Bullish options flow was detected in CVM stock on January 17, 2020.

I would watch that bearish PUT options flow though as the order was large. To trade this, we recommend the 30-minute time frame.

CVM stock in the 30-minute time frame.

The gold line marks the low we would not want to see the stock drop below because in a continuation pattern, we expect the stock to continue to form higher lows marked with red-dotted lines. If CVM stock breaks below the gold line and falls back down to the red-dotted line or below, the continuation pattern of higher lows would be violated. The reason we are being so tough on this stock is because of the large PUT order detected on January 17, 2020. If the stock is going to fall, we’d rather wait to take an entry at a lower price.

On January 13, 2020, H.C. Wainwright analyst Vernon Bernardino initiated coverage of CEL-SCI with a Buy rating and $18 price target. The analyst is bullish on the shares based on the potential for lead product Multikine to be the first neoadjuvant cancer drug to improve survival in head and neck cancer patients by its administration prior to surgery and initiation of conventional treatment, and the Independent Data Monitoring Committee’s recommendation for advancement of the ongoing Phase 3 clinical trial that he believes suggests a favorable outcome in Multikine-treated patients.

On December 16, 2019, CEL-SCI Corporation (NYSE American: CVM) reported key clinical and corporate developments achieved during fiscal 2019.

Clinical and Corporate Developments included:

  • In March and October 2019, the Independent Data Monitoring Committee (IDMC) for the Company’s pivotal Phase 3 head and neck cancer study of its investigational immunotherapy Multikine* (Leukocyte Interleukin, Injection) had an official review of the study data and recommended that the trial continue until the appropriate number of events has occurred. The data from all 928 enrolled patients were provided to the IDMC by the clinical research organization (CRO) responsible for data management of this Phase 3 study. At the most recent IDMC meeting in October 2019 the IDMC reviewed “progression free and overall survival and limited demographic and safety data available for the aforementioned protocol.”
  • CEL-SCI is now awaiting final study results in its Phase 3 head and neck cancer trial. All that remains to be done in this pivotal Phase 3 study, the largest in the world in head and neck cancer, is to continue to track patient survival until it can be determined if 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 met. The primary endpoint will be determined after a total of 298 events (deaths) have occurred in the two main comparator arms of the study and have been recorded in the study database. These final results could be available soon, since the last cancer patients were treated in September 2016, and the first cancer patients in the study were treated in early 2011.
  • On May 11, 2019 and July 3, 2019, new data were presented on CEL-SCI’s experimental LEAPS therapeutic antigen-specific treatment for rheumatoid arthritis. The work was performed in conjunction with researchers at Rush University Medical Center, Chicago, Illinois. In June 2019, CEL-SCI was also an exhibitor and showcased its presentation at the BIO International Convention where it was selected to be part of the Innovation Zone sponsored by the U.S. National Institutes of Health (NIH). The focus was the Company’s experimental LEAPS platform technology and CEL-SCI’s ongoing development of a LEAPS based therapeutic antigen-specific treatment for rheumatoid arthritis.
  • The U.S. Patent and Trademark Office granted CEL-SCI two patents for its LEAPS technology during fiscal 2019. As announced in January 2019, the patents relate to methods for diagnosing, preventing, and treating disease by generating or modulating the immune response through the use of specific peptides.
  • Two scientific articles regarding CEL-SCI’s LEAPS program were published in March and July 2019. The Journal of Clinical & Cellular Immunology published “Why Don’t We Have a Vaccine Against Autoimmune Diseases?” co-written by Dr. Ken Rosenthal of Roseman University College of Medicine, and CEL-SCI’s Roy Carambula, Research Associate and Daniel Zimmerman Ph.D., Senior Vice President of Cellular Immunology. International Immunopharmacology published “Lessons From Next Generation Influenza Vaccines For Inflammatory Disease Therapies” authored by Dr. Zimmerman and two other CEL-SCI scientists, along with Dr. Rosenthal of Northeast Ohio Medical University and Roseman University.
  • On June 28, 2019, CEL-SCI joined the broad-market Russell 3000® Index that was effective after the US market opened on July 1, 2019.
  • CEL-SCI raised approximately $14.5 million during fiscal 2019 through the exercise of warrants.

“Following the two most recent data reviews of our Phase 3 head and neck cancer trial, the Independent Data Monitoring Committee (IDMC) recommended we continue the study until the appropriate number of events (deaths) have occurred in the two main groups. We found this recommendation very encouraging because it has been almost nine years since our study started, and more patients in our trial are surviving longer than had been anticipated,” stated CEL-SCI CEO, Geert Kersten.

“Since CEL-SCI is blinded to the study results, we do not know what proportion of the patients who are living longer than expected were treated with the Multikine regimen and what proportion received Standard of Care. However, it seems reasonable that a significant proportion of the patients who are living longer than predicted would have received the Multikine regimen because, to our knowledge, there has been no reported improvement in survival of the Standard of Care patients since our study began. We also believe the IDMC would not have recommended that we continue with this Phase 3 study if, after review of the clinical data, they had not seen that Multikine helps these cancer patients.”

“The goal of our Phase 3 study is to keep patients alive longer by improving the current ‘intent to cure’ first line cancer treatment. We believe the delay in reaching the required number of events, 298, to conclude our study may be a predictor of a better overall survival outcome than we originally hypothesized. Yervoy, the first approved cancer immunotherapy blockbuster drug had a similar situation in its Phase 3 trial and this turned out to be a huge blessing for both patients and Bristol-Myers Squibb shareholders. At CEL-SCI, we are hoping for a similar outcome,” Kersten concluded.

finviz dynamic chart for  cvm

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