New Risk • Aug 16
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -US$17m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$17m free cash flow). Earnings are forecast to decline by an average of 20% per year for the foreseeable future. Shareholders have been substantially diluted in the past year (154% increase in shares outstanding). Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable next year (US$28m net loss next year). Share price has been volatile over the past 3 months (14% average weekly change). Market cap is less than US$100m (US$26.9m market cap). Announcement • Aug 05
CEL-SCI Corporation Publishes Study Supporting Multikine Biomarker Strategy And Reports Survival Benefit In Oral Cancer CEL-SCI Corporation announced the publication of its study, "A Novel Neoadjuvant Immunotherapy Confers Improved Overall Survival in Oral Cancer Patients with Low Tumor PD-L1 Expression: The IT-MATTERS Clinical Trial – Prognostic Role of Tumor PD-L1 Expression," in the internationally recognized journal Oral Oncology. The peer-reviewed publication provides scientific evidence supporting the biomarker strategy that forms the foundation for selecting patients in CEL-SCI's upcoming global Confirmatory Registration Study of Multikine (Leukocyte Interleukin, Injection). The Oral Oncology published study identifies low and zero tumor PD-L1 expression (TPS <10%) and the absence of lymph node involvement (N0) as prognostic biomarkers for selecting patients most likely to achieve substantial survival benefit from Multikine administered before surgery. In this biomarker-selected patient population, patients receiving the Multikine treatment regimen prior to surgery followed by standard of care achieved a 73.4% five-year overall survival (OS) rate compared with 45.8% for patients receiving surgery followed by standard of care alone, corresponding to a hazard ratio of 0.34 (p=0.0012) and a 28.6% absolute improvement in five-year survival. The published study also demonstrated a statistically significant improvement in progression-free survival (PFS), with a 49% reduction in the risk of disease progression or death (PFS hazard ratio 0.51; p=0.0197) compared to control in the same patient population. The peer-reviewed publication concludes that these biomarkers can be used prospectively to identify patients most likely to benefit from Multikine and guide future clinical studies in head and neck (squamous cell carcinoma) cancer. The publication in Oral Oncology notes that currently approved checkpoint inhibitor therapies are generally directed toward patients with higher PD-L1 expression, while Multikine's unique mechanism of action enables it to benefit patients whose tumors express low (TPS <10%), as well as zero (0%) PD-L1. CEL-SCI is preparing to commence enrollment in its global 212-patient Confirmatory Registration Study, which will evaluate Multikine in newly diagnosed, previously untreated, locally advanced resectable head and neck oral cancer patients with low and zero (TPS <10%) PD-L1 tumor expression and no lymph node involvement—the same patient population reported on in the newly published study in Oral Oncology. The trial is designed with approximately 97% statistical power to confirm the previously observed overall survival benefit. Multikine is a novel cancer immunotherapy administered before surgery as a treatment for newly diagnosed previously untreated locally advanced head and neck cancer. Its goal is to activate a person’s immune system to fight cancer before the ravages of surgery, radiation and chemotherapy have weakened the immune system. In the world’s largest head and neck cancer Phase 3 study, Multikine increased the 5-year survival rate of the target patient population to 73% vs 45% in patients treated with standard of care alone and halved the risk of death from 55% to 27%. Multikine (Leukocyte Interleukin, Injection), given right after diagnosis and before surgery, has been administered to over 740 patients and has an excellent safety profile compared to other cancer drugs. It has received Orphan Drug designation from the FDA for neoadjuvant therapy in patients with squamous cell carcinoma (cancer) of the head and neck. Multikine (Leukocyte Interleukin, Injection) is the trademark that CEL-SCI has registered for this investigational therapy. 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. Announcement • Jul 30
CEL-SCI Corporation Announces Oncology Journal Accepts for Publication New Multikine Phase 3 Data Demonstrating Overall Survival Benefit in Underserved Head and Neck Cancer Patients CEL-SCI Corporation announced that a manuscript highlighting the latest findings from its Phase 3 study titled "A Novel Neoadjuvant Immunotherapy Confers Improved Overall Survival in Oral Cancer Patients with Low Tumor PD-L1 Expression: The IT-MATTERS Clinical Trial – Prognostic Role of Tumor PD-L1 Expression," has been accepted for publication in Oral Oncology, one of the world's leading peer-reviewed journals dedicated to head and neck cancer research and treatment. The manuscript, authored by Eyal Talor, Ph.D. and colleagues, is based on data from CEL-SCI's landmark Phase 3 IT-MATTERS clinical trial evaluating Multikine (Leukocyte Interleukin, Injection) in the treatment of newly diagnosed treatment naïve, resectable, locally advanced head and neck cancer patients. In accordance with the journal's publication policies, CEL-SCI will disclose the scientific findings following publication in Oral Oncology. In CEL-SCI’s Phase 3 study, a well-defined population of newly diagnosed, previously untreated, locally advanced resectable head and neck cancer patients with low tumor PD-L1 expression and no lymph node involvement treated with Multikine before receiving standard of care had a 73% five-year overall survival rate compared to 45% in patients receiving standard of care alone. Unlike currently available immune checkpoint inhibitor therapies that primarily target patients with higher PD-L1 expression, Multikine is being developed specifically for patients with low PD-L1 tumor expression—an underserved patient population with limited treatment options and a recognized unmet medical need. CEL-SCI is preparing to commence enrollment in its global 212-patient Confirmatory Registration Study, which is designed to confirm the previously observed overall survival benefit in this predefined target patient population. The registration study aims to enroll patients globally at clinical centers across the United States, Europe and Asia and is designed based on the approximately 97% statistical power to detect the previously observed overall survival hazard ratio of 0.34 in the same selected population of the completed Phase 3 study. Multikine is a novel cancer immunotherapy administered before surgery as a treatment for newly diagnosed previously untreated locally advanced head and neck cancer. Its goal is to activate a person’s immune system to fight cancer before the ravages of surgery, radiation and chemotherapy have weakened the immune system. In the world’s largest head and neck cancer Phase 3 study in the same selected population, Multikine increased the 5-year survival rate of the target patient population to 73% vs 45% in patients treated with standard of care alone and halved the risk of death from 55% to 27%. Multikine (Leukocyte Interleukin, Injection), given right after diagnosis and before surgery, has been dosed in over 740 patients and received Orphan Drug designation from the FDA for neoadjuvant therapy in patients with squamous cell carcinoma (cancer) of the head and neck. Multikine (Leukocyte Interleukin, Injection) is the trademark that CEL-SCI has registered for this investigational therapy. 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. 
