At last check, CEL-SCI Corporation (CVM) shares were down -5.65% to trade at $8.19 in pre-market trading. During Wednesday’s trading session, CEL-SCI stock rose 8.50% to $8.68. CVM stock volume was 7.55 million shares, compared to the one million shares averaged over the past 50 days. In the past week, CVM shares have moved down by -32.35%. The company’s shares have fallen by -37.01% over the last 12 months.
Over the past three months, shares have fallen -46.72%, while over the last six months they fell -30.67%. A total of 40.05 million shares were outstanding as of the end of June, with the market capitalization of CVM standing at $398.67 million. CVM’s stock has been losing ground even after it sent a letter to shareholders clarifying the confusion surrounding one of its studies.
What did CVM write to shareholders?
CEL-SCI believes that encouraging an immune system boost while it is still intact will provide the greatest benefit to a patient. Thus, in the Phase 3 study, CVM used its investigational product Multikine first and BEFORE surgery and radiotherapy, or surgery and concurrent radiotherapy and chemotherapy, for those newly diagnosed with advanced primary squamous cell carcinoma of the head and neck. With its unique approach, CVM stands out from the competition. For patients receiving Multikine plus radiation and surgery, the study demonstrated excellent survival results. The survival benefit was negated when chemotherapy was added.
CEL-SCI sent out a shareholder letter yesterday to clarify some confusion about CVM’s Phase 3 study results announced last week.
Here are some highlights of the letter:
- As a result of CVM’s Multikine immunotherapy, the world’s largest Phase 3 study of newly diagnosed advanced primary head and neck cancer demonstrated a statistically significant survival benefit of 14.1% after receiving surgery and radiotherapy.
- A CVM study involves about 155,000 patients per year and 40% of the total study population.
- CVM noted that there appears to be confusion concerning whether data from one of the 2 potential treatment arms is adequate for approval despite the fact that it shows benefits for its patients.
- As explained by CVM, the protocol stipulated that the analysis for the successful treatment arm must be conducted before the unblinding.
- CVM can use this data to seek FDA approval for its successful treatment.
- This data has been reviewed by CVM and deemed safe, and it knows that it can be used in seeking FDA approval based on this data.
- CVM’s Phase 3 results showed that this treatment arm’s overall survival (OS) benefit was robust and durable for five years, without any safety issues, something that is uncommon for cancer drugs.
- At 5-years, Multikine-treated patients had a 14.1% absolute advantage over the unknown control group in overall survival, according to CVM.
How CVM is planning to move forward?
CEL-SCI (CVM) announced results from a Phase 3 study on June 28, 2021, which showed that Multikine achieved all of the protocol requirements stated in the study protocol in patients receiving surgery and radiation as their standard therapies. CVM will apply for and seek FDA approval to use Multikine in this patient population for the treatment of advanced primary head and neck cancer.
