CALIDI Biotherapeutics Forms Partnership with Avance Clinical to Streamline Australian Regulatory Approval and Expedite CLD-401 Clinical Trials Launch

Written by Emily J. Thompson, Senior Investment Analyst

Source: moomoo

Updated: 6 days ago

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Should l Buy CLDI?

Source: moomoo

Partnership Announcement: Calidi Biotherapeutics has announced a partnership with Avance Clinical to facilitate clinical trials in Australia.
Regulatory Approval: The partnership aims to accelerate the initiation of clinical trials for CLD-401, a therapeutic product.
Focus on Clinical Trials: The collaboration will leverage Avance Clinical's expertise to navigate the regulatory landscape in Australia.
Goal of the Initiative: The initiative is designed to expedite the development and testing of innovative therapies in the Australian market.

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About CLDI

Calidi Biotherapeutics, Inc. is a clinical-stage immuno-oncology company. The Company is developing proprietary allogeneic stem cell-based and enveloped virus platforms to potentiate and deliver oncolytic viruses (vaccinia virus and adenovirus) and, potentially, other molecules to cancer patients. It is focused on developing two proprietary stem cell-based platforms and one enveloped vaccinia virus platform designed to protect the oncolytic virus, whether natural or engineered, from neutralization by the patient’s immune defenses, allowing for greater infection of the tumor cells and leading to a potential improvement in the antitumor activity of oncolytic viruses over traditional naked oncolytic virus therapies. Its product candidates include the CLD-101 product for high grade glioma (HGG), CLD-101 product for Recurrent HGG, CLD-201 product for solid tumors, CLD-301 (AAA) for multiple indications and CLD-400 (RTNova) for certain lung cancer and metastatic solid tumors.

About the author

Emily J. Thompson

Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.

Calidi Biotherapeutics Reports FY Loss and Public Offering

3 days agoseekingalpha

Financial Loss: Calidi Biotherapeutics reported a FY GAAP EPS of -$5.95, indicating significant challenges in profitability that could undermine investor confidence and negatively impact stock performance.
Cash Flow Status: As of December 31, 2025, the company had approximately $5.6 million in cash, a substantial decrease from $9.6 million in 2024, reflecting liquidity constraints that may limit future operational and R&D investments.
Public Offering Plan: Calidi plans a $5.2 million underwritten public offering, which aims to strengthen its capital base; however, market reactions may be subdued due to the company's current financial condition, leading to a decline in share price.
Restricted Cash Situation: The company maintained $0.2 million in restricted cash as of December 31, 2025, indicating a cautious approach to cash utilization that may affect its financial flexibility in the short term.

Calidi Biotherapeutics Accelerates CLD-401 Clinical Trial Initiation

3 days agoNewsfilter

Clinical Trial Partnership: Calidi has partnered with Australia's Avance Clinical to rapidly initiate the first-in-human clinical trial for CLD-401, which is expected to significantly enhance the drug's market entry speed and strengthen the company's competitive position in oncology.
Positive FDA Feedback: The company received encouraging feedback from the FDA through Type D interactions, confirming that its manufacturing and analytical approaches align with FDA guidance, with plans to file an IND by the end of 2026, paving the way for CLD-401's clinical development.
Successful Fundraising: Calidi raised $6 million in gross proceeds from a public offering in Q1 2026 and an additional $0.5 million from ATM sales in Q4 2025, bolstering its financial position and extending its cash runway for ongoing projects.
Increased R&D Spending: Research and development expenses reached $2.4 million in Q4 2025, up from $1.8 million in the same period of 2024, reflecting the company's ongoing investment in advancing CLD-401 and other projects to meet market demand for innovative therapies.

CALIDI BIOTHERAPEUTICS INC REPORTS Q4 NET LOSS OF $0.57 PER SHARE

3 days agomoomoo

Company Overview: Calidi Biotherapeutics is a biotechnology company focused on developing innovative therapies.
Financial Performance: The company reported a net loss of $0.57 per share for the fourth quarter.

Calidi Partners with Avance for First-in-Human Trial of CLD-401

6 days agoNASDAQ.COM

Partnership for Clinical Trial: Calidi Biotherapeutics has partnered with Avance Clinical to rapidly initiate a first-in-human clinical trial for its investigational candidate CLD-401, marking a significant advancement in addressing high unmet medical needs in non-small cell lung cancer and other tumor types.
Trial Objectives: The trial aims to evaluate the safety, pharmacodynamics, and efficacy of CLD-401 as a monotherapy in patients with solid tumors who have exhausted all other therapeutic options, indicating a potential positive impact on this patient population.
FDA Filing Plans: Calidi plans to file an IND for CLD-401 with the FDA in 2026, demonstrating the company's confidence in the drug's development and laying the groundwork for future market access.
Stock Price Reaction: Following the announcement of the partnership, Calidi's stock rose 3.65% to $0.30 in pre-market trading, reflecting market optimism regarding the collaboration and its potential outcomes.