Calidi Biotherapeutics, Inc 8-K, filed Aug 16, 2023
Calidi Biotherapeutics, Inc. (CLDI)
About this 8-K
Calidi Biotherapeutics, Inc filed this 8-K on August 16, 2023.
Items reported
- Item 7.01: Regulation FD disclosure
- Item 9.01: Financial statements and exhibits
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
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Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
| Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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Emerging growth company
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| Item 7.01. | Regulation FD Disclosure. |
Attached as Exhibit 99.1, and incorporated by reference, is a presentation prepared by Calidi Biotherapeutics, Inc. for discussions with investors.
On August 16, 2023, First Light Acquisition Group, Inc. (“FLAG”) issued the press release attached hereto as Exhibit 99.2.
The information in this Item 7.01, including Exhibits 99.1, and 99.2, is furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to liabilities under that section, and shall not be deemed to be incorporated by reference into the filings of First Light Acquisition Group, Inc. under the Securities Act of 1933, as amended or the Exchange Act, regardless of any general incorporation language in such filings. This Current Report will not be deemed an admission as to the materiality of any information of the information in this Item 7.01, including Exhibits 99.1, and 99.2.
| Item 9.01. | Financial Statements and Exhibits. |
(d) Exhibits.
The Exhibit Index is incorporated by reference herein.
Forward-Looking Statements
This Current Report on Form 8-K contains forward-looking statements for purposes of the “safe harbor” provisions under the United States Private Securities Litigation Reform Act of 1995. Terms such as “anticipates,” “believe,” “continue,” “could,” “estimate,” “expect,” “intends,” “may,” “might,” “plan,” “possible,” “potential,” “predicts,” “project,” “should,” “would” as well as similar terms, are forward-looking in nature. The forward-looking statements contained in this discussion are based on Calidi’s current expectations and beliefs concerning future developments and their potential effects. There can be no assurance that future developments affecting Calidi will be those that it has anticipated. These forward-looking statements involve a number of risks, uncertainties (some of which are beyond Calidi’s control) or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. Factors that may cause actual results to differ materially from current expectations include, but are not limited to: the occurrence of any event, change or other circumstances that could give rise to the termination of negotiations and any subsequent definitive agreements with respect to the business combination between FLAG and Calidi (the “Business Combination”); the outcome of any legal proceedings that may be instituted against FLAG, Calidi, the combined company or others following the announcement of the Business Combination, the PIPE Investment proposed to be consummated concurrently with the Business Combination, and any definitive agreements with respect thereto; the inability to complete the Business Combination due to the failure to obtain approval of the shareholders of FLAG, the inability to complete any PIPE Investment or other financing needed to complete the Business Combination, or to satisfy other conditions to closing; changes to the proposed structure of the Business Combination that may be required or appropriate as a result of applicable laws or regulations or as a condition to obtaining regulatory approval of the Business Combination; the ability to meet stock exchange listing standards following the consummation of the Business Combination; the risk that the Business Combination disrupts current plans and operations of Calidi as a result of the announcement and consummation of the Business Combination; the ability to recognize the anticipated benefits of the Business Combination or to realize estimated pro forma results and underlying assumptions, including with respect to estimated shareholder redemptions; costs related to the Business Combination; changes in applicable laws or regulations; the evolution of the markets in which Calidi competes; the inability of Calidi to defend its intellectual property and satisfy regulatory requirements; the ability to implement business plans, forecasts, and other expectations after the completion of the proposed Business Combination, and identify and realize additional opportunities; the risk of downturns and a changing regulatory landscape in the highly competitive pharmaceutical industry; the impact of potential global conflicts (including the current conflict in Ukraine) may have on capital markets or on Calidi’s or FLAG’s business; the impact of the COVID-19 pandemic on Calidi’s business; and other risks and uncertainties set forth in the section entitled “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements” in FLAG’s final prospectus dated September 9, 2021 and Annual Report on Form 10-K for the year ended December 31, 2022, as filed with the SEC on March 31, 2023, and the risks and uncertainties indicated in the Registration Statement and the definitive proxy statement to be delivered to FLAG’s shareholders, including those set forth under “Risk Factors” therein, and other documents filed or to be filed with the SEC by FLAG.
Additional Information and Where to Find It
FLAG has filed with the SEC a registration statement on Form S-4 (as may be amended from time to time, the “Registration Statement”), which includes a definitive proxy statement of FLAG, and a prospectus in connection with the proposed business combination transaction involving FLAG and Calidi. The definitive proxy statement and other relevant documents have been mailed to FLAG shareholders as of July 11, 2023, the record date established for voting on the Business Combination. FLAG securityholders and other interested persons are advised to read the definitive proxy statement/prospectus, in connection with FLAG’s solicitation of proxies for the special meeting because these documents will contain important information about FLAG, Calidi, and the Business
Combination. Investors, securityholders and other interested persons will also be able to obtain copies of the Registration Statement, the proxy statement/prospectus and all other relevant documents filed or that will be filed with the SEC by FLAG, once such documents are filed, free of charge, on the SEC’s website at www.sec.gov or by directing a request to: First Light Acquisition Group, Inc., 11110 Sunset Hills Road #2278, Reston, VA 20190.
Participants in the Solicitation
FLAG and Calidi and their respective directors and officers and other members of management and employees may be deemed participants in the solicitation of proxies in connection with the proposed business combination. FLAG shareholders and other interested persons may obtain, without charge, more detailed information regarding directors and officers of FLAG in FLAG’s Annual Report on Form 10-K for the year ended December 31, 2022, as filed with the SEC on March 31, 2023. Information regarding the persons who may, under SEC rules, be deemed participants in the solicitation of proxies from FLAG’s shareholders in connection with the proposed business combination will be included in the definitive proxy statement/prospectus that FLAG intends to file with the SEC.
No Offer or Solicitation
This communication does not constitute (i) a solicitation of a proxy, consent or authorization with respect to any securities or in respect of the proposed Business Combination or (ii) an offer to sell, a solicitation of an offer to buy, or a recommendation to buy any security of Calidi, FLAG or any of their respective affiliates. There shall not be any sale of any securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the laws of such other jurisdiction. No offering of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended, or an exemption therefrom.
EXHIBIT INDEX
| Exhibit No. | Description | |
| 99.1 | Analyst Day Presentation. | |
| 99.2 | Press release issued August 16, 2023. | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document). | |
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| First Light Acquisition Group, Inc. | ||||||
| Dated: August 16, 2023 | ||||||
| By: | /s/ Michael J. Alber | |||||
| Name: Michael J. Alber | ||||||
| Title: Chief Financial Officer | ||||||
Exhibit 99.1 The following is a presentation for use by Calidi Biotherapeutics, Inc. and First Light Acquisition Group (FLAG) at an analyst day on August 16, 2023 in connection with their proposed business combination. ANALYST TEACH -IN DAY | AUGUST 2023 Arming the Immune System to Kill Cancer A novel stem cell-based therapy with payload designed to target and kill tumor cells
Forward-Looking Statements and Legal Disclaimer Forward-Looking Statements This presentation contains forward-looking statements for purposes of the “safe harbor” provisions under the United States Private Securities Litigation Reform Act of 1995. Terms such as “anticipates,” “believe,” “continue,” “could,” “estimate,” “expect,” “intends,” “may,” “might,” “plan,” “possible,” “potential,” “predicts,” “project,” “should,” “would” as well as similar terms, are forward-looking in nature. The forward-looking statements contained in this presentation are based on Calidi’s current expectations and beliefs concerning future developments and their potential effects. There can be no assurance that future developments affecting Calidi will be those that it has anticipated. These forward-looking statements involve a number of risks, uncertainties (some of which are beyond Calidi’s control) or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. Factors that may cause actual results to differ materially from current expectations include, but are not limited to: the occurrence of any event, change or other circumstances that could give rise to the termination of negotiations and any subsequent definitive agreements with respect to the Business Combination; the outcome of any legal proceedings that may be instituted against FLAG, Calidi, the combined company or others following the announcement of the Business Combination, any PIPE Investment that may be proposed to be consummated concurrently with the Business Combination, and any definitive agreements with respect thereto; the inability to complete the Business Combination due to the failure to obtain approval of the shareholders of FLAG, the inability to complete any PIPE Investment or other financing needed to complete the Business Combination, or to satisfy other conditions to closing; changes to the proposed structure of the Business Combination that may be required or appropriate as a result of applicable laws or regulations or as a condition to obtaining regulatory approval of the Business Combination; the ability to meet stock exchange listing standards following the consummation of the Business Combination; the risk that the Business Combination disrupts current plans and operations of Calidi as a result of the announcement and consummation of the Business Combination; the ability to recognize the anticipated benefits of the Business Combination or to realize estimated pro forma results and underlying assumptions, including with respect to estimated shareholder redemptions; costs related to the Business Combination; changes in applicable laws or regulations; the evolution of the markets in which Calidi competes; the inability of Calidi to defend its intellectual property and satisfy regulatory requirements; the ability to implement business plans, forecasts, and other expectations after the completion of the proposed Business Combination, and identify and realize additional opportunities; the risk of downturns and a changing regulatory landscape in the highly competitive pharmaceutical industry; the impact of potential global conflicts (including the current conflict in Ukraine) may have on capital markets or on Calidi’s or FLAG’s business; the impact of the COVID-19 pandemic on Calidi’s business; and other risks and uncertainties set forth in the section entitled “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements” in FLAG’s final prospectus dated September 9, 2021 and Annual Report on Form 10-K for the year ended December 31, 2022, as filed with the SEC on March 31, 2023, and the risks and uncertainties indicated in the Registration Statement and the definitive proxy statement delivered to FLAG’s shareholders, including those set forth under “Risk Factors” therein, and other documents filed or to be filed with the SEC by FLAG. Presentation Disclaimer This presentation (the “Presentation”) is preliminary in nature and for informational purposes only to assist parties in making their own evaluation with respect to the proposed business combination between First Light Acquisition Group, Inc., a Delaware special purpose acquisition corporation (“FLAG”) and Calidi Biotherapeutics, Inc., a Nevada corporation (together with its subsidiaries and divisions, “Calidi”), and which we refer to as the “Business Combination.” The information contained herein does not purport to be all-inclusive and does not constitute or involve any recommendation with respect to the voting, purchase or sale of any security or as to any other matter by FLAG, Calidi or any other person and none of FLAG, Calidi, nor any of their respective affiliates makes any representation or warranty, express or implied, as to the accuracy, completeness or reliability of the information contained in this Presentation. FLAG and Calidi expressly disclaim any and all liability for representations, expressed or implied, contained in, or for omissions from, this Presentation or any other written or oral communication transmitted to any interested party in the course of its evaluation of the Company. Certain information contained herein has been derived from sources prepared by third parties. While such information is believed to be reliable for the purposes used herein, the FLAG and Calidi make no representation or warranty with respect to the accuracy of such information. This Presentation is not intended to form the basis of any investment decision by the recipient and does not constitute investment, tax, financial or legal advice. Accordingly, neither Calidi nor FLAG nor any of their respective affiliates, directors, officers, employees or advisers or any other person shall be liable for any direct, indirect or consequential loss or damages suffered by any person as a result of relying on any statement in or omission from this Presentation and any such liability is expressly disclaimed. Page © 2023 Calidi Biotherapeutics, Inc. І Company Proprietary; Patents issued and pending 2
Forward-Looking Statements and Legal Disclaimer (continued) Additional Information and Where to Find It FLAG has filed with the SEC a registration statement on Form S-4 (as may be amended from time to time, the “Registration Statement”), which includes a definitive proxy statement of FLAG, and a prospectus in connection with the proposed business combination transaction involving FLAG and Calidi. The definitive proxy statement and other relevant documents have been mailed to FLAG shareholders as of July 11, 2023, the record date established for voting on the Business Combination. FLAG securityholders and other interested persons are advised to read the definitive proxy statement/prospectus, in connection with FLAG’s solicitation of proxies for the special meeting because these documents will contain important information about FLAG, Calidi, and the Business Combination. Investors, securityholders and other interested persons will also be able to obtain copies of the Registration Statement, the proxy statement/prospectus and all other relevant documents filed or that will be filed with the SEC by FLAG, once such documents are filed, free of charge, on the SEC’s website at www.sec.gov or by directing a request to: First Light Acquisition Group, Inc., 11110 Sunset Hills Road #2278, Reston, VA 20190. Participants in the Solicitation FLAG and Calidi and their respective directors and officers and other members of management and employees may be deemed participants in the solicitation of proxies in connection with the proposed business combination. FLAG shareholders and other interested persons may obtain, without charge, more detailed information regarding directors and officers of FLAG in FLAG’s Annual Report on Form 10-K for the year ended December 31, 2022, as filed with the SEC on March 31, 2023. Information regarding the persons who may, under SEC rules, be deemed participants in the solicitation of proxies from FLAG’s shareholders in connection with the proposed business combination will be included in the definitive proxy statement/prospectus that FLAG intends to file with the SEC. No Offer or Solicitation This presentation does not constitute (i) a solicitation of a proxy, consent or authorization with respect to any securities or in respect of the proposed Business Combination or (ii) an offer to sell, a solicitation of an offer to buy, or a recommendation to buy any security of Calidi, FLAG or any of their respective affiliates. There shall not be any sale of any securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the laws of such other jurisdiction. No offering of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended, or an exemption therefrom. Page © 2023 Calidi Biotherapeutics, Inc. І Company Proprietary; Patents issued and pending 3
Agenda Topic Presenter Calidi Overview Stephen Thesing Strategy Allan Camaisa Oncolytic Viruses, Stem Cells, and IP Antonio F. Santidrian, PhD CLD-101 | NeuroNova Boris Minev, MD CLD-201 | SuperNova Boris Minev, MD Manufacturing Capability Amish Patel, PhD Corporate Governance & Government Affairs Wendy Pizarro Finance Tony Kalajian The Path Forward Allan Camaisa © 2023 Calidi Biotherapeutics, Inc. І Company Proprietary; Patents issued and pending 4
Executive Team with Proven Track Record Boris Minev, Stephen M.D. Allan Camaisa Thesing President, Medical & Chairman & CEO Scientific Affairs, Acting Chief Business Officer CMO Antonio F. Wendy David Sans, Pizarro, Esq. Santidrian, PH.D. PH.D. Chief Administrative Chief Corporate Officer & Chief Legal Development Officer SVP, Global Head of Officer R&D Amish Patel, Tony Kalajian PH.D. Acting CFO Vice President of Technical Operations Page © 2023 Calidi Biotherapeutics, Inc. І Company Proprietary; Patents issued and pending 5
Board of Directors with Deep Biopharma Expertise Allan Camaisa Dr. Heehyoung Lee Chairman of the Board Director Scott Leftwich James Schoeneck Vice Chairman of the Board Director George Ng Alfonso Zulueta Director Director © 2023 Calidi Biotherapeutics, Inc. І Company Proprietary; Patents issued and pending 6
Calidi Board of Advisors Bernie Fox, Ph.D. Maciej (Matt) S Lesniak, MD Chair, Department of Neurological Surgery © 2023 Calidi Biotherapeutics, Inc. І Company Proprietary; Patents issued and pending 7
Calidi Board of Advisors – continued Santosh Kesari, MD, PhD Ewa Carrier, MD Vice President, Clinical Development, FibroGen, Inc. Chair and Professor, Department of Translational Neuro-Oncology and Neurotherapeutics, Saint She has published many high-impact John’s Cancer Institute articles in the areas of stem cell transplantation, cancer stem cells, and cancer vaccines. Dr. Dmitriy Zamarin, MD PhD George Peoples, MD, FACS An accomplished medical oncologist who specializes in Founder and CMO, Cancer Insight CRO the care of women with gynecologic cancers, including Professor, Surgery, Uniformed Services University cervical, ovarian, and endometrial cancers at Sloan Professor (adjunct), Surgical Oncology, MD Kettering Cancer Center in New York Anderson Cancer Center Dr. Ashok Srivastava, MD, PhD, MBA Chief Medical Officer, Senior Vice President Immuno-Oncology, Medical Oncology and Hematology Drug Development, Medical Affairs and Pharmacovigilance for CliniFomatrix Page 8
First-In-Class Stem Cell Based Platforms to Deliver Oncolytic Payloads Increase survival rate and therapeutic efficacy in patients suffering targeted delivery of from a wide variety of cancers through allogeneic stem cells loaded with oncolytic viruses (OV) Calidi’s Vision Provide safe and tolerable therapeutic options for cancer patients that improve quality of life and reduce frequency of treatments Arming the Immune System to Kill Using proprietary and scalable, commercially viable state-of-the-art OV and cell-based delivery platforms Cancer Leverage first-in-class platform to drive partnerships with big pharma, government and academia to streamline development pathways Page © 2023 Calidi Biotherapeutics, Inc. І Company Proprietary; Patents issued and pending 9
Highlights Calidi Biotherapeutics is a clinical-stage biopharmaceutical company revolutionizing oncolytic viral therapies with stem cell-based platforms CLD-101: Neural stem cell (NSC) product candidates loaded with oncolytic adenovirus Two Differentiated Stem Cell Platforms 1 CLD-201: Allogeneic Adipose-derived Mesenchymal Stem Cells (AD-MSC) loaded with oncolytic vaccinia virus Large Target Markets in Areas of High First CLD-101 programs target HGG, with a well-defined regulatory pathway and accelerated approval potential 2 Unmet Need CLD-201 trials will focus on multiple solid tumor types (Triple Negative Breast Cancer, Head & Neck, Metastatic Melanoma) CLD-101: Phase1 trial in newly diagnosed HGG - COMPLETED; Phase 1b trial initiating 1H 2024 Three Clinical Development Programs 3 CLD-101: Phase 1 trial in recurrent HGG – initiated in 1H 2023 CLD-201: Phase 1 trial in solid tumor indications (Triple Negative Breast, Head & Neck, Metastatic Melanoma) 2H 2024 Scalable, cost-efficient manufacturing platform and GMP-grade adipose-derived allogeneic stem cell bank and NSC bank Cutting Edge Stem Cell Manufacturing sufficient to support commercial launch 4 Processes Opportunity to license cell bank products Page © 2023 Calidi Biotherapeutics, Inc. І Company Proprietary; Patents issued and pending 10
Differentiated Wholly-Owned Pipeline in Multiple Cancer Indications Multiple partnership opportunities to potentiate and deliver other existing OV’s, combination therapies and joint development of next generation therapies Non-clinical Pivotal Product Platform Target Indications Discovery Phase 1 Phase 2 Partner studies Trial Newly Diagnosed High Entering Phase 1b/2 Grade Glioma CLD-101 NeuroNova Recurrent High Grade Phase 1 started Glioma Advanced Solid Tumors FDA Pre-IND – Planned Phase 1 (TNBC, Melanoma, Head CLD-201 and Neck) SuperNova Metastatic Solid Tumors CLD-202 Page © © 2 20 02 23 3 C Ca alliid dii B Biio ot th he er ra ap pe eu ut tiic cs s, , I In nc c. . ІІ Co Com mp pa an ny y P Pr ro op pr riie et ta ar ry y; ; P Pa at te en nt ts s iis ss su ue ed d a an nd d p pe en nd diin ng g 11 Cancer indications
Company Strategy Allan Camaisa Chief Executive Officer & Chairman of the Board
Novel platform: off-the-shelf, cell-based allogeneic stem cells combined with oncolytic viruses Cell Therapy with OV Calidi is revolutionizing the effective delivery of oncolytic viruses for targeted therapy against difficult-to-treat cancers with an off-the-shelf, potent universal cell-based delivery allogeneic stem cell and oncolytic virus combination for use in multiple oncology indications. © 2023 Calidi Biotherapeutics, Inc. І Company Proprietary; Patents issued and pending Image from De Bousser, E.; Callewaert, N.; Festjens, N. T Cell Engaging Immunotherapies, Highlighting Chimeric Antigen Receptor (CAR) T Cell Therapy. Cancers 2021, 13, 6067. https://doi.org/10.3390/ cancers13236067 13
Calidi’s Unique Value Proposition Overcoming Obstacles to Prior Universal Cancer Therapeutic Generation Oncolytic with Potential to Address a Immunotherapy Wide Range of Solid Tumors Track Record of Successful Solving the Challenge of Non-Dilutive Fundraising Manufacturing with Scalable, through Government and Commercially Viable Non-Profit Grants Allogeneic Stem Cell Platform © 2023 Calidi Biotherapeutics, Inc. І Company Proprietary; Patents issued and pending 14
Key Partners Partnerships with leading cancer organizations provide validation to Calidi’s unique approach, financing to support clinical trials, and deep expertise in oncology © 2023 Calidi Biotherapeutics, Inc. І Company Proprietary; Patents issued and pending 15
From Autologous to Allogeneic, developing a Universal Cancer therapy Prior safety study was conducted using autologous stem cells Future studies will be conducted using allogeneic stem cells The Past The Present and Future Autologous Allogeneic Immune Rejection Stealth Low immunogenicity (Stealth) Cost High Low Potency Patient stem cell dependent Normalized No, requires personalized Off-the-shelf, Product Availability manufacturing Available when needed Patient target Personalized Universal Opportunity to Scale No Yes © 2023 Calidi Biotherapeutics, Inc. І Company Proprietary; Patents issued and pending 16
% Cytotoxicity .1 1 10 .1 1 10 100 100 BT-549 BT-549 HS-578T HS-578T Breast Breast MCF7 MCF7 MDA-MB-231 MDA-MB-231 MDAMB468 MDAMB468 SF-268 SF-268 SF-295 SF-295 SF-539 SF-539 CNS CNS SNB-19 SNB-19 SNB75 SNB75 U251 U251 Calidi’s SuperNova: CLD-201 Pre-Clinical Program: Universal Therapeutic HCT-116 HCT-116 HCT-15 HCT-15 Colon HT29 HT29 Colon KM12 KM12 Cancer Treatment SW620 SW620 HL-60 HL-60 Leukemia RPMI-8226 Leukemia RPMI-8226 For Multiple Solid Tumor Types SR SR Personalized Cancer treatment LOX IMVI LOX IMVI CLD-201 observed pre-clinical indications of killing M14 M14 MALME-3M MelanoM mealanoma MALME-3M nearly all tested tumor cell lines (>50) MDAMB435 MDAMB435 SK-MEL S -2 K-MEL-2 SK-MEL-28 SK-MEL-28 0.1 1 10 0.1 1 10 .1 1 10 .1 1 10 .1 1 10 UACC-62 UACC-62 100 A498 100 100 100 1 A50 490 100 A549 A A4 59 48 9 A498BT-549 BT-549 ACHN AsPC1 EKVX Ability to treat only EKVX 50 HS-578T A549 50 HS-5 A 75 84T 9 BT-549 HOP-62 HOP-B 6 x2 PC3 Breast Breast MCF7 ACHN MCF7 one (1) Patient ACHN CAKI-1 HOP-92 HOP- C9 aP2 an2 MDA-MB-231 AsPC1 MDA-MB-231 DU-145 AsPC1 NSCL H226 H226 NSCL EKVX MDAMB468 MDAMB468 BT-549 FG BT-549 NCI-H23 NCI-H23 H226 Manufacturing SF-268 HCI-H460 SF-268 BxPC3 BxPC3 NCI-H322M NCI-H322M HCT-116 SF-295 HCT-15 SF-295 CAKI- H 1CI-H460 Cancer patient HCI-H460 Personalized Therapy CAKI-1 HL-60 SF-539 HO N P-C 62I-H522 SF-539 NC Ca I-P Ha 5n 22 2 CaPan2 CNS HOP-92 CNS SNB-19 IGR-O HV S-5I1 7G 8TR-OV1 SNB-19 DU-145 DU-145 HT29 NCI/ADR-RES SNB75 NCI/ADR-R IGE R-S OV1 SNB75 EKVX EKVX KM12 Calidi’s Universal Cancer treatment OVCAR-3 OVCA LR OX- 3 IMVI U251 U251 FG M14 FG OvarianOvarian OVCAR4 OVCAR4 MALME-3M HCT-116 HCT-116 H22 M6 CF7 H226 OVCAR5 OVCAR5 MDA-MB-231 HCT-15 HCT-15 MDAMB435 HCI-H46 O 0VCAR-8 50 OVCAR-8 50 HCI-H460 MDAMB468 Colon HT29 Colon HT29 MiapacaS 2 KOV3 HC SK T-O 1V 16 3 HCT-116 NCI/ADR-RES KM12 KM12 AsP NC CI-1 H23AsPC1 Ability to treat HCT-15 HCT-15 NCI-H322M SW620 SW620 BxPC3 BxP NCC I-H3 522 HL-60 1- 1.7 million of HL-60 OVCAR-3 HL-60 HL-60 Pancreas CaPan2 Pancreas CaPa OVn C2 AR4 HOP-62 OVCAR5 HOP-62 FG Leukemia RPMI-8226 FG patients per year Leukemia RPMI-8226 OVCAR-8 HOP- P9 AN2 C-1 HOP-92 Miapaca2 SR Miapaca2 SR RPMI-8226 HS-578 SFT -268 HS-578T PANC-1PANC-1 LOX IMVI LOX IMVI SF-295 SF-53D 9 U-145 DU H-T 12 49 5 HT29 Prostate MP 1r 4ostate M14 SK-MEL-2 SK-MEL-28 A498 IGR- A O 4V 91 8 Manufacturing One (1) treatment IGR-OV1 Melanoma MALME M -3 A M LME-3M SKOV3 Melanoma ACHN ACH SN N 12C KM12 K MM D1 A 2MB435 SNB-19 MDAMB435 Universal Therapy for all patients CAKI-1 CAKS I- N1 B75 LOX IMVI LOX IM SK VI-MEL-2 SR SK-MEL-2 SN12C Renal SN12C Renal SW620 M14 S M K1 -4 MEL-28 TK10 SK-MEL-28 TK10 TK10 U251 UACC-62 MALME- U3 AC M C-62 MU AA LC MC E- -3 6M 2 UO-31 UO-31 UO-31 0 0 0 0 MCF7 A549 A M5 C4 F9 7 EKVX MDA-MB-231 EKVX 50 MDA-MB-231 50 HOP-62 HOP-62 MDAMB435 MDAMB435 50 50 HOP-92 HOP-92 MDAMB468 MDAMB468 H226 NSCL H226 Miapaca2 NSCL Miapaca2 © 2023 Calidi Biotherapeutics, Inc. І Company Proprietary; Patents issued and pending NCI-H23 NCI-H23 NCI/ADR-RES Page 17 NCI/ADR-RES NCI-H322M NCI-H322M NCI-H23 NCI-H23 HCI-H460 HCI-H460 NCI-H322M NCI-H322M NCI-H522 NCI-H522 NCI-H522 NCI-H522 IGR-OV1 IGR-OV1 OVCAR-3 OVCAR-3 NCI/ADR-RES NCI/ADR-RES OVCAR4 OVCAR4 OVCAR-3 OVCAR-3 OVCAR5 OVCAR5 Ovarian Ovarian OVCAR4 OVCAR4 OVCAR-8 OVCAR-8 OVCAR5 OVCAR5 PANC-1 PANC-1 OVCAR-8 OVCAR-8 RPMI-8226 RPMI-8226 SKOV3 SKOV3 SF-268 SF-268 AsPC1 AsPC1 SF-295 SF-295 BxPC3 BxPC3 SF-539 SF-539 CaPan2 PancrePaasncreas CaPan2 SK-MEL-2 SK-MEL-2 FG FG SK-MEL-28 SK-MELM -2i8apaca2 Miapaca2 SKOV3 SKOV3 PANC-1 PANC-1 SN12C SN12C DU-145 DU-145 Prostate Prostate A498 SNB-19 SN AB 4-9 18 9 SNB75 ACHN A SN CB H7 N 5 CAKI-1 SR CAKI-1 SR Renal SN12C SW620 Renal S S N W 16 22 C 0 TK10 TK10 TK10 TK10 UO-31 UO-31 U251 U251 0 0 UACC-62 UACC-62 UO-31 UO-31 0 0
Calidi Financing Timeline Series B $25M SPAC $3.1M Funds to Date $1M $4M $50M 2015 2016 2017 2018 2019 2020 2021 2022 2023 © 2023 Calidi Biotherapeutics, Inc. І Company Proprietary; Patents issued and pending
Oncolytic Viruses, Stem Cells, and Intellectual Property Antonio F. Santidrian, PhD Senior Vice President, Global Head of R&D
ONCOLYTIC VIRUSES: ANTI-TUMOR MECHANISMS Once the OV reaches the tumor it TUMOR cells triggers three distinct anti-tumor mechanisms: 2.DIRECT ONCOLYSIS 3.ANTITUMOR IMMUNITY 1.VASCULAR COLLAPSE (Killing) Activated T cells can now locate, attack and destroy distant tumors. Durable Anti-tumor immunity Adapted from Lee et al Nature Rev Urol 2018 © 2023 Calidi Biotherapeutics, Inc. І Company Proprietary; Patents issued and pending Page 20
Oncolytic Viruses Lead to High Therapeutic Index • Minimal systemic toxicity, toxicity profile non-overlapping with Standard of Care • Mechanism of Action – non- overlapping with Standard of Care • Low probability to generate resistance (not seen so far), target multiple oncogenic pathways • Virus dose in the tumor increases with time, as opposed to classical drug pharmacokinetics © 2023 Calidi Biotherapeutics, Inc. І Company Proprietary; Patents issued and pending 21
Calidi Overcomes the Obstacles to Oncolytic Viral Therapy Challenges with Naked OV Therapy Calidi’s Solution Allogeneic Oncolytic Virus-Loaded Stem Cells Unprotected Oncolytic Virus Stem cell loaded with Active Rapid inactivation Inactivated Stem cell protects Oncolytic Viruses Oncolytic by immune Oncolytic (OV) and amplifies OV Viruses system Viruses Successfully Tumor is Targeted Untouched Tumor Allogeneic Stem Cells Naked oncolytic viruses are quickly Calidi’s Allogeneic eliminated by the patient’s immune system, Protect, Amplify, Deliver Stem Cell Platforms leading to limited therapeutic potential and Potentiate OV’s © 2023 Calidi Biotherapeutics, Inc. І Company Proprietary; Patents issued and pending 22
Induction of Anti-Tumor Immune Response 2. ANTIGEN PRESENTING 1. TUMOR CELL CELLS PROCESS AND RELEASES TARGET PRESENT ANTIGENS TO T ANTIGENS CELLS 4. ACTIVATED T CELLS INACTIVE CAN NOW DETECT T CELL AND DESTROY 3. T-CELL INITIATES ACTIVATED DISTANT TUMORS ACTIVATION AND T CELL PROLIFERATION CALIDI’S ADVANCED THERAPEUTIC CANDIDATES ARE INTENDED TO ACT AS MONOTHERAPY OR IN COMBINATION WITH MODERN IMMUNO-ONCOLOGY AGENTS (CHECKPOINT INHIBITORS OR CAR-T, AMONG OTHERS) © 2023 Calidi Biotherapeutics, Inc. І Company Proprietary; Patents issued and pending 23
Allogeneic Stem Cell Platforms CLD-101 and CLD-201 use oncolytic viruses loaded into stem cells • Possess an inherent ability to distribute throughout a brain tumor mass as well as migrate to distant tumor sites Neural Stem Cells (NSC) regardless of tumor size, anatomic location, or tissue type • CLD-101: NeuroNova (NNV) is composed of an immortalized NSC line loaded with an engineered oncolytic adenovirus • Completed clinical trial documenting the therapy was well-tolerated and observed signals of efficacy in patients with newly diagnosed glioblastoma (GBM) • Publication in the journal Lancet Oncology • AD-MSC have significant advantages over other MSCs because of their ease of extraction, maintained potency Adipose-derived with age of the donor, significant anti-inflammatory & immune-suppressive properties and documented tumor Mesenchymal Stem homing ability Cells (AD-MSC) • CLD-201: SuperNova (SNV) is composed of a GMP manufactured AD-MSC line loaded with an oncolytic vaccinia virus • Completed autologous cell clinical trial documenting the therapy was well-tolerated and observed signals of efficacy in 24 patients with advanced solid tumors and 2 patients with AML • Publication in the Journal of Translational Medicine (Autologous) and Cancers journal (Allogeneic) © 2023 Calidi Biotherapeutics, Inc. І Company Proprietary; Patents issued and pending 24
Calidi’s Platform Advantages Cell Protected: Oncolytic Virus Herpes Virus Vaccinia Virus Herpes Virus Adenovirus Vaccinia Virus Platform Adenovirus Engineered Virus ✔ ✔ ✔ ✔ ✔ FDA Approved Virus X ✔ X X X Reduced viral elimination by the ✔ X X X X immune system Virally-encoded therapeutic expressed ✔ X X X X at administration Stem cell-derived ✔ X X X X immune modulators © 2023 Calidi Biotherapeutics, Inc. І Company Proprietary; Patents issued and pending 25
Maximizing Therapeutic Responses with Directed Localized Administration CLD-101 Directed – Localized administration (Neuronova) ü High therapeutic index of treated lesion/areas ü Low toxicity CLD-201 ü Strong activation of local and systemic antitumor (Supernova) immunity ü In situ vaccination ü Efficacy of intratumoral approach shown in clinic trials Page © 2023 Calidi Biotherapeutics, Inc. І Company Proprietary; Patents issued and pending 26
Broad IP Protection Across All Clinical Programs in Development Allogeneic Adipose Tissue-derived and Neural Stem Cell Platforms for Delivery of Oncolytic Viruses Tropic Cell-Based Two US Issued Virotherapy for the Use of Neural Stem Cells to Deliver Oncolytic Adenovirus Patents, One Pending Treatment of Cancer Issued in multiple Use of Adipose Derived Stromal Cells (Autologous & Allogeneic) to Smallpox Vaccine for territories Treatment of Cancer Deliver Oncolytic Viruses Combination Immunotherapy Use of Stem Cells and Oncolytic Viruses, in Combination with Issued in multiple Approach for Treatment of territories Immunotherapies Cancer Enhanced Systems for Cell New Patent-May 2023 Methods to Potentiate and Deliver Naturally Occurring and Armed Mediated Oncolytic Viral -Issued in 1 territory, Viruses Using Stem Cells Pending multiple territories Therapy Issued and allowed in 2 Cell-Based Vehicle for territories. Potentiation of Viral New Genetically Modified Cell Delivery Vehicles Improving Potency Pending in multiple Therapy territories Page © © 2 20 02 23 3 C Ca alliid dii B Biio ot th he er ra ap pe eu ut tiic cs s, , I In nc c. . ІІ Co Com mp pa an ny y P Pr ro op pr riie et ta ar ry y; ; P Pa at te en nt ts s iis ss su ue ed d a an nd d p pe en nd diin ng g 27
CLD-101 (NeuroNova) Boris Minev, MD President, Medical & Scientific Affairs
High-Grade Glioma: Common and Difficult to Treat US Glioblastoma New Diagnoses 13,400 13,200 13,000 12,800 12,600 12,400 Sen. John McCain Sen. Ted Kennedy Beau Biden 12,200 12,000 • Glioblastoma market to reach $10.2B in 2030 with an 11,800 anticipated CAGR of 12.8% during forecast period 21-30 11,600 • $300k to $450k treatment cost • 300,000 cases WW every year Sources: EF Hutton Group Research © 2023 Calidi Biotherapeutics, Inc. І Company Proprietary; Patents issued and pending Cancer.org 29 R. Stupp, et al., NEJM, 2005, vol. 352, p 987 2022 2023 2024 2025 2026 2027 2028 2029 2030 2031 2032 2033 2034 2035 2036 2037 2038
High-Grade Gliomas High-Grade Gliomas have the most rapid tumor progression rate of any glioma, with poor survival rates 5-Year Relative Survival Rate of Patients with High-Grade Gliomas Age 20-44 45-54 55-64 64+ 5-Year Survival Rate 22% 9% 6% <6% Standard of Care was developed 18 years ago, and essentially has not changed. • Pioneered by Roger Stupp in 2005 using radiotherapy, temozolomide, and surgical resection Sources: EF Hutton Group Research © 2023 Calidi Biotherapeutics, Inc. І Company Proprietary; Patents issued and pending Cancer.org 30 R. Stupp, et al., NEJM, 2005, vol. 352, p 987
CLD-101: Platform Overview Adenovirus (CRAd-S-pk7) for CLD-101 Amplifies selectively in tumor cells Radiation treatment upregulates Survivin expression Ø Possess an inherent ability to distribute throughout a brain tumor mass as well as migrate to distant tumor sites regardless of tumor size, anatomic location, or tissue type Neural Stem Cells Ø Calidi’s product CLD-101 is composed of an immortalized NSC line loaded with an engineered oncolytic adenovirus (NSC): Ø Completed Phase 1 clinical trial documenting excellent safety and signals of efficacy in patients with newly diagnosed high grade glioma (HGG) Calidi’s manufacturing of virus-loaded neural stem cells is proprietary, scalable, reproducible and commercially viable Page 31 © © 2 20 02 23 3 C Ca alliid dii B Biio otth he er ra ap pe eu uttiic cs s,, IIn nc c.. ІІ Co Com mp pa an ny y P Pr ro op pr riie etta ar ry y;; P Pa atte en ntts s iis ss su ue ed d a an nd d p pe en nd diin ng g
CLD-101: Significant Published Clinical Results Neural Stem Cell Delivery of an Oncolytic Adenovirus in Newly Diagnosed Patients with Malignant Glioma: A First-in-Human, Phase 1 Clinical Trial (Lancet Oncology, 2021 Aug;22(8):1103-1114) Agent: CLD-101 (NSC-CRAd-S-pk7): Neural stem cells loaded with CRAd-S-pk7 - a chimeric adenoviral vector containing a pk7 fiber modification and a survivin promoter driving E1A replication Methods: After neurosurgical resection, NSC/CRAd-S-pk7 was injected into the walls of the resection cavity. Within 10-14 days, treatment with temozolomide and radiotherapy was initiated Page © © 2 20 02 23 3 C Ca alliid dii B Biio ot th he er ra ap pe eu ut tiic cs s, , I In nc c. . ІІ Co Com mp pa an ny y P Pr ro op pr riie et ta ar ry y; ; P Pa at te en nt ts s iis ss su ue ed d a an nd d p pe en nd diin ng g 32
CLD-101: Significant Published Clinical Results • Treatment with CLD-101 (NSC-CRAd-S-pk7) was safe and tolerable • Treatment achieved favorable therapeutic outcomes in patients with newly diagnosed malignant glioma: best overall response saw one patient responding partially to treatment, another progressing, and 10 with stable disease • The median progression-free survival was 9.1 months, and the median overall survival was 18.4 months • Importantly, in the subset of patients with glioma containing an unmethylated MGMT promoter, the median progression- free survival and overall survivals were 8.8 vs. 5.3 months and 18 vs. 12.7 months, respectively © 2023 Calidi Biotherapeutics, Inc. І Company Proprietary; Patents issued and pending 33
CLD-101: Clinical Trial Results in Patients with Newly-diagnosed High Grade Glioma Patient Demographics Tumor Type Tumor Criteria N (N=12) % Demographic Criteria N (N=12) % 18-29 1 8 Wild type 10 83.3 40-49 3 25 IDH1 mutant 2 16.7 IDH1/2 status Age (years) 50-59 3 25 IDH2 mutant 0 0 60-69 4 33 70-79 1 8 Methylated 3 25 MGMT Male 5 42 Unmethylated 9 75 Gender Female 7 58 Number of Cohort Cohort Cohort Total Response Best Response 95% CI Subjects 1 2 3 Evaluable Rate Partial Response 1 1 0 0 12 8.33% (0.21%, 38.48%) iRANO Tumor Response Rate Stable Disease 10 2 2 6 12 83.33% (51.59%, 97.91%) Pseudo- 1 0 1 0 12 8.33% (0.21%, 38.48%) Progression © 2023 Calidi Biotherapeutics, Inc. І Company Proprietary; Patents issued and pending 34
CLD-101: Ongoing Trial in Patients with Recurrent High-Grade Glioma Ongoing Phase 1 trial at City of Hope Indication: Recurrent High-Grade Glioma First Patient In: Q2 2023 © 2023 Calidi Biotherapeutics, Inc. І Company Proprietary; Patents issued and pending 35
CLD-101: Planned Trial in Patients with Newly-diagnosed High-Grade Glioma Planned Phase 1b/2 Trial at Northwestern University Indication: Newly-Diagnosed High-Grade Glioma T1 First Patient In: 1H 2024 © 2023 Calidi Biotherapeutics, Inc. І Company Proprietary; Patents issued and pending 36
CLD-201 (SuperNova) Boris Minev, MD President, Medical & Scientific Affairs
Solid Tumors: Significant Total Addressable Market Global Solid Tumors Market Growth U.S. Estimated Addressable Market – Solid Tumors Tumor Type U.S. Annual Incidence U.S. Annual Deaths 600 NSCLC - Squamous 59,500 33,500 CAGR: 500 NSCLC – Adeno 79,500 44,600 11.09% SCLC 33,000 22,500 400 Breast 287,900 43,300 300 Head & Neck 67,000 15,400 200 Cut. Melanoma 99,800 7,700 Pancreatic 64,000 50,550 100 Prostate 288,300 34,700 0 2022 2032 Ovarian 19,900 12,800 998,900 265,050 Sources: Guggenheim Research © 2023 Calidi Biotherapeutics, Inc. І Company Proprietary; Patents issued and pending H.C. Wainwright Research 38 American Cancer Society Precedence Research USD, Billions
Calidi’s Oncolytic Vaccinia Virus CAL1 Vaccinia Virus Advantages: • Not a human pathogen • Safely used as a vaccine for smallpox • Key natural attenuations improve tumor selectivity • Highly cytolytic for most tumor types • Large insertion capacity allows cloning of therapeutic payloads © 2023 Calidi Biotherapeutics, Inc. І Company Proprietary; Patents issued and pending Kaufman, H., Kohlhapp, F. & Zloza, A. Oncolytic viruses: a new class of immunotherapy drugs. Nat Rev Drug Discov 14, 642–662 (2015). 39 https://doi.org/10.1038/nrd4663
Completed study with AUTOLOGOUS Stem Cells loaded with the CAL1 Virus Trial Results: Combined application of Stem cells and CAL1 virus was well-tolerated in all patients The results of the plasma cytokine assays suggested inflammatory reaction starting approximately 1 week after treatment. No cytokine storm was observed in any patient The results of the flow cytometry assays show induction of immune response with memory T cells approximately 1 month after treatment. In 38% of the patients, viral DNA reappeared in patient’s peripheral blood 1 week after treatment, indicative of intra-tumoral virus amplification without uncontrolled viremia or systemic toxicity. This viral DNA reappearance correlated with an increased survival. Strong initial signals of efficacy observed © 2023 Calidi Biotherapeutics, Inc. І Company Proprietary; Patents issued and pending 40
Durable Tumor Regression and Survival Calidi Autologous Study: Positive Results in Combination With Checkpoint Inhibitor • Stage IV_B • Age/Sex: 70/M • Injected tumor was previously resistant to chemo- and radio-therapy • Diagnosis: Metastatic Head & Neck SCC Patient Case: Patient #SI01-021 Day 194 post-treatment: Day 17 post-treatment Day 45 post-treatment Day 52 post-treatment complete response previously resistant tumor Primary objective - Safety: There were no treatment-related side effects has fully regressed Secondary objective, Response and Patient Survival: 43 days after treatment the patient received Opdivo (anti-PD-1 treatment) and 76 days after treatment the patient received local radiation therapy 194 days post treatment the previously resistant tumor had fully regressed © 2023 Calidi Biotherapeutics, Inc. І Company Proprietary; Patents issued and pending Minev, et al. Journal of Translational Medicine (2019) 17:271 41
Durable Tumor Regression and Survival (continued) • Age/Sex: 68/M • Diagnosis: Thyroid Papillary Carcinoma • Stage IV Patient Case: Patient #SI01-047 Day 85 post-treatment: tumor Day 30 post-treatment Day 65 post-treatment has fully regressed Primary objective - Safety: There were no treatment-related side effects Secondary objective, Response and Patient Survival: 36 hours after treatment, patient received Ipilimumab (anti-CTLA-4), by 85 days tumor fully regressed © 2023 Calidi Biotherapeutics, Inc. І Company Proprietary; Patents issued and pending Minev, et al. Journal of Translational Medicine (2019) 17:271 42
Calidi’s next generation product: CLD-201 – ALLOGENEIC Stem Cells loaded with the CAL1 Virus ADVANTAGES of Using Allogeneic Stem Cells: IMPROVED POTENCY: larger number of viral particles inside the stem cells BETTER REPRODUCIBILITY: CLD-201 product is composed of cultured and expanded mesenchymal stem cells only, ensuring reproducibility with very minimal lot-to-lot variations SCALE: CLD-201 can be used to treat many patients, as billions of doses can be manufactured from a single mini liposuction of a healthy donor, using Calidi’s manufacturing protocols IMPROVED PATIENT COMPLIANCE: Patients are not subjected to a liposuction procedure, which has a potential to cause infection and other complications REDUCED COST: Significantly lower cost per dose as there is no need to manufacture, characterize and release individual product from each patient © 2023 Calidi Biotherapeutics, Inc. І Company Proprietary; Patents issued and pending 43
Development of Allogeneic Cell-Based Product VP-001 GMP master cell bank p2 Calidi owns 8 allogeneic adult adipose (AAA)-derived stem cell (AD-MSC) banks + 1 NSC proliferation/scalability profile Allogeneic GMP Master cell bank p2 (VP01), is used in several clinical trials to treat patients with COVID-19-induced acute respiratory distress syndrome (ARDS) (Pivotal trial ongoing via partnership) VP-001 is avaliable for additional partnerships New manufacturing protocols offer the potential to generate quadrillions of doses of stem cells from a single donor 1 single donor can be used for multiple indications, clinical development programs and commercialization Scaled-up VP-001 cells maintained: - Genetic stability - Identity - Biological activity at thawing © 2023 Calidi Biotherapeutics, Inc. І Company Proprietary; Patents issued and pending 44
Advantages of Calidi’s Technology Vaccinia virus (VACV) engineered to express red fluorescent protein. RED signal indicates virus amplification leading to killing of cancer cells Treatment: CAL1 – naked virus Treatment: CAL1 - naked virus Treatment: CAL1 + AD-MSC PC3 (prostate cancer) PC3 (prostate cancer) PC3 (prostate cancer) + HUMAN SERUM + HUMAN SERUM 24h 24h 24h 24h 24h Treatment efficacy is restored when Human serum can inhibit oncolytic Preclinical in vitro data shows adipose derived stem cells (AD-MSC) virus activity by blocking its capacity that Vaccinia Virus (VACV) kills are used to protect and potentiate tumor cells to infect and kill tumor cells the oncolytic vaccinia virus Page © 2023 Calidi Biotherapeutics, Inc. І Company Proprietary; Patents issued and pending 45
CLD-201: Improved efficacy in tumor models in vivo Stem cells (AD-MSCs) increase therapeutic efficacy in mouse models of CAL1-vaccinia virus in vivo after intra- tumoral administration CT26 PC3 © 2023 Calidi Biotherapeutics, Inc. І Company Proprietary; Patents issued and pending 46
CLD-201: Therapeutic Response in Different Mouse Models Cell Line Cancer Type Growth Inhibition Models B16-F10 Melanoma 78% Syngeneic EMT-6 Breast 69% Syngeneic CT-26 Colon 77% Syngeneic Tramp-C2 Prostate 99% Syngeneic RM-1 Prostate 57% Syngeneic PC3 Prostate 59% Xenograft MDA-MB-231 Breast 98% Xenograft © 2023 Calidi Biotherapeutics, Inc. І Company Proprietary; Patents issued and pending 47
CLD-201: Intratumoral administration induces significant systemic therapeutic response (abscopal effect) Bilateral tumor-bearing colon cancer (CT26) mouse model. CAL1 (naked) CLD-201 (+ stem cells) Distant tumor Left untreated Ø Only 1 tumor was treated. Ø Therapeutic response was followed in both tumors Three (3x) intratumoral administrations of CLD-201 (Stem cells + CAL1) but not naked virus (CAL1) inhibit tumor growth of both treated and distant untreated tumors Page © © 2 20 02 23 3 C Ca alliid dii B Biio ot th he er ra ap pe eu ut tiic cs s, , I In nc c. . ІІ Co Com mp pa an ny y P Pr ro op pr riie et ta ar ry y; ; P Pa at te en nt ts s iis ss su ue ed d a an nd d p pe en nd diin ng g 48 Control Cal1 (1X) Cal1 (3X) CLD-201 (1X) CLD-201 (3X) Control Cal1 (1X) Cal1 (3X) CLD-201 (1X) CLD-201 (3X)
CLD-201: Local administration induced both robust local and systemic immune cell infiltration CD4 Teffs/ Tregs CD4 (T cells) CD8 (T cells) Tregs CD8/Treg Control Treatment Control Treatment Control Treatment Control Treatment Control Treatment Groups were compared by unpaired two-tailed T-test (*P < 0.05, **P < 0.01, ***P < 0.001 ) Page © © 2 20 02 23 3 C Ca alliid dii B Biio ot th he er ra ap pe eu ut tiic cs s, , I In nc c. . ІІ Co Com mp pa an ny y P Pr ro op pr riie et ta ar ry y; ; P Pa at te en nt ts s iis ss su ue ed d a an nd d p pe en nd diin ng g 49
CLD-201: Development Pathway Pre-IND meeting held Next Steps cGMP Final Drug Product Manufacturing to be completed in 1Q 2024, Phase 1 clinical trial initiation in 2H 2024: A Phase 1/2 study of intra-tumoral administration of CLD-201, alone or in combination with checkpoint inhibitors, in patients with advanced metastatic solid tumors Indications: TNBC, unresectable melanoma, squamous cell head and neck carcinoma Page © © 2 20 02 23 3 C Ca alliid dii B Biio ot th he er ra ap pe eu ut tiic cs s, , I In nc c. . ІІ Co Com mp pa an ny y P Pr ro op pr riie et ta ar ry y; ; P Pa at te en nt ts s iis ss su ue ed d a an nd d p pe en nd diin ng g 50
CLD-201: Planned Clinical Development A Phase 1/2 study of intra-tumoral administration of CLD-201, alone or in combination with checkpoint inhibitors, in patients with advanced metastatic solid tumors Part 1: Dose Escalation • Classical 3+3 trial design. Three dose levels will be tested, alone or in combination with Checkpoint Inhibitor (anti PD-L1) • Three to 6 patients will be enrolled at each dose level depending on DLTs observed. Part 2: Expansion in Three Indications • Ten patients with metastatic melanoma, ten patients with triple-negative breast cancer (TNBC), and ten patients with squamous cell head & neck carcinoma will be treated • The single SNV1 dose is identified in Part 1 of this trial. Part 3: Expansion in the Best-Responding Indication – Phase 2 • 30 to 50 patients with the best responding indication determined in Part 2 • The single SNV1 dose is identified in Part 1 of this trial. © 2023 Calidi Biotherapeutics, Inc. І Company Proprietary; Patents issued and pending 51
Clinical and Commercial Manufacturing and Supply Chain Amish Patel, PhD VP, Technical Operations
Manufacturing and Supply Chain: Overview First in Class stem cell loaded oncolytic virus therapy platform with successful GMP production • Scalable, cost-efficient manufacturing platform • GMP-grade adipose-derived allogeneic stem cell bank and Virus banks sufficient to support clinical and commercial launch • Treatment designed for (CLD201 SNV) or (CLD101 NNV) as a cryopreserved vial ready to use • Opportunity to license cell bank products © 2023 Calidi Biotherapeutics, Inc. І Company Proprietary; Patents issued and pending 53
Virus amplification Manufacturing activities for CLD-101 (NeuroNova NNV) CLD-101 (NNV): Neural stem cells (NSC) delivering CRAd-s-pk7 oncolytic Adenovirus Virus Seed Master Virus Seed Virus amplification CRAd-s-pk7 oncolytic Stock (MVSS) Adenovirus CRAd-s-pk7 Master Cell Bank (MCB) A549 Virus host cell line Finished Drug Working Virus Seed Virus loading into stem cells Product (FDP) Stock (WVSS) Virus loaded stem CRAd-s-pk7 Indications: cells • Newly Diagnosed High Grade Glioma Master Cell Bank (MCB) • Recurrent High Grade Glioma Neural stem cells (NSC) For allogeneic use Cryopreservation Release and stability © 2023 Calidi Biotherapeutics, Inc. І Company Proprietary; Patents issued and pending
Virus amplification Manufacturing activities for CLD-201 (SuperNova SNV) CLD-201 (SNV): Adipose-derived MSC (AD-MSC) delivering oncolytic Vaccinia Virus CAL1 Master Virus Bank Virus amplification Virus Seed (MVB) Vaccinia Virus CAL1 Vaccina Virus CAL1 Master Cell Bank (MCB) CV-1 Virus host cell line Working Virus Banks Virus loading into stem cells Finished Drug Product Indications: (WVB) (FDP) Advanced Solid Tumors Vaccina Virus CAL1 Virus loaded stem cells • Triple-Negative Breast Cancer • Melanoma Master Cell Bank (MCB) • Head and Neck Cancer AD-MSC For allogeneic use Cryopreservation Release and stability © 2023 Calidi Biotherapeutics, Inc. І Company Proprietary; Patents issued and pending
Roadmap to Phase 2 and commercialization: CDMO selection progress Preclinical development Phase 1 Phase 2/Phase 3/Commercial Development 2025 onwards Timeline 2021 2022 2023 2024 Today GMP Production at CDMO Current CDMO vendors Initiate new CDMO Commercial-ready process Pilot/GMP drug product batches evaluation Partnering with selected CDMOs Scale-up Tech Transfer Scale–up in house SNV NNV Supply Chain CDMO Analytical Drug &storage Virus banks Stem Cell banks Virus banks Stem Cell banks Drug Product Product Ö Quote Available 1 Ö Ö Ö Ö Ö Ö Ö / Ö Quote Pending 2 Ö Ö Ö Ö Ö Ö Ö / Ö Ö Ö Ö Ö Ö Ö 3 / • Table listed selected CDMOs with good capability match and quality and regulatory experience • Top 3 of 26 evaluated CDMOs © 2023 Calidi Biotherapeutics, Inc. І Confidential and Proprietary; Patents issued and pending
Corporate Governance & Government Affairs Wendy Pizarro Chief Legal Officer
Commitment to Diversity, Equity & Inclusion in Clinical Trials Increase under-represented communities in clinical trials • For Example: Non-Hispanic Black women are disproportionately burdened with the highest breast cancer death rates in Los Angeles (18%). Strategic Planning – Education, Access and Community Outreach • Initiatives include: • Unbiased and inclusive screening protocols for diverse enrollment • Outreach sensitive to diverse languages & cultures • Partnerships with local clinics, community centers, leaders & volunteers • Accessible & inclusive marketing, e.g., social media, flyers, & outreach • Participation in community/cultural fairs and women’s advocacy events • Translation services and referral networks for ongoing engagement • Educational workshops, health fairs, family days *Key Differentiator for Government Contracts & Grants* © 2023 Calidi Biotherapeutics, Inc. І Company Proprietary; Patents issued and pending 58
CIRM Grants Awarded Supporting Calidi’s Lead Programs Grant type: CLIN2 - Clinical Trial Stage Program $12 Granted to: City of Hope (PI: Dr. Portnow) Million Product: CLD-101 (NNV2) Objective: Support Phase 1 clinical trial in Recurrent High-Grade Glioma Dec. ‘22 Grant type: CLIN1 – Late-Stage Pre-clinical Program $3.1 Granted to: Calidi Biotherapeutics (PI: Dr. Minev) Million Product: CLD-201 (SNV1) Objective: Support manufacturing, Non-clinical and other IND-enabling activities Dec. ‘22 © 2023 Calidi Biotherapeutics, Inc. І Company Proprietary; Patents issued and pending 59
Finance Tony Kalajian Chief Financial Officer
Financials and Timing of Filings ØMarcum LLP engaged as new auditor effective November 2022 ØPCAOB/SEC compliant audits of FY2022 and FY2021 consolidated financial statements completed ØInterim period Q1 2023 review completed and signed off included in the S-4 A/3 filed ØQ2 2023 interim period financials due by August 14, 2023 - expect to include in the “Super 8-K” after we close ØQ3 2023 interim period financials due by November 14, 2023 - expect to be filed in our first Form 10Q ØCommenced SOX implementation – expect to complete project by end of year 2023 – for management certifications (404a only) in the 2023 annual report. © 2023 Calidi Biotherapeutics, Inc. І Company Proprietary; Patents issued and pending 61
The Path Forward Allan Camaisa Chief Executive Officer & Chairman of the Board
Rapidly Growing OV Market With High Unmet Medical Needs Large total addressable Rapidly growing OV market Differentiated technology market with high unmet needs with early signals of efficacy • Large total addressable • Additional data needed to market across current show clinical differentiation 2021 2030 indications of focus: vs. competitor base Melanoma, GBM, TNBC, H&N 1 6-8 • 40 assets in OV Clinical approved approved • ~56k patients across all Calidi pipeline OV OVs indications** (U.S. only) $150M* $2.4B* • 5-6 key OV Competitors • $9-11B*** (U.S. TAM) (*) Oncolytic Virus Immunotherapy Market Size is Predicted to Hit US$ 2.4 Billion by 2030 | BioSpace (**) Types of Cancer | Cancer.Net (***) Oncology Cancer Drugs Market Size is projected to reach USD (globenewswire.com) © 2023 Calidi Biotherapeutics, Inc. І Company Proprietary; Patents issued and pending 63
Initial Target Indications Have a U.S. Estimated Annual TAM of $9B+ Calidi U.S. total addressable market (2022E) Estimates do not account for treatment rate, Billions of USD physician prescribing behavior, competition • Assuming annual pricing similar to other or other correction adjustments 12 I/O therapies (e.g., Keytruda), Calidi’s $9-11B U.S. TAM was estimated to be $9-11B in 10 2022 • Given the sizable patient 8 $3.5-4.5B populations, there is particularly 6 significant opportunity within Triple Negative Breast Cancer (TNBC) and $2-2.5B 4 Head & Neck Cancer indications $2.5-3.5B 2 • Note: Exclusive of other solid tumor indications $0.5-1B 0 Melanoma TNBC* GBM** Head & Neck 2022E Projected ~3.6K ~17K ~12K ~23K ~56K Patients © 2023 Calidi Biotherapeutics, Inc. І Company Proprietary; Patents issued and pending (*) https://www.cancer.org/cancer/breast-cancer/about/how-common-is-breast-cancer.html 64
Upcoming Key Milestones: 2023 & 2024 2023 2024 1H 2H 1H 2H First patient dosed CLD-101 CLD-101 (NNV1) (NNV1) First patient Interim Clinical trial CLD-101 dosed CLD-101 results CLD-101 (NNV2) (NNV2) (NNV2) First patient dosed CLD-201 cGMP Final Drug CLD-201 (SNV1) Product (SNV1) Manufactured Anticipated Calidi Corporate deSPAC IPO Updates © 2023 Calidi Biotherapeutics, Inc. І Company Proprietary; Patents issued and pending 65
Review of Highlights Calidi Biotherapeutics is a clinical-stage biopharmaceutical company revolutionizing oncolytic viral therapies with stem cell-based platforms CLD-101: Neural stem cell (NSC) product candidates loaded with oncolytic adenovirus Two Differentiated Stem Cell Platforms 1 CLD-201: Allogeneic Adipose-derived Mesenchymal Stem Cells (AD-MSC) loaded with oncolytic vaccinia virus Large Target Markets in Areas of High First CLD-101 programs target HGG, with a well-defined regulatory pathway and accelerated approval potential 2 Unmet Need CLD-201 trials will focus on multiple solid tumor types (Triple Negative Breast Cancer, Head & Neck, Metastatic Melanoma) CLD-101: Phase1 trial in newly diagnosed HGG - COMPLETED; Phase 1b trial initiating 1H 2024 Three Clinical Development Programs 3 CLD-101: Phase 1 trial in recurrent HGG – initiated in 1H 2023 CLD-201: Phase 1 trial in solid tumor indications (Triple Negative Breast, Head & Neck, Metastatic Melanoma) 2H 2024 Scalable, cost-efficient manufacturing platform and GMP-grade adipose-derived allogeneic stem cell bank and NSC bank Cutting Edge Stem Cell Manufacturing sufficient to support commercial launch 4 Processes Opportunity to license cell bank products Page © 2023 Calidi Biotherapeutics, Inc. І Company Proprietary; Patents issued and pending 66
Thank You Contact: Stephen Thesing sthesing@calidibio.com
Exhibit 99.2
FLAG STOCKHOLDERS: REMINDER TO VOTE FOR PROPOSED BUSINESS COMBINATION
RESTON, Va. — August 16, 2023 — First Light Acquisition Group, Inc. (“FLAG”) (NYSE American: FLAG), a special purpose acquisition company, reminds FLAG stockholders that the FLAG Board of Directors unanimously recommends that FLAG stockholders vote FOR the proposed business combination (the “Business Combination”) with Calidi Biotherapeutics, Inc. (“Calidi”), a clinical-stage biotechnology company that is pioneering the development of allogeneic cell-based delivery of oncolytic viruses.
The special meeting to consider and vote on the Business Combination will be held at 10:30 a.m. Eastern Time on August 22, 2023 via live webcast, as described in FLAG’s proxy statement/prospectus dated August 4, 2023 (the “Proxy Statement”). The Proxy Statement is available in the Investor Resources section of FLAG’s website as well as on www.sec.gov. Holders of FLAG common stock as of the close of business on July 11, 2023 are entitled to vote at the special meeting.
Closing of the Business Combination is currently expected to occur on August 24, 2023, subject to final stockholder approval and satisfaction of other closing conditions.
FLAG public stockholders are entitled to elect to redeem their public shares for a pro rata portion of the funds held in FLAG’s trust account prior to the redemption deadline of 5:00 pm ET on August 18, 2023.
FLAG public stockholders who do not redeem their shares are entitled to their pro rata portion of up to an additional 2,000,000 shares of the post-combination company at closing. Any such shares that are not issued to non-redeeming public stockholders, may be used as incentives in connection with an equity or debt-linked security investment in FLAG or Calidi that facilitates the closing or the post-closing liquidity of FLAG and its subsidiaries.
If you are a stockholder and have any questions about how to vote or direct a vote in respect of your shares of FLAG Common Stock, you may call MacKenzie Partners, Inc., FLAG’s proxy solicitor, at (212) 929-5500 (Call Collect) or (800) 322-2885 (Call Toll Free) or by email at proxy@mackenziepartners.com.
About Calidi Biotherapeutics, Inc.
Calidi Biotherapeutics is a clinical-stage immuno-oncology company with proprietary technology that is revolutionizing the effective delivery and potentiation of oncolytic viruses for targeted therapy against difficult-to-treat cancers. Calidi Biotherapeutics is advancing in clinical development a potent allogeneic stem cell and oncolytic virus combination for use in multiple oncology indications. Calidi’s off-the-shelf, universal cell-based delivery platforms are designed to protect, amplify, and potentiate oncolytic viruses currently in development leading to enhanced efficacy and improved patient safety. Calidi Biotherapeutics is headquartered in San Diego, California. For more information, please visit calidibio.com.
About First Light Acquisition Group, Inc.
First Light Acquisition Group is a blank check company organized for the purpose of effecting a merger, share exchange, asset acquisition, share purchase, recapitalization, reorganization, or other similar business combination with one or more businesses or entities. The company is sponsored by a group of former industry and federal leaders with extensive experience operating public companies and organizations in highly regulated industries, and is led by Thomas Vecchiolla, Chief Executive Officer of FLAG.
Additional Information and Where to Find It
FLAG has filed with the SEC a registration statement on Form S-4 (as may be amended from time to time, the “Registration Statement”), which includes a definitive proxy statement of FLAG, and a prospectus in connection with the proposed business combination transaction involving FLAG and Calidi. The definitive proxy statement and other relevant documents have been mailed to FLAG shareholders as of July 11, 2023, the record date established for voting on the Business Combination. FLAG securityholders and other interested persons are advised to read the definitive proxy statement/prospectus, in connection with FLAG’s solicitation of proxies for the special meeting because these documents will contain important information about FLAG, Calidi, and the Business Combination. Investors, securityholders and other interested persons will also be able to obtain copies of the Registration Statement, the proxy statement/prospectus and all other relevant documents filed or that will be filed with the SEC by FLAG, once such documents are filed, free of charge, on the SEC’s website at www.sec.gov or by directing a request to: First Light Acquisition Group, Inc., 11110 Sunset Hills Road #2278, Reston, VA 20190.
Participants in the Solicitation
FLAG and Calidi and their respective directors and officers and other members of management and employees may be deemed participants in the solicitation of proxies in connection with the proposed business combination. FLAG shareholders and other interested persons may obtain, without charge, more detailed information regarding directors and officers of FLAG in FLAG’s Annual Report on Form 10-K for the year ended December 31, 2022, as filed with the SEC on March 31, 2023. Information regarding the persons who may, under SEC rules, be deemed participants in the solicitation of proxies from FLAG’s shareholders in connection with the proposed business combination will be included in the definitive proxy statement/prospectus that FLAG intends to file with the SEC.
No Offer or Solicitation
This communication does not constitute (i) a solicitation of a proxy, consent or authorization with respect to any securities or in respect of the proposed Business Combination or (ii) an offer to sell, a solicitation of an offer to buy, or a recommendation to buy any security of Calidi, FLAG or any of their respective affiliates. There shall not be any sale of any securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the laws of such other jurisdiction. No offering of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended, or an exemption therefrom.
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Forward-Looking Statements
This Current Report on Form 8-K contains forward-looking statements for purposes of the “safe harbor” provisions under the United States Private Securities Litigation Reform Act of 1995. Terms such as “anticipates,” “believe,” “continue,” “could,” “estimate,” “expect,” “intends,” “may,” “might,” “plan,” “possible,” “potential,” “predicts,” “project,” “should,” “would” as well as similar terms, are forward-looking in nature. The forward-looking statements contained in this discussion are based on Calidi’s current expectations and beliefs concerning future developments and their potential effects. There can be no assurance that future developments affecting Calidi will be those that it has anticipated. These forward-looking statements involve a number of risks, uncertainties (some of which are beyond Calidi’s control) or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. Factors that may cause actual results to differ materially from current expectations include, but are not limited to: the occurrence of any event, change or other circumstances that could give rise to the termination of negotiations and any subsequent definitive agreements with respect to the Business Combination; the outcome of any legal proceedings that may be instituted against FLAG, Calidi, the combined company or others following the announcement of the Business Combination, the PIPE Investment proposed to be consummated concurrently with the Business Combination, and any definitive agreements with respect thereto; the inability to complete the Business Combination due to the failure to obtain approval of the shareholders of FLAG, the inability to complete any PIPE Investment or other financing needed to complete the Business Combination, or to satisfy other conditions to closing; changes to the proposed structure of the Business Combination that may be required or appropriate as a result of applicable laws or regulations or as a condition to obtaining regulatory approval of the Business Combination; the ability to meet stock exchange listing standards following the consummation of the Business Combination; the risk that the Business Combination disrupts current plans and operations of Calidi as a result of the announcement and consummation of the Business Combination; the ability to recognize the anticipated benefits of the Business Combination or to realize estimated pro forma results and underlying assumptions, including with respect to estimated shareholder redemptions; costs related to the Business Combination; changes in applicable laws or regulations; the evolution of the markets in which Calidi competes; the inability of Calidi to defend its intellectual property and satisfy regulatory requirements; the ability to implement business plans, forecasts, and other expectations after the completion of the proposed Business Combination, and identify and realize additional opportunities; the risk of downturns and a changing regulatory landscape in the highly competitive pharmaceutical industry; the impact of potential global conflicts (including the current conflict in Ukraine) may have on capital markets or on Calidi’s or FLAG’s business; the impact of the COVID-19 pandemic on Calidi’s business; and other risks and uncertainties set forth in the section entitled “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements” in FLAG’s final prospectus dated September 9, 2021 and Annual Report on Form 10-K for the year ended December 31, 2022, as filed with the SEC on March 31, 2023, and the risks and uncertainties indicated in the Registration Statement and the definitive proxy statement to be delivered to FLAG’s shareholders, including those set forth under “Risk Factors” therein, and other documents filed or to be filed with the SEC by FLAG.
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