A downtrend has been apparent in Calidi Biotherapeutics, Inc. (CLDI) lately. While the stock has lost 14% over the past two weeks, it could witness a trend reversal as a hammer chart pattern was formed in its last trading session. This could mean that the bulls have been able to counteract the bears to help the stock find support.While the formation of a hammer pattern is a technical indication of nearing a bottom with potential exhaustion of selling pressure, rising optimism among Wall Street analysts abou ...

Exhibit 99.1 Calidi Biotherapeutics Reports First Quarter 2025 Financial Results and Recent Operational Highlights SAN DIEGO, May 14, 2025 -- (Business Wire) -- Calidi Biotherapeutics Inc. (NYSE American: CLDI) ("Calidi"), a clinical-stage biotechnology company pioneering the development of systemic oncolytic targeted immunotherapies with the potential to deliver genetic payloads, today reported its first quarter 2025 operating and financial results and reviewed recent business highlights. "We are extremely ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE QUARTERLY PERIOD ENDED MARCH 31, 2025 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File Number 001-40789 Calidi Biotherapeutics, Inc. (Exact name of registrant as specified in its charter) Delaware 86-2967193 (State or other jurisdiction of incorporation or organization) ...

Bolstered management team with hires of Chief Executive Officer and Chief Medical Officer with deep biopharmaceutical experienceAnnounced selection of IL15-superagonist as first payload to be delivered into tumors with Calidi’s first lead candidate using its systemic antitumor virotherapy platform, Redtail; IND filing expected in the second half of 2026 IND cleared by FDA for CLD-201 clinical trial SAN DIEGO, May 14, 2025 (GLOBE NEWSWIRE) -- Calidi Biotherapeutics Inc. (NYSE American: CLDI) (“Calidi”), a cl ...

SAN DIEGO, April 28, 2025 (GLOBE NEWSWIRE) -- Calidi Biotherapeutics Inc. (NYSE American: CLDI) ("Calidi"), a clinical-stage biotechnology company developing a new generation of targeted antitumor virotherapies, today announced the selection of IL15 superagonist (Il15-IL15Ra) as the first payload to be delivered into tumors using its systemic antitumor virotherapy platform, RTNova. New preclinical data were presented at the American Association for Cancer Research (AACR) Annual Meeting on April 27, 2025, in ...

SAN DIEGO, April 25, 2025 (GLOBE NEWSWIRE) -- Calidi Biotherapeutics Inc. (NYSE American: CLDI) (“Calidi”), a clinical-stage biotechnology company developing a new generation of targeted antitumor virotherapies, today announced that in connection with the appointment of Eric Poma, Ph.D. as Chief Executive Officer , the Company’s Compensation Committee and the Board of Directors has approved the grant of an inducement non-qualified stock option for Dr. Poma for the purchase of 726,412 shares with an exercise ...

SAN DIEGO, April 17, 2025 (GLOBE NEWSWIRE) -- Calidi Biotherapeutics Inc. (NYSE American: CLDI) (“Calidi”), a clinical-stage biotechnology company pioneering targeted antitumor virotherapies, announced today that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for CLD-201. This investigational, allogeneic stem cell-based immunotherapy is set to advance into clinical development for the treatment of solid tumors in adults, focusing on breast cancer, head ...

SAN DIEGO, April 10, 2025 (GLOBE NEWSWIRE) -- Calidi Biotherapeutics Inc. (NYSE:CLDI) ("Calidi"), a clinical-stage biotechnology company developing a new generation of targeted antitumor virotherapies, today announced the appointment of Guy Travis Clifton, MD as Chief Medical Officer, Consultant and Advisor. "With our recently filed IND for a company sponsored, dose escalation trial of CLD-201 in adult patients with solid tumors, Dr. Clifton's oncology and advisory experience will be invaluable to us and ou ...

Financial Performance and Capital Raising - In Q4 2024, Calidi Biotherapeutics raised $9.5 million in gross proceeds from two public offerings, $2.0 million from warrant exercises, and $3.1 million from its at-the-market program[6] - A subsequent public offering in January 2025 raised an additional $4.25 million in gross proceeds[6] - The total capital raised has strengthened the company's cash position, allowing it to meet capital requirements without reliance on the Standby Equity Purchase Agreement (SEPA)[6] - The SEPA, which allowed the company to issue and sell up to $25.0 million of its common stock, was terminated effective January 23, 2025, with no outstanding borrowings or fees due[4][5] Financial Reporting and Estimates - The preliminary financial information provided is subject to further internal review and may differ from final results due to ongoing closing procedures[8][10] - Management's estimates are based on preliminary information and may change as actual results are compiled[9][10] Forward-Looking Statements and Risks - Forward-looking statements regarding future financial performance are subject to risks and uncertainties that could cause actual results to differ materially[11] - The company operates in a competitive environment, and new risks may emerge that could impact forward-looking statements[11] - The company has no obligation to update forward-looking statements unless required by law[12] Press Release and Communication - The press release regarding the bolstered cash balance and termination of the SEPA was issued on January 28, 2025[13]

Financial Performance - The company has incurred an accumulated deficit of approximately $121.7 million as of December 31, 2024, with net losses of approximately $22.2 million and $29.2 million for the years ended December 31, 2024 and 2023, respectively [242]. - The company has not generated any revenue from product sales to date and does not expect to do so in the foreseeable future [247]. - The company has experienced recurring losses from operations since inception, raising substantial doubt about its ability to continue as a going concern [395]. Research and Development - Research and development expenses are expected to significantly increase due to the commencement and continuation of clinical trials for product candidates [243]. - The company intends to initiate a Phase 1b or Phase 2 clinical trial for its lead product candidate CLD-101 for newly diagnosed high-grade glioma (HGG) [255]. - The company plans to apply for an Investigational New Drug application (IND) for its product candidate CLD-201, which utilizes allogeneic adipose-derived mesenchymal stem cell [255]. - The company may develop product candidates in combination with other therapies, exposing it to additional risks related to those therapies [282]. - The company is committed to pay up to $10 million in clinical trial costs for CLD-101 for newly diagnosed HGG and recurrent HGG, with contingent consideration of up to $18.7 million based on development milestones achieved [262]. Regulatory Challenges - The success of the company is highly dependent on obtaining regulatory approval for CLD-101 for newly diagnosed HGG and recurrent HGG, as well as CLD-201 and CLD-400 [264]. - The company faces significant challenges in obtaining regulatory approval for its product candidates due to their novel approach using allogeneic neural stem cells and oncolytic viruses [276]. - The regulatory approval pathway for the company's product candidates may be complex, lengthy, and expensive, with no guarantee of approval [278]. - The company may experience delays in clinical trials or regulatory approvals due to heightened safety and contagion rules for live, gene-modified viruses [280]. - The design and conduct of the company's clinical trials differ from previously conducted trials, posing substantial risks for satisfactory outcomes [281]. Market and Competition - The commercial success of adenovirus-based product candidates, including CLD-101 for newly diagnosed and recurrent HGG, depends on public acceptance of immuno-oncology therapies [285]. - The company faces substantial competition from major pharmaceutical and biotechnology companies, which may have greater resources and expertise [297]. - The commercial success of product candidates will depend on their efficacy, safety, convenience, and pricing compared to competitors [301]. - The company may face competition from biosimilars if its products are approved, leading to increased competitive pressure [338]. Funding and Capital Requirements - Future capital requirements may increase significantly due to the scope and costs of product discovery, preclinical and clinical development [256]. - The company may need to raise substantial additional funding to continue its product development programs and operations [255]. - The company may need to sell additional shares or issue debt to meet cash payment obligations, which could delay or reduce development and commercialization activities [263]. - The company may need to curtail clinical and research initiatives if it fails to secure additional capital, potentially delaying its business plans [396]. Compliance and Legal Risks - The company is subject to ongoing legislative and enforcement scrutiny regarding drug pricing practices, which may impact its pricing strategies [345]. - The company must comply with strict advertising and promotion regulations, and failure to do so could result in substantial fines and damage to reputation [330]. - The company is subject to various anti-corruption laws, including the FCPA, which prohibit bribery and could lead to significant penalties if violated [407]. - Compliance with federal and state healthcare laws is critical, as violations could result in substantial penalties and adversely affect the company's financial condition [410]. Operational Challenges - The company lacks a sales and marketing infrastructure, which may hinder the commercialization of current or future product candidates [352]. - The company may face challenges in establishing effective sales and marketing capabilities, which could delay drug launches and increase commercialization expenses [354]. - The company is highly dependent on the expertise of its executive officers and key personnel, making recruitment and retention critical to its success [385]. - The company identified material weaknesses in internal controls over financial reporting, particularly in accounting for derivatives and cash flow statements [400]. External Factors - The change in presidential administration in 2025 introduces uncertainty regarding potential modifications to FDA requirements, which could materially affect business operations and financial condition [308]. - Legislative changes, such as the ACA, could impose additional costs and competition from biosimilars, affecting the company's profitability [342]. - Changes in U.S. and international trade policies, including tariffs, may negatively impact the company's business and operating results [381]. - Unstable global economic conditions could adversely affect the company's financial condition, stock price, and results of operations [382].