SAN DIEGO, Nov. 14, 2024 (GLOBE NEWSWIRE) -- Calidi Biotherapeutics, Inc. (NYSE AMERICAN: CLDI) (“Calidi” or the “Company”), a clinical-stage biotechnology company developing a new generation of targeted immunotherapies, today announced that it has priced its public offering of 4,437,869 shares of the Company’s common stock at a price of $1.69 per share. The closing of the offering is expected to occur on or about November 15, 2024, subject to the satisfaction of customary closing conditions. Ladenburg Thal ...

SAN DIEGO, Nov. 13, 2024 (GLOBE NEWSWIRE) -- Calidi Biotherapeutics, Inc. (NYSE AMERICAN: CLDI) (“Calidi” or the “Company”), a clinical-stage biotechnology company developing a new generation of targeted immunotherapies, today announced that it intends to offer to sell shares of its common stock (and/or pre-funded warrants (“Pre-Funded Warrants”) in lieu thereof) in an public offering. All of the shares of common stock (and/or Pre-funded Warrants) are to be sold by the Company. Ladenburg Thalmann & Co. Inc. ...

Financial Performance - Calidi Biotherapeutics reported a net loss of $5.1 million, or $0.65 per share, for Q3 2024, compared to a net loss of $2.0 million, or $1.41 per share, for the same period in 2023[7]. - Research and development expenses decreased to $2.2 million in Q3 2024 from $3.3 million in Q3 2023[7]. - General and administrative expenses were $3.1 million for Q3 2024, down from $4.0 million in Q3 2023[8]. Funding and Financial Position - The company raised $2 million through a registered direct offering and concurrent private placement in October 2024[6]. - As of September 30, 2024, Calidi had approximately $1.9 million in cash and $0.2 million in restricted cash, consistent with December 31, 2023[8]. - Total current liabilities increased to $11.6 million as of September 30, 2024, compared to $10.2 million at the end of 2023[11]. - Total assets decreased to $6.7 million as of September 30, 2024, down from $10.0 million at the end of 2023[11]. - The accumulated deficit increased to $117.6 million as of September 30, 2024, compared to $99.6 million at the end of 2023[11]. Clinical Developments - The FDA cleared Northwestern University's IND application for Calidi's NeuroNova (CLD-101) clinical trial in high-grade glioma, expected to start in early 2025[4]. - Data on RTNova (CLD-400) was presented at multiple international conferences, highlighting its potential to target multiple tumor sites[5].

Announced FDA Clearance of the Northwestern University IND Application for NeuroNova (CLD-101) Clinical Trial in High-Grade Glioma.Presented data supporting RTNova (CLD-400), the company’s systemic antitumor virotherapy platform, at the International Oncolytic Virotherapy Conference (IOVC) in Rotterdam, Netherlands, the Society for Immunotherapy of Cancer (SITC) Annual Meeting, and at Immuno US 2024 in San Diego, California.Raised $2 million in a registered direct offering and concurrent private placement. ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 or FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE QUARTERLY PERIOD ENDED SEPTEMBER 30, 2024 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File Number 001-40789 | --- | --- | --- | --- | |-------|-------|-----------------------|-------| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 86-2967193 ...

- RTNova, an innovative systemic antitumor enveloped virotherapy, unlocks new possibilities in cancer therapy - RTNova addresses challenges posed by untargetable and untreatable metastatic diseases, offering a potential transformative solution with wide-ranging applications SAN DIEGO, Oct. 24, 2024 (GLOBE NEWSWIRE) --  Calidi Biotherapeutics Inc. (NYSE American: CLDI) (“Calidi”), a clinical-stage biotechnology company developing a new generation of targeted antitumor virotherapies and viral vectors, will pr ...

SAN DIEGO, Oct. 23, 2024 (GLOBE NEWSWIRE) -- Calidi Biotherapeutics, Inc. (NYSE AMERICAN: CLDI) (“Calidi” or the “Company”), a clinical-stage biotechnology company developing a new generation of targeted immunotherapies, today announced that it has entered into a definitive securities purchase agreement with certain institutional investors for the purchase and sale of 2,050,000 shares of the Company’s common stock at a price of $1.00 per share of common stock in a registered direct offering. In addition, in ...

SAN DIEGO, Oct. 18, 2024 (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 the staff of NYSE Regulation has determined to commence proceedings to delist the warrants — ticker symbol CLDI WS — of Calidi Biotherapeutics, Inc. (the "Company"), each whole warrant exercisable for 1/10th of a share of common stock at an exercise price of $115.00 per whole sh ...

[Press Release Overview](index=1&type=section&id=Press%20Release%20Overview) Calidi Biotherapeutics' Q2 2024 report highlights the launch of Nova Cell, key leadership appointments, and a new U.S. patent [Q2 2024 Key Highlights](index=1&type=section&id=Q2%202024%20Key%20Highlights) Calidi Biotherapeutics reported its Q2 2024 operating and financial results, highlighting the launch of its Nova Cell subsidiary with a $2 million investment, the strengthening of its leadership team with key appointments, and the receipt of a new U.S. patent for its SuperNova technology, advancing its CLD-201 program - Launched Nova Cell subsidiary with a **$2 million investment** from Dr. Ronald Rigor to advance Calidi's Adult Adipose Allogeneic (AAA) stem cell innovative programs[1](index=1&type=chunk) - Strengthened the team with the appointment of Dr. George E. Peoples to the Board of Directors and Dr. Mark Gilbert to the Medical Advisory Board[1](index=1&type=chunk) - Received a new U.S. patent for the company's novel SuperNova technology, positioning Calidi to advance its CLD-201 program into the clinic[1](index=1&type=chunk) [Second Quarter 2024 and Recent Corporate Developments](index=1&type=section&id=Second%20Quarter%202024%20and%20Recent%20Corporate%20Developments) This section details Calidi's strategic investments, leadership appointments, intellectual property advancements, and capital raising activities during Q2 2024 [Strategic Investments and Subsidiaries](index=1&type=section&id=Strategic%20Investments%20and%20Subsidiaries) Calidi announced a $2 million strategic investment by Dr. Ronald Rigor into its new subsidiary, Nova Cell, Inc., formed to develop innovative stem cell-based products. Dr. Rigor also made an additional $1 million investment directly into Calidi's oncology pipeline - Nova Cell, Inc. was launched with a **$2 million strategic investment** from Dr. Ronald Rigor in July 2024 to advance Calidi's Adult Adipose Allogeneic (AAA) stem cell programs[2](index=2&type=chunk) - Dr. Rigor invested an additional **$1 million** into Calidi to further its oncology pipeline assets and was appointed as a member of Calidi's Scientific and Medical Advisory Board[2](index=2&type=chunk) [Board and Advisory Appointments](index=1&type=section&id=Board%20and%20Advisory%20Appointments) The company strengthened its leadership by appointing Dr. George Peoples, a Professor of Surgery and Surgical Oncology, to its Board of Directors, and Dr. Mark Gilbert, former Chief of Neuro-Oncology Branch at NIH, to its Medical Advisory Board - Dr. George Peoples, MD, FACS, Professor of Surgery and adjunct Professor of Surgical Oncology at MD Anderson Cancer Center, was appointed as a Class II director to the Board of Directors[2](index=2&type=chunk) - Dr. Mark Gilbert, MD, scientist emeritus at NIH and former Chief of the Neuro-Oncology Branch, was appointed to the Calidi Medical Advisory Board[1](index=1&type=chunk)[3](index=3&type=chunk) [Intellectual Property and Technology Advancement](index=1&type=section&id=Intellectual%20Property%20and%20Technology%20Advancement) Calidi secured a new U.S. patent for its SuperNova technology platform, which involves incubating cells with an oncolytic virus to express immunomodulatory proteins, enhancing viral delivery to tumor sites by shielding the payload from the immune system - Received a patent covering the novel SuperNova technology platform, which combines stem cells and an oncolytic virus for a defined period, allowing expression of immunomodulatory proteins and shielding the viral payload from the immune system for targeted delivery to tumor sites[1](index=1&type=chunk)[3](index=3&type=chunk) - The SuperNova platform is composed of adipose-derived mesenchymal stem cells loaded with oncolytic vaccinia virus[3](index=3&type=chunk) [Capital Raising Activities](index=1&type=section&id=Capital%20Raising%20Activities) Calidi generated $2.5 million in gross proceeds during July and August 2024 through the exercise of warrants - Received **$2.5 million in gross proceeds** during July and August 2024 pursuant to warrant exercises[4](index=4&type=chunk) [Second Quarter Financial Results](index=2&type=section&id=Second%20Quarter%20Financial%20Results) This section presents Calidi Biotherapeutics' financial performance for the second quarter of 2024, including net loss, expenses, and balance sheet details [Summary Financial Performance](index=2&type=section&id=Summary%20Financial%20Performance) Calidi reported a reduced net loss of $5.8 million, or $1.40 per share, for Q2 2024, significantly down from $12.5 million, or $14.24 per share, in Q2 2023. Research and development expenses decreased, while general and administrative expenses slightly increased. Cash and restricted cash totaled $1.0 million as of June 30, 2024 Summary Financial Performance (in thousands) | Metric | Q2 2024 (in thousands) | Q2 2023 (in thousands) | Change (YoY) | | :----- | :--------------------- | :--------------------- | :----------- | | Net Loss | $(5,767) | $(12,501) | Improved by $6,734 | | Net Loss per Share | $(1.40) | $(14.24) | Improved by $12.84 | | R&D Expenses | $(2,167) | $(3,177) | Decreased by $1,010 | | G&A Expenses | $(3,605) | $(3,360) | Increased by $245 | | Cash (as of June 30, 2024 / Dec 31, 2023) | $836 (June 30, 2024) | $1,949 (Dec 31, 2023) | Decreased by $1,113 | | Restricted Cash (as of June 30, 2024 / Dec 31, 2023) | $200 (June 30, 2024) | $200 (Dec 31, 2023) | No change | [Detailed Financial Statements](index=2&type=section&id=Detailed%20Financial%20Statements) This section provides a comprehensive breakdown of Calidi Biotherapeutics' financial position and operational results through its condensed consolidated balance sheets and statements of operations [Condensed Consolidated Balance Sheets](index=2&type=section&id=CALIDI%20BIOTHERAPEUTICS%2C%20INC.%20CONDENSED%20CONSOLIDATED%20BALANCE%20SHEETS) This table presents Calidi Biotherapeutics' financial position, detailing assets, liabilities, and stockholders' deficit as of June 30, 2024, and December 31, 2023 Condensed Consolidated Balance Sheets (in thousands) | ASSETS (in thousands) | June 30, 2024 (Unaudited) | December 31, 2023 | | :-------------------- | :------------------------ | :---------------- | | **CURRENT ASSETS** | | | | Cash | $836 | $1,949 | | Prepaid expenses and other current assets | $789 | $2,354 | | Total current assets | $1,625 | $4,303 | | **NONCURRENT ASSETS** | | | | Machinery and equipment, net | $1,061 | $1,270 | | Operating lease right-of-use assets, net | $3,518 | $4,073 | | Other noncurrent assets | $227 | $373 | | **TOTAL ASSETS** | **$6,431** | **$10,019** | | **LIABILITIES AND STOCKHOLDERS' DEFICIT** | | | | **CURRENT LIABILITIES** | | | | Accounts payable | $4,460 | $2,796 | | Related party accounts payable | $87 | $81 | | Accrued expenses and other current liabilities | $3,236 | $4,896 | | Related party accrued expenses and other current liabilities | $504 | $536 | | Term notes payable, net of discount, including accrued interest | $233 | $529 | | Related party term notes payable, net of discount, including accrued interest | $2,539 | $278 | | Related party bridge loan payable, including accrued interest | $211 | — | | Related party other current liability | $597 | — | | Finance lease liability, current | $68 | $81 | | Operating lease right-of-use liability, current | $1,117 | $1,035 | | Total current liabilities | $13,052 | $10,232 | | **NONCURRENT LIABILITIES** | | | | Operating lease right-of-use liability, noncurrent | $2,461 | $3,037 | | Finance lease liability, noncurrent | $180 | $216 | | Convertible notes payable, including accrued interest | $1,925 | — | | Warrant liability | $524 | $623 | | Related party warrant liability | $41 | $48 | | Related party term notes payable, net of discount, including accrued interest | — | $2,060 | | Other noncurrent liabilities | — | $1,500 | | Related party other noncurrent liabilities | — | $538 | | **TOTAL LIABILITIES** | **$18,183** | **$18,254** | | **STOCKHOLDERS' DEFICIT** | **$(11,752)** | **$(8,235)** | | **TOTAL LIABILITIES AND STOCKHOLDERS' DEFICIT** | **$6,431** | **$10,019** | [Condensed Consolidated Statements of Operations](index=4&type=section&id=CALIDI%20BIOTHERAPEUTICS%2C%20INC.%20CONDENSED%20CONSOLIDATED%20STATEMENTS%20OF%20OPERATIONS) This table details Calidi Biotherapeutics' operational expenses, other income/expenses, and net loss for the three months ended June 30, 2024, and 2023 Condensed Consolidated Statements of Operations (in thousands) | OPERATING EXPENSES (in thousands) | Three Months Ended June 30, 2024 (Unaudited) | Three Months Ended June 30, 2023 | | :-------------------------------- | :------------------------------------------- | :------------------------------- | | Research and development | $(2,167) | $(3,177) | | General and administrative | $(3,605) | $(3,360) | | Total operating expense | $(5,772) | $(6,537) | | Loss from operations | $(5,772) | $(6,537) | | **OTHER INCOME (EXPENSES), NET** | | | | Interest expense | $(108) | $(98) | | Interest expense – related party | $(165) | $(208) | | Change in fair value of debt, other liabilities, and derivatives | $86 | $(1,074) | | Change in fair value of debt, other liabilities, and derivatives – related party | $9 | $(2,773) | | Series B convertible preferred stock financing costs – related party | — | $(2,680) | | Grant income | $181 | $889 | | Other income (expense), net | $10 | $(16) | | Total other income (expenses), net | $13 | $(5,960) | | LOSS BEFORE INCOME TAXES | $(5,759) | $(12,497) | | Income tax provision | $(8) | $(4) | | **NET LOSS** | **$(5,767)** | **$(12,501)** | | Deemed dividend on warrants | $(1,671) | — | | **NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS** | **$(7,438)** | **$(12,501)** | | Net loss per share; basic and diluted | $(1.40) | $(14.24) | | Weighted average common shares outstanding; basic and diluted | 5,328 | 878 | [About Calidi Biotherapeutics](index=2&type=section&id=About%20Calidi%20Biotherapeutics) This section provides an overview of Calidi Biotherapeutics, detailing its focus on immuno-oncology and its proprietary stem cell-based virotherapy platforms [Company Overview and Technology](index=2&type=section&id=Company%20Overview%20and%20Technology) Calidi Biotherapeutics is a clinical-stage immuno-oncology company focused on developing a new generation of targeted antitumor virotherapies. Its proprietary technology utilizes potent allogeneic stem cells to deliver oncolytic viruses for various oncology indications, including high-grade gliomas and solid tumors, aiming to enhance efficacy and patient safety - Calidi Biotherapeutics is a clinical-stage immuno-oncology company with proprietary technology designed to arm the immune system to fight cancer[6](index=6&type=chunk) - The company's novel stem cell-based platforms utilize potent allogeneic stem cells capable of carrying payloads of oncolytic viruses for use in multiple oncology indications, including high-grade gliomas and solid tumors[6](index=6&type=chunk) - Calidi's clinical stage off-the-shelf, universal cell-based delivery platforms (e.g., SuperNova) and preclinical enveloped virotherapies are designed to protect, amplify, and potentiate oncolytic viruses, potentially treating or preventing metastatic disease[6](index=6&type=chunk) [Forward-Looking Statements](index=2&type=section&id=Forward-Looking%20Statements) This section contains a standard disclaimer regarding forward-looking statements, highlighting inherent risks and uncertainties that may cause actual results to differ [Disclaimer](index=2&type=section&id=Disclaimer) This section provides a standard disclaimer regarding forward-looking statements, cautioning that actual results may differ materially due to various risks and uncertainties, including capital raising, clinical trial outcomes, and regulatory approvals - The press release may contain forward-looking statements subject to multiple risks and uncertainties that could cause actual results to differ materially and adversely[7](index=7&type=chunk) - Key risks include the ability to raise sufficient capital, the potential for early clinical trial results to change, and the risk of not receiving FDA approval for therapeutic candidates[7](index=7&type=chunk)

Launched Nova Cell subsidiary with $2 million investment from Dr. Ronald Rigor to advance Calidi's Adult Adipose Allogeneic (AAA) stem cell innovative programs Strengthened team with the appointment of Dr. George E. Peoples, MD, FACS, adjunct professor of Surgical Oncology at MD Anderson Cancer Center, to the company's Board of Directors, and the addition of Mark Gilbert, MD, scientist emeritus at the National Institutes of Health (NIH), to its Medical Advisory Board Received a new U.S. patent for the compa ...