CVM Cel-Sci Corporation

12.33
-1.02  -8%
Previous Close 13.35
Open 13.15
52 Week Low 6.35
52 Week High 18
Market Cap $476,234,956
Shares 38,624,084
Float 36,965,509
Enterprise Value $509,652,122
Volume 507,576
Av. Daily Volume 529,988
Stock charts supplied by TradingView

Upcoming Catalysts

Drug Stage Catalyst Date
Multikine
Head and Neck cancer
Phase 3
Phase 3
Premium membership is required to view catalyst dates, analyst ratings, earnings dates and cash burn data. Click here to unlock and sign up to a 14-day FREE TRIAL.

Latest News

  1. LEAPS Platform Technology being developed as a therapeutic vaccine for rheumatoid arthritis with support of a NIAMS grant of the NIH

    CEL-SCI Corporation (NYSE:CVM) today announced that the European Patent Office has issued CEL-SCI patent: European Patent 2989121 to be published on October 7, 2020, and titled "Method of Preparation and Composition of Peptide Constructs for Treatment of Rheumatoid Arthritis" for the Company's LEAPS platform technology. CEL-SCI's LEAPS technology relates to peptide constructs which may be useful in the treatment or prevention of autoimmune diseases, particularly rheumatoid arthritis, asthma, allergies, and host versus graft (or graft versus host) rejection.

    "The basic goal of this technology is to 'modulate…

    LEAPS Platform Technology being developed as a therapeutic vaccine for rheumatoid arthritis with support of a NIAMS grant of the NIH

    CEL-SCI Corporation (NYSE:CVM) today announced that the European Patent Office has issued CEL-SCI patent: European Patent 2989121 to be published on October 7, 2020, and titled "Method of Preparation and Composition of Peptide Constructs for Treatment of Rheumatoid Arthritis" for the Company's LEAPS platform technology. CEL-SCI's LEAPS technology relates to peptide constructs which may be useful in the treatment or prevention of autoimmune diseases, particularly rheumatoid arthritis, asthma, allergies, and host versus graft (or graft versus host) rejection.

    "The basic goal of this technology is to 'modulate' the immune system of a patient with Rheumatoid Arthritis, and other autoimmune diseases, away from the body attacking itself to a more normal immune response where the body does not attack itself. This should result in a decrease or elimination of the symptoms of the disease. We are in the process of completing pre-IND studies for CEL-4000, being developed against Rheumatoid Arthritis, and hope to start human studies with CEL-4000 next year. LEAPS is also currently being tested at the University of Georgia vaccine center against COVID-19," said Dr. Daniel Zimmerman, Senior Vice President of Research, Cellular Immunology.

    The LEAPS platform technology is being developed as a potential therapeutic vaccine for rheumatoid arthritis under phase I and phase II SBIR grants of over $1.7 million from National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) of the U.S. National Institutes of Health (NIH) which was used in part to fund IND enabling studies in non-human primates.

    In animal challenge tests conducted in arthritic diseased animals using CEL-4000 as a therapeutic treatment in collaboration with our Rush Universities Medical center collaborators and co-inventors on this patent, LEAPS platform technology has been shown to direct the immune response preferentially to a cellular (e.g. T-cell) response, reducing pro inflammatory cytokines (IFNγ and IL17A) and enhancing production of anti-inflammatory cytokines (IL4 and IL10). Additional studies in other disease models have shown either cellular, humoral (antibody) or mixed pathway immune responses depending on the disease model and the desired type of protection.

    LEAPS is a patented, T-cell modulation, peptide epitope delivery technology that enables CEL-SCI to design and synthesize proprietary peptide immunogens. LEAPS compounds consist of a small T-cell binding peptide ligand linked with a disease-associated peptide antigen. Usually given after the disease process is initiated and underway. That is not being used as a preventative agent or conventional preventative vaccine.

    The LEAPS conjugates can potentially be utilized to treat diseases for which antigenic epitope sequences have already been identified, such as: a number of infectious diseases, some cancers, autoimmune diseases (e.g., rheumatoid arthritis), allergic asthma and allergy, and select CNS diseases (e.g., Alzheimer's).

    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 treated patients who are newly diagnosed with advanced primary squamous cell carcinoma of the head and neck with the investigational product Multikine* first, BEFORE they received surgery, radiation and/or chemotherapy. This approach is unique. Most other cancer immunotherapies are administered only after conventional therapies have been tried and/or failed. Multikine (Leukocyte Interleukin, Injection), has received Orphan Drug designation from the FDA for neoadjuvant therapy in patients with squamous cell carcinoma (cancer) of the head and neck.

    CEL-SCI believes that this Phase 3 study is the largest Phase 3 study in the world for the treatment of head and neck cancer. Per the study's protocol, newly diagnosed patients with advanced primary squamous cell carcinoma of the head and neck were treated with the Multikine treatment regimen first - for 3 weeks prior to receiving the Standard of Care (SOC), which involves surgery, radiation or concurrent radiochemotherapy. Multikine is designed to help the immune system "see" the tumor at a time when the immune system is still relatively intact and thereby thought to better be able to mount an attack on the tumor. The aim of treatment with Multikine is to boost the body's immune system prior to SOC to attack the cancer. The Phase 3 study is fully enrolled with 928 patients and the last patient was treated in September 2016. To prove an overall survival benefit, the study requires CEL-SCI to wait until 298 events have occurred among the two main comparator groups. This study milestone occurred in late April 2020. The study is currently in the database lock and analysis phase.

    The Company's LEAPS technology is being developed for rheumatoid arthritis and as a potential treatment of COVID-19 in hospitalized and at-high-risk 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, including statements with respect to Multikine and the Phase 3 clinical trial of Multikine in patients with advanced primary squamous cell carcinoma of the head and neck. 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. Factors that could cause or contribute to such differences include an inability to duplicate the clinical results demonstrated in clinical trials or nonclinical 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 amended report on Form 10-K/A for the year ended September 30, 2019. 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, and 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. Moreover, no definitive conclusions can be drawn from the early-phase, clinical-trials data involving the investigational therapy Multikine. Further research is required, and early-phase clinical trial results must be confirmed in the Phase 3 clinical trial of this investigational therapy that is in progress.

    View Full Article Hide Full Article
  2. CEL-SCI Corporation (NYSE:CVM) today issued a letter to its shareholders.

    Dear CEL-SCI Shareholders:

    We all know people who have been diagnosed with cancer. Some were deemed to be curable, while others were not. Our goal with our Multikine* (Leukocyte Interleukin, Injection) immunotherapy treatment is to increase the success rate of a cancer patient's first treatment. We want to help cancer patients live significantly longer and potentially increase their chances of being cured. And we want to do so with minimal to no toxicity from our Multikine immunotherapy treatment regimen. That is a huge goal, and that is why we have never given up during its long development. If proven to work for head and neck cancer, a truly horrible disease, we believe…

    CEL-SCI Corporation (NYSE:CVM) today issued a letter to its shareholders.

    Dear CEL-SCI Shareholders:

    We all know people who have been diagnosed with cancer. Some were deemed to be curable, while others were not. Our goal with our Multikine* (Leukocyte Interleukin, Injection) immunotherapy treatment is to increase the success rate of a cancer patient's first treatment. We want to help cancer patients live significantly longer and potentially increase their chances of being cured. And we want to do so with minimal to no toxicity from our Multikine immunotherapy treatment regimen. That is a huge goal, and that is why we have never given up during its long development. If proven to work for head and neck cancer, a truly horrible disease, we believe that our unique Multikine immunotherapy will prove to be useful for a number of other solid tumors including breast cancer, cervical cancer, melanoma, and more.

    The usual oncology drug development paradigm is to test a drug for its effectiveness in recurrent cancer patients, those whose tumors have come back after the initial standard of care (SOC) treatments failed. That makes business sense since the drug being developed gets to market faster with less money at risk. But this paradigm makes no sense with our Multikine immunotherapy treatment because the first cancer treatments cause profound damage to our immune system. Our Multikine treatment regimen has been shown to act by stimulating a sustainable anti-tumor immune response to fight the cancer. Therefore, in order to maximize the benefit of immunotherapy for patients, we feel it is only logical that Multikine should be given as the first treatment, before surgery, radiation and chemotherapy have damaged the immune system, since that is the time when the immune system is still intact. This approach, using an immunotherapy right after cancer diagnosis and before surgery, makes Multikine unique and a first in a new class of drugs.

    The first patients we targeted in our Multikine development program were those with advanced (stages 3 and 4) primary (just diagnosed and not yet treated) squamous cell carcinoma (cancer) of the head and neck. This patient population was chosen for the following reasons:

    1. Head and neck cancer affects a large number (>650,000) of people worldwide.
    2. It is an extremely devastating and debilitating disease that is highly visible, and can interfere with eating, speaking, swallowing, and breathing.
    3. Patients with this disease have an extreme unmet medical need as no products have been approved by the FDA for this patient population in over 50 years.
    4. We have FDA orphan drug status for Multikine in this disease.
    5. There is only one standard of care (SOC) treatment for this disease.

    The current SOC for advanced primary head and neck cancer patients is surgery followed by radiation or surgery followed by radiation and concurrent chemotherapy. This treatment regimen is given with "intent to cure" (that is what the medical community calls this current SOC treatment), yet typically no more than 50% of the patients will be alive at 3 years post diagnosis. We need to and must do much better for these patients.

    The recurrences that occur in head and neck cancer patients treated with the current SOC therapy are thought to be mostly due to tumor micro-metastases that the surgeon cannot see, and thus cannot remove, and that radiation and chemotherapy do not manage to kill. We believe that only a healthy immune system, correctly activated, can find and destroy these tumor micro-metastases before they cause recurrence of the cancer. We want to make the current "intent to cure" cancer treatment more successful by having our Multikine immunotherapy treatment regimen activate the immune system to kill the tumor micro-metastases.

    We reached the end of our pivotal Phase 3 study in head and neck cancer in April 2020. The Clinical Research Organizations (CROs) running the study are now involved in the study phase of performing data lock/analysis.

    If our Phase 3 study is successful, the results would truly be revolutionary, demonstrating a new way of treating cancer. The study was designed to prove this novel concept and maximize our chances of proving success. We took no shortcuts and addressed the major concerns of the scientific community:

    1. The study is well-controlled and the outcomes are blinded to us until the end.
    2. The study was run as a real-world representation of the disease in 100 centers in over 20 countries.
    3. In addition to Overall Survival (OS) as the primary endpoint for the study there are several secondary endpoints which are indicative of meaningful clinical benefit.
    4. The number of patients (928) in the study is large enough to yield significant results, and the duration (9 years and 4 months) long enough to provide reliable results assessing response/outcome duration. To our knowledge, our Phase 3 study is the largest ever done in advanced primary head and neck cancer.
    5. We purchased the cisplatin chemotherapy, used as part of the SOC treatment, only from manufacturers meeting U.S. and EU standards, and distributed it to all clinical sites. We did so to ensure that all study patients received the same chemotherapy drug, thus avoiding the use of cisplatin with different quality levels, which might have caused variation in results following treatment.
    6. We standardized and controlled the radiotherapy given by each clinical site in our study with the help of the radiation quality control group at MD Anderson – a group which also controls radiotherapy in studies conducted by major pharma and government groups in the U.S. and Europe.
    7. We built a dedicated commercial sized manufacturing plant for Multikine prior to the start of the Phase 3 study to eliminate important regulatory hurdles pertaining to manufacturing. All of the Multikine lots used in the Phase 3 clinical study were manufactured in this facility.

    We also met with the FDA before starting the Phase 3 study. All suggestions made by the FDA were incorporated into the Phase 3 protocol:

    1. We agreed to make the primary study endpoint Overall Survival, the gold standard for cancer drug approval.
    2. We agreed to add a third study group.
    3. The plans for our Multikine manufacturing plant were reviewed by the FDA prior to its construction. All suggestions made by the FDA with respect to design were incorporated into the plant when constructed.
    4. The plant was inspected on several occasions by a European Qualified Person prior to and during the Phase 3 clinical trial to assure compliance with the EU directives for the manufacture of medicinal products.
    5. The European Qualified Person also released all of the Multikine lots for use in the EU countries in compliance with EU Directives.

    Early this year we took one more step to ensure the completeness, accuracy, and validity of the study data. We tasked a group of physicians from Ergomed and ICON, the two CROs managing the Phase 3 study, to perform a 100% medical review of all of the study patients. That is akin to doing a 100% audit of all of the medical results.

    In early May 2020 we announced that we had reached the required 298 events (deaths) among the two main comparator groups, signifying the end of the Phase 3 study. We announced that the two CROs would be performing data lock and the complete data analysis. Only when the complete analysis has been concluded according to a pre-specified statistical analysis plan, will CEL-SCI become privy to the study results. Per SEC regulations we will then notify you, our shareholders, of the results at that time.

    Data lock is a complex, in-depth, and time intensive review process of all of the study data from beginning to end to ensure it is complete and accurate. This process is even more complicated for our Phase 3 study because it involved three treatment arms as well as four treatment modalities, Multikine, surgery, radiation, and chemotherapy.

    To be used in support of a FDA license application or a product registration anywhere in the world, every data point in each patient's case report form concerned with, among other things, their selection, randomization, laboratory assessments, safety and efficacy evaluations of all treatment(s) received must be reviewed, and the source data verified as complete, accurate and correct. Since the data from our study will most likely be audited by regulatory authorities prior to any license or approval being granted, the data lock procedures must be completed with extreme care before the data base can finally be locked and a complete analysis of the study results can be performed. The analysis will evaluate the safety of the Multikine treatment regimen and determine if the primary, secondary and tertiary study endpoints of the Phase 3 study have been met.

    The length of time it takes to lock data from a study and analyze it depends on the size and complexity of the study, the number of study sites and personnel involved, and the period of time over which the study was conducted. Our Phase 3 study was very complex and was conducted in 928 patients over the course of 9.5 years in 100 medical centers on 3 continents. The CROs have to review a lot more data for our study than in most other studies, which are not as large, not as complex or geographically dispersed, and did not run for such a long period of time.

    The COVID-19 pandemic has complicated and delayed the data lock process for our Phase 3 study and added to our workload. Direct access to the source data at the clinical sites has sometimes been limited due to the pandemic by governments, institutions and the availability of the study personnel required to respond to any matters/queries requiring resolution. In some cases, and in compliance with guidance issued by the FDA and other regulatory bodies, it has been possible to perform remote data reviews and source data verification, but not in all. From what we can see the CROs are doing a good job, but everything takes longer as a consequence of the COVID-19 pandemic. The bottom line is that we have highly skilled professionals around the world working to resolve this, and they are getting it done. We are almost at the end!

    Should the results of our Phase 3 study confirm that our Multikine immunotherapy treatment regimen provides a meaningful clinical benefit for the patients in our Phase 3 trial, as we saw in our final Phase 2 Multikine clinical trial, we expect to file a license application for Multikine with the FDA for its use as a neoadjuvant (pre-surgery) treatment in advanced primary head and neck cancer patients. If approved, this license would allow us to commercially distribute Multikine for this indication. Given the fact that advanced primary head and neck cancer is a clear unmet medical need with no FDA approval in well over 50 years and that Multikine appears to be safe and well tolerated based on the data available from all of our previous clinical trials, we would be surprised if such a license were not granted. We are currently expanding our Multikine manufacturing facility in Maryland so we will be able to meet the expected demand for the product when a license is granted.

    Come December 31, we want to be able to look back on the year and know that, in spite of the COVID issues and delays, we did not take shortcuts and we did everything right. We believe that we have a "really good shot" at creating a truly novel cancer drug that seeks to help cancer patients live significantly longer and potentially increase their chances of a cure. And we also believe that we will be able to do so with minimal to no added toxicity from our Multikine immunotherapy.

    We thank you very much for all your help and support as we eagerly await the final data read-out from our Phase 3 cancer study.

    Sincerely,

    Geert Kersten

    Chief Executive Officer

    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, including statements with respect to Multikine and the Phase 3 clinical trial of Multikine in patients with advanced primary squamous cell carcinoma of the head and neck. 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. Factors that could cause or contribute to such differences include an inability to duplicate the clinical results demonstrated in clinical trials or nonclinical 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 amended report on Form 10-K/A for the year ended September 30, 2019. 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, and 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. Moreover, no definitive conclusions can be drawn from the early-phase, clinical-trials data involving the investigational therapy Multikine. Further research is required, and early-phase clinical trial results must be confirmed in the Phase 3 clinical trial of this investigational therapy that is in progress.

    View Full Article Hide Full Article
  3. CEL-SCI Corporation (NYSE:CVM), a Phase 3 cancer immunotherapy company, today announced that it will be presenting at the H.C. Wainwright 22nd Annual Global Investment Conference. The virtual conference will be held on September 14-16, 2020. Geert Kersten, Chief Executive Officer of CEL-SCI, will present on Monday, September 14 at 1:30 p.m. ET.

    For those who wish to listen to the live webcast, please use the following link https://wsw.com/webcast/hcw7/cvm/1476790. The webcast will be archived on CEL-SCI's investor relations website, https://cel-sci.com/new-investor-information/ for 90 days following the live presentation.

    About CEL-SCI Corporation

    CEL-SCI believes that boosting a patient's immune system while it is still intact should…

    CEL-SCI Corporation (NYSE:CVM), a Phase 3 cancer immunotherapy company, today announced that it will be presenting at the H.C. Wainwright 22nd Annual Global Investment Conference. The virtual conference will be held on September 14-16, 2020. Geert Kersten, Chief Executive Officer of CEL-SCI, will present on Monday, September 14 at 1:30 p.m. ET.

    For those who wish to listen to the live webcast, please use the following link https://wsw.com/webcast/hcw7/cvm/1476790. The webcast will be archived on CEL-SCI's investor relations website, https://cel-sci.com/new-investor-information/ for 90 days following the live presentation.

    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 treated patients who are newly diagnosed with advanced primary squamous cell carcinoma of the head and neck with the investigational product Multikine* first, BEFORE they received surgery, radiation and/or chemotherapy. This approach is unique. Most other cancer immunotherapies are administered only after conventional therapies have been tried and/or failed. Multikine (Leukocyte Interleukin, Injection), has received Orphan Drug designation from the FDA for neoadjuvant therapy in patients with squamous cell carcinoma (cancer) of the head and neck.

    CEL-SCI believes that this Phase 3 study is the largest Phase 3 study in the world for the treatment of head and neck cancer. Per the study's protocol, newly diagnosed patients with advanced primary squamous cell carcinoma of the head and neck were treated with the Multikine treatment regimen first - for 3 weeks prior to receiving the Standard of Care (SOC), which involves surgery, radiation or concurrent radiochemotherapy. Multikine is designed to help the immune system "see" the tumor at a time when the immune system is still relatively intact and thereby thought to better be able to mount an attack on the tumor. The aim of treatment with Multikine is to boost the body's immune system prior to SOC to attack the cancer. The Phase 3 study is fully enrolled with 928 patients and the last patient was treated in September 2016. To prove an overall survival benefit, the study requires CEL-SCI to wait until 298 events have occurred among the two main comparator groups. This study milestone occurred in late April 2020. The study is currently in the database lock and analysis phase.

    The Company's LEAPS technology is being developed for rheumatoid arthritis and as a potential treatment of COVID-19 in hospitalized and at-high-risk 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, including statements with respect to Multikine and the Phase 3 clinical trial of Multikine in patients with advanced primary squamous cell carcinoma of the head and neck. 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. Factors that could cause or contribute to such differences include, an inability to duplicate the clinical trials or nonclinical 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/A for the year ended September 30, 2019. 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, and 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. Moreover, no definitive conclusions can be drawn from the early-phase, clinical-trials data involving the investigational therapy Multikine. Further research is required, and early-phase clinical trial results must be confirmed in the Phase 3 clinical trial of this investigational therapy that is in progress.

    View Full Article Hide Full Article
  4. CEL-SCI Corporation (NYSE:CVM) today reported financial results for the quarter ended June 30, 2020 and provided an update on clinical developments:

    • CEL-SCI reached the targeted threshold of 298 events (deaths) required to conduct the data evaluation for its global pivotal Phase 3 head and neck cancer study of Multikine* (Leukocyte Interleukin, Inj.) immunotherapy. The study is currently in the database lock and analysis phase. CEL-SCI will be advised of the results when the analysis is finalized, and the study results will be announced to the public and investors at that time.
    • CEL-SCI initiated the development of an immunotherapy with the potential to treat the COVID-19 coronavirus using its patented LEAPS peptide technology. The initial…

    CEL-SCI Corporation (NYSE:CVM) today reported financial results for the quarter ended June 30, 2020 and provided an update on clinical developments:

    • CEL-SCI reached the targeted threshold of 298 events (deaths) required to conduct the data evaluation for its global pivotal Phase 3 head and neck cancer study of Multikine* (Leukocyte Interleukin, Inj.) immunotherapy. The study is currently in the database lock and analysis phase. CEL-SCI will be advised of the results when the analysis is finalized, and the study results will be announced to the public and investors at that time.
    • CEL-SCI initiated the development of an immunotherapy with the potential to treat the COVID-19 coronavirus using its patented LEAPS peptide technology. The initial animal experiments showed that after only one injection, LEAPS COVID-19 conjugates induced antibody responses faster and in much higher titers than expected against a non-mutating region of the virus that causes COVID-19. These animal experiments provide the basis for moving forward into animal challenge studies with live virus SARS-CoV-2, the causative agent of COVID-19, at the University of Georgia Vaccine Center.
    • CEL-SCI signed a collaboration agreement with the University of Georgia's Center for Vaccines and Immunology to develop the LEAPS COVID-19 immunotherapy. Initial studies with COVID-19 aim to replicate prior successful preclinical experiments of LEAPS against the H1N1pandemic flu virus in mice conducted at and in collaboration with the National Institutes for Allergies and Infectious Diseases (NIAID). These studies demonstrated improvement in both morbidity and mortality of H1N1 infected animals treated with the LEAPS-H1N1 construct as compared to controls. CEL-SCI believes its COVID-19 approach is unique for two reasons: 1) LEAPS focuses on a non-changing part of the virus; and 2) LEAPS has both anti-viral and anti-inflammatory attributes. The goal is to develop a more successful treatment for infected patients.
    • CEL-SCI raised approximately $27.0 million in gross proceeds during the nine months ended June 30, 2020 through the sale of common stock through public offerings and the exercise of warrants.

    "Our goal is to create the first non-toxic cancer drug that is effective in increasing survival. This is the first cancer drug in decades that would be used to improve the success rate of the current first ‘intent to cure' head and neck cancer standard of care treatment. Now that the long Phase 3 study is finished, the organizations who run the study are responsible for cleaning up/collecting all final data and analyzing it. This is a very big job since the study ran for 9.5 years in 100 hospitals in 24 countries. Once we know the final study results, we will share them with our shareholders. We believe that our Multikine will help these patients," stated CEL-SCI CEO, Geert Kersten.

    During the nine months ended June 30, 2020, the Company's cash increased by approximately $11.7 million. Significant components of this increase include approximately $14.0 million in net proceeds from the sale of common stock through public offerings, approximately $12.1 million in proceeds from the exercise of warrants and options and employee stock purchases of approximately $0.2 million, offset by net cash used to fund the Company's regular operations, including its Phase 3 clinical trial, of approximately $11.7 million, approximately $1.6 million of equipment and leasehold improvement expenditures, approximately $0.7 million for payments of stock issuance costs and approximately $0.6 million in lease payments.

    CEL-SCI reported a net loss of $24.7 million for the nine months ended June 30, 2020 versus a net loss of $17.3 million for the nine months ended June 30, 2019. CEL-SCI reported a net loss of $10.2 million for the quarter ended June 30, 2020 versus a net loss of $12.1 million for the quarter ended June 30, 2019.

    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 treated patients who are newly diagnosed with advanced primary squamous cell carcinoma of the head and neck with the investigational product Multikine first, BEFORE they received surgery, radiation and/or chemotherapy. This approach is unique. Most other cancer immunotherapies are administered only after conventional therapies have been tried and/or failed. Multikine (Leukocyte Interleukin, Injection), has received Orphan Drug designation from the FDA for neoadjuvant therapy in patients with squamous cell carcinoma (cancer) of the head and neck.

    CEL-SCI believes that this Phase 3 study is the largest Phase 3 study in the world for the treatment of head and neck cancer. Per the study's protocol, newly diagnosed patients with advanced primary squamous cell carcinoma of the head and neck were treated with the Multikine treatment regimen first - for 3 weeks prior to receiving the Standard of Care (SOC), which involves surgery, radiation or concurrent radiochemotherapy. Multikine is designed to help the immune system "see" the tumor at a time when the immune system is still relatively intact and thereby thought to better be able to mount an attack on the tumor. The aim of treatment with Multikine is to boost the body's immune system prior to SOC to attack the cancer. The Phase 3 study is fully enrolled with 928 patients and the last patient was treated in September 2016. To prove an overall survival benefit, the study requires CEL-SCI to wait until 298 events have occurred among the two main comparator groups. This study milestone occurred in late April 2020. The study is currently in the database lock and analysis phase.

    The Company's LEAPS technology is being developed for rheumatoid arthritis and as a potential treatment of COVID-19 in hospitalized and at-high-risk 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, including statements with respect to Multikine and the Phase 3 clinical trial of Multikine in patients with advanced primary squamous cell carcinoma of the head and neck. 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. Factors that could cause or contribute to such differences include an inability to duplicate the clinical results demonstrated in clinical trials or nonclinical 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 amended report on Form 10-K/A for the year ended September 30, 2019. 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, and 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. Moreover, no definitive conclusions can be drawn from the early-phase, clinical-trials data involving the investigational therapy Multikine. Further research is required, and early-phase clinical trial results must be confirmed in the Phase 3 clinical trial of this investigational therapy that is in progress.

    CEL-SCI CORPORATION

    CONDENSED STATEMENTS OF OPERATIONS

    NINE MONTHS ENDED JUNE 30, 2020 AND 2019

    (UNAUDITED)

     

     

    2020

     

     

    2019

     

     

    Grant income

    $

    530,106

     

    $

    386,121

     

     

    Operating Expenses:

    Research and development

     

    12,511,830

     

     

    9,269,772

     

    General and administrative

     

    8,389,821

     

     

    5,667,510

     

    Total operating expenses

     

    20,901,651

     

     

    14,937,282

     

     

     

    Operating loss

     

    (20,371,545

    )

     

    (14,551,161

    )

     

    Other income

     

    38,741

     

     

    54,575

     

    Loss on derivative instruments

     

    (3,565,347

    )

     

    (3,316,384

    )

    Warrant inducement expense

     

    (805,753

    )

     

    -

     

    Other non-operating gains

     

    774,245

     

     

    1,877,197

     

    Interest expense, net

     

    (777,898

    )

     

    (1,350,774

    )

    Net loss

     

    (24,707,557

    )

     

    (17,286,547

    )

     

    Modification of warrants

     

    (21,734

    )

     

    -

     

     

    Net loss available to common shareholders

    $

    (24,729,291

    )

    $

    (17,286,547

    )

     
     

    Net loss per common share - basic and diluted

    $

    (0.68

    )

    $

    (0.58

    )

     

    Weighted average common shares outstanding - basic and diluted

     

    36,230,092

     

     

    30,046,241

     

     

    CEL-SCI CORPORATION

    CONDENSED STATEMENTS OF OPERATIONS

    THREE MONTHS ENDED JUNE 30, 2020 AND 2019

    (UNAUDITED)

     

     

    2020

     

     

    2019

     

     

    Grant income

    $

    195,874

     

    $

    108,938

     

     

    Operating Expenses:

    Research and development

     

    3,912,870

     

     

    2,965,512

     

    General and administrative

     

    3,192,403

     

     

    2,353,525

     

    Total operating expenses

     

    7,105,273

     

     

    5,319,037

     

     

     

    Operating loss

     

    (6,909,399

    )

     

    (5,210,099

    )

     

    Other income

     

    1,845

     

     

    18,448

     

    Loss on derivative instruments

     

    (1,282,829

    )

     

    (7,905,519

    )

    Warrant inducement expense

     

    (805,753

    )

     

    -

     

    Other non-operating (losses) gains

     

    (950,935

    )

     

    1,455,844

     

    Interest expense, net

     

    (273,708

    )

     

    (443,442

    )

     

    Net loss available to common shareholders

    $

    (10,220,779

    )

    $

    (12,084,768

    )

     
     

    Net loss per common share - basic and diluted

    $

    (0.27

    )

    $

    (0.37

    )

     

    Weighted average common shares outstanding - basic and diluted

     

    37,453,539

     

     

    33,051,888

     

     

     

    View Full Article Hide Full Article
  5. CEL-SCI Corporation (NYSE:CVM) announces that it has concluded animal experiments using its LEAPS COVID 19 conjugate that provide the basis for moving forward into animal challenge studies with live virus SARS-CoV-2, the causative agent of COVID 19, at the University of Georgia Vaccine Center. These SARS-CoV-2 challenge studies seek to repeat the success of animal challenge studies conducted previously at the NIH/NIAID emerging diseases laboratory during the threatened H1N1 flu pandemic.

    The LEAPS COVID 19 conjugate has been designed employing the same concepts as were used to construct the LEAPS H1N1 conjugate which was successfully employed in previous H1N1 pandemic flu studies. In those prior studies reduced morbidity and mortality were…

    CEL-SCI Corporation (NYSE:CVM) announces that it has concluded animal experiments using its LEAPS COVID 19 conjugate that provide the basis for moving forward into animal challenge studies with live virus SARS-CoV-2, the causative agent of COVID 19, at the University of Georgia Vaccine Center. These SARS-CoV-2 challenge studies seek to repeat the success of animal challenge studies conducted previously at the NIH/NIAID emerging diseases laboratory during the threatened H1N1 flu pandemic.

    The LEAPS COVID 19 conjugate has been designed employing the same concepts as were used to construct the LEAPS H1N1 conjugate which was successfully employed in previous H1N1 pandemic flu studies. In those prior studies reduced morbidity and mortality were observed in H1N1 virus infected animals treated with the LEAPS H1N1 construct. The LEAPS H1N1 conjugates were administered after virus challenge as a therapeutic intervention. We believe these results and the positive results achieved in studies with LEAPS constructs in other diseases are strongly suggestive that the LEAPS COVID 19 challenge studies at the University of Georgia Vaccine Center may also be successful.

    The recent animal experiments showed that LEAPS COVID 19 conjugates induced faster and much higher than expected antibody responses against a non-mutating region of the virus that causes COVID 19, after only one injection. It is important to note that IgG antibodies response was generated within 10 days of a single immunization. Generation of IgG requires activation of dendritic, T and B cells in order to promote the class switch from IgM to IgG antibody.

    Daniel Zimmerman, Ph.D., Senior VP of Research Cellular Immunology at CEL-SCI and discoverer of the LEAPS technology said; "We now have the immunogenicity data showing that the LEAPS technology may work against COVID 19. Similar results were obtained with LEAPS-H1N1 conjugates, in animals that were infected with H1N1 virus and subsequently treated with LEAPS-H1N1 conjugates. Those challenge studies resulted in a decrease in morbidity and mortality against pandemic flu H1N1 in a mouse model study conducted at the NIAID. These studies give us confidence that the challenge studies we are now undertaking with live virus SARS-CoV-2 in an animal model of COVID 19 at the University of Georgia Vaccine Center will be successful."

    Background on LEAPS and its Relevance to COVID 19:

    CEL-SCI's goal is to develop an immunotherapy with the potential to treat the COVID 19 coronavirus using its patented LEAPS peptide technology. The LEAPS peptides utilize conserved regions of coronavirus proteins to stimulate protective antibody and cell mediated T cell responses and reduce viral load. The LEAPS peptide technology can be used to construct immunotherapeutic peptides that exhibit both antiviral and anti-inflammatory properties at the same time. Consequently, these products not only target the virus infection against which they are directed, but also elicit the appropriate protective response(s) against it, without exacerbating an overly active inflammation.

    CEL-SCI's studies are utilizing the LEAPS peptide approach which is unique in its proven ability in animals to elicit both a cell mediated antiviral response and an anti-inflammatory immunomodulating response by activating CD8 T lymphocytes. Previous studies showed that LEAPS immunogens can prevent lethal infection by herpes simplex virus (HSV), and stop the inflammatory disease progression of rheumatoid arthritis in animal models. LEAPS peptides against HSV demonstrated that the T cell response was sufficient to prevent viral disease, and if there was residual virus production, anti-viral antibody was generated to further control the spread of the virus.

    The LEAPS-COVID-19 peptide conjugates are directed towards antigens within the NP protein of SARS-Cov-2 the causative agent of COVID-19 that elicit cytolytic T cell responses to virus infected cells. Unlike glycoprotein spike antigens which are important for antibody-based vaccines, these antigens are less variable between viral strains and less likely to change in response to antibodies elicited by prior infection or other vaccines. Cytolytic T cell responses attack the virus infected cellular "factories" within the infected host in order to eliminate the source of virus and help subdue the infection.

    Ligand Epitope Antigen Presentation System (LEAPS) platform technology has demonstrated in several animal models the ability to design antigen-specific immunotherapeutic peptides that preferentially direct the immune response to a cellular (e.g., T-cell), humoral (antibody) or mixed response and are also capable of enhancing important T-regulatory (Treg) responses. Therefore, the LEAPS technology provides the opportunity to develop immunotherapeutic products for diseases for which disease associated antigenic peptide(s) sequences have already been identified, such as: a number of infectious diseases, some cancers, autoimmune diseases (e.g., RA), allergic asthma and allergy, select CNS diseases (e.g., Alzheimer's) and the virus SARS-Cov-2, the causative agent of COVID-19.

    The Company's LEAPS technology is currently also being developed as a therapeutic vaccine for rheumatoid arthritis and is supported by $1.5 million grant for IND enabling studies from the National Institute of Arthritis and Musculoskeletal and Skin Diseases.

    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 its global pivotal Phase 3 study CEL-SCI treated patients who are newly diagnosed with advanced primary squamous cell carcinoma of the head and neck with Multikine* first, BEFORE they received surgery, radiation and/or chemotherapy. This approach is unique. Most other cancer immunotherapies are administered only after conventional therapies have been tried and/or failed. Multikine (Leukocyte Interleukin, Injection), has received Orphan Drug designation from the FDA for neoadjuvant therapy in patients with squamous cell carcinoma (cancer) of the head and neck.

    CEL-SCI's Phase 3 study is the largest Phase 3 study in the world for the treatment of head and neck cancer. Per the study's protocol, newly diagnosed patients with advanced primary squamous cell carcinoma are treated with the Multikine treatment regimen for 3 weeks prior to the Standard of Care (SOC) which involves surgery, chemotherapy and/or radiation. Multikine is designed to help the immune system "see" the tumor at a time when the immune system is still relatively intact and thereby thought to better able to mount an attack on the tumor. The aim of treatment with Multikine is to boost the body's immune system prior to SOC. The Phase 3 study is fully enrolled with 928 patients and the last patient was treated in September 2016. To prove an overall survival benefit, the study requires CEL-SCI to wait until 298 events have occurred among the two main comparator groups.

    The Company has operations in Vienna, Virginia, and in/near 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, including statements with respect to Multikine and the Phase 3 clinical trial of Multikine in patients with advanced primary squamous cell carcinoma of the head and neck. 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. Factors that could cause or contribute to such differences include, an inability to duplicate the clinical trials or nonclinical 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/A for the year ended September 30, 2019. 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, and 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. Moreover, no definitive conclusions can be drawn from the early-phase, clinical-trials data involving the investigational therapy Multikine. Further research is required, and early-phase clinical trial results must be confirmed in the Phase 3 clinical trial of this investigational therapy that is in progress.

    View Full Article Hide Full Article
View All Cel-Sci Corporation News