VIENNA, Va. / Aug 11, 2023 / Business Wire / CEL-SCI Corporation (NYSE American: CVM) today reported financial results for the quarter ended June 30, 2023, as well as key clinical and corporate developments.

Clinical and Corporate Developments this quarter include:

• CEL-SCI had a productive pre-submission meeting with Canada’s regulator, Health Canada, to determine the best regulatory path toward market approval. Health Canada advised CEL-SCI to request advance consideration for approval under a Notice of Compliance with Conditions (NOCC) policy which facilitates earlier access for physicians and patients to promising new drugs for patients suffering from serious, life-threatening, or severely debilitating diseases. CEL-SCI is preparing an application for the NOCC approval as suggested and plans to file it by early next year. If Health Canada grants the NOCC, then it is possible that CEL-SCI could begin commercialization in 2024.
• Europe is a priority market for CEL-SCI, as Europe has more than twice the number of head and neck cancer cases diagnosed each year as compared to the United States (US). CEL-SCI is seeking conditional marketing authorization for Multikine in Europe. Based on the published guidelines, the Company believes it meets the requirements for conditional approval of Multikine and has plans for meetings with regulators in the fall.
• CEL-SCI had a collaborative and positive meeting with the U.S. Food and Drug Administration (FDA). The FDA acknowledged the great need for improved treatments for head and neck cancer, particularly the locally advanced oral cavity that CEL-SCI is targeting and is open to close collaboration with CEL-SCI to help demonstrate that Multikine could fill this need. Preliminary feedback from the FDA included that the selection criteria developed by CEL-SCI from its Phase 3 data could be used to determine which locally advanced oral cavity cancer patients might benefit from Multikine treatment. CEL-SCI is preparing additional information about its Multikine development plan for a follow-up meeting with the FDA based on this feedback. A confirmatory clinical trial will be conducted based on the agreed upon selection criteria for patients that will be treated with Multikine as assessed by methods including PET-CT/MRI screening. CEL-SCI will collaborate closely with the FDA on the design of a clinical protocol that will allow the Company to generate, as expeditiously as possible, the confirmatory data they will require for approval of Multikine in the US. Importantly, this study is also expected to have intermediate endpoints during study enrollment for potential accelerated approval based on interim results.
• Potentially quite impactful PD-L1 biomarker data from CEL-SCI’s Phase 3 study was presented at the American Head and Neck Cancer Society’s 11^th Annual International Conference on Head and Neck Cancer titled “Tumor cell PD-L1 biomarker confirms Leukocyte Interleukin Injection (LI) treatment (Tx) survival outcome advantage in naïve locally advanced primary head & neck squamous cell carcinoma (SCCHN), the IT-MATTERS Study”. The data demonstrated that the tumors of patients who responded best to Multikine in the Phase 3 study had low levels of the PD-L1 biomarker. Currently approved checkpoint inhibitors (Keytruda and Opdivo) which are indicated for treatment of unresectable or recurrent or metastatic head and neck cancer are known to work best in patients whose tumors express high PD-L1 levels and are less likely to work in patients whose tumors express low PD-L1. These contrasting PD-L1 data observed in patients responsive to Multikine vs those observed in patients treated with checkpoint inhibitors are very significant.

The data are expected to be helpful in key ways:

• Supporting marketing approval by using PD-L1 as a marker to select patients who are most likely to benefit from Multikine

• Positioning Multikine as a combination therapy with checkpoint inhibitors

• Combination studies may be conducted in partnership with a larger pharma company that has an approved PD-L1 checkpoint inhibitor

• Should combination studies with checkpoint inhibitors be successful not only would patients benefit substantially, but the financial benefits to CEL-SCI could be very large

• The global PD-L1/PD-1 therapeutics market was valued at $34.8 billion in 2022

• Data presented at the European Society for Radiotherapy and Oncology (ESTRO) 2023 Congress in May confirmed that Multikine significantly prolonged overall survival in head and neck cancer. The presentation titled “Histopathology population (HPP) confirms Multikine* [Leukocyte Interleukin Injection (LI)] treatment (Tx) outcome in naïve locally advanced primary head & neck squamous cell carcinoma SCCHN)” provided findings from a histopathology and tumor biomarker analysis of its Phase 3 study that confirmed Multikine-treated subjects had improved 5-year survival, showed improved progression free survival and improved local regional control, and a significantly lowered death rate compared to control subjects who received standard of care alone.

“The growing body of data on the efficacy of Multikine presented at peer-reviewed conferences is highly encouraging as we move forward with regulatory meetings and submissions with the world’s most respected regulators in the world in addition to FDA. The data has also allowed us to define very well the population of patients who have the greatest benefit from Multikine treatment. This is a crucial part of our approval strategy in this unmet medical need as we are aiming for conditional/accelerated approval pathways with multiple regulators,” stated CEL-SCI CEO, Geert Kersten. “We are also excited about the new prospect of developing Multikine in conjunction with a pharma partner as a combination therapy with a checkpoint inhibitor to boost patient outcomes.

Financial Results

CEL-SCI reported a loss per share for the quarter ending June 30, 2023 of $0.19 versus a loss of $0.23 for the quarter of June 30, 2022.

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. Therefore, in the Phase 3 study, CEL-SCI studied patients who were newly diagnosed with locally advanced primary squamous cell carcinoma of the head and neck (oral cavity and soft-palate) with the investigational product Multikine first, BEFORE they received surgery and radiotherapy or surgery plus concurrent radiotherapy and chemotherapy (the current standard of care for these patients). We believe this approach is unique. Most other cancer immunotherapies are administered only after conventional therapies have been tried and/or failed.

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. The Phase 3 study enrolled 928 patients.

Multikine (Leukocyte Interleukin, Injection) 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. Such statements include, but are not limited to, statements about the terms, expected proceeds, use of proceeds and closing of the offering. 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, 2022. 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.