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Calidi Biotherapeutics Reports First Quarter 2026 Financial Results and Recent Operational Highlights

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Calidi Biotherapeutics (NYSE American: CLDI) reported first quarter 2026 results and R&D updates. Net loss attributable to common stockholders was $4.4 million, or $0.43 per share, versus $5.0 million, or $2.21, a year earlier. Cash and restricted cash totaled $6.8 million at March 31, 2026.

General and administrative expenses fell to $1.6 million from $2.6 million, while research and development expenses rose to $2.6 million from $2.4 million. The company highlighted new CLD-401 and RedTail platform data, a CLD-401 IND target by year-end 2026, and a partnership with TransferAI.

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AI-generated analysis. Not financial advice.

Positive

  • Net loss narrowed to $4.4 million from $5.0 million year over year
  • General and administrative expenses reduced to $1.6 million from $2.6 million
  • Cash balance increased to $6.6 million from $5.6 million quarter over quarter
  • Multiple new CLD-401 and RedTail data presentations at major scientific conferences
  • Collaboration with TransferAI to streamline IND submission for CLD-401
  • CLD-401 IND filing goal set for year-end 2026

Negative

  • Net loss of $4.4 million for Q1 2026
  • Research and development expenses increased to $2.6 million from $2.4 million
  • Limited cash and restricted cash position of $6.8 million as of March 31, 2026

News Market Reaction – CLDI

-2.26%
12 alerts
-2.26% News Effect
-17.3% Trough in 22 hr 57 min
-$70K Valuation Impact
$3.05M Market Cap
0.1x Rel. Volume

On the day this news was published, CLDI declined 2.26%, reflecting a moderate negative market reaction. Argus tracked a trough of -17.3% from its starting point during tracking. Our momentum scanner triggered 12 alerts that day, indicating notable trading interest and price volatility. This price movement removed approximately $70K from the company's valuation, bringing the market cap to $3.05M at that time.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

Net loss: $4.4M Net loss per share: $0.43 R&D expenses: $2.6M +5 more
8 metrics
Net loss $4.4M Q1 2026 net loss attributable to common stockholders (vs. $5.0M in Q1 2025)
Net loss per share $0.43 Q1 2026 net loss per share (vs. $2.21 in Q1 2025)
R&D expenses $2.6M Research and development in Q1 2026 (vs. $2.4M in Q1 2025)
G&A expenses $1.6M General and administrative in Q1 2026 (vs. $2.6M in Q1 2025)
G&A reduction $1.0M Reduction in general and administrative from Q1 2025 to Q1 2026
Cash balance $6.6M Cash as of March 31, 2026 (vs. $5.6M at December 31, 2025)
Restricted cash $0.2M Restricted cash as of March 31, 2026 (unchanged vs. December 31, 2025)
CLD-401 IND timing By end of 2026 Company expectation for CLD-401 IND submission

Market Reality Check

Price: $0.1690 Vol: Volume 2,041,041 is 0.19x...
low vol
$0.1690 Last Close
Volume Volume 2,041,041 is 0.19x the 20-day average of 10,492,855, suggesting a modest participation in the 8.11% pre-news gain. low
Technical Shares trade below the 200-day MA of 1.44 and remain 98.97% under the 52-week high, despite sitting 11.1% above the 52-week low.

Peers on Argus

CLDI is up 8.11% while key peers like APRE (-1.76%), CELZ (-5.15%), and INAB (-1...
2 Up 1 Down

CLDI is up 8.11% while key peers like APRE (-1.76%), CELZ (-5.15%), and INAB (-1.85%) are down, indicating stock-specific strength rather than a broad biotech move.

Common Catalyst Both CLDI and peer GNPX had gene/cell therapy presentations at ASGCT, pointing to a conference-driven news cluster rather than a uniform price trend.

Previous Earnings Reports

5 past events · Latest: Mar 27 (Negative)
Same Type Pattern 5 events
Date Event Sentiment Move Catalyst
Mar 27 Q4/FY25 results Negative -11.7% Reported Q4 and full-year 2025 losses and detailed capital-raising activities.
Nov 13 Q3 2025 results Neutral -1.3% Delivered Q3 2025 update with RedTail data and additional equity financing.
Aug 08 Q2 2025 results Positive +0.6% Shared Q2 2025 financials plus CLD-401 data and CLD-201 Fast Track status.
May 14 Q1 2025 results Positive +3.8% Announced Q1 2025 loss improvement, new leadership, and IND progress.
Mar 31 Q4/FY24 results Negative -1.6% Reported Q4 and full-year 2024 net losses and early clinical advances.
Pattern Detected

Earnings updates have typically coincided with net losses and have often been followed by mild to moderate negative price reactions.

Recent Company History

Over the last year, Calidi’s earnings releases have consistently highlighted pipeline progress alongside ongoing losses. Prior updates covered Q4/FY 2024, Q1–Q4 2025, and capital raises that extended cash runway but came with going‑concern language. Price reactions to these five earnings events averaged about -2.05%, with the largest one-day drop of -11.67% following the Q4/FY 2025 release. Today’s Q1 2026 report continues the pattern of losses but adds visible G&A reductions and a slightly higher cash balance.

Historical Comparison

-2.0% avg move · In the past five earnings releases, CLDI’s average move was about -2.05%. Today’s +8.11% pre-news ga...
earnings
-2.0%
Average Historical Move earnings

In the past five earnings releases, CLDI’s average move was about -2.05%. Today’s +8.11% pre-news gain on Q1 2026 results stands out versus that generally negative pattern.

Tag-specific history shows repeated quarterly losses but steady advancement of CLD-401 and related platforms, with earnings updates often pairing financing steps with development milestones.

Market Pulse Summary

This announcement underscores Calidi’s efforts to balance R&D progress with tighter spending. Q1 202...
Analysis

This announcement underscores Calidi’s efforts to balance R&D progress with tighter spending. Q1 2026 featured a net loss of $4.4M, higher R&D of $2.6M, and G&A trimmed to $1.6M, while cash rose to $6.6M. Operationally, the company reiterated its goal of a CLD-401 IND by end of 2026 and highlighted new RedTail data across major conferences. Investors may watch future quarters for further cost control, financing steps, and clinical transitions.

Key Terms

t-cell engager, tumor microenvironment, il15-sa, nk cells, +3 more
7 terms
t-cell engager medical
"create in vivo T-cell engagers that simultaneously express both a T-cell engager"
A T-cell engager is a type of medicine designed to help the body's immune system attack cancer cells more effectively. It works by acting like a bridge that brings immune cells (T-cells) close to cancer cells, prompting a targeted attack. For investors, T-cell engagers are significant because they represent innovative treatments that could lead to new growth opportunities in the healthcare and biotech sectors.
tumor microenvironment medical
"profound immune changes in the tumor microenvironment induced by CLD-401"
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.
il15-sa medical
"IL15-SA expression may dramatically expand the therapeutic window of IL-15-mediated"
IL15-SA is a laboratory-engineered version of the immune signaling protein interleukin‑15, modified to be more potent or longer‑lasting than the natural molecule so it stimulates immune cells more strongly. For investors, it matters because these 'superagonist' drugs are developed to boost the body’s ability to fight cancer or infections; successful clinical results can meaningfully increase a biotech's value, while failures or safety issues carry substantial downside risk.
nk cells medical
"recruitment and activation of T, NK, NK-T, and gamma delta (γδ) T-cells"
Natural killer (NK) cells are a type of immune system cell that helps the body defend itself against threats like viruses and cancer by quickly identifying and destroying abnormal cells. Their activity can influence overall health and disease progression, which may impact market sectors related to healthcare and biotechnology. Understanding NK cells provides insight into how the body responds to illnesses that can affect economic and investment landscapes.
gamma delta (γδ) t-cells medical
"NK, NK-T, and gamma delta (γδ) T-cells that lead to a robust therapeutic response"
A type of white blood cell that acts like a small, fast-response security team in the immune system, recognizing stressed or abnormal cells directly instead of waiting for a detailed ID badge. Investors care because these cells are being developed as the basis for new immune therapies and diagnostics — their unique behavior can be turned into drugs, cell therapies, or biomarkers, but also brings different scientific and manufacturing risks compared with conventional treatments.
trop-2 medical
"CLD-501, a TROP-2 in vivo T-cell engager"
Trop-2 is a protein that sits on the surface of many cancer cells and helps relay growth signals; doctors and researchers measure it as a sign of tumor behavior and use it as a target for therapies. For investors, Trop-2 matters because drugs designed to bind that surface protein act like a specialized key fitting a lock on cancer cells—successful therapies or diagnostic tests tied to Trop-2 can drive clinical progress, regulatory decisions and commercial value in oncology-focused companies.
extracellular enveloped medical
"RedTail extracellular enveloped and CD55-overexpressing virus (EEV) to avoid immune"
An extracellular enveloped particle is a form of a virus particle that carries an extra outer membrane after leaving an infected cell. That added membrane can help the virus move between cells and hide from the immune system, like a ball covered in a slippery layer that makes it harder to catch. For investors, this matters because such forms can affect how contagious or treatment-resistant a pathogen is and therefore influence demand for vaccines, therapeutics, diagnostics, and regulatory scrutiny.

AI-generated analysis. Not financial advice.

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  • Presented new data on CLD-401 at the AACR conference in San Diego, CA, detailing the profound immune changes in the tumor microenvironment induced by CLD-401; IND filing for CLD-401 expected by end of 2026
  • Presented new data on RedTail at the AACR conference in San Diego, CA detailing the use of the RedTail platform to create in vivo T-cell engagers that simultaneously express both a T-cell engager and a T-cell activator at high levels exclusively in the tumor microenvironment; presented new data on CLD-501, a TROP-2 in vivo T-cell engager
  • Demonstrated $1 million reduction in general and administrative expenses from Q1-2025 to Q1-2026
  • Speaker presentation at ASGCT conference in Boston, MA highlighting IL15-SA expression may dramatically expand the therapeutic window of IL-15-mediated treatment
  • Speaker presentation at IOVC conference showcasing the ability of the RedTail extracellular enveloped and CD55-overexpressing virus (EEV) to avoid immune clearance
  • Strategic partnership with TransferAI to drive efficiencies in IND submission process for CLD-401

SAN DIEGO, May 14, 2026 (GLOBE NEWSWIRE) -- Calidi Biotherapeutics Inc. (NYSE American: CLDI) (“Calidi” or the “Company”), a biotechnology company pioneering the development of targeted genetic medicines, today reported its first quarter 2026 operating and financial results and reviewed recent business highlights.

“We are excited about the continued progress at Calidi,” said Eric Poma, PhD, Calidi Biotherapeutics CEO. “We continue to advance CLD-401, the first lead from our RedTail platform, towards the clinic and have built a world-class scientific advisory board to aid those efforts. We have also expanded what the RedTail platform can do with our new approach of in situ T-cell engagers.”

First Quarter 2026 and Recent Corporate Developments

  • On April 21, 2026, presented new data at the American Association of Cancer Research (AACR) annual meeting in San Diego, California. Data at AACR detailed the profound immune changes in the tumor microenvironment induced by CLD-401 including the recruitment and activation of T, NK, NK-T, and gamma delta (γδ) T-cells that lead to a robust therapeutic response in the immunocompetent animal models. Immune activation of cell types that do not require antigen expression or HLA positivity represents a potential new mechanism of immune response that could drive efficacy in patients that have progressed or were refractory to current immune therapy
  • On April 19, 2026, Calidi presented data at the AACR meeting that showcased RedTail viruses that can express both a functional T-cell engager, capable of binding targeted solid tumor cells, and IL-15 SA at high concentrations, allowing for simultaneous T-cell activation and high expression in situ of a T-cell engager. Localized expression of a T-cell engager and a T-cell activator may overcome the key challenges seen with T-cell engagers in solid tumors. The Company presented data on its first in situ T-cell engager, CLD-501, a T-cell engager targeting TROP2
  • Recorded a $1.0 million reduction in general and administrative expenses from Q1-2025 to Q1-2026, demonstrating the Company’s commitment to efficient use of capital. The reduction was primarily due to reduced headcount, consulting, and rent expenses
  • On May 14, 2026, presented as a featured speaker at the American Society for Gene and Cell Therapy (ASGCT) conference in Boston, Massachusetts, highlighting that the ability of CLD-401 to induce high levels of IL15-SA expression in the tumor microenvironment while maintaining low circulating levels may dramatically expand the therapeutic window of IL-15-mediated treatment
  • On April 28, 2026, presented data at the Internation Oncolytic Virus Conference (IOVC) in Reykjavik, Iceland, showcasing the ability of the RedTail extracellular enveloped and CD55-overexpressing virus (EEV) to avoid immune clearance, replicate only in target cells, and deliver high concentrations of genetic medicine to sites of disease
  • In April 2026, entered a collaboration with TransferAI to drive efficiencies in Calidi’s IND submission for CLD-401 by using TransferAI’s proprietary agentic artificial intelligence platform, SofieTM, including pre-built and customizable orchestrations for biopharma. TransferAI’s Sofie platform will work alongside Calidi’s teams, helping orchestrate complex regulatory workflows while preserving the rigor required for IND submissions, providing support for Calidi to achieves its goal of submitting the CLD-401 IND by year end

First Quarter 2026 Financial Results

The Company reported a net loss attributable to common stockholders of $4.4 million, or $0.43 per share, for the three months ended March 31, 2026, compared to a net loss attributable to common stockholders of $5.0 million, or $2.21 per share, for the same period in 2025.

Research and development expenses were $2.6 million for the three months ended March 31, 2026, compared to $2.4 million for the comparable period in 2025.

General and administrative expenses were $1.6 million for the three months ended March 31, 2026, compared to $2.6 million for the comparable period in 2025.

The Company had approximately $6.6 million in cash and $0.2 million in restricted cash as of March 31, 2026, compared to $5.6 million in cash and $0.2 million in restricted cash as of December 31, 2025.

About Calidi Biotherapeutics

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, the Company’s plans strategies, priorities and key operational initiatives for fiscal year 2026, including the Company’s plan to submit an Investigational New Drug (“IND”) application by the end of 2026, 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; and, with respect to the Company’s fiscal year 2026 initiatives, including the timing and ability to submit an IND application by the end of 2026, the risk that actual results may differ materially due to, among other things, the timing, cost and results of research and development activities and preclinical studies; interactions with, and the timing and substance of feedback from, regulatory authorities (including that any preliminary interactions with the FDA may not be indicative of future outcomes or regulatory success); changes in applicable laws or regulations; manufacturing and supply chain matters; the availability of capital and other resources; and changes in business, market, economic or competitive conditions. 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.

Contacts:

For Investors:

IR@calidibio.com 

For Media:

PR@calidibio.com 

 
CALIDI BIOTHERAPEUTICS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands, except for par value data)
 
  March 31,
2026
  December 31,
2025
 
  (Unaudited)    
ASSETS        
CURRENT ASSETS        
Cash $6,631  $5,600 
Prepaid expenses and other current assets  722   656 
Total current assets  7,353   6,256 
NONCURRENT ASSETS        
Machinery and equipment, net  758   781 
Operating lease right-of-use assets, net  1,342   1,682 
Other noncurrent assets  138   138 
TOTAL ASSETS $9,591  $8,857 
LIABILITIES AND TOTAL EQUITY        
CURRENT LIABILITIES        
Accounts payable $849  $595 
Related party accounts payable  51   18 
Accrued expenses and other current liabilities  1,313   1,276 
Related party accrued expenses and other current liabilities  119   530 
Finance lease liability, current  154   111 
Operating lease right-of-use liability, current  1,350   1,405 
Total current liabilities  3,836   3,935 
NONCURRENT LIABILITIES        
Operating lease right-of-use liability, noncurrent  6   277 
Finance lease liability, noncurrent  147   171 
Promissory note  600   600 
Warrant liability  62   107 
Related party warrant liability  5   8 
TOTAL LIABILITIES  4,656   5,098 
TOTAL EQUITY  4,935   3,759 
TOTAL LIABILITIES AND TOTAL EQUITY $9,591  $8,857 


CALIDI BIOTHERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except per share data)
 
       
  Three Months Ended March 31, 
  2026  2025 
  (Unaudited) 
OPERATING EXPENSES        
Research and development $(2,587) $(2,425)
General and administrative  (1,600)  (2,637)
Total operating expense  (4,187)  (5,062)
Loss from operations  (4,187)  (5,062)
OTHER INCOME, NET        
Interest expense  (33)  (34)
Interest expense – related party  (5)  (38)
Change in fair value of other liabilities and derivatives  45   32 
Change in fair value of other liabilities and derivatives – related party  3   3 
Grant income     50 
Other income (expense), net  73   (10)
Total other income, net  83   3 
LOSS BEFORE INCOME TAXES  (4,104)  (5,059)
Income tax provision  (4)  (3)
NET LOSS $(4,108) $(5,062)
Net loss attributable to noncontrolling interest     (76)
NET LOSS ATTRIBUTABLE TO CONTROLLING INTEREST  (4,108)  (4,986)
Deemed dividend on warrants  (309)   
NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS  (4,417)  (4,986)
Net loss per share; basic and diluted $(0.43) $(2.21)
Weighted average common shares outstanding; basic and diluted  10,308   2,257 



FAQ

What were Calidi Biotherapeutics (CLDI) Q1 2026 financial results?

Calidi Biotherapeutics reported a Q1 2026 net loss attributable to common stockholders of $4.4 million, or $0.43 per share. According to the company, this compares with a net loss of $5.0 million, or $2.21 per share, for the same quarter in 2025.

How did Calidi Biotherapeutics (CLDI) operating expenses change in Q1 2026?

In Q1 2026, Calidi Biotherapeutics’ research and development expenses were $2.6 million and general and administrative expenses were $1.6 million. According to the company, R&D rose from $2.4 million, while G&A declined from $2.6 million year over year.

What is Calidi Biotherapeutics’ (CLDI) cash position after Q1 2026?

As of March 31, 2026, Calidi Biotherapeutics held $6.6 million in cash and $0.2 million in restricted cash. According to the company, this compares with $5.6 million in cash and $0.2 million in restricted cash at December 31, 2025.

What progress did Calidi Biotherapeutics (CLDI) report on CLD-401 in 2026?

Calidi Biotherapeutics reported new CLD-401 data showing immune changes in the tumor microenvironment and IL15-SA expression characteristics. According to the company, it aims to submit an IND for CLD-401 by the end of 2026, supported by a collaboration with TransferAI.

What is the TransferAI partnership’s role for Calidi Biotherapeutics (CLDI)?

Calidi Biotherapeutics entered an April 2026 collaboration with TransferAI to support the CLD-401 IND process. According to the company, TransferAI’s Sofie platform will help orchestrate complex regulatory workflows and drive efficiencies toward the planned year-end 2026 IND submission.

What new RedTail platform and CLD-501 data did Calidi Biotherapeutics (CLDI) share?

Calidi Biotherapeutics presented data on RedTail viruses expressing both a T-cell engager and IL-15 SA, and on CLD-501, a TROP2 in vivo T-cell engager. According to the company, localized expression may address challenges with T-cell engagers in solid tumors.