Calidi Biotherapeutics Reports Third Quarter 2024 Operating and Financial Results
Calidi Biotherapeutics (NYSE: CLDI) reported Q3 2024 financial results and key developments. The FDA cleared Northwestern University's IND application for NeuroNova (CLD-101), with Phase 1b/2 clinical trials in high-grade glioma expected to begin in early 2025. The company presented data on RTNova (CLD-400), their systemic antitumor virotherapy platform, at multiple conferences. Financially, Calidi reported a net loss of $5.1 million ($0.65 per share) compared to $2.0 million ($1.41 per share) in Q3 2023. The company raised $2 million through a registered direct offering and had $1.9 million in cash as of September 30, 2024.
Calidi Biotherapeutics (NYSE: CLDI) ha riportato i risultati finanziari del terzo trimestre 2024 e le principali novità. La FDA ha approvato la richiesta IND della Northwestern University per NeuroNova (CLD-101), con l'inizio previsto dei trial clinici di fase 1b/2 in pazienti con glioma ad alto grado all'inizio del 2025. L'azienda ha presentato dati su RTNova (CLD-400), la loro piattaforma di viroterapia antitumorale sistemica, in diverse conferenze. Dal punto di vista finanziario, Calidi ha riportato una perdita netta di 5,1 milioni di dollari (0,65 dollari per azione) rispetto ai 2 milioni di dollari (1,41 dollari per azione) del terzo trimestre 2023. L'azienda ha raccolto 2 milioni di dollari tramite un'offerta diretta registrata e disponeva di 1,9 milioni di dollari in contanti al 30 settembre 2024.
Calidi Biotherapeutics (NYSE: CLDI) informó sobre los resultados financieros del tercer trimestre de 2024 y desarrollos clave. La FDA aprobó la solicitud IND de la Universidad Northwestern para NeuroNova (CLD-101), con el inicio de ensayos clínicos de fase 1b/2 en glioma de alto grado previsto para principios de 2025. La compañía presentó datos sobre RTNova (CLD-400), su plataforma de viroterapia antitumoral sistémica, en múltiples conferencias. Desde el punto de vista financiero, Calidi reportó una pérdida neta de 5,1 millones de dólares (0,65 dólares por acción) en comparación con los 2 millones de dólares (1,41 dólares por acción) del tercer trimestre de 2023. La empresa recaudó 2 millones de dólares a través de una oferta directa registrada y tenía 1,9 millones de dólares en efectivo al 30 de septiembre de 2024.
칼리디 바이오테라퓨틱스 (NYSE: CLDI)는 2024년 3분기 재무 결과와 주요 개발 사항을 보고했습니다. FDA는 노스웨스턴 대학교의 NeuroNova (CLD-101) IND 신청을 승인했으며, 고등급 신경교종에 대한 1b/2상 임상 시험이 2025년 초에 시작될 것으로 예상됩니다. 이 회사는 여러 회의에서 그들의 전신 항종양 바이로테라피 플랫폼인 RTNova (CLD-400) 관련 데이터를 발표했습니다. 재무적으로, 칼리디는 510만 달러의 순손실(주당 0.65달러)를 보고했으며, 이는 2023년 3분기 200만 달러(주당 1.41달러)와 비교되는 수치입니다. 회사는 등록된 직접 제안을 통해 200만 달러를 모금하였고, 2024년 9월 30일 기준으로 190만 달러의 현금을 보유하고 있었습니다.
Calidi Biotherapeutics (NYSE: CLDI) a annoncé ses résultats financiers pour le troisième trimestre 2024 ainsi que des développements clés. La FDA a approuvé la demande IND de l'Université Northwestern pour NeuroNova (CLD-101), avec des essais cliniques de phase 1b/2 sur le gliome de haut grade qui devraient commencer début 2025. L'entreprise a présenté des données sur RTNova (CLD-400), sa plateforme de virothérapie anticancéreuse systémique, lors de plusieurs conférences. Sur le plan financier, Calidi a annoncé une perte nette de 5,1 millions de dollars (0,65 dollar par action) par rapport aux 2,0 millions de dollars (1,41 dollar par action) du troisième trimestre 2023. L'entreprise a levé 2 millions de dollars par le biais d'une offre directe enregistrée et disposait de 1,9 million de dollars en espèces au 30 septembre 2024.
Calidi Biotherapeutics (NYSE: CLDI) hat die finanziellen Ergebnisse für das dritte Quartal 2024 und wichtige Entwicklungen bekannt gegeben. Die FDA hat den IND-Antrag der Northwestern University für NeuroNova (CLD-101) genehmigt, wobei die klinischen Phase 1b/2-Studien bei hochgradigem Gliom voraussichtlich Anfang 2025 beginnen werden. Das Unternehmen präsentierte Daten zu RTNova (CLD-400), ihrer systemischen antitumoralen Virotherapie-Plattform, auf mehreren Konferenzen. Finanziell berichtete Calidi von einem Nettoverlust von 5,1 Millionen US-Dollar (0,65 US-Dollar pro Aktie) im Vergleich zu 2,0 Millionen US-Dollar (1,41 US-Dollar pro Aktie) im dritten Quartal 2023. Das Unternehmen erhielt 2 Millionen US-Dollar durch ein registriertes Direktangebot und hatte zum 30. September 2024 1,9 Millionen US-Dollar an Bargeld.
- FDA clearance for NeuroNova (CLD-101) IND application
- Reduction in R&D expenses from $3.3M to $2.2M year-over-year
- Reduction in G&A expenses from $4.0M to $3.1M year-over-year
- Net loss increased to $5.1M from $2.0M year-over-year
- Low cash position of $1.9M
- Need for additional funding demonstrated by $2M offering
Insights
The financial picture for Calidi raises significant concerns. Despite reducing R&D expenses from
The
The FDA clearance for NeuroNova (CLD-101) IND represents a significant milestone in addressing high-grade glioma, an aggressive brain cancer with poor prognosis. The stem cell-based delivery platform for oncolytic viruses is innovative, potentially improving targeted delivery to tumor sites. The RTNova (CLD-400) platform's systemic approach could be groundbreaking by addressing the common challenge of immune system elimination that plagues many oncolytic virus therapies.
However, the planned Phase 1b/2 trial initiation in early 2025 appears ambitious given the current financial constraints. The development of two complex biological platforms (NeuroNova and RTNova) simultaneously requires substantial resources that may strain the company's capital.
- 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.
SAN DIEGO, Nov. 12, 2024 (GLOBE NEWSWIRE) -- Calidi Biotherapeutics Inc. (NYSE American: CLDI) (“Calidi”), a clinical-stage biotechnology company developing a new generation of targeted antitumor virotherapies, today reported its operating and financial results for the third quarter ended September 30, 2024, and reviewed recent business highlights.
“Calidi continues to advance our development programs while expanding our industry-leading position in targeted antitumor virotherapies,” said Allan Camaisa, CEO and Chairman of the Board of Calidi Biotherapeutics. “In addition, we are pleased that Northwestern University has received U.S. FDA clearance to advance our CLD-101 program in the clinic for newly diagnosed high-grade glioma.”
Third Quarter 2024 and Recent Corporate Developments
- The U.S. Food and Drug Administration (FDA) has cleared Northwestern University’s Investigational New Drug (IND) application for Calidi’s NeuroNova (CLD-101). CLD-101 is a novel stem-cell based platform designed to deliver oncolytic viruses to tumors, enhancing their antitumor effects. The Phase 1b/2 clinical trial in newly diagnosed high-grade glioma is expected to commence in early 2025 at Northwestern University.
- Data was presented on RTNova (CLD-400), Calidi’s systemic antitumor virotherapy platform, at the International Oncolytic Virotherapy Conference (IOVC) in Rotterdam, Netherlands, at Immuno US 2024 in San Diego, California and the Society for Immunotherapy of Cancer (SITC) annual meeting. RTNova is a systemic treatment designed for reduced elimination by the humoral immune system. It targets multiple tumor sites, killing tumor cells while altering the tumor immune microenvironment. This novel systemic therapeutic approach not only facilitates easier administration but also broadens the potential patient population who can benefit from this treatment.
- Calidi announced in October the completion of a definitive securities purchase agreement with certain institutional investors, raising
$2 million in a registered direct offering and concurrent private placement.
Third Quarter 2024 Financial Results
The Company reported a net loss of
Research and development expenses were
General and administrative expenses were
The Company had approximately
About Calidi Biotherapeutics:
Calidi Biotherapeutics (NYSE American: CLDI) is a clinical-stage immuno-oncology company with proprietary technology designed to arm the immune system to fight cancer. Calidi’s novel stem cell-based platforms are utilizing potent allogeneic stem cells capable of carrying payloads of oncolytic viruses for use in multiple oncology indications, including high-grade gliomas and solid tumors. Calidi’s clinical stage off-the-shelf, universal cell-based delivery platforms are designed to protect, amplify, and potentiate oncolytic viruses leading to enhanced efficacy and improved patient safety. Calidi’s preclinical off-the-shelf enveloped virotherapies are designed to target disseminated solid tumors. This dual approach can potentially treat, or even prevent, metastatic disease. Calidi Biotherapeutics is headquartered in San Diego, California. For more information, please visit www.calidibio.com.
Forward-Looking Statements
This press release may contain 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,” “towards,” “would” as well as similar terms, are forward-looking in nature, but the absence of these words does not mean that a statement is not forward-looking. These forward-looking statements include, but are not limited to, statements concerning upcoming key milestones (including the reporting of interim clinical results and the dosing of patients), planned clinical trials, and statements relating to the safety and efficacy of Calidi’s therapeutic candidates in development. Any forward-looking statements contained in this discussion are based on Calidi’s current expectations and beliefs concerning future developments and their potential effects and are subject to multiple risks and uncertainties that could cause actual results to differ materially and adversely from those set forth or implied in such forward-looking statements. These risks and uncertainties include, but are not limited to, the risk that Calidi is not able to raise sufficient capital to support its current and anticipated clinical trials, the risk that early results of clinical trials do not necessarily predict final results and that one or more of the clinical outcomes may materially change following more comprehensive review of the data, and as more patient data becomes available, the risk that Calidi may not receive FDA approval for some or all of its therapeutic candidates. Other risks and uncertainties are set forth in the section entitled “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements” in the Company’s Registration Statements filed with the SEC on (i) Form S-4 filed on August 2, 2023 and the corresponding prospectus filed on August 4, 2023, and (ii) on Form S-1 filed on April 15, 2024, and the Company’s periodic reports filed with the SEC on (i) Form 10-K filed on March 15, 2024, (ii) Form 10-Q filed on May 14, 2024, and (iii) Form 10-Q filed on August 13, 2024. These reports may be amended or supplemented by other reports we file with the SEC from time to time.
For Investors:
Dave Gentry, CEO
RedChip Companies, Inc.
1-407-644-4256
CLDI@redchip.com
| CALIDI BIOTHERAPEUTICS, INC. CONDENSED CONSOLIDATED BALANCE SHEETS (In thousands except for par value data) | ||||||||
| September 30, 2024 | December 31, 2023 | |||||||
| (Unaudited) | ||||||||
| ASSETS | ||||||||
| CURRENT ASSETS | ||||||||
| Cash | $ | 1,897 | $ | 1,949 | ||||
| Prepaid expenses and other current assets | 324 | 2,354 | ||||||
| Total current assets | 2,221 | 4,303 | ||||||
| NONCURRENT ASSETS | ||||||||
| Machinery and equipment, net | 982 | 1,270 | ||||||
| Operating lease right-of-use assets, net | 3,237 | 4,073 | ||||||
| Other noncurrent assets | 217 | 373 | ||||||
| TOTAL ASSETS | $ | 6,657 | $ | 10,019 | ||||
| LIABILITIES AND STOCKHOLDERS’ DEFICIT | ||||||||
| CURRENT LIABILITIES | ||||||||
| Accounts payable | $ | 3,574 | $ | 2,796 | ||||
| Related party accounts payable | — | 81 | ||||||
| Accrued expenses and other current liabilities | 2,567 | 4,896 | ||||||
| Related party accrued expenses and other current liabilities | 496 | 536 | ||||||
| Term notes payable, net of discount, including accrued interest | 242 | 529 | ||||||
| Related party term notes payable, net of discount, including accrued interest | 2,631 | 278 | ||||||
| Related party bridge loan payable, including accrued interest | 217 | — | ||||||
| Related party other current liability | 620 | — | ||||||
| Finance lease liability, current | 69 | 81 | ||||||
| Operating lease right-of-use liability, current | 1,163 | 1,035 | ||||||
| Total current liabilities | 11,579 | 10,232 | ||||||
| NONCURRENT LIABILITIES | ||||||||
| Operating lease right-of-use liability, noncurrent | 2,161 | 3,037 | ||||||
| Finance lease liability, noncurrent | 166 | 216 | ||||||
| Warrant liability | 163 | 623 | ||||||
| Related party warrant liability | 13 | 48 | ||||||
| Convertible notes payable, including accrued interest | 1,773 | — | ||||||
| Related party term notes payable, net of discount, including accrued interest | — | 2,060 | ||||||
| Promissory note | 600 | — | ||||||
| Other noncurrent liabilities | — | 1,500 | ||||||
| Related party other noncurrent liabilities | — | 538 | ||||||
| TOTAL LIABILITIES | 16,455 | 18,254 | ||||||
| Commitments and contingencies (Note 11) | ||||||||
| STOCKHOLDERS’ DEFICIT | ||||||||
| Common stock, | 1 | 1 | ||||||
| Additional paid-in capital | 107,408 | 91,383 | ||||||
| Non-controlling interest | 485 | — | ||||||
| Accumulated other comprehensive loss, net of tax | (74 | ) | (47 | ) | ||||
| Accumulated deficit | (117,618 | ) | (99,572 | ) | ||||
| Total stockholders’ deficit | (9,798 | ) | (8,235 | ) | ||||
| TOTAL LIABILITIES AND STOCKHOLDERS’ DEFICIT | $ | 6,657 | $ | 10,019 | ||||
| CALIDI BIOTHERAPEUTICS, INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (In thousands, except per share data) | |||||||||||||
| Three Months Ended September 30, | |||||||||||||
| 2024 | 2023 | ||||||||||||
| (Unaudited) | |||||||||||||
| OPERATING EXPENSES | |||||||||||||
| Research and development | $ | (2,153 | ) | $ | (3,251 | ) | |||||||
| General and administrative | (3,073 | ) | (3,970 | ) | |||||||||
| Total operating expense | (5,226 | ) | (7,221 | ) | |||||||||
| Loss from operations | (5,226 | ) | (7,221 | ) | |||||||||
| OTHER INCOME (EXPENSES), NET | |||||||||||||
| Interest expense | (98 | ) | (101 | ) | |||||||||
| Interest expense – related party | (134 | ) | (223 | ) | |||||||||
| Change in fair value of debt, other liabilities, and derivatives | 352 | 845 | |||||||||||
| Change in fair value of debt, other liabilities, and derivatives – related party | 28 | 4,473 | |||||||||||
| Debt extinguishment | — | (139 | ) | ||||||||||
| Debt extinguishment – related party | — | (332 | ) | ||||||||||
| Grant income | — | 693 | |||||||||||
| Other income (expense), net | 8 | (8 | ) | ||||||||||
| Total other income (expenses), net | 156 | 5,208 | |||||||||||
| LOSS BEFORE INCOME TAXES | (5,070 | ) | (2,013 | ) | |||||||||
| Income tax credit (provision) | 1 | (11 | ) | ||||||||||
| NET LOSS | $ | (5,069 | ) | $ | (2,024 | ) | |||||||
| Net loss attributable to noncontrolling interest | (15 | ) | — | ||||||||||
| NET LOSS ATTRIBUTABLE TO CONTROLLING INTEREST | $ | (5,054 | ) | $ | (2,024 | ) | |||||||
| Deemed dividend on warrants | — | — | |||||||||||
| NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS | $ | (5,054 | ) | $ | (2,024 | ) | |||||||
| Net loss per share; basic and diluted | $ | (0.65 | ) | $ | (1.41 | ) | |||||||
| Weighted average common shares outstanding; basic and diluted | 7,824 | 1,431 | |||||||||||
FAQ
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