CEL-SCI Appoints Robert Watson as Chairperson of the Board

Rhea-AI Summary

CEL-SCI (NYSE American: CVM) has appointed Robert Watson as Chairperson of the Board. Watson, who joined the board in 2017, has an extensive background in the healthcare sector, particularly in capital formation and partnerships. He has facilitated over $750 million in transactions throughout his career.

Watson's appointment comes at a pivotal moment for CEL-SCI, as the company prepares for a confirmatory Registration Study for its immunotherapy drug, Multikine. The FDA approved this study based on positive efficacy and safety data from over 750 patients. Multikine showed a 73% survival rate compared to 45% in the control group at five years post-treatment.

The forthcoming study will enroll 212 patients with advanced primary head and neck cancer, a condition impacting an estimated 100,000 patients annually. Watson expressed confidence in confirming the drug’s efficacy and safety, emphasizing his commitment to CEL-SCI’s mission.

Positive

• Appointment of Robert Watson, an experienced leader with a solid track record in capital formation.
• FDA approval for a confirmatory Registration Study for Multikine based on strong efficacy and safety data.
• Multikine demonstrated a 73% survival rate at five years in advanced primary head and neck cancer patients.

Negative

• Upcoming Registration Study might add additional costs and operational challenges.
• Enrollment of only 212 patients may raise concerns over the study's statistical power and broader applicability.

VIENNA, Va.--(BUSINESS WIRE)-- CEL-SCI Corporation (NYSE American: CVM) today announced that Robert (“Bob”) Watson, who has served as a Director of the Company since 2017, has been appointed Chairperson of the Board.

Bob is an accomplished business leader who began his career as an investment banker. With over four decades of experience across various healthcare markets, Bob brings extensive expertise in capital formation strategies and partnerships to drive an efficient capital structure. During his career as CEO or President of private and publicly traded companies in the healthcare sector, Bob negotiated over a half dozen exits and more than $750 million in capital transactions including IPOs, secondary offerings, and debt instruments.

“I have greatly appreciated Bob’s guidance as a Director of CEL-SCI. His recent retirement from an active CEO role created the bandwidth for him to assume additional responsibilities as our Chairperson. The team and I are excited to have Bob involved at this level where his capital markets expertise will be highly valuable,” stated CEL-SCI CEO Geert Kersten.

Based on robust efficacy and safety data in over 750 patients for its immunotherapy drug, Multikine, CEL-SCI received the U.S. Food and Drug Administration’s go-ahead to conduct a confirmatory Registration Study for the treatment of newly diagnosed advanced primary head and neck cancer. Multikine, a true first-line cancer therapy, significantly extended life in its target patient population demonstrating a 73% survival rate with Multikine vs. only 45% without at 5 years after treatment. The small, focused, confirmatory Registration Study will enroll only 212 patients with a high unmet need for an estimated 100,000 patients annually.

Bob Watson commented, “Having been on the path with CEL-SCI toward FDA approval of Multikine, it is my honor to be able to stand side by side with the management team as we complete the final leg of this amazing journey to bring a pre-surgical immunotherapy to patients with head and neck cancer. As stated previously, we are very confident that the Registration Study will confirm the excellent safety and efficacy results demonstrated in prior studies.”

About CEL-SCI Corporation

CEL-SCI believes that boosting a patient’s immune system while it is still intact should provide the greatest possible impact on survival. Multikine is designed to help the immune system "target" the tumor at a time when the immune system is still relatively intact and thereby thought to be better able to mount an attack on the tumor.

Multikine (Leukocyte Interleukin, Injection), a true first-line cancer therapy, has been dosed in over 750 patients and received Orphan Drug designation from the FDA for neoadjuvant therapy in patients with squamous cell carcinoma (cancer) of the head and neck. Multikine significantly extended life in its target patient population demonstrating a 73% survival rate with Multikine vs. only 45% without at 5 years after treatment. Based on this very strong data, the FDA agreed to CEL-SCI’s target patient selection criteria and gave the go-ahead to conduct a small, focused, confirmatory Registration Study which will enroll 212 patients. CEL-SCI will enroll newly diagnosed advanced primary head and neck cancer patients with no lymph node involvement (determined via PET scan) and with low PD-L1 tumor expression (determined via biopsy), representing over 100,000 patients annually.

The Company has operations in Vienna, Virginia, and near/in Baltimore, Maryland.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. When used in this press release, the words "intends," "believes," "anticipated," "plans" and "expects," and similar expressions, are intended to identify forward-looking statements. Such statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected. Factors that could cause or contribute to such differences include an inability to duplicate the clinical results demonstrated in clinical studies, timely development of any potential products that can be shown to be safe and effective, receiving necessary regulatory approvals, difficulties in manufacturing any of the Company's potential products, inability to raise the necessary capital and the risk factors set forth from time to time in CEL-SCI's filings with the Securities and Exchange Commission, including but not limited to its report on Form 10-K for the year ended September 30, 2023. The Company undertakes no obligation to publicly release the result of any revision to these forward-looking statements which may be made to reflect the events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.

* Multikine (Leukocyte Interleukin, Injection) is the trademark that CEL-SCI has registered for this investigational therapy. This proprietary name is subject to FDA review in connection with the Company's future anticipated regulatory submission for approval. Multikine has not been licensed or approved for sale, barter or exchange by the FDA or any other regulatory agency. Similarly, its safety or efficacy has not been established for any use.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240708501317/en/

Gavin de Windt

CEL-SCI Corporation

(703) 506-9460

Source: CEL-SCI Corporation

FAQ

What is the significance of Robert Watson’s appointment as Chairperson of CEL-SCI?

Robert Watson brings over four decades of experience in healthcare markets, particularly in capital formation and partnerships, which is expected to strengthen CEL-SCI’s leadership and financial strategies.

How will Robert Watson’s leadership impact CEL-SCI?

Watson’s expertise in capital formation and his experience in healthcare could help CEL-SCI secure better financial deals and partnerships, potentially enhancing the company's capital structure.

What are the expected outcomes of CEL-SCI's confirmatory Registration Study for Multikine?

The study aims to confirm Multikine’s efficacy and safety for treating newly diagnosed advanced primary head and neck cancer, following a previous study showing a 73% survival rate compared to 45% without the drug after five years.

When did CEL-SCI receive FDA approval for the Multikine confirmatory Registration Study?

CEL-SCI received FDA approval for the confirmatory Registration Study based on robust efficacy and safety data from over 750 patients.

What is the scope of CEL-SCI’s upcoming confirmatory Registration Study for Multikine?

The study will enroll 212 patients with advanced primary head and neck cancer, a condition affecting approximately 100,000 patients annually.