What is Calidi Biotherapeutics' IND timeline for CLD-401?

Calidi targets an IND filing in Q4 2026 for CLD-401, its lead RedTail platform candidate designed to deliver IL-15 superagonist to tumors in non-small cell lung cancer, triple-negative breast cancer, and head and neck cancer patients.

How did Calidi reduce its debt in 2025?

Calidi reduced term debt and notes payable by $3.1 million in 2025, from $3.8 million at year-end 2024 to $0.7 million at December 31, 2025 (preliminary, unaudited).

What is Calidi's cash position?

As of Q3 2025, Calidi had $10.4 million in cash, a significant improvement from $1.9 million in Q3 2024, driven by equity raises and debt reduction.

Calidi Biotherapeutics (CLDI)·Q4 2025 Earnings Summary

Calidi Biotherapeutics Stock Jumps 5% on IND Filing Timeline, Debt Reduction

January 29, 2026 · by Fintool AI Agent

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Calidi Biotherapeutics (NYSE American: CLDI) released its 2025 year-end corporate update, outlining key accomplishments and 2026 milestones. The pre-revenue biotech announced plans to file an IND for its lead RedTail candidate CLD-401 by Q4 2026, while reporting significant debt reduction and operating cost improvements. Shares rose +4.7% on the announcement.

What Did Management Announce?

The 8-K corporate update focused on four key areas:

1. IND Filing Target — Q4 2026 Calidi intends to file an Investigational New Drug (IND) application for CLD-401, a systemically delivered oncolytic virus engineered to express IL-15 superagonist in the tumor microenvironment. The Phase I study is expected to be conducted in a basket of solid tumors including non-small cell lung cancer (NSCLC), triple-negative breast cancer (TNBC), and head and neck cancer.

2. Debt Reduction — 82% Decrease Term debt and notes payable (including accrued interest) dropped from $3.8 million at December 31, 2024 to just $0.7 million at December 31, 2025 — a $3.1 million reduction.

3. G&A Cost Cuts — $2.3M Savings General and administrative expenses decreased by $2.3 million in the first nine months of 2025 compared to the same period in 2024, reflecting management's focus on capital efficiency.

4. Leadership Changes The company completed a CEO transition to Eric Poma, PhD, who brings 25+ years of biopharma experience, and appointed Guy Travis Clifton, MD as Chief Medical Officer.

How Did the Stock React?

CLDI shares rose +4.7% on January 28, 2026, closing at $1.03 on volume of 83,436 shares — above the 50-day average. The stock remains down significantly from its 52-week high of $19.20, reflecting the typical volatility of pre-revenue biotech names.

Metric	Value
Close (Jan 28)	$1.03
Change	+4.7%
Volume	83,436
Market Cap	~$7.4M
52-Week Range	$0.98 - $19.20

What Is Calidi's Financial Position?

Calidi is a pre-revenue biotech company. Key financial metrics (preliminary, subject to audit):

Metric	Q3 2024	Q4 2024	Q1 2025	Q2 2025	Q3 2025
Cash & Equivalents	$1.9M	$9.6M	$10.6M	$5.3M	$10.4M
Total Debt	$9.0M	$7.0M	$4.7M	$4.0M	$3.3M
Operating Expenses	$5.2M	$4.0M	$5.1M	$5.7M	$5.0M
Net Loss	($5.1M)	($4.1M)	($5.0M)	($5.7M)	($5.1M)

The company's cash position improved substantially in 2025, while debt was reduced by more than half. Quarterly burn rate has remained relatively stable at ~$5M.

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What Are the Key 2026 Catalysts?

Management outlined three major milestones for 2026:

CLD-401 IND Filing (Q4 2026) — The lead RedTail candidate targeting metastatic solid tumors with IL-15 superagonist delivery
BiTE Proof-of-Concept Data — Demonstrating the RedTail platform's ability to deliver tumor-localized bi-specific T cell engagers (BiTEs) alongside T-cell amplifiers
Non-Oncology Applications — Exploring new payloads for inflammatory and immune diseases, targeting other cell types via envelope engineering

What Is the RedTail Platform?

The RedTail platform is Calidi's proprietary engineered enveloped oncolytic virus technology designed for systemic delivery. Key features:

Immune Evasion: Engineered CD55 expression allows the virus to avoid immune clearance after systemic administration
Tumor Targeting: Designed to home to metastatic sites and replicate only in tumor cells
Payload Delivery: Can express high levels of genetic medicines (like IL-15 superagonist) directly in the tumor microenvironment

CLD-401, the lead candidate, showed promising preclinical data presented at ASCO (May 2025) and SITC (November 2025), demonstrating enhanced biological efficacy in immunocompetent tumor models.

What Changed From Last Quarter?

Area	Q3 2025 Status	Q4 2025 Update
IND Timeline	Completing IND-enabling studies	Q4 2026 filing target confirmed
Debt	$3.3M total debt	Reduced to $0.7M (term debt + notes)
Leadership	New CEO appointed	SAB reconstituted with Pfizer's former CMO
Platform	Preclinical data presented	BiTE and non-oncology expansion announced

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Key Risks

Cash Runway: With ~$10M in cash and quarterly burn of ~$5M, the company has limited runway. Additional financing will likely be needed before IND filing.

Clinical Risk: CLD-401 is in preclinical development. IND filing is subject to completion of IND-enabling studies and regulatory interactions.

Dilution Risk: The company has raised capital through equity offerings, and further dilution is probable given the development stage and capital requirements.

Forward Catalysts

Catalyst	Expected Timing
CLD-401 IND-enabling studies completion	H1 2026
BiTE + T-cell amplifier proof-of-concept data	2026
Non-oncology proof-of-concept data	2026
CLD-401 IND filing	Q4 2026

This analysis is based on Calidi Biotherapeutics' 8-K filed January 28, 2026, containing preliminary, unaudited financial information subject to audit completion.