Calidi Biotherapeutics Reports Second Quarter 2024 Operating and Financial Results
Calidi Biotherapeutics Inc. (NYSEAM: CLDI) reported its Q2 2024 financial results and recent business highlights. Key developments include:
1. Launched Nova Cell subsidiary with a $2 million investment from Dr. Ronald Rigor to advance AAA stem cell programs.
2. Strengthened team with appointments of Dr. George E. Peoples to the Board of Directors and Dr. Mark Gilbert to the Medical Advisory Board.
3. Received a new U.S. patent for SuperNova technology, enhancing the CLD-201 program.
4. Reported a net loss of $5.8 million ($1.40 per share) for Q2 2024, compared to $12.5 million ($14.24 per share) in Q2 2023.
5. R&D expenses were $2.2 million, down from $3.2 million in Q2 2023.
6. Cash position of $0.8 million as of June 30, 2024.
Calidi Biotherapeutics Inc. (NYSEAM: CLDI) ha riportato i risultati finanziari del secondo trimestre 2024 e i recenti sviluppi aziendali. I principali sviluppi includono:
1. Avvio della sussidiaria Nova Cell con un investimento di 2 milioni di dollari da parte del Dr. Ronald Rigor per far progredire i programmi di cellule staminali AAA.
2. Rafforzamento del team con la nomina di Dr. George E. Peoples nel Consiglio di Amministrazione e Dr. Mark Gilbert nel Consiglio Consultivo Medico.
3. Ricevuto un nuovo brevetto negli Stati Uniti per la tecnologia SuperNova, che migliora il programma CLD-201.
4. Riportato una perdita netta di 5,8 milioni di dollari (1,40 dollari per azione) per il secondo trimestre 2024, rispetto a 12,5 milioni di dollari (14,24 dollari per azione) nel secondo trimestre 2023.
5. Le spese per R&S sono state di 2,2 milioni di dollari, in calo rispetto ai 3,2 milioni di dollari nel secondo trimestre 2023.
6. Posizione di cassa di 0,8 milioni di dollari al 30 giugno 2024.
Calidi Biotherapeutics Inc. (NYSEAM: CLDI) reportó sus resultados financieros del segundo trimestre de 2024 y los recientes desarrollos comerciales. Los principales desarrollos incluyen:
1. Lanzamiento de la subsidiaria Nova Cell con una inversión de 2 millones de dólares por parte del Dr. Ronald Rigor para avanzar en los programas de células madre AAA.
2. Fortalecimiento del equipo con las nominaciones de Dr. George E. Peoples a la Junta Directiva y Dr. Mark Gilbert a la Junta Asesora Médica.
3. Recibido un nuevo patentado en EE. UU. para la tecnología SuperNova, mejorando el programa CLD-201.
4. Reportada una pérdida neta de 5.8 millones de dólares (1.40 dólares por acción) para el segundo trimestre de 2024, en comparación con 12.5 millones de dólares (14.24 dólares por acción) en el segundo trimestre de 2023.
5. Los gastos de I+D fueron de 2.2 millones de dólares, en comparación con 3.2 millones de dólares en el segundo trimestre de 2023.
6. Posición de efectivo de 0.8 millones de dólares al 30 de junio de 2024.
Calidi Biotherapeutics Inc. (NYSEAM: CLDI)는 2024년 2분기 재무 결과와 최근 사업 하이라이트를 보고했습니다. 주요 개발 사항은 다음과 같습니다:
1. AAA 줄기 세포 프로그램을 발전시키기 위해 Dr. Ronald Rigor로부터 200만 달러의 투자를 받아 Nova Cell 자회사를 출범했습니다.
2. George E. Peoples 박사를 이사회에, Mark Gilbert 박사를 의료 자문 위원회에 임명하여 팀을 강화했습니다.
3. CLD-201 프로그램을 향상시키는 SuperNova 기술에 대한 새로운 미국 특허를 받았습니다.
4. 2024년 2분기 동안 580만 달러의 순손실 (주당 1.40 달러)을 보고했으며, 이는 2023년 2분기 1250만 달러 (주당 14.24 달러)와 비교됩니다.
5. 연구개발(R&D) 비용은 220만 달러로, 2023년 2분기 320만 달러에서 감소했습니다.
6. 2024년 6월 30일 기준 현금 보유액은 80만 달러입니다.
Calidi Biotherapeutics Inc. (NYSEAM: CLDI) a annoncé ses résultats financiers du deuxième trimestre 2024 ainsi que les récents moments forts de l'entreprise. Les principaux développements incluent :
1. Lancement de la filiale Nova Cell avec un investissement de 2 millions de dollars de Dr. Ronald Rigor pour faire avancer les programmes de cellules souches AAA.
2. Renforcement de l'équipe avec les nominations de Dr. George E. Peoples au Conseil d'Administration et Dr. Mark Gilbert au Conseil Consultatif Médical.
3. Obtention d'un nouveau brevet américain pour la technologie SuperNova, améliorant le programme CLD-201.
4. Signalé une perte nette de 5,8 millions de dollars (1,40 dollar par action) pour le deuxième trimestre 2024, comparé à 12,5 millions de dollars (14,24 dollars par action) au deuxième trimestre 2023.
5. Les dépenses de R&D s'élevaient à 2,2 millions de dollars, en baisse par rapport à 3,2 millions de dollars au deuxième trimestre 2023.
6. Position de trésorerie de 0,8 millions de dollars au 30 juin 2024.
Calidi Biotherapeutics Inc. (NYSEAM: CLDI) hat seine Finanzzahlen für das zweite Quartal 2024 und aktuelle Geschäftshighlights veröffentlicht. Zu den wichtigsten Entwicklungen gehören:
1. Gründung der Tochtergesellschaft Nova Cell mit einer Investition von 2 Millionen Dollar vom Dr. Ronald Rigor zur Förderung der AAA-Stammzellprogramme.
2. Verstärkung des Teams mit der Ernennung von Dr. George E. Peoples in den Vorstand und Dr. Mark Gilbert in den medizinischen Beirat.
3. Erhalt eines neuen US-Patents für die SuperNova-Technologie, die das CLD-201-Programm verbessert.
4. Meldung eines Gesamtverlusts von 5,8 Millionen Dollar (1,40 Dollar pro Aktie) für das zweite Quartal 2024 im Vergleich zu 12,5 Millionen Dollar (14,24 Dollar pro Aktie) im zweiten Quartal 2023.
5. Die Forschung und Entwicklungskosten beliefen sich auf 2,2 Millionen Dollar, im Vergleich zu 3,2 Millionen Dollar im zweiten Quartal 2023.
6. Bargeldposition von 0,8 Millionen Dollar zum 30. Juni 2024.
- Launched Nova Cell subsidiary with $2 million investment from Dr. Ronald Rigor
- Received new U.S. patent for SuperNova technology, strengthening IP position
- Appointed Dr. George Peoples to Board of Directors and Dr. Mark Gilbert to Medical Advisory Board
- Reduced net loss from $12.5 million in Q2 2023 to $5.8 million in Q2 2024
- Decreased R&D expenses from $3.2 million in Q2 2023 to $2.2 million in Q2 2024
- Received $2.5 million gross proceeds from warrant exercises in July and August 2024
- Cash position decreased from $1.9 million on December 31, 2023, to $0.8 million on June 30, 2024
- Continued net loss of $5.8 million in Q2 2024
- Slight increase in general and administrative expenses from $3.4 million in Q2 2023 to $3.6 million in Q2 2024
Insights
Calidi Biotherapeutics' Q2 2024 results show a mixed financial picture. The company's net loss narrowed significantly to
Calidi's strategic moves in Q2 2024 demonstrate a focus on advancing its novel therapies. The launch of Nova Cell subsidiary, backed by Dr. Rigor's investment, could accelerate the development of Adult Adipose Allogeneic stem cell programs. The new patent for SuperNova technology is a significant IP milestone, potentially enhancing the CLD-201 program's value. Key appointments to the Board and Advisory Board bring valuable oncology expertise. However, the
Calidi's market positioning in targeted antitumor virotherapies appears to be strengthening. The new SuperNova patent and the formation of Nova Cell subsidiary indicate a two-pronged strategy focusing on both proprietary technology and potential service offerings. This diversification could create multiple revenue streams in the future. The high-profile appointments of Dr. Peoples and Dr. Gilbert add credibility and may attract investor interest. However, the company's financial constraints could limit its ability to capitalize on these advantages. Calidi's success will depend on its ability to secure additional funding and rapidly advance its clinical programs, particularly in the competitive oncology space. Investors should closely monitor the company's cash burn rate and upcoming clinical milestones.
- Launched Nova Cell subsidiary with
$2 million investment from Dr. Ronald Rigor to advance Calidi’s Adult Adipose Allogeneic (AAA) stem cell innovative programs
- Strengthened team with the appointment of Dr. George E. Peoples, MD, FACS, adjunct professor of Surgical Oncology at MD Anderson Cancer Center, to the company’s Board of Directors, and the addition of Mark Gilbert, MD, scientist emeritus at the National Institutes of Health (NIH), to its Medical Advisory Board
- Received a new U.S. patent for the company’s novel SuperNova technology, positioning Calidi to advance its CLD-201 program into the clinic. The patent covers a unique cancer treatment combining stem cells and a smallpox vaccine, strengthening Calidi’s position in developing innovative therapies for advanced solid tumors
SAN DIEGO, Aug. 13, 2024 (GLOBE NEWSWIRE) -- Calidi Biotherapeutics Inc. (NYSEAM: CLDI) (“Calidi”), a clinical-stage biotechnology company developing a new generation of targeted antitumor virotherapies, today reported its operating and financial results for the second quarter ended June 30, 2024, and reviewed recent business highlights.
“Calidi is making solid progress across our development programs while continuing to innovate and expand our industry-leading position in targeted antitumor virotherapies,” said Allan Camaisa, CEO and Chairman of the Board of Calidi Biotherapeutics. “In addition, we are proud to have received a new U.S. Patent for our SuperNova technology, further strengthening our IP position as we advance the CLD-201 program into the clinic.”
Second Quarter 2024 and Recent Corporate Developments
- Announced a
$2 million strategic investment in July 2024 by Dr. Ronald Rigor into its new subsidiary, Nova Cell, Inc. (“Nova Cell”), to advance Calidi’s Adult Adipose Allogeneic (AAA) stem cell innovative programs. Nova Cell was formed to be a technology service provider that develops innovative stem cell-based products using Calidi’s advanced cellular manufacturing process. Dr. Rigor also invested an additional$1 million into Calidi to further its oncology pipeline of assets. In connection with Dr. Rigor’s investment, he was appointed as a member of Calidi’s Scientific and Medical Advisory Board.
- Appointed George Peoples, MD, FACS, to the company’s Board of Directors, as a Class II director. Dr. Peoples serves as a Professor of Surgery at the Uniformed Services University of the Health Sciences (USUHS) and an adjunct Professor of Surgical Oncology at MD Anderson Cancer Center.
- Appointed Mark Gilbert, MD, to the Calidi Medical Advisory Board. 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 laboratory and clinical investigators conducted groundbreaking research that advanced science in the brain tumor field.
- Received patent covering novel SuperNova technology platform. The patent covers a composition where cells are incubated with an oncolytic virus for a defined period allowing the expression of at least one immunomodulatory protein or recombinant therapeutic protein encoded by the virus, by virtue of association of the virus, with the carrier cell. Calidi has shown preclinically the potential of SuperNova to shield the viral payload from the immune system allowing for its delivery to tumor sites. The SuperNova platform is composed of adipose-derived mesenchymal stem cells loaded with oncolytic vaccinia virus.
- Received
$2.5 million gross proceeds during July and August 2024 pursuant to warrant exercises.
Second Quarter 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 Form S-4 filed on August 2, 2023, on Form S-1 filed on October 6, 2023, on Form S-1 filed on January 29, 2024, as amended on February 7, 2024, on Form 10-K filed on March 15, 2024, and Final Prospectus filed on April 17, 2024.
For Investors and Media:
Stephen Thesing
| CALIDI BIOTHERAPEUTICS, INC. | ||||||||
| CONDENSED CONSOLIDATED BALANCE SHEETS | ||||||||
| (In thousands except for par value data) | ||||||||
| June 30, 2024 | December 31, 2023 | |||||||
| (Unaudited) | ||||||||
| ASSETS | ||||||||
| CURRENT ASSETS | ||||||||
| Cash | $ | 836 | $ | 1,949 | ||||
| Prepaid expenses and other current assets | 789 | 2,354 | ||||||
| Total current assets | 1,625 | 4,303 | ||||||
| NONCURRENT ASSETS | ||||||||
| Machinery and equipment, net | 1,061 | 1,270 | ||||||
| Operating lease right-of-use assets, net | 3,518 | 4,073 | ||||||
| Other noncurrent assets | 227 | 373 | ||||||
| TOTAL ASSETS | $ | 6,431 | $ | 10,019 | ||||
| LIABILITIES AND STOCKHOLDERS’ DEFICIT | ||||||||
| CURRENT LIABILITIES | ||||||||
| Accounts payable | $ | 4,460 | $ | 2,796 | ||||
| Related party accounts payable | 87 | 81 | ||||||
| Accrued expenses and other current liabilities | 3,236 | 4,896 | ||||||
| Related party accrued expenses and other current liabilities | 504 | 536 | ||||||
| Term notes payable, net of discount, including accrued interest | 233 | 529 | ||||||
| Related party term notes payable, net of discount, including accrued interest | 2,539 | 278 | ||||||
| Related party bridge loan payable, including accrued interest | 211 | — | ||||||
| Related party other current liability | 597 | — | ||||||
| Finance lease liability, current | 68 | 81 | ||||||
| Operating lease right-of-use liability, current | 1,117 | 1,035 | ||||||
| Total current liabilities | 13,052 | 10,232 | ||||||
| NONCURRENT LIABILITIES | ||||||||
| Operating lease right-of-use liability, noncurrent | 2,461 | 3,037 | ||||||
| Finance lease liability, noncurrent | 180 | 216 | ||||||
| Convertible notes payable, including accrued interest | 1,925 | — | ||||||
| Warrant liability | 524 | 623 | ||||||
| Related party warrant liability | 41 | 48 | ||||||
| Related party term notes payable, net of discount, including accrued interest | — | 2,060 | ||||||
| Other noncurrent liabilities | — | 1,500 | ||||||
| Related party other noncurrent liabilities | — | 538 | ||||||
| TOTAL LIABILITIES | 18,183 | 18,254 | ||||||
| STOCKHOLDERS’ DEFICIT | (11,752 | ) | (8,235 | ) | ||||
| TOTAL LIABILITIES AND STOCKHOLDERS’ DEFICIT | $ | 6,431 | $ | 10,019 | ||||
| CALIDI BIOTHERAPEUTICS, INC. | ||||||||
| CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | ||||||||
| (In thousands, except per share data) | ||||||||
| Three Months Ended June 30, | ||||||||
| 2024 | 2023 | |||||||
| (Unaudited) | ||||||||
| OPERATING EXPENSES | ||||||||
| Research and development | $ | (2,167 | ) | $ | (3,177 | ) | ||
| General and administrative | (3,605 | ) | (3,360 | ) | ||||
| Total operating expense | (5,772 | ) | (6,537 | ) | ||||
| Loss from operations | (5,772 | ) | (6,537 | ) | ||||
| OTHER INCOME (EXPENSES), NET | ||||||||
| Interest expense | (108 | ) | (98 | ) | ||||
| Interest expense – related party | (165 | ) | (208 | ) | ||||
| Change in fair value of debt, other liabilities, and derivatives | 86 | (1,074 | ) | |||||
| Change in fair value of debt, other liabilities, and derivatives – related party | 9 | (2,773 | ) | |||||
| Series B convertible preferred stock financing costs – related party | — | (2,680 | ) | |||||
| Grant income | 181 | 889 | ||||||
| Other income (expense), net | 10 | (16 | ) | |||||
| Total other income (expenses), net | 13 | (5,960 | ) | |||||
| LOSS BEFORE INCOME TAXES | (5,759 | ) | (12,497 | ) | ||||
| Income tax provision | (8 | ) | (4 | ) | ||||
| NET LOSS | $ | (5,767 | ) | $ | (12,501 | ) | ||
| Deemed dividend on warrants | (1,671 | ) | — | |||||
| NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS | $ | (7,438 | ) | $ | (12,501 | ) | ||
| Net loss per share; basic and diluted | $ | (1.40 | ) | $ | (14.24 | ) | ||
| Weighted average common shares outstanding; basic and diluted | 5,328 | 878 | ||||||
FAQ
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