Calidi Biotherapeutics Inc Stock Price, News & Analysis

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.

Calidi Biotherapeutics (NYSE: CLDI) reported a cash balance of $9.6 million as of December 31, 2024, and announced the termination of its Standby Equity Purchase Agreement (SEPA) with YA II PN, effective January 23, 2025. The company secured significant funding through multiple channels in Q4 2024, including $9.5 million from public offerings, $2.0 million from warrant exercises, and $3.1 million from its ATM facility. In January 2025, an additional public offering raised $4.25 million in gross proceeds.

The company's strengthened financial position led to the termination of the unused SEPA, which had provided the option to sell up to $25 million of common stock over three years. Recent developments include the acceptance of their RTNova platform abstract for presentation at the AACR Annual Meeting and FDA clearance for a Phase 1b/2 trial of CLD-101 for high-grade gliomas, scheduled to begin enrollment in Q1 2025.

Calidi Biotherapeutics (NYSE: CLDI) announced the acceptance of its abstract for presentation at the AACR Annual Meeting in Chicago (April 25-30, 2025). The presentation, titled 'Development of a Systemic Enveloped Virotherapy for Targeting All Metastatic Sites,' will showcase data from their proprietary RTNova systemic platform.

The platform features a novel vaccinia virus strain enveloped with human cell membrane (extracellular enveloped virus or EEV), designed to target distant tumors while avoiding immune system elimination. This technology aims to address treatment challenges in advanced-stage metastatic cancers, particularly when intratumoral administration isn't feasible.

The company also plans to submit additional data about RTNova's lead clinical candidate selection at the ASCO Annual Meeting in June 2025. This development complements Calidi's existing clinical and preclinical work on localized and intratumoral cell-based virotherapies with SNV (SuperNova) and NNV (NeuroNova).

Calidi Biotherapeutics (NYSE American: CLDI), a clinical-stage biotechnology company focused on targeted antitumor virotherapies, has completed its previously announced public offering. The company sold 5,000,000 shares of common stock at $0.85 per share, raising gross proceeds of approximately $4.25 million.

Ladenburg Thalmann & Co. Inc. served as the exclusive placement agent for the offering, which was conducted under an effective Form S-3 registration statement. The final prospectus was filed with the SEC on January 10, 2025, and is available through the SEC's website and Ladenburg Thalmann & Co. Inc.