TME resistance seen with BiTEs.

When does Calidi (CLDI) expect to submit an IND for CLD‑401?

Calidi anticipates submitting an IND application for CLD‑401 by the end of 2026. According to the company, IND‑enabling studies are underway to support that planned IND submission timeline.

How does the RedTail platform aim to improve BiTE delivery for solid tumors?

RedTail is a systemically delivered virotherapy designed to selectively target tumors and express therapeutic payloads locally. According to the company, RedTail can avoid immune clearance and convert tumors into local producers of IL‑15 superagonist to enhance T‑cell activation.

Will Calidi seek partnerships to advance RedTail and CLD‑401 development?

Yes, Calidi is actively pursuing strategic partnerships to accelerate clinical development and broaden RedTail’s impact. According to the company, these efforts aim to expand functionality and speed translation from IND‑enabling studies to clinical trials.