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Calidi Biotherapeutics Announces Launch of Nova Cell Subsidiary and $3 Million Aggregate Investment from Dr. Ronald Rigor

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Calidi Biotherapeutics (NYSE American: CLDI) has launched a new subsidiary, Nova Cell, Inc., and secured a $3 million investment from Dr. Ronald Rigor. The investment includes $2 million for Nova Cell and $1 million for Calidi's oncology pipeline. Nova Cell will focus on advancing Calidi's Adult Adipose Allogeneic (AAA) stem cell programs for regenerative medicine applications.

Dr. Rigor, a Board-Certified Dermatologist and Stem Cell Therapy expert, joins Calidi's Scientific and Medical Advisory Board. He receives exclusive rights to use AAA stem cells and Calidi's CLD-201 product in the Philippines. Nova Cell aims to tap into the global stem cell therapy market, projected to reach $31.4 billion by 2030. The company plans to begin generating revenue by supplying AAA stem cells to Dr. Rigor's patients in 2025.

Calidi Biotherapeutics (NYSE American: CLDI) ha lanciato una nuova sussidiaria, Nova Cell, Inc., e ha ottenuto un investimento di 3 milioni di dollari da parte del Dott. Ronald Rigor. L'investimento comprende 2 milioni di dollari per Nova Cell e 1 milione di dollari per il pipeline oncologico di Calidi. Nova Cell si concentrerà sul progresso dei programmi di cellule staminali Adult Adipose Allogeneic (AAA) di Calidi per applicazioni di medicina rigenerativa.

Il Dott. Rigor, un dermatologo certificato e esperto in terapia con cellule staminali, si unisce al Comitato Scientifico e Medico di Calidi. Riceve diritti esclusivi per utilizzare le cellule staminali AAA e il prodotto CLD-201 di Calidi nelle Filippine. Nova Cell punta a sfruttare il mercato globale della terapia con cellule staminali, previsto per raggiungere i 31,4 miliardi di dollari entro il 2030. L'azienda prevede di iniziare a generare ricavi fornendo cellule staminali AAA ai pazienti del Dott. Rigor nel 2025.

Calidi Biotherapeutics (NYSE American: CLDI) ha lanzado una nueva subsidiaria, Nova Cell, Inc., y ha asegurado una inversión de 3 millones de dólares por parte del Dr. Ronald Rigor. La inversión incluye 2 millones de dólares para Nova Cell y 1 millón de dólares para el pipeline oncológico de Calidi. Nova Cell se centrará en avanzar en los programas de células madre Adult Adipose Allogeneic (AAA) de Calidi para aplicaciones de medicina regenerativa.

El Dr. Rigor, un dermatólogo certificado y experto en terapia con células madre, se une al Consejo Asesor Científico y Médico de Calidi. Recibe derechos exclusivos para usar células madre AAA y el producto CLD-201 de Calidi en Filipinas. Nova Cell tiene como objetivo aprovechar el mercado global de terapia con células madre, que se proyecta alcanzará los 31,4 mil millones de dólares para 2030. La empresa planea comenzar a generar ingresos suministrando células madre AAA a los pacientes del Dr. Rigor en 2025.

칼리디 바이오테라퓨틱스 (NYSE American: CLDI)가 새로운 자회사 노바 셀, Inc.를 출범시키고, 론 래고르 박사로부터 300만 달러 투자를 확보했습니다. 이 투자는 노바 셀에 200만 달러, 칼리디의 종양학 파이프라인에 100만 달러를 포함합니다. 노바 셀은 칼리디의 성인 지방 이식(allogeneic) 줄기세포 프로그램 (AAA)을 재생의학 응용을 위해 발전시키는 데 집중할 것입니다.

론 래고르 박사는 보드 인증 피부과 의사이자 줄기세포 치료 전문가로, 칼리디의 과학 및 의료 자문 위원회에 합류합니다. 그는 필리핀에서 AAA 줄기세포와 칼리디의 CLD-201 제품을 사용할 수 있는 독점권을 받습니다. 노바 셀은 글로벌 줄기세포 치료 시장에 진출할 계획이며, 이 시장은 2030년까지 314억 달러에 이를 것으로 예상됩니다. 이 회사는 2025년부터 래고르 박사 환자에게 AAA 줄기세포를 공급하여 수익을 창출할 계획입니다.

Calidi Biotherapeutics (NYSE American: CLDI) a lancé une nouvelle filiale, Nova Cell, Inc., et a sécurisé un investissement de 3 millions de dollars de Dr. Ronald Rigor. L'investissement comprend 2 millions de dollars pour Nova Cell et 1 million de dollars pour le pipeline oncologique de Calidi. Nova Cell se concentrera sur la promotion des programmes de cellules souches Adult Adipose Allogeneic (AAA) de Calidi pour des applications en médecine régénérative.

Dr. Rigor, dermatologue certifié et expert en thérapie par cellules souches, rejoint le Conseil Consultatif Scientifique et Médical de Calidi. Il obtient des droits exclusifs pour utiliser les cellules souches AAA et le produit CLD-201 de Calidi aux Philippines. Nova Cell vise à exploiter le marché mondial de la thérapie par cellules souches, qui devrait atteindre 31,4 milliards de dollars d'ici 2030. La société prévoit de commencer à générer des revenus en fournissant des cellules souches AAA aux patients du Dr. Rigor en 2025.

Calidi Biotherapeutics (NYSE American: CLDI) hat eine neue Tochtergesellschaft, Nova Cell, Inc., gegründet und eine 3-Millionen-Dollar-Investition von Dr. Ronald Rigor gesichert. Die Investition umfasst 2 Millionen Dollar für Nova Cell und 1 Million Dollar für Calidis Onkologie-Pipeline. Nova Cell wird sich auf die Weiterentwicklung von Calidis Adult Adipose Allogeneic (AAA) Stammzellprogrammen für regenerative Medizin konzentrieren.

Dr. Rigor, ein von der Behörde anerkannter Dermatologe und Experte für Stammzelltherapien, wird Mitglied des wissenschaftlichen und medizinischen Beratungsgremiums von Calidi. Er erhält exklusive Rechte zur Nutzung von AAA-Stammzellen und Calidis Produkt CLD-201 auf den Philippinen. Nova Cell strebt an, den weltweiten Markt für Stammzelltherapie zu erschließen, der Prognosen zufolge bis 2030 31,4 Milliarden Dollar erreichen wird. Das Unternehmen plant, ab 2025 Einnahmen durch die Versorgung von Dr. Rigors Patienten mit AAA-Stammzellen zu generieren.

Positive
  • Secured $3 million investment from Dr. Ronald Rigor
  • Launched Nova Cell subsidiary to expand into regenerative medicine market
  • Exclusive licensing agreement for AAA stem cells and CLD-201 product in the Philippines
  • Appointment of Dr. Rigor to Scientific and Medical Advisory Board
  • Potential to tap into $31.4 billion global stem cell therapy market by 2030
  • Plans to generate revenue from AAA stem cells supply by 2025
Negative
  • None.

Insights

The launch of Nova Cell and the $3 million investment from Dr. Ronald Rigor represent a significant development for Calidi Biotherapeutics (NYSE American: CLDI). This move could potentially diversify CLDI's revenue streams and expand its market reach. Here's why this news is noteworthy:

  • The $2 million investment in Nova Cell positions CLDI to tap into the rapidly growing stem cell therapy market, projected to reach $31.4 billion by 2030.
  • The additional $1 million investment in CLDI, with favorable terms including discounted stock and warrants, demonstrates investor confidence in the company's oncology pipeline.
  • The exclusive licensing agreement for the Philippines market could open up new revenue opportunities in a growing Asian healthcare market.
  • The partnership with Dr. Rigor, an experienced stem cell therapy expert, adds credibility and potential for accelerated market entry.

However, investors should note that revenue generation from Nova Cell is not expected until 2025, indicating a relatively long runway before potential returns materialize. The success of this venture will largely depend on regulatory approvals and market acceptance of AAA stem cell therapies.

Calidi's expansion into regenerative medicine through Nova Cell is a strategic move that leverages its existing Adult Adipose Allogeneic (AAA) stem cell technology. This diversification could significantly broaden the company's impact in the healthcare sector:

  • The AAA stem cells, originally developed for Calidi's cancer platform CLD-201 (SuperNova), now have potential applications in cosmetics, orthopedics and autoimmune diseases.
  • Calidi's proprietary cell expansion method and specialized media could provide a competitive edge in the stem cell market, potentially offering superior scalability.
  • The appointment of Dr. Rigor to the Scientific and Medical Advisory Board brings valuable expertise in stem cell therapy and could accelerate product development.

However, it's important to recognize that the stem cell therapy field is still evolving, with ongoing debates about efficacy and safety. Regulatory hurdles and potential long-term side effects of stem cell therapies remain concerns that could impact market adoption. The success of Nova Cell will depend on rigorous clinical validation of its AAA stem cell applications beyond oncology.

The launch of Nova Cell and the partnership with Dr. Rigor present an intriguing market opportunity for Calidi Biotherapeutics:

  • The global stem cell therapy market's projected growth to $31.4 billion by 2030 indicates substantial market potential for Nova Cell's offerings.
  • The exclusive license for the Philippines market could serve as a valuable testbed for Calidi's AAA stem cell therapies, potentially leading to broader Asian market expansion.
  • The agreement to develop innovative stem cell-based products like anti-aging creams for the Philippines market could tap into the lucrative cosmeceuticals sector.

However, market success is not guaranteed. Challenges include:

  • Intense competition in the stem cell therapy space from established players and other biotech startups.
  • Potential regulatory hurdles, especially in new markets like the Philippines.
  • Consumer education and acceptance of stem cell-based therapies and products.
The partnership with Dr. Rigor, who runs one of the largest stem cell centers in the Philippines, could provide valuable market insights and accelerate adoption. However, investors should closely monitor Nova Cell's progress in product development and regulatory approvals to gauge its market potential.

SAN DIEGO, July 29, 2024 (GLOBE NEWSWIRE) -- Calidi Biotherapeutics, Inc. (NYSE American: CLDI or “Calidi”), a clinical-stage biotechnology company developing a new generation of targeted antitumor virotherapies, announced a $2 million strategic investment 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. Dr Rigor also invested an additional $1 million into Calidi to further its oncology pipeline of assets.

Dr. Ronald Rigor, an accomplished Board-Certified Dermatologist, Internal Medicine, and Stem Cell Therapy expert with offices in Los Angeles, CA USA and Metro Manila, Philippines (BGC), has taken a significant step to advance regenerative medicine by investing in Calidi’s new Nova Cell subsidiary. The investment comprises of (i) a $1 million dollar subscription agreement to purchase a combination of CLDI common stock at a 10% discount to the closing price on July 22, 2024 and warrants to purchase 600,000 shares of common stock at a 20% premium to the closing price on July 22, 2024; and (ii) a $2 million dollar investment to purchase common stock of Nova Cell. Based on Calidi’s advanced cellular manufacturing process, this investment will unlock the potential of off-the-shelf AAA stem cells. Furthermore, in connection with Dr. Rigor’s investment, Calidi is proud to announce his appointment as a member of its Scientific and Medical Advisory Board.

With reasonable rights of first refusal, Dr. Rigor also receives an exclusive license to purchase and use the AAA stem cell line in the Philippines for regenerative purposes and to administer Calidi’s CLD-201 product (Super Nova platform addressing multiple solid tumors) for clinical investigations or commercial use in the Philippines. Furthermore, with reasonable rights of first refusal, Dr. Rigor has agreed that Nova Cell will be his exclusive technology service provider to develop innovative stem cell-based products, such as anti-aging creams and lotions, for sale in the Philippines.

Calidi started harvesting the AAA stem cells from healthy adult donors five years ago, adhering to FDA guidelines, for its cancer platform, CLD-201 (SuperNova). Today, through its new subsidiary, Nova Cell, the company is now expanding potential uses from oncology to other fields that require regenerative medical applications, such as cosmetics, orthopedics, auto-immune diseases, and various other therapies.

“According to Precedence Research, the global stem cell therapy market is rapidly growing and estimated to reach $14.5 billion in 2024 and grow to $31.4 billion by 2030. Our AAA stem cell technology will have the potential to lead this market. Our proprietary cell expansion method and specialized media, developed by Calidi’s scientists and process development team, will offer significant scalability advantages over other mesenchymal stem cell lines,” said Allan Camaisa, Co-Founder, Chairman, and CEO of Calidi Biotherapeutics. “We are genuinely excited to have Dr. Rigor partner with our team of talented scientists at Nova Cell. Together, we share a common belief that stem cell clinics will be the next frontier in wellness and health, bringing the regenerative properties of AAA stem cells and extending and improving overall quality of life. Nova Cell plans to begin generating revenue by supplying AAA stem cells to Dr. Rigor for his patients in 2025.”

“As the founder of one of the largest and fastest growing stem cell centers in the Philippines, I am delighted to partner with and invest in Nova Cell. This is a fantastic opportunity to provide best-in-class stem cell therapy treatments which could meet a huge unmet need in the Philippines,” said Dr. Ronald Rigor. “We look forward to bringing Nova Cell’s extensive experience in stem cell therapy production to provide innovative therapies to patients and to elevate the health and wellness industry in the Philippines.”

Nova Cell enables Calidi to unlock a valuable asset in AAA stem cells, generating current and future value. Establishing Nova Cell as a new subsidiary will also enhance the strategic focus and resource allocation efficiency for both Calidi, which is dedicated to cancer therapies, and Nova Cell, which concentrates on innovative regenerative treatments and other conditions utilizing stem cells.

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

IR@Calidibio.com


FAQ

What is the new subsidiary launched by Calidi Biotherapeutics (CLDI)?

Calidi Biotherapeutics (CLDI) has launched Nova Cell, Inc., a new subsidiary focused on advancing Adult Adipose Allogeneic (AAA) stem cell programs for regenerative medicine applications.

How much did Dr. Ronald Rigor invest in Calidi Biotherapeutics (CLDI) and Nova Cell?

Dr. Ronald Rigor invested a total of $3 million, with $2 million going to Nova Cell and $1 million to Calidi Biotherapeutics (CLDI) for its oncology pipeline.

What exclusive rights did Dr. Rigor receive from Calidi Biotherapeutics (CLDI)?

Dr. Rigor received exclusive rights to purchase and use AAA stem cells in the Philippines for regenerative purposes and to administer Calidi's CLD-201 product for clinical investigations or commercial use in the Philippines.

When does Nova Cell plan to start generating revenue from AAA stem cells?

Nova Cell plans to begin generating revenue by supplying AAA stem cells to Dr. Rigor's patients in 2025.

What is the projected value of the global stem cell therapy market by 2030, according to Calidi Biotherapeutics (CLDI)?

According to Precedence Research cited by Calidi Biotherapeutics (CLDI), the global stem cell therapy market is projected to reach $31.4 billion by 2030.

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