Calidi Biotherapeutics Inc Stock Price, News & Analysis

Calidi Biotherapeutics (NYSE: CLDI) has appointed Dr. Guy Travis Clifton as Chief Medical Officer, Consultant and Advisor. This announcement comes as the company advances its targeted antitumor virotherapies through clinical development.

Dr. Clifton brings over 17 years of experience in drug development, early phase trials, and cancer immunotherapy. He previously served as CMO at Parthenon Therapeutics/Incendia Therapeutics and has been a practicing surgical oncologist in the US Army since 2013. His expertise includes advising over 20 companies and authoring more than 80 peer-reviewed publications.

The appointment aligns with Calidi's recent IND filing for a dose escalation trial of CLD-201 in adult patients with solid tumors. The company is developing two platforms: a systemic approach using extracellular enveloped viruses to target metastatic tumors, and an intratumoral approach using stem cells to protect and enhance virotherapy potency.

Calidi Biotherapeutics (NYSE AMERICAN: CLDI) has successfully closed its previously announced registered direct offering and concurrent private placement, raising $3.9 million in gross proceeds. The transaction includes:

• 3,325,000 shares of common stock
• Pre-funded warrants for 2,728,000 shares at $0.001 exercise price
• Series G warrants for 6,053,000 shares at $0.6954 exercise price

The combined offering price was set at $0.65 per share. The Series G warrants will be exercisable after six months and expire seven and a half years following the initial exercise date. Ladenburg Thalmann & Co. Inc. served as the exclusive placement agent. The company plans to use the proceeds for working capital, general corporate purposes, and advancing its pre-clinical and clinical programs.

Calidi Biotherapeutics (NYSE: CLDI) reported its Q4 and full-year 2024 financial results, highlighting significant progress across its three therapeutic platforms. The company demonstrated success in delivering gene therapy payload to tumors using its systemic antitumor virotherapy platform.

Key developments include: filing an IND for CLD-201 Phase 1 trial for multiple solid tumors in March 2025, advancing recruitment for a Phase 1 trial at Northwestern University for newly diagnosed high-grade glioma patients, and enrolling 14 patients in a City of Hope Phase 1 trial for recurrent high-grade glioma.

Financial results show a Q4 2024 net loss of $4.1 million ($0.27 per share), compared to $8.2 million in Q4 2023. Full-year 2024 net loss was $23.8 million ($2.97 per share). The company ended 2024 with $9.6 million in cash.

Calidi Biotherapeutics (NYSE AMERICAN: CLDI) has announced a $3.9 million financing through a registered direct offering and concurrent private placement. The company will sell 3,325,000 shares of common stock at $0.65 per share and pre-funded warrants for up to 2,728,000 shares at $0.649 per warrant to a single institutional investor.

The deal includes series G warrants in a private placement to purchase up to 6,053,000 shares at $0.6954 per share, exercisable after six months with a 7.5-year term. Ladenburg Thalmann & Co. Inc. is serving as the exclusive placement agent. The closing is expected around March 31, 2025.

The clinical-stage biotechnology company plans to use the proceeds for working capital, general corporate purposes, and advancing its pre-clinical and clinical programs in targeted immunotherapies.

Calidi Biotherapeutics (NYSE: CLDI) and City of Hope have reported progress on their Phase 1 clinical trial evaluating CLD-101, a neural stem cell-based oncolytic virotherapy for recurrent high-grade glioma. The trial, which is the first to assess a multiple-dose regimen of this novel treatment, has successfully treated 14 participants with up to four weekly intracerebral doses.

The study, supported by a $12 million award from the California Institute for Regenerative Medicine (CIRM), is currently enrolling participants for the highest treatment schedule. Dr. Jana Portnow, co-director of City of Hope's Brain Tumor Program and principal investigator, reported that all treatments have been well-tolerated.

The trial has expanded to include Northwestern University Feinberg School of Medicine and Stanford University Hospitals. The technology, licensed from the University of Chicago on behalf of City of Hope and University of Alabama, aims to improve clinical outcomes using stem cell technology to deliver oncolytic virus payloads to cancer sites.

Calidi Biotherapeutics (NYSE: CLDI) has announced promising preclinical results for its systemic RTNova platform, demonstrating successful delivery of transient gene therapy payloads to targeted tumors. The company's tumor-specific virotherapy has shown effectiveness in killing over 60 different tumor cell lines.

The platform utilizes an innovative vaccinia virus strain with human cell membrane protection, designed to treat advanced-stage metastatic cancers, particularly when intratumoral administration isn't feasible. New data reveals that a single dose of their tumor-selective triple knockout (3KO) RT virus with a specific immunotherapeutic payload significantly altered the tumor microenvironment, achieving 80% leukocyte infiltration for 3KO RT and 92% with the payload, compared to 46% in untreated cases.

The treatment demonstrated complete tumor eradication in certain preclinical models, combining direct tumor killing with robust antitumor immune responses. This breakthrough enables potential development of multiple assets for various indications and opens doors for partnership opportunities.

Calidi Biotherapeutics (NYSE:CLDI) will be featured on Bloomberg TV's RedChip Small Stocks, Big Money™ show on March 1, 2025, at 7 p.m. ET. During the interview, CFO Andrew Jackson discusses the company's oncolytic virotherapy (OV) platforms for cancer treatment.

The company's technology utilizes stem cells to protect, amplify, and enhance oncolytic viruses for targeting cancer cells. Their pipeline includes CLD-101, currently in Phase 1/1b trials with upcoming Phase 1b/2 study, and CLD-201 targeting Phase 1 initiation in 2025. The company estimates its addressable U.S. market at $13-15 billion.

Calidi Biotherapeutics (NYSE American: CLDI) has announced the start of recruitment for a new CLD-101 clinical trial at Northwestern University Hospital. The trial will focus on patients with newly diagnosed high-grade glioma, an aggressive form of brain cancer. The company has completed shipping the first batch of CLD-101, which combines allogeneic neural stem cells with oncolytic adenovirus CRAd-S-pk7.

This Phase 1B/2 trial, led by Dr. Maciej Lesniak and Dr. Roger Stupp, will implement a multiple-dose regime, building upon a previous Phase 1 trial that showed promising results with single doses in 12 patients. The study has received NIH/NCI SPORE funding and aims to enhance therapeutic efficacy in newly diagnosed patients. The trial is particularly significant as it involves Dr. Stupp, known for developing the FDA-approved Stupp Protocol for Glioblastoma treatment.

Calidi Biotherapeutics (NYSE American: CLDI) has announced an upcoming live investor webinar scheduled for February 5, 2025, at 4:15 p.m. ET. The event will feature presentations from CFO Andrew Jackson and CSO Antonio F. Santidrian, who will discuss the company's cell-based delivery platforms for enhanced cancer treatment.

The webinar will showcase Calidi's leading programs, including CLD-400 for metastatic cancers, CLD-201 for advanced solid tumors, and CLD-101 for high-grade glioma. The event, hosted by RedChip Companies, will include a live Q&A session with management. Investors can register for free and submit questions in advance or during the event.