• View the letter: Click Here

VIENNA, Va. / Oct 30, 2023 / Business Wire / CEL-SCI Corporation (NYSE American: CVM) today released a letter to shareholders from the Company’s CEO, Geert Kersten. The very comprehensive letter details the data reported on the efficacy of Multikine (Leukocyte Interleukin, Injection)* in the head and neck cancer target patient population as well as CEL-SCI’s plan to file for immediate regulatory approval. The shareholder letter can be read in full on the Company’s website (https://cel-sci.com/) or by clicking HERE.

Below is the letter’s introduction:

Dear Shareholders

This shareholder letter will be longer and much more detailed than prior letters. My goal is to show you the clinical data supporting Multikine’s survival benefits, explain how we identified the target population of head and neck cancer patients who should receive Multikine, and describe our efforts with the world’s leading regulatory bodies to bring Multikine to market as quickly as possible.

Why are we confident that Multikine should be approved as soon as possible? First, we can clearly identify patients who should get Multikine. Second, Multikine definitely benefits patients by causing pre-surgical responses. Third, the Multikine survival benefit in the target population is outstanding. Fourth, as a statistical matter, another trial is more than 95% likely to be successful and therefore should not be necessary for approval. Fifth, there are regulatory pathways specifically designed for our situation where the target population is selected from the larger Phase 3 study population. We believe that we meet these factors with strong evidentiary support and are eager to move forward.

A Well-Defined Target Population

Last week at the European Society for Medical Oncology (ESMO) conference—the most important annual European cancer conference—we presented new data on Multikine’s efficacy that is far superior to the results we presented last year. We accomplished this by focusing our target population on patients mostly to have pre-surgical responses to Multikine. We identified these patients based on the clinical data, cellular analysis, and advice from regulators and top consultants, including two of the most respected head and neck immuno-oncologists in the world. This is a huge achievement, because it means Multikine patients can be identified upon diagnosis with tests that physicians routinely use in cancer screenings. In addition, we can now meet a critical regulatory requirement: the writing of an approval label for Multikine.

Multikine Undeniably Helps Patients, Period.

Certain facts about Multikine cannot be denied. First, Multikine leads to pre-surgical responses, meaning that Multikine’s benefits become immediately apparent for many within just a few weeks of treatment. Second, if you have a pre-surgical response, then your survival is greatly improved. Therefore, we know that Multikine improves survival for those with pre-surgical responses. I will show you the data that proves this to be true.

The Clinical Data Is Outstanding

By way of summary, Phase 3 patients in the finalized target population saw the following:

• risk of death cut in half at five years versus the control;
• 28.6% absolute 5-year overall survival benefit versus control (p=0.0015);
• 0.349 hazard ratio vs control (95% CIs [0.18, 0.66], Wald p=0.0012);
• >35% rate of pre-surgery tumor reductions and/or downstages (p<0.01); and
• low PD-L1 tumor expression (vs high PD-L1 where Keytruda and Opdivo work best).

CEL-SCI Has All The Ingredients For Approval

We can identify at diagnosis the patients most likely to have pre-surgical responses to Multikine. The survival statistics in this target population are so good that it is hard to imagine how they could be challenged or ignored. Multikine’s safety profile is very favorable compared to other oncology agents. And, we have a manufacturing plant that can make an estimated $2 billion worth of Multikine annually.

CEL-SCI is ready—and we believe patients and doctors are, too. A new drug for our targeted disease (previously-untreated locally advanced primary resectable squamous cell carcinoma of the head and neck) has not been approved by FDA in decades. The current standard of care provides only a 50-50 chance of living past five years. Large companies have tried and failed to improve this figure. Patients desperately need better treatments.

We now have the ingredients for delivering results to investors as well. While the biotech stock market always has its ups and downs, and has been dismal lately, the clinical data will stand firm and drive the final success for CEL-SCI. We have presented our new data to regulators in Europe and the UK. Canada and the United States (FDA) have not yet seen these data, and we plan to present to them in the next quarter.

CEL-SCI plans to seek approval for immediate patient access to Multikine without waiting on the results of a new trial wherever possible. There are regulatory pathways specifically designed for such approvals that CEL-SCI is pursuing worldwide. These pathways are called “conditional approvals” (or, in the U.S., accelerated approval) which means you can be approved first while a confirmatory study is ongoing and before that study is completed. Our situation—where we have selected a portion of the Phase 3 study for our target population—is precisely why these regulatory pathways were adopted by regulatory bodies, so that patients do not need to wait many years before gaining access to promising drugs that have already been shown to provide clinical benefit.

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 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). This approach is called neo-adjuvant. Most other cancer immunotherapies are administered only after conventional therapies have been tried and/or failed. 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.

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. CEL-SCI has completed a 928 patient Phase 3 clinical trial in locally advanced primary head and neck cancer patients.

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.