Core Insights - Calidi Biotherapeutics has announced the issuance of a new patent for its SuperNova technology, enhancing its intellectual property portfolio and enabling the advancement of its CLD-201 program into clinical trials [1][3][8] Company Overview - Calidi Biotherapeutics is a clinical-stage biotechnology company focused on developing targeted antitumor virotherapies, utilizing a novel stem cell-based platform to enhance the immune system's ability to fight cancer [10] - The company is headquartered in San Diego, California, and aims to address the unmet need for effective treatments of solid tumors [10] Technology and Innovation - The newly granted patent (U.S. Patent No. 12,036,278) covers methods and compositions related to cancer immunotherapy, specifically combining a smallpox vaccine with adipose-derived mesenchymal stem cells loaded with oncolytic vaccinia virus [8][9] - The patent broadens previously allowed claims to include 21 smallpox vaccine virus strains, which supports the potential of the SuperNova platform to shield viral payloads from the immune system, enhancing delivery to tumor sites [9] Clinical Development - Calidi plans to submit an Investigational New Drug (IND) application to initiate its first-in-human clinical trial for the CLD-201 program, which is an off-the-shelf allogeneic therapy targeting advanced solid tumors [2][3] - The company has reported initial clinical success with its autologous adipose-derived stem cells loaded with vaccinia oncolytic viruses, indicating a promising path forward for its therapies [2]

"We are honored that Dr. Gilbert has recognized the revolutionary science at Calidi Biotherapeutics in both tumoral and glioblastoma cancer treatment. He joins other luminaries on our Medical Advisory Board who also believe in our stem-cell based therapy's potential to offer hope and better results for those with cancer," said Allan Camaisa, CEO of Calidi. Dr. Gilbert most recently served as the Chief of the Neuro-Oncology Branch at NIH from 2014 to 2024. Under Dr. Gilbert's leadership, his team of laborato ...

Financial Performance - Reported a net loss of $7.2 million, or $0.20 per share, for Q1 2024, compared to a net loss of $6.5 million, or $0.75 per share, for the same period in 2023[5] - Cash and restricted cash totaled $1.4 million as of March 31, 2024, down from $2.1 million as of December 31, 2023[8] - Total liabilities increased to $21.98 million as of March 31, 2024, up from $18.25 million as of December 31, 2023[16] Fundraising and Capital - Closed a public offering of 15,197,500 shares of common stock and accompanying warrants, raising gross proceeds of $6.1 million[4] - Anticipates initiating a Phase 1 trial with Northwestern University in Q3 2024, subject to additional capital being raised[18] Research and Development - Research and development expenses were $2.7 million for Q1 2024, compared to $2.6 million for the same period in 2023[13] - Unveiled the RTNova systemic platform, which has demonstrated preclinical ability to resist inactivation by human serum and target diverse tumor types[4] - Plans to present three posters at the 2024 ASCO Annual Meeting, including an update from the ongoing Phase 1 trial of CLD-101 in recurrent high-grade glioma[18] - Presented new data at the AACR Annual Meeting supporting the first-in-class use of stem cells to protect and potentiate antitumor virotherapies[18] General and Administrative Expenses - General and administrative expenses increased to $4.0 million for Q1 2024, up from $2.8 million in the comparable period of 2023[6]

[PART I - FINANCIAL INFORMATION](index=3&type=section&id=PART%20I%20-%20FINANCIAL%20INFORMATION) This section presents the unaudited condensed consolidated financial statements and management's analysis of the company's financial condition and results of operations [Item 1. Condensed Consolidated Financial Statements (unaudited)](index=3&type=section&id=Item%201.%20Condensed%20Consolidated%20Financial%20Statements%20(unaudited)) The unaudited condensed consolidated financial statements for Calidi Biotherapeutics, Inc. as of March 31, 2024, show a net loss of **$7.2 million** for the quarter and an accumulated deficit of **$106.8 million**, raising going concern doubts [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) The balance sheet as of March 31, 2024, shows total assets decreased to **$7.4 million** and total liabilities increased to **$22.0 million**, resulting in a larger stockholders' deficit Balance Sheet Comparison (in thousands) | Metric | March 31, 2024 | December 31, 2023 | | :--- | :--- | :--- | | Cash | $1,143 | $1,949 | | Total Current Assets | $1,936 | $4,303 | | **Total Assets** | **$7,405** | **$10,019** | | Total Current Liabilities | $14,953 | $10,232 | | **Total Liabilities** | **$21,978** | **$18,254** | | **Total Stockholders' Deficit** | **($14,573)** | **($8,235)** | [Condensed Consolidated Statements of Operations](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) For the three months ended March 31, 2024, the company reported a net loss of **$7.2 million**, an increase from the prior year, driven by higher operating expenses Statement of Operations Summary (in thousands, except per share data) | Metric | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | | :--- | :--- | :--- | | Research and development | ($2,743) | ($2,622) | | General and administrative | ($4,009) | ($2,792) | | **Loss from operations** | **($6,752)** | **($5,414)** | | Total other expenses, net | ($469) | ($1,044) | | **Net Loss** | **($7,225)** | **($6,462)** | | Net loss per share; basic and diluted | ($0.20) | ($0.75) | | Weighted average common shares outstanding | 35,552 | 8,655 | [Condensed Consolidated Statements of Cash Flows](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operating activities increased to **$3.8 million** in Q1 2024, partially offset by **$3.0 million** from financing activities, leading to a net cash decrease Cash Flow Summary (in thousands) | Activity | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | | :--- | :--- | :--- | | Net cash used in operating activities | ($3,831) | ($3,107) | | Net cash used in investing activities | ($5) | ($137) | | Net cash provided by financing activities | $3,013 | $3,791 | | **Net (decrease) increase in cash** | **($806)** | **$547** | [Notes to Condensed Consolidated Financial Statements](index=9&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) The notes detail the company's operations, accounting policies, 'going concern' warning, debt, warrants, and significant post-quarter financing events - The company has experienced recurring losses and negative cash flows, with an accumulated deficit of **$106.8 million** as of March 31, 2024. Management has concluded there is substantial doubt about the company's ability to continue as a going concern for the next 12 months[39](index=39&type=chunk)[64](index=64&type=chunk) - In March 2024, the company entered into a settlement agreement involving the issuance of **$3.5 million** in convertible notes, with **$2.0 million** for cash and **$1.5 million** to settle prior funding claims[5](index=5&type=chunk) - Subsequent to the quarter end, in April 2024, the company closed a public offering for gross proceeds of approximately **$6.1 million**, extended the maturity of several term notes, and repaid a **$1.5 million** convertible note[307](index=307&type=chunk)[308](index=308&type=chunk)[309](index=309&type=chunk) - The company is involved in legal proceedings, including a dispute with a former Chief Accounting Officer and a recently settled matter with physicians regarding stock options, which resulted in the issuance of restricted stock and warrants[233](index=233&type=chunk)[295](index=295&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=45&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's clinical-stage status, significant operating losses, and substantial doubt about its going concern ability, highlighting recent financing efforts - The company is a clinical-stage immuno-oncology firm developing stem cell-based platforms (NeuroNova™, SuperNova™) to deliver oncolytic viruses for cancer treatment, with key candidates including CLD-101 for gliomas and CLD-201 for solid tumors[313](index=313&type=chunk)[323](index=323&type=chunk)[324](index=324&type=chunk) - Management explicitly states there is substantial doubt about the company's ability to continue as a going concern, as existing cash as of May 10, 2024, is insufficient to continue operations through June 2024 without raising additional capital[327](index=327&type=chunk)[392](index=392&type=chunk) Q1 2024 vs Q1 2023 Operating Expense Comparison (in thousands) | Expense Category | Q1 2024 | Q1 2023 | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Research & Development | $2,743 | $2,622 | $121 | 5% | | General & Administrative | $4,009 | $2,792 | $1,217 | 44% | | **Total Operating Expenses** | **$6,752** | **$5,414** | **$1,338** | **25%** | - To address liquidity issues, the company raised **$3.0 million** from convertible notes in Q1 2024 and an additional **$6.1 million** in gross proceeds from a public offering in April 2024[409](index=409&type=chunk)[509](index=509&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=60&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, the company is not required to provide detailed market risk disclosures and believes it has no significant exposure to interest rate, foreign currency, or inflation risks - As a smaller reporting company, the company is not required to provide detailed disclosures about market risk[445](index=445&type=chunk) - The company does not believe it has significant exposure to interest rate risk, foreign currency risk, or inflation[417](index=417&type=chunk)[439](index=439&type=chunk)[440](index=440&type=chunk) [Item 4. Controls and Procedures](index=61&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of March 31, 2024, with no material changes to internal control over financial reporting - The CEO and CFO concluded that disclosure controls and procedures were effective as of March 31, 2024[422](index=422&type=chunk) - There were no changes in internal control over financial reporting during the quarter that materially affected, or were reasonably likely to materially affect, the company's internal controls[423](index=423&type=chunk) [PART II - OTHER INFORMATION](index=61&type=section&id=PART%20II%20-%20OTHER%20INFORMATION) This section covers legal proceedings, key risk factors, unregistered equity sales, and other required disclosures [Item 1. Legal Proceedings](index=61&type=section&id=Item%201.%20Legal%20Proceedings) The company is subject to litigation, including a recent complaint filed by a former Chief Accounting Officer regarding share restrictions - On May 1, 2024, former CAO Tony Kalajian filed a complaint against the company regarding the restrictive legend on **139,423** shares of Common Stock, seeking damages and an order to remove the legend[348](index=348&type=chunk)[425](index=425&type=chunk) [Item 1A. Risk Factors](index=61&type=section&id=Item%201A.%20Risk%20Factors) Critical risks include insufficient cash for ongoing operations, substantial doubt about going concern, and significant stockholder dilution from future capital raises and price reset features - The company has insufficient cash to continue operations for the next 12 months, raising substantial doubt about its ability to continue as a going concern[427](index=427&type=chunk)[449](index=449&type=chunk) - Future sales of common stock to raise capital will result in significant dilution to existing stockholders and could cause the share price to fall[428](index=428&type=chunk)[450](index=450&type=chunk) - Certain outstanding warrants and convertible notes have exercise or conversion prices that are subject to a reset, which could significantly increase the number of shares issuable and cause further dilution[430](index=430&type=chunk)[451](index=451&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=64&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) In February 2024, the company issued **50,000** shares of common stock to a consultant, with another **50,000** shares to be issued later, under a registration exemption - On March 25, 2024, the company issued **50,000** shares of common stock to a consultant for marketing services, with another **50,000** shares to be issued later, and the issuance was exempt from registration under Section 4(a)(2) of the Securities Act[432](index=432&type=chunk)[453](index=453&type=chunk) [Item 3. Defaults Upon Senior Securities](index=64&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reported no defaults upon its senior securities during the period - None[433](index=433&type=chunk)[454](index=454&type=chunk) [Item 4. Mine Safety Disclosures](index=64&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not applicable[434](index=434&type=chunk)[462](index=462&type=chunk) [Item 5. Other Information](index=64&type=section&id=Item%205.%20Other%20Information) The company reported no other information for this item - None[435](index=435&type=chunk)[455](index=455&type=chunk) [Item 6. Exhibits](index=65&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including various agreements, officer certifications, and XBRL data files - Exhibits filed include agreements for convertible promissory notes, a settlement agreement, officer certifications, and XBRL interactive data files[436](index=436&type=chunk)[457](index=457&type=chunk)[464](index=464&type=chunk)

Exhibit 99.1 Calidi Biotherapeutics Reports Fourth Quarter and Full-Year 2023 Operating and Financial Results - City of Hope, a leader in cancer research and treatment, was awarded $5.3 million from California Institute for Regenerative Medicine (CIRM) to develop a treatment for metastatic ovarian cancer using Calidi's licensed lead asset, NeuroNova (CLD101) - Announced novel systemic enveloped oncolytic virotherapy platform, RTNova, designed to target diverse tumor types - Strengthened team with the appoin ...

8 CLD-400 (RTNova) for certain lung cancer and Metastatic Solid Tumors, Our pre-clinical program involving enveloped oncolytic viruses is in the discovery phase of development and builds upon our research of using cells to protect, potentiate and deliver virotherapies. Our CLD-400 platform is derived from the research conducted in our prior pre-clinical CLD-202 program. The RTNova platform utilizes an engineered vaccinia virus enveloped by a cell membrane, that is potentially capable of targeting lung cance ...

SAN DIEGO--(BUSINESS WIRE)--Calidi Biotherapeutics, Inc. (NYSEAM: CLDI) (“Calidi”), a clinical-stage biotechnology company developing a new generation of targeted immunotherapies, today announced an upcoming presentation to provide details on the development of the Company’s systemic enveloped oncolytic virotherapy platform which has the potential to provide a universal treatment for a broad range of advanced tumor types. Stephen Thesing, Chief Business Officer of Calidi, will be presenting at the Biocom Gl ...

On October 27, 2022, the California Institute for Regenerative Medicine ("CIRM") approved Calidi's application for a CIRM grant for Calidi's continued development of the SNV1 program. CIRM awarded Calidi approximately $3.1 million of CIRM funding conditioned that Calidi co-fund approximately $0.8 million under the requirements of the CIRM application. On December 28, 2022, Calidi received the Notice of Award from CIRM for this grant and Calidi expects to be able to draw the funds over the next 18 months bas ...

The Company established the initial fair value for the warrants on September 14, 2021, the date of the consummation of the Company's IPO. The Company used a lattice model and Monte Carlo simulation model to value the warrants. The Company allocated the proceeds received from (i) the sale of Units (which is inclusive of one share of Class A common stock and one-half of one Public Warrant), (ii) the sale of Private Placement Warrants, and (iii) the issuance of Class B common stock, first to the warrants based ...

For the quarterly period ended March 31, 2023 Delaware 86-2967193 (State or other jurisdiction of incorporation or organization)(I.R.S. Employer Identification No.) Securities registered pursuant to Section 12(g) of the Act: None Non-accelerated filer ☒ Smaller reporting company ☒ Emerging growth company ☒ As of May 15, 2023, there were 4,128,024 shares of the Company's Class A common stock, par value $0.0001 per share, and 5,750,000 shares of the Company's Class B common stock, par value $0.0001, issued an ...