February 20 20 CEL-SCI Corporation Geert Kersten 8229 Boone Boulevard, Suite 802 NYSE American: CVM Chief Executive Offjcer Vienna, VA 22182, USA - Phone: (703) 506-9460
Forward Looking Statements This presentations contains “forward-looking safety profjle and related adverse events of our and uncertainties, the forward-looking events statements” within the meaning of the Private product candidates; our ability to manufacture and circumstances described in this presentation Securities Litigation Reform Act of 1995, Section suffjcient amounts of Multikine or our other may not occur and actual results could differ 27A of the Securities Act of 1933, as amended, product candidates for use in our clinical studies materially from those anticipated or implied in and Section 21E of the Securities Exchange Act or, if approved, for commercialization activities such forward-looking statements. Accordingly, of 1934, as amended. You can generally identify following such regulatory approvals; our plans you are cautioned not to place undue reliance on these forward-looking statements by forward- with respect to collaborations and licenses these forward-looking statements. looking words such as “anticipates,” “believes,” related to the development, manufacture or sale “expects,” “intends,” “future,” “could,” “estimates,” of our product candidates; our expectations as “plans,” “would,” “should,” “potential,” “continues” to future fjnancial performance, expense levels and similar words or expressions (as well as and liquidity sources; our ability to compete with other words or expressions referencing future other companies that are or may be developing events, conditions or circumstances). These or selling products that are competitive with forward-looking statements involve risks, our product candidates; anticipated trends uncertainties and other important factors that and challenges in our potential markets; and may cause our actual results, performance or our ability to attract, retain and motivate key achievements to be materially different from any personnel. future results, performance or achievements expressed or implied by such forward-looking All forward-looking statements contained herein statements, including, but not limited to: the are expressly qualifjed in their entirety by this progress and timing of, and the amount of cautionary statement, the risk factors set forth expenses associated with, our research, under the heading “Risk Factors” and elsewhere development and commercialization activities for in our public fjlings, and in the documents our product candidates, including Multikine; the incorporated or deemed to be incorporated by success of our clinical studies for our product reference therein. The forward-looking statement candidates; our ability to obtain U.S. and foreign contained in this presentation speak only as regulatory approval for our product candidates of their respective dates. Except to the extent and the ability of our product candidates to required by applicable laws and regulations, meet existing or future regulatory standards; our we undertake no obligation to update these expectations regarding federal, state and foreign forward-looking statements to refmect new regulatory requirements; the therapeutic benefjts information, events or circumstances after the and effectiveness of our product candidates; the date of this presentation. In light of these risks 2
FDA Disclaimer Statement Multikine is the trademark that CEL-SCI has Potential conclusions could only be drawn registered for this investigational therapy, if the initial observations in the early-phase and this proprietary name is subject to FDA studies relating to the potential adverse events review in connection with our future anticipated associated with Multikine administration in regulatory submission for approval. Multikine treating head and neck cancer are confjrmed has not been licensed or approved for sale, in the well controlled Multikine Phase 3 clinical barter or exchange by the FDA or any other study, CEL-SCI’s Phase 3 study is completed regulatory agency. Similarly, its safety or successfully, and the FDA licenses the product effjcacy has not been established for any use. following their review of all of the data related Moreover, no defjnitive conclusions can be to Multikine submitted in CEL-SCI’s license drawn from the early-phase, clinical-trials data application. summarized in this presentation involving the investigational therapy Multikine (Leukocyte Interleukin, Injection). Further research is required, and early-phase clinical trial results must be confjrmed in the well-controlled Phase 3 clinical trial of this investigational therapy that is currently in progress. Each page of this presentation must be looked at in the context of the whole presentation, not by itself, and is merely meant to be a summary of the full and detailed information on the Company in its public fjlings and its website. 3
Creating the World’s First Cancer Immunotherapy Drug to Be Administered Before Surgery Micrometastases around the tumor and in the lymph nodes are a major cause of cancer recurrence. Cancer treatment today involves aggressive surgery, including the removal of the tongue, because of the fear that tumor micrometastases will survive the first round of cancer treatments and cause tumor recurrence. Radiation or radiochemotherapy are often given after surgery to kill left over micrometastases, but … it does not always work. We believe that the patient’s own immune system, if activated while it is still strong (before surgery, radiation and chemotherapy), has the capacity to both find and kill these tumor micrometastases. Therefore, the combination of our immunotherapy drug Multikine with surgery plus radiation/chemotherapy should be more successful in eliminating all of the tumor cells than the current standard therapies of surgery plus radiation/chemotherapy, alone. This is a simple concept that we aim to prove correct in head and neck cancer. Phase III results are due soon. 4
Phase 3 Study Design -Timing of Multikine Treatment Regimen Advanced Primary Head and Neck Cancer Current 1 st Line SOC* 4 weeks Radiotherapy Usual Drug Development Path Focuses or Chemo / Radiotherapy on Recurrent Cancer Surgery Diagnosis Multikine Treatment Key t ruda (3 weeks) Proposed New 1st Line SOC* (upon Phase 3 success) * Standard of Care 5
Multikine Treatment 3 Weeks Before Surgery Aims to Cure Cancer or Increase Time to Recurrence Multikine is administered to previously untreated, newly diagnosed head and neck cancer patients right after diagnosis for three weeks before the current standard of care treatments (surgery followed by radiation or combined radio-chemotherapy). There is no delay of surgery or follow on standard of care treatments. The intent of adding Multikine treatment to the current standard of care treatment regimen is to either cure the patient or increase the time to recurrence of the patient’s cancer since there is a known correlation between increased time to recurrence and increased survival of patients. No severe toxicity was reported as being associated with Multikine when it was added to the current standard of care in Phase 2 clinical trials. Our experience in our Phase 3 study with respect to toxicity has paralleled what was seen during the Phase 2 studies. The most common misconception with respect to the use of Multikine is that it is in competition with all of the FDA approved immunotherapies (e.g., Keytruda, Opdivo, CAR-T, and many more) that have been recently in the news. In contrast to Multikine, these other immunotherapies are indicated only for patients whose cancers have recurred following standard of care treatment (surgery etc.) or those patients with metastatic cancer where surgery is no longer an option. The use of these other cancer immunotherapies in the patient population being treated with Multikine would be inappropriate and unethical because they are administered over many months, which would cause a delay in the application of the currently used standard of care treatment which is potentially curative on its own. Further, the extreme toxicities that may be associated with these new products would preclude their use in patients that are potentially curable by the current standard of care. We are at the end of an over nine year Phase 3 clinical trial to prove this novel way of treating cancer. 6
Equity Summary CEL-SCI Corporation NYSE American: CVM Clinical Trial Stage Phase 3 cancer immunotherapy and early stage rheumatoid arthritis vaccine Market Capitalization Approximately $ 60 0 million Trading Volume Approximately 830 ,000 shares per day (last 90 days) Shares Outstanding Approximately 36. 5 million shares Share Price Approximately $ 1 6.50 Share based information as of February 14, 2020 7
Product Candidates Candidate Preclinical Phase 1 Phase 2 Phase 3 Marketing approval MULTIKINE Head and neck cancer Neoadjuvant therapy in patients with squamous cell carcinoma of the head and neck (administered right after diagnosis, before the fjrst standard cancer treatment) – Global Pivotal Phase 3 Study HPV Cervical dysplasia in HIV/HPV co-infected patients (University of Maryland) L.E.A.P.S. Technology Rheumatoid Arthritis CEL-2000: Phase 1 enabling Studies CEL-4000 (NIH Grant) Pandemic Flu treatment: (NIAID) Breast Cancer 8
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