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CEL-SCI (NYSE: CVM) partners with Amarox on Multikine in Saudi Arabia

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Rhea-AI Filing Summary

CEL-SCI Corporation has signed a strategic partnership with Amarox to register, commercialize, and distribute its investigational cancer immunotherapy Multikine for head and neck cancer in Saudi Arabia, with an option to expand into Gulf Cooperation Council countries.

Amarox will lead all Saudi Food and Drug Authority regulatory activities, including seeking Breakthrough Medicine Designation, and will become the exclusive distributor in Saudi Arabia if SFDA approval is granted. Net revenue from Multikine sales in Saudi Arabia will be shared equally on a 50%/50% basis, while CEL-SCI keeps global intellectual property and manufacturing rights. The deal targets a fast-growing Saudi cancer immunotherapy market projected to reach $2.7 billion by 2033 and aligns with Saudi Arabia’s Vision 2030 health initiatives.

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Insights

Strategic Saudi partnership sets a clear potential path to Multikine commercialization.

CEL-SCI has secured Amarox as its regulatory and commercial partner for Multikine in Saudi Arabia. Amarox will manage all SFDA interactions, seek Breakthrough Medicine Designation, and, upon approval, hold exclusive distribution rights, while revenues are split on a 50%/50% net basis.

The agreement keeps Multikine ownership, manufacturing know-how, and global rights with CEL-SCI, limiting structural concessions to shared local economics. It leverages Amarox’s established SFDA track record and oncology focus in a region where immunotherapy is projected to become a $2.7 billion cancer market by 2033.

Actual financial impact depends on achieving SFDA Breakthrough Medicine Designation and subsequent approval, as Multikine remains investigational. Further clarity on regulatory progress, timing, and any GCC expansion terms would likely come from subsequent company communications and future filings.

Saudi immunotherapy market $2.7 billion by 2033 Projected size of Saudi cancer immunotherapy segment
Revenue split 50%/50% net revenue Multikine sales in Saudi Arabia between CEL-SCI and Amarox
Head and neck cancer incidence 900,000 cases per year Newly diagnosed head and neck cancer cases globally
Patients dosed with Multikine Over 740 patients Cumulative Multikine dosing experience referenced
SFDA shortage ranking period 3 consecutive years Amarox ranked #1 in 2022, 2023, 2024
Breakthrough Medicine Designation regulatory
"including seeking the SFDA’s Breakthrough Medicine Designation which, upon granting, would make Multikine rapidly available"
A breakthrough medicine designation is a formal status granted by a drug regulator that signals a new treatment shows substantial promise for a serious condition and qualifies for faster, more intensive review. For investors it matters because the designation can shorten development time, reduce some regulatory hurdles and raise the likelihood of eventual approval, similar to giving a promising product a VIP fast‑track through the approval process which can boost a company’s value and investor interest.
neoadjuvant immunotherapy medical
"potentially making Saudi Arabia the first region in the world to commercialize this neoadjuvant immunotherapy"
Orphan Drug designation regulatory
"received Orphan Drug designation from the FDA for neoadjuvant therapy in patients with squamous cell carcinoma"
Orphan drug designation is a special status given to medicines developed to treat rare diseases affecting only a small number of people. This status often provides benefits like faster approval processes and financial incentives, making it more attractive for companies to develop these drugs. For investors, it signals potential for exclusive market rights and reduced competition, which can impact the drug’s profitability.
Saudi Food and Drug Authority (SFDA) regulatory
"lead all communications with the Saudi Food and Drug Authority (SFDA)"
Saudi Food and Drug Authority (SFDA) is the national regulator that sets and enforces safety and quality rules for food, medicines, medical devices and cosmetics in Saudi Arabia. Its approvals, inspections and rules act like traffic signals for companies — green lights let products be sold and grow revenue, while delays or restrictions can limit market access, affect sales and change a company’s investment risk and value.
Vision 2030 other
"in alignment with Saudi Arabia’s Vision 2030 initiative"
A "Vision 2030" is a publicly stated long-range roadmap that sets goals, reforms and priorities a government or company intends to achieve by the year 2030. For investors it signals the areas likely to receive funding, regulatory change or policy support—like new industries, infrastructure or cost cuts—so it helps spot potential opportunities and risks much like a route map shows which roads will be expanded or closed over the next decade.
Understanding 8-K Material Events →

EXHIBIT 99

 

 

8229 Boone Boulevard, Suite 802

COMPANY CONTACT:

Vienna, Va. 22182 USA

Gavin de Windt

Telephone (703) 506-9460

CEL-SCI Corporation

www.cel-sci.com

(703) 506-9460

 

CEL-SCI Enters Strategic Agreement with Amarox for the Registration, Commercialization, and Distribution of Multikine in Saudi Arabia

 

 

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 50%/50% revenue sharing agreement for Multikine sales in Saudi Arabia upon receipt of Breakthrough Medicine Designation

 

 

 

 

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 Amarox to act as the local regulatory representative and lead all communications with the Saudi Food and Drug Authority (SFDA)

 

 

 

 

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 Amarox ranked #1 for SFDA applications for critical and unavailable medicine for 3 consecutive years

 

 

 

 

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 Amarox to be exclusive commercial distributor of Multikine in Saudi Arabia, upon SFDA approval, with optional expansion to GCC countries

 

 

 

 

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 Immunotherapy is among the fastest-growing segments in the Saudi cancer market, projected to reach $2.7 billion by 2033

 

Vienna, VA, May 11, 2026 -- CEL-SCI Corporation (NYSE American: CVM) today announced it has signed a strategic partnership, distribution, and revenue sharing agreement with Amarox for regulatory affairs, marketing and potential commercialization of *Multikine® (Leukocyte Interleukin, Injection) in the treatment of head and neck cancer in Saudi Arabia, with an optional extension for the Gulf Cooperation Council (GCC) countries including Bahrain, Kuwait, Oman, Qatar, and the United Arab Emirates.

 

Amarox will support and coordinate the local regulatory process with SFDA, including seeking the SFDA’s Breakthrough Medicine Designation which, upon granting, would make Multikine rapidly available to patients in Saudia Arabia, representing a pivotal shift in CEL-SCI’s commercial trajectory.

 

The companies will share net revenue from sales of Multikine in Saudi Arabia on a 50%/50% basis.

 

Upon SFDA approval, Amarox will receive exclusive rights to distribute Multikine for the treatment of head and neck cancer in Saudi Arabia. CEL-SCI retains full ownership of all Multikine intellectual property, manufacturing know-how and global rights.

 

“Our collaboration with Amarox marks a transformative milestone for CEL-SCI as we advance Multikine toward commercialization in Saudi Arabia and potentially throughout the GCC region,” said Geert Kersten, Chief Executive Officer of CEL-SCI. “This agreement establishes an attractive long-term revenue-sharing structure for CEL-SCI and aligns us with one of the region’s most respected pharmaceutical and regulatory organizations.”

 

 
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“Amarox’s excellent track record with the SFDA, combined with its deep commercial infrastructure and oncology expertise, significantly strengthens our ability to bring Multikine to patients in a region prioritizing rapid access to breakthrough cancer therapies. We believe this partnership could position Saudi Arabia as one of the first market globally to commercialize Multikine and represents an important step in CEL-SCI’s broader international commercialization strategy,” Kersten concluded.

 

Dr. Abdullah Alzomaie, Chief Executive Officer of Amarox noted: “Saudi Arabia is rapidly advancing its position as a regional hub for innovative healthcare and advanced therapies. We are pleased to collaborate with CEL-SCI in exploring the regulatory pathway for Multikine and evaluating its potential role in addressing unmet needs in oncology care across Saudi Arabia and the GCC region.”

 

Strong Validation from Leading Regional Oncology Partner

 

Amarox, one of the fastest growing pharmaceutical companies in Saudi Arabia, is engaged in manufacturing, marketing, and supply of best-in-class therapies. The company is expanding its portfolio of oncology products with a special emphasis on serving the unmet and poorly met needs of countries in the Middle East. As one of the most agile and rapidly expanding pharmaceutical companies in Saudi Arabia, Amarox is focused on regulatory excellence, oncology, specialty pharmaceuticals, and innovative therapies across Saudi Arabia and the GCC region. This strategic partnership reflects Amarox’s interest in exploring the regulatory and commercial potential of innovative oncology therapies in the region.

 

Amarox has demonstrated strong engagement with the SFDA to address unmet needs, and ranks #1 for applications in the SFDA’s shortage and unregistered medicines initiative for three consecutive years—2022, 2023, and 2024.

 

Strategic Alignment with Saudi Vision 2030

 

The SFDA Breakthrough Medicine Program, among other accelerated pathways, aims to facilitate and accelerate development and review of new drugs that address unmet medical needs in the treatment of serious or life-threatening conditions in alignment with Saudi Arabia’s Vision 2030 initiative. By targeting this designation, CEL-SCI and Amarox are aligning Multikine with a high-priority national health initiative, potentially making Saudi Arabia the first region in the world to commercialize this neoadjuvant immunotherapy.

 

First Berlin, a leading corporate finance and investment boutique based in Berlin, Germany, specializing in independent research, capital market advisory, and investment banking services for small- and mid-cap companies across various sectors, acted as CEL-SCI’s sole advisor in structuring and executing the strategic partnership with Amarox.

 

About Multikine

 

Multikine is a cancer immunotherapy administered before surgery as a treatment for newly diagnosed previously untreated head and neck cancer. Its goal is to activate a person’s immune system to fight cancer before the ravages of surgery, radiation and chemotherapy have weakened the immune system.

 

 
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About Head and Neck Cancer

 

Head and neck cancer is the 6th most common cancer, with approximately 900,000 newly diagnosed cases per year globally. The newly diagnosed stage 3 and 4 patients with this cancer represent a severe unmet need.

 

About CEL-SCI Corporation

 

CEL-SCI believes that boosting a patient’s immune system before surgery, radiotherapy and chemotherapy have damaged it, 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), given right after diagnosis and before surgery, has been dosed in over 740 patients and received Orphan Drug designation from the FDA for neoadjuvant therapy in patients with squamous cell carcinoma (cancer) of the head and neck.

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, inability to finalize a partnering agreement 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, 2025. 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.

 

 
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Source: View Original Filing on SEC EDGAR

FAQ

What did CEL-SCI (CVM) announce about Multikine in Saudi Arabia?

CEL-SCI announced a strategic partnership with Amarox to pursue registration, commercialization, and distribution of its investigational Multikine immunotherapy in Saudi Arabia. Amarox will handle SFDA regulatory interactions and, upon approval, become exclusive distributor, under a 50%/50% net revenue-sharing structure for Saudi sales.

How will CEL-SCI and Amarox share Multikine revenue in Saudi Arabia?

CEL-SCI and Amarox agreed to split net revenue from Multikine sales in Saudi Arabia on a 50%/50% basis. This profit-sharing model applies if Multikine is approved by the Saudi Food and Drug Authority and commercial sales begin under Amarox’s exclusive distribution rights.

What role will Amarox play in Multikine’s approval process with the SFDA?

Amarox will act as CEL-SCI’s local regulatory representative and lead all communications with the Saudi Food and Drug Authority. Its responsibilities include coordinating the regulatory process and seeking Breakthrough Medicine Designation to potentially speed Multikine’s availability to Saudi patients.

Does the CEL-SCI and Amarox agreement cover countries beyond Saudi Arabia?

The agreement focuses on Saudi Arabia but includes an optional extension to Gulf Cooperation Council countries. These potential territories include Bahrain, Kuwait, Oman, Qatar, and the United Arab Emirates, expanding Multikine’s possible commercial footprint if the collaboration progresses successfully.

How large is the Saudi cancer immunotherapy market CEL-SCI is targeting?

The immunotherapy segment of the Saudi cancer market is projected to reach about $2.7 billion by 2033. CEL-SCI’s partnership with Amarox is aimed at positioning Multikine within this fast-growing category, contingent on successful regulatory review and potential approval by the SFDA.

What is Multikine and for which patients is CEL-SCI developing it?

Multikine is an investigational cancer immunotherapy given before surgery for newly diagnosed head and neck cancer. It aims to stimulate the immune system before surgery, radiation, and chemotherapy weaken it, and has been dosed in over 740 patients, with FDA Orphan Drug designation for this neoadjuvant use.

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