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CEL-SCI Corporation:
Strong Speculative Buy Recommendation
with the potential of
extra-ordinary capital appreciation

CEL-SCI Corporation (CVM: $1.80) – Strong Speculative Buy Recommendation with the potential of extra-ordinary capital appreciation:

CVM is a Phase 3 Cancer immunotherapy company. The Phase 3 study is fully enrolled with 928 patients. The company believes it is most logical to boost the patient's immune system while it is still intact in order to have the greatest possible impact on survival.

Therefore, CVM treats patients who are newly diagnosed with head and neck cancer with its lead investigational immunotherapy Multikine (leukocyte Interleukin, Injection), before they have received surgery, radiation and/or chemotherapy. Head and neck cancer represents about 6% of all cancers. Multikine has received Orphan Drug designation from the FDA for the treatment of head and neck cancer patients with advanced squamous cell carcinoma. The company has received patents for Multikine from the US, Europe, China and Japan.

Head and neck squamous cell carcinoma (HNSCC) accounts for 63,000 new diagnosis annually within the United States (630,000 worldwide). HNSCC is a disease with high unmet medical needs and a prognosis of 5 year survival is due to late diagnosis and limited therapeutic options.

CANCER IMMUNOTHERAPIES, have enormous potential
and have captured close to 50% of the overall oncology drug market.

Multikineis is a first-line and novel immunotherapeutic approach to advanced primary HNSCC that boost/enhance the anti-tumor responses of the immune system prior to standard of care regimen.

The Phase 3 head and neck cancer study's Independent Data Monitoring Committee completed a review of the data from all 928 patients enrolled in the study and recommended continuing as constituted, as there was no evidence of any significant safety questions. It was determined that CVM Phase 3 head and neck study is fully enrolled. All 928 patients are now being followed per the protocol. The primary endpoint of the study, a 10% improvement in overall survival of the Multikine treatment regimen plus Standard of Care (SOC) vs. SOC alone, will be determined after a total of 298 deaths have occurred in these two main comparator arms of the study and have been recorded in the database. All that remains to be done in this pivotal Phase study is to continue to track patient survival until the primary endpoint has been met. It has been estimated that this will happen during the first half of 2019 when the survival rate can reached.

Multikine immmunotherapy is designed for use as first-line therapy in primary advanced HNSCC to promote and enhance the anti-tumor responses of the immune system prior to other SOC regimen (i.e. surgery, radiation and chemotherapy). Multikine helps the immune system recognize the tumor at a time when the immune system is still relatively intact and thereby better able to exert anti-tumor responses.

There is a current arbitration against “Company “X” that originally ran the clinical test and is being sued due to alleged incompetence. The determination of award is anticipated by the end of the 2nd Quarter of 2018 and the company is suing in excess of $50+ million. This would equal at least $3 dollars in cash/sh. It could easily be twice that amount.

A second drug candidate is the L.EA.P.S. (Ligand Epitope Antigen Presentation System) technology composed of: LEAPS-H1N1-DC, a product candidate under development for the potential treatment of pandemic influenza in hospitalized patients, and CEL-4000, a vaccine product candidate under development for the potential treatment of rheumatoid arthritis. The usual and customary road traveled by many junior biotech companies is to raise money and then raise additional funds as the Phase of trials head toward success. Once a level of success has been reached the large biotech enters the picture with a partnership that supplies cash or buys the company.

During the next few weeks the company will enter into the final closing arguments concerning a lawsuit with “Company “X”. CVM has demands of $50+ million because mismanaged and poor execution of their Phase 3 trial concerning their drug, “Multikine”. The anticipated positive results for the company would be a much needed cash infusion.

Phase 3 companies are being sold for billions of dollars and CVM's Phase 3 trial only presents shareholders with a market-cap of less than $32 million! Getting to Phase 3 is not an easy accomplishment to say the least! During the 1st half of 2019 CVM should complete the current phase and if it shows the resulted needed to proceed it is very possible that someone will come along and buy the company out for $3-4 billion or $100.00 and $130.00/sh!

We have a stock that is currently trading at $1.80 and in reality a moonshot on the launchpad! The real risk could be not owning a position in CVM at current levels. We have placed a strong speculative buy recommendation for short and long capital appreciation. The upside potential in our opinion outweighs the downside risk.

Editor’s Note: The complete recommendation can be read here.
CVM phone number 703 506 9460 • website: http://www.cel-sci.com

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