# EDGAR Filing Document

**Accession Number:** 0000725363
**File Stem:** 0001654954-26-004910
**Filing Date:** 2026-5
**Character Count:** 19754
**Document Hash:** 8522a7f93751675cac0d3b36d38f3340
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001654954-26-004910.hdr.sgml**: 20260514

**ACCESSION NUMBER**: 0001654954-26-004910

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 17

**CONFORMED PERIOD OF REPORT**: 20260511

**ITEM INFORMATION**: Entry into a Material Definitive Agreement

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20260514

**DATE AS OF CHANGE**: 20260514

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** CEL SCI CORP
- **CENTRAL INDEX KEY:** 0000725363
- **STANDARD INDUSTRIAL CLASSIFICATION:** BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836]
- **ORGANIZATION NAME:** 03 Life Sciences
- **EIN:** 840916344
- **STATE OF INCORPORATION:** CO
- **FISCAL YEAR END:** 0930

**FILING VALUES:**
- **FORM TYPE:** 8-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-11889
- **FILM NUMBER:** 26980455

**BUSINESS ADDRESS:**
- **STREET 1:** 8229 BOONE BLVD .
- **STREET 2:** SUITE 802
- **CITY:** VIENNA
- **STATE:** VA
- **ZIP:** 22182
- **BUSINESS PHONE:** 7035069460

**MAIL ADDRESS:**
- **STREET 1:** 8229 BOONE BLVD.
- **STREET 2:** SUITE 802
- **CITY:** VIENNA
- **STATE:** VA
- **ZIP:** 22182

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** INTERLEUKIN 2 INC
- **DATE OF NAME CHANGE:** 19880317

?xml version='1.0' encoding='ASCII'? cvm_8k.htm

**UNITED STATES**

**SECURITIES AND EXCHANGE COMMISSION**

**WASHINGTON, D.C. 20549**

**FORM 8-K**

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the

Securities Exchange Act of 1934

Date of Report (date of earliest event reported): **May 11, 2026**

---

| |
|:---|
| **CEL-SCI CORPORATION** |
| (Exact name of Registrant as specified in its charter) |

---

---

| | | |
|:---|:---|:---|
| **Colorado** | **001-11889** | **84-0916344** |
| (State or other jurisdiction<br>of incorporation) | (Commission<br>File No.) | (IRS Employer<br>Identification No.) |

---

**8229 Boone Blvd. #802**

**<u>Vienna, VA 22182</u>**

(Address of principal executive offices, including Zip Code)

Registrant's telephone number, including area code: **<u>(703) 506-9460</u>**

**<u>N/A</u>**

(Former name or former address if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligations of the registrant under any of the following provisions:

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-14c))

Securities registered pursuant to Section 12(b) of the Act:

---

| | | |
|:---|:---|:---|
| **Title of Each Class** | **Trading Symbol(s)** | **Name of Each Exchange on Which Registered** |
| Common Stock, par value $0.01 per share | CVM | NYSE American |

---

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§203.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§204.12b-2 of this chapter.

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

**Item 1.01 Entry into a Material Definitive Agreement.**

On May 11, 2026 , the Company issued a press release, filed as Exhibit 99, concerning 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.

**Item 9.01 Financial Statements and Exhibits.**

---

| | |
|:---|:---|
| Exhibit No. | Description |
| [10(sss)](cvm_ex10sss.htm) | [Agreement with Amarox](cvm_ex10sss.htm) |
| [99](cvm_ex99.htm) | [Press Release re. Agreement with Amarox](cvm_ex99.htm) |

---

2<br>

**SIGNATURES**

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

Date: May 14, 2026

---

| | |
|:---|:---|
| **CEL-SCI CORPORATION** | **CEL-SCI CORPORATION** |
| By:  | /s/ Geert Kersten |
|  | Geert Kersten |
|  | Chief Executive Officer |

---

3<br>

## Ex-10.Sss

**EXHIBIT 10(sss)**

**DISTRIBUTION AGREEMENT**

This Distribution Agreement ("Agreement") is entered into as of 10th of May 2026 between:

**CEL-SCI Corporation** ("CEL-SCI" or "Manufacturer") located at 8229 Boone Boulevard, Suite 802, Vienna VA 22182, USA

and

**Saudi Amarox Co.** ("Amarox" or "Distributor") a company incorporated under the laws of Saudi Arabia and having registration number 1010461754 and registered office at Aljameah Street, Malaz Quarter, Riyadh, Saudi Arabia 11441

Collectively referred to as the "Parties".

1. PURPOSE

This Agreement defines the collaboration between the Parties for the registration, commercialization, and distribution of the Product "Multikine" in the Territory.

1.1 Upon SFDA approval, Amarox shall have the exclusive right to Distribute the Product and to use CEL-SCI Trademarks and Promotional Materials in the Territory.

1.2 CEL-SCI retains all rights, title, and interest in Product intellectual property, including patents, know-how, and data.

2. TERRITORY

Kingdom of Saudi Arabia (primary), with optional expansion to GCC countries upon mutual agreement.

3. REGULATORY RESPONSIBILITIES

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

3.2 CEL-SCI shall have the right to be consulted and informed on key regulatory matters and may participate in regulatory discussions, subject to Amarox coordination and applicable laws.

3.3 All official communications with SFDA shall be conducted by Amarox.

3.4 CEL-SCI shall provide complete and compliant dossiers, including clinical, quality, and manufacturing data in accordance with SFDA requirements.

4. REVENUE SHARE

The Parties shall share Net Revenue from sales of the Product in the Territory equally, on a 50/50 basis.

Net Revenue means, with respect to the Product and for any Calendar Quarter, an amount equal to the gross Net amounts invoiced and actually collected by Distributor for sales of the Product to Third Parties in the Territory during such Calendar Quarter.

5. COST ALLOCATION

5.1 Notwithstanding any other provision of this Agreement, Amarox's financial obligation shall be strictly limited to 50% of the official SFDA product registration fees only, as set out in Clause 5.2.

For the avoidance of doubt, Amarox shall not bear any other costs, expenses, or financial obligations of any kind related to the Product, including but not limited to clinical studies, bioequivalence studies, pharmacoeconomic studies, market access activities, localization, translation, manufacturing, or any additional regulatory requirements requested by SFDA.

This Clause shall prevail over any conflicting provision in this Agreement

5.2 Amarox financial obligation shall be strictly limited to 50% of the official SFDA product registration fees only.

5.3 CEL-SCI shall bear all other costs, including but not limited to clinical studies, bioequivalence studies, pharmacoeconomic studies, manufacturing requirements, and any additional SFDA data requirements.

5.4 In case of rejection due to dossier deficiencies or regulatory non-compliance attributable to CEL-SCI, CEL-SCI shall fully reimburse Amarox for all incurred costs.

6. PRODUCT APPROVAL & COMMERCIALIZATION

6.1 Upon SFDA approval, Amarox shall act as the exclusive commercial distributor of the Product in the Territory.

6.2 Amarox's responsibilities shall include the marketing, sales, and distribution of the Product in the Territory, in accordance with this Agreement and Applicable Law.

7. PRODUCT LIABILITY & RESPONSIBILITY

7.1 CEL-SCI shall be solely responsible for the Product's quality, manufacturing compliance, and safety.

7.2 Amarox shall not be liable for any defects in the Product, manufacturing issues, or adverse effects arising from the Product, except to the extent caused by Amarox's own acts or omissions.

7.3 CEL-SCI shall indemnify Amarox against claims arising from Product manufacturing defects or quality issues.

7.4 Amarox shall indemnify CEL-SCI against claims arising from Amarox's acts, omissions, or Distribution activities.

8. PHARMACOVIGILANCE

8.1 Amarox shall perform local pharmacovigilance activities in the Territory as required by the SFDA.

8.2 CEL-SCI shall remain responsible for global safety evaluation and scientific integrity.

9. COMMUNICATIONS

9.1 Each Party shall protect the other Party's Confidential Information (including trade secrets and data) for five (5) years after termination or expiration of this Agreement.

9.2 Amarox shall provide CEL-SCI with timely regulatory updates while reasonably assisting CEL-SCI in fulfilling its regulatory communication requirements in the Territory.

9.3 CEL-SCI may participate in key discussions upon prior coordination with Amarox.

9.4 Amarox shall lead all government tenders for the Product in the Territory. Detailed tender procedures to be agreed post-SFDA approval.

10. TERM & TERMINATION

10.1 This Agreement commences on the Effective Date and continues for an initial term of five (5) years from the First Commercial Sale in the Territory (the "Initial Term"), automatically renewing for successive one (1) year periods (each a "Renewal Term) or a Party provides written notice of non-renewal at least ninety (90) days prior to the end of the then-current term. "First Commercial Sale" means the first arm's-length sale of Product to a Third Party by Distributor in the Territory following receipt of Marketing Authorization.

10.2 The Parties agree to negotiate and finalize detailed term and termination provisions in good faith upon SFDA approval of the Product, incorporating the principles of this Agreement.

11. GENERAL

This Agreement reflects a balanced allocation of responsibilities between Amarox and CEL-SCI, to be performed in good faith as a strategic partnership, with clear delineation of regulatory, commercial, cost-sharing, and liability roles as outlined herein.

This Agreement shall be governed by the laws of Singapore.

Date: 07<sup>th</sup> of May 2026

---

| | |
|:---|:---|
| **CEL-SCICORP.** | **AMAROX** |
| /s/ Geert Kersten | /s/ Abdullah Alzomaie |
| Name: Geert Kersten, CEO | Name: Abdullah Alzomaie, CEO |

---

## Ex-99

**EXHIBIT 99**

---

| | |
|:---|:---|
| ![](cvm_ex99img4.jpg) | ![](cvm_ex99img6.jpg) |

---

---

| | |
|:---|:---|
| 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**

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

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

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

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

·  ***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."

"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.

**About Head and Neck Cancer**

Head and neck cancer is the 6<sup>th</sup> 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.*