New Risk • May 04
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of American stocks, typically moving 17% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (17% average weekly change). Shareholders have been substantially diluted in the past year (189% increase in shares outstanding). Revenue is less than US$1m. Minor Risk Market cap is less than US$100m (US$18.5m market cap). Announcement • Apr 18
CEL-SCI Corporation has filed a Follow-on Equity Offering in the amount of $15 million. CEL-SCI Corporation has filed a Follow-on Equity Offering in the amount of $15 million.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 3,440,367
Price\Range: $4.36
Discount Per Security: $0.3052
Security Name: Pre-Funded Warrants
Security Type: Equity Warrant
Securities Offered: 3,440,367 Announcement • Dec 31
CEL-SCI Corporation Provides Clinical and Corporate Developments CEL-SCI Corporation announced that it is in final preparations to start enrollment of its 212-patient U.S. Confirmatory Registration Study for Multikine in newly diagnosed locally advanced head and neck cancer patients. The U.S. Food and Drug Administration (FDA) has given CEL-SCI the go-ahead for the study. Enrollment is expected to begin in Spring 2026. CEL-SCI plans to seek early approval based on early tumor response data which is expected by 2028. An application was submitted for Breakthrough Medicine Designation for Multikine in the treatment of head and neck cancer in Saudi Arabia as recommended by the Saudi Food and Drug Authority (SFDA). This was done in combination with a Saudi company, also as recommended by the SFDA. In response to an additional request, CEL-SCI also submitted a blueprint for its strategy to support and become a part of the Saudi Arabia's ambitious Vision 2030 goals to further advance the Kingdom's global leadership in biotechnology. CEL-SCI's cGMP dedicated manufacturing facility commissioning was validated and manufacturing of Multikine for the confirmatory Registration Study was completed, a significant milestone towards starting enrollment. Should Multikine receive regulatory clearance for patient access and sales in Saudi Arabia based on the Breakthrough Medicine Designation, CEL-SCI is ready to manufacture and ship doses to Saudi Arabia from its U.S. facility while diversifying its geographic manufacturing base with support from Saudi counterparts. CEL-SCI is working closely with Ergomed, a clinical research organization (CRO) with a strong track record of fast enrolment and high-quality study delivery, to complete the final preparations for its confirmatory Registration Study. Ergomed has been a strategic partner and collaborator for over 10 years and was instrumental in successfully completing the Phase 3 study. A new study supports CEL-SCI's strategy to seek early approval in the U.S. In June 2025, the FDA approved Merck's KEYTRUDA®? (pembrolizumab), an anti-PD-L1 therapy, for the treatment of adult patients with resectable locally advanced head and neck squamous cell carcinoma (HNSCC) whose tumors express PD-L1. Of note, the FDA granted Merck priority review in February 2025 and approval in June 2025 based on interim results. Multikine (Leukocyte Interleukin, Injection), a true first-line cancer therapy, 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. Based on the data from the completed randomized controlled Phase 3 study of 928 patients, the FDA concurred with CEL-SCI's target patient selection criteria and gave the go-ahead to conduct a confirmatory Registration Study which will enroll 212 patients. Factors that the data from the prior Phase 3 study will enroll 212 patients in the U.S. New Risk • Dec 29
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). Shareholders have been substantially diluted in the past year (262% increase in shares outstanding). Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (US$9.6m net loss in 2 years). Share price has been volatile over the past 3 months (12% average weekly change). Market cap is less than US$100m (US$37.8m market cap). Announcement • Aug 30
CEL-SCI Corporation has completed a Follow-on Equity Offering in the amount of $10.0008 million. CEL-SCI Corporation has completed a Follow-on Equity Offering in the amount of $10.0008 million.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 1,111,200
Price\Range: $9
Discount Per Security: $0.63 Announcement • Aug 28
CEL-SCI Corporation has filed a Follow-on Equity Offering. CEL-SCI Corporation has filed a Follow-on Equity Offering.
Security Name: Common Stock
Security Type: Common Stock
Security Name: Pre-Funded Warrants
Security Type: Equity Warrant Announcement • Aug 15
CEL-SCI Corporation's Multikine Head and Neck Cancer Immunotherapy Breakthrough Medicine Designation Filed in Saudi Arabia CEL-SCI Corporation announced that a Breakthrough Medicine Designation application has been filed with the Saudi Food and Drug Authority (SFDA) for Multikine (Leukocyte Interleukin, Injection) in the Kingdom of Saudi Arabia by one of the Kingdom's premier pharmaceutical and healthcare companies. CEL-SCI has signed a Memorandum of Understanding (MOU) with this Saudi pharma company for the commercialization of Multikine in Saudi Arabia. A final partnership agreement is expected during the 3rd quarter of 2025. Multikine is a cancer immunotherapy administered before surgery as a treatment for newly diagnosed previously untreated head and neck cancer. The goal is to ensure that promising medicines are available as soon as it can be concluded that the medicines' benefits justify their risks. Eligible includes having to fulfill all of the following four criteria in order to gain a Breakthrough Medicine Designation: Target serious debilitating or life-threatening conditions with unmet medical need. The medicinal product is likely to offer major advantages over methods currently used. The potential adverse effects of the medicinal product are considered to be outweighed by the benefits, allowing for the reasonable expectation of a positive benefit/risk balance. The product is not registered at any regulatory authority at the time of submission of the designation request. Price Target Changed • Aug 13
Price target increased by 29% to US$300 Up from US$232, the current price target is provided by 1 analyst. New target price is 3,493% above last closing price of US$8.35. Stock is down 76% over the past year. The company is forecast to post a net loss per share of US$12.30 next year compared to a net loss per share of US$15.31 last year. Recent Insider Transactions • Jul 29
Chief Executive & Financial Officer recently bought US$200k worth of stock On the 25th of July, Geert Kersten bought around 29k shares on-market at roughly US$6.85 per share. This transaction amounted to 67% of their direct individual holding at the time of the trade. This was the largest purchase by an insider in the last 3 months. This was Geert's only on-market trade for the last 12 months. Announcement • Jul 15
CEL-SCI Corporation has completed a Follow-on Equity Offering in the amount of $5.73 million. CEL-SCI Corporation has completed a Follow-on Equity Offering in the amount of $5.73 million.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 1,500,000
Price\Range: $3.82
Discount Per Security: $0.2674 Announcement • Jun 18
Cel-Sci Corporation Announces Fda's Approval of Keytruda for Pd-L1 Positive Head and Neck Cancer Patients Signals A Clear Pathway for Cel-Sci's Multikine to Address A Major Unmet Need in Pd-L1 Negative Cancer Patients CEL-SCI Corporation celebrated the U.S. Food and Drug Administration's (FDA) approval of Merck's KEYTRUDA®? (pembrolizumab), an anti-PD-1 therapy, for the treatment of adult patients with resectable locally advanced head and neck squamous cell carcinoma (HNSCC) whose tumors express PD-L1 (Combined Positive Score [CPS]1) as determined by an FDA-approved test. Merck's application was granted the FDA's priority review on February 25, 2025, and regulatory approval was granted on June 13, 2025, based on interim results from Keytruda's Phase 3 KEYNOTE-689 trial. Last week the FDA approved Keytruda as a perioperative (before and after surgery) treatment for resectable locally advanced Head and neck cancer patients whose tumors expressed PD-L1 at a positive level. In Merck's Phase 3 KEYNOTE-69 trial, Keytruda reduced the risk of recurrence and progression by 30%, compared with standard of care, in patients whose tumors expressed PD- L1 (CPS 1). The study did not show an improvement in overall survival. Patients with low to zero levels of PD-L1 did not benefit from Keytruda. In contrast to the results of the KEYNOTE-689, CEL-SCI's Phase 3 study showed that Multikine treated patients whose tumors expressed low (Tumor Proportion Score [TPS <10) to zero PD-L1, had their risk of death reduced by 66% (hazard ratio 0.34, 95% CI [0.18, 0.65, p=0.0012) and extended the 5-year overall survival to 73% compared to 45% in the standard of care, log rank p=0.0015. About 70% of the patients in CEL-SCI's phase 3 study had low to zero levels of PD -L1. The company has received the FDA's go-ahead for a confirmatory Registration Study with 212 patients based on results from the completed Multikine Phase 3 study in head and neck cancer patients. The patients in the Phase 3 study that benefits from Multikine pre-surgery treatment showed an almost 4-year median overall survival advantage over control, and pre-surgery tumor responses to Multikine predicted survival benefit. Board Change • Jun 09
No independent directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 1 experienced director. 2 highly experienced directors. No independent directors (3 non-independent directors). Director Bob Watson was the last director to join the board, commencing their role in 2017. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of independent directors. Insufficient board refreshment. Announcement • May 21
Cel-Sci Corporation's Multikine Investigational Cancer Medicine Potentially Available for Commercialization by Summer 2025 in Saudi Arabia CEL-SCI Corporation announced it has completed its Breakthrough Medicine Designation application for Multikine (Leukocyte Interleukin, Injection) for submission to the Saudi Food and Drug Authority (SFDA) in Saudi Arabia. Multikine is an immunotherapy administered before surgery as a treatment for newly diagnosed previously untreated head and neck cancer. The Breakthrough Designation Application is expected to be formally submitted to the SFDA on CEL-SCI's behalf within the next few weeks by the Company's prospective Saudi partner, one of the country's premier pharmaceutical and healthcare companies. belief is that Multikine meets all requirements for Breakthrough Medicine Designation as published by the SFDA. Together with prospective local partner, are hopeful that will be able to help patients in Saudi Arabia. Under the SFDA's new Breakthrough Medicine Designation program, Multikine would immediately become available for patient access and reimbursement upon it being granted Breakthrough Medicine Designation. Head and neck cancers constitute approximately 5% of all cancer cases in Saudi Arabia. The SFDA Breakthrough Medicine Program aims to facilitate and accelerate development and review of new drugs that address unmet medical needs in the treatment of serious or life-threatening conditions in alignment with Saudi Arabia's Vision 2030 initiative which seeks to make Saudi Arabia a global biotech hub. The goal is to ensure that promising medicines are available as soon as it can be concluded that the medicines' benefits justify their risks. Eligible criteria include all four of the following in order to gain a Breakthrough Medicine Designation: Target serious debilitating or life-threatening conditions with unmet medical need. The medicinal product is likely to offer major advantage over methods currently used. The potential adverse effects of the medicinal product are considered to be outweighed by the benefits, allowing for the reasonable expectation of a positive benefit/risk balance. The product is not registered at any regulatory authority at the time of submission of the designation request. Multikine is designed to help the immune system "target" the tumor at a time when the immune system is still relatively intact and thereby thought to be better able to mount an attack on the tumor. Multikine (Leukocytes Interleukin, In 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. Based on the data from the completed randomized controlled Phase 3 study, the FDA concurred with CEL-SCI's target patient selection criteria and gave the go-ahead to conduct a confirmatory Registration Study. The study will enroll 212 newly diagnosed locally advanced primary treatment naive resectable head and neck cancer patients. The Company has operations in Vienna, Virginia, and near/in Baltimore, Maryland. 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 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, inability to finalize a partnering agreement 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 for the year ended September 30, 2024. New Risk • May 15
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$18m 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$18m free cash flow). Share price has been highly volatile over the past 3 months (19% average weekly change). Shareholders have been substantially diluted in the past year (55% increase in shares outstanding). Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable next year (US$22m net loss next year). Market cap is less than US$100m (US$20.3m market cap). Announcement • Apr 23
CEL-SCI Corporation to File for Regulatory Approval of Multikine in Saudi Arabia--Pursuing Local Partnerships for Commercialization and Manufacturing to Serve Middle East and North Africa Market CEL-SCI Corporation announced that it met with the Saudi Food and Drug Authority (SFDA) to discuss the development of Multikine cancer immunotherapy (Leukocyte Interleukin, Injection), the vast amount of Multikine data available to support a marketing application for its use as a treatment of head and neck cancer, and the possible pathways to a marketing application in Saudi Arabia. Based on discussions with the SFDA, CEL-SCI is preparing to submit a regulatory filing for the approval of Multikine as a neoadjuvant (pre-surgical) treatment of newly diagnosed previously untreated locally advanced head and neck cancer. The submission will be made based on all data from CEL-SCI's concluded 928-patient randomized controlled Phase 3 study and is expected to be filed as a Conditional Approval with Breakthrough Therapy designation. The SFDA's usual response time for a complete submission for such an application is thought to be approximately 60 days after filing. The Kingdom of Saudi Arabia's Vision 2030 includes a National Biotechnology Strategy, which is poised to position the Kingdom as a regional and global biotech hub with a far-reaching impact in biomanufacturing and medical innovation. Multikine is designed to help the immune system "target" the tumor at a time when the immune system is still relatively intact and thereby thought to be better able to mount an attack on the tumor. 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. Based on the data from the completed randomized controlled Phase 3 study, the FDA concurred with CEL-SCI's target patient selection criteria and gave the go-ahead to conduct a confirmatory Registration Study. The study will enroll 212 newly diagnosed locally advanced primary treatment naive resectable head and neck cancer patients with no lymph node involvement (determined via PET scan) and with low PD-L1 tumor expression (determined via biopsy), representing about 100,000 patients annually. The Company has operations in Vienna, Virginia, and near/in Baltimore, Maryland. 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 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, inability to raise the necessary Capital, inability to finalize a partnering agreement and the risk factors set out 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 for the year ended September 30, 2024. 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), Multikine (Leukocytes Interleukin, In injection), given right after diagnosis and Before surgery, has been dosed Injection), given right after diagnosed over 740 patients and received Orphan Drug designation from the FDA to neoadjuvant therapy in Patients with squamous cell carcinoma of the head and neck cancer, and to establish a local Multikine manufacturing facility that would serve the entire Middle East and North Africa market. The company envision such a partnership encompassing funding, regulatory support, post-approval commercial launch, and distribution. Announcement • Apr 08
CEL-SCI Corporation Announces Clinical Data from Multikine®? Phase 3 Study and Cancer Cell (2025) CEL-SCI Corporation announced that a study titled "Distinct CD8+ T cell dynamics associate with response to neoadjuvant cancer immunotherapies" by Li Housaiyin et. al., Cancer Cell (2025) provides support for CEL-SCI's approach aimed at seeking early regulatory approval for Multikine (Leukocyte Interleukin, Injection) as a neoadjuvant in the treatment of newly diagnosed previously untreated locally advanced head and neck cancer based on early tumor responses. The concept that tumor responses predict survival has been acknowledged for many cancer types and has led to accelerated approval of many cancer drugs. The study in Cancer Cell, which had 41 evaluable patients, gives further support that this is also true in the neoadjuvant pre-surgical immunotherapy treatment of head and neck cancer. CEL-SCI's 212-patient Confirmatory Registration Study, which has received the FDA's go-ahead, is designed to verify the statistically significant efficacy and safety results from the Company's previously completed Phase 3 randomized controlled Multikine trial. During the Multikine Phase 3 clinical trial, the 5-year survival rate of the target patient population for the confirmatory study increased to 73% when patients were treated with Multikine before surgery vs 45% for control patients who received only the standard of care treatments [Log rank p=0.0015 and a hazard ratio of 0.35 (0.18, 0.65; Wald p=0.0012]. As a neoadjuvant therapy, Multikine is given to patients right after diagnosis, prior to surgery. Multikine is designed to help the immune system "target" the tumor at a time when the immune system is still relatively intact and thereby thought to be better able to mount an attack on the tumor. Multikine (Leukocytes Interleukin, In 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. Based on the data from the completed randomized controlled Phase 3 study, the FDA concurred with CEL-SCI's target patient selection criteria and gave the go-ahead to conduct a confirmatory Registration Study. The study will enroll 212 newly diagnosed locally advanced primary treatment naive resectable head and neck cancer patients with no lymph node involvement (determined via PET scan) and with low PD-L1 tumor expression (determined via biopsy), representing about 100,000 patients annually. The Company has operations in Vienna, Virginia, and near/in Baltimore, Maryland. 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 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, inability to finalize a partnering agreement 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 for the year ended September 30, 2024. Breakeven Date Change • Mar 30
No longer forecast to breakeven The 2 analysts covering CEL-SCI no longer expect the company to break even during the foreseeable future. The company was expected to make a profit of US$473.6m in 2026. New consensus forecast suggests the company will make a loss of US$17.5m in 2026. Announcement • Mar 25
CEL-SCI Corporation Reports New Data: Treatment with Multikine Resulted in Up to 95% Improvement in Quality of Life for Head and Neck Cancer Patients CEL-SCI Corporation announced new data has been published from its prior Phase 3 study of Multikine (Leukocyte Interleukin, Injection) in newly diagnosed, treatment naive, resectable, locally advanced head and neck cancer patients in the highly regarded peer reviewed journal Pathology and Oncology Research (POR). The article titled "Neoadjuvant Leukocyte Interleukin Injection Immunotherapy Improves Overall Survival in Low-risk Locally Advanced Head and Neck Squamous Cell carcinoma -The IT-MATTERS Study" included a comprehensive presentation of results from CEL-SCI's Phase 3 trial, the largest study ever conducted for newly diagnosed locally advanced head and neck cancer. Based on the exceptional efficacy results and favorable safety profile for Multikine in a cohort of patients in the Phase 3 study, the U.S. Food and Drug Administration has given CEL-SCI the go ahead to initiate a confirmatory Registration Study of Multikine in newly diagnosed, previously untreated resectable stage 3 and 4 head and neck cancer patients who had no lymph node involvement and low PD-L1 tumor expression. Upon the Registration Study achieving full enrollment, CEL-SCI plans to seek early approval based on early tumor responses which were shown to correspond with survival rates. During the completed Phase 3 clinical trial, the 5-year overall survival rate of the target patient population (disease stage 3 and 4 patients who had no lymph node involved and low PD-L1 tumors), which is the same population that will participate in the confirmatory study, increased to 73% when patients were treated with Multikine vs 45% for control patients who received only standard of care treatments. Multikine (Leukocytes Interleukin, In 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. Based on the data from the completed randomized controlled Phase 3 study, the FDA concurred with CEL-SCI's target patient selection criteria and gave the go-ahead to conduct a confirmatory Registration Study. The study will enroll 212 newly diagnosed locally advanced primary treatment naive resectable head and neck cancer patients with no lymph node involvement (determined via PET scan) and with low PD-L1 tumor expressions (determined via biopsy), representing about 100,000 patients annually. Factors that could cause or contribute to such differences include an inability to duplicate the clinical 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 for the year ended September 30, 2024. This proprietary name is subject to FDA review in the journal. Announcement • Mar 24
CEL-SCI Corporation, Annual General Meeting, May 19, 2025 CEL-SCI Corporation, Annual General Meeting, May 19, 2025. Location: 8229 boone blvd., vienna, virginia 22182, United States Announcement • Mar 19
CEL-SCI Corporation has completed a Follow-on Equity Offering in the amount of $2.558801 million. CEL-SCI Corporation has completed a Follow-on Equity Offering in the amount of $2.558801 million.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 4,012,500
Price\Range: $0.16
Discount Per Security: $0.0112
Security Name: Pre-Funded Warrants
Security Type: Equity Warrant
Securities Offered: 11,987,500
Price\Range: $0.1599
Discount Per Security: $0.0112 Announcement • Feb 20
CEL-SCI Corporation to Initiate Multikine Confirmatory Phase 3 Cancer Trial CEL-SCI Corporation announced it is in the final stages for the launch of its 212-patient Confirmatory Registration Study for Multikine (Leukocyte Interleukin, Injection) in newly diagnosed locally advanced head and neck cancer patients. This final Registration Study is specifically designed to confirm the statistically significant efficacy and safety results from CEL-SCI's previously completed randomized controlled Phase 3 trial. This new Registration Study targets the population of previously untreated resectable stage 3 and 4 head and neck cancer patients who had no lymph node involvement and low PD-L1 tumor expression. During the completed Phase 3 clinical trial, the 5-year survival rate of the target patient population increased to 73% when patients were treated with Multikine vs 45% for control patients who received only the standard of care treatments. Key aspects of the new Confirmatory Registration Study are as follows: Enlisting clinical sites and investigators in numerous countries across 3 continents; Full enrollment expected by second quarter 2026 with plans to seek early approval at that time based on early tumor responses--Potential to set a new standard of care; FDA concurred with the overall design of the Registration Study in meetings last year; Final clinical protocol submitted to FDA in December 2024; Multikine extended median overall survival by nearly 4 years in prior Phase 3 study; A new model for healthcare--Immunotherapy given before surgery to boost the immune system and make the first cancer treatment more successful - may set the first new standard of care in more than half a century. There were no safety signals identified, Multikine administration did not interfere with disease directed treatment/therapy, and Multikine did not add to the treatment burden imparted by the standard of care. Following the U.S. Food and Drug Administration's (FDA) go-ahead to conduct the Registration Study, CEL-SCI finalized the clinical protocol based on constructive comments from FDA reviewers and senior staff. The final clinical protocol was submitted to the FDA in December 2024. The study is titled: A Phase III, Open Label, Randomized, Controlled, Multi-Center Study of the Effects of Neoadjuvant Leukocyte Interleukin Incjection (LI) Plus Standard of Care Versus Standard of Care Only in Treatment Naive Adults With Resectable Locally Advanced Primary Primary Primary Primary Primary Primary Primary Tumor Programmed Death Ligand 1 Expression (Defined as Tumor Proportion Score <10). Ergomed, the clinical research organization (CRO) for the Registration Study, is currently identifying clinical sites and investigators. Multikine (Leukocytes Interleukin, In 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. Based on the data from the completed randomized controlled Phase 3 study, the FDA concurred with CEL-SCI's target patient selection criteria and gave the go-ahead to conduct a confirmatory Registration Study. The study will enroll 212 newly diagnosed locally advanced primary treatment naive resectable head and neck cancer patients with no lymph node involvement (determined via PET scan) and with low PD-L1 tumor expressions (determined via biopsy), representing about 100,000 patients annually. Factors that could cause or contribute to such differences include an inability to duplicate the clinical results demonstrated in clinical studies, timely development of any potential products that can be shown to be safe and effective, receiving necessary regulatory approvals, and the Company's Phase 3 trial. Announcement • Jan 02
CEL-SCI Corporation has completed a Follow-on Equity Offering in the amount of $4.999442 million. CEL-SCI Corporation has completed a Follow-on Equity Offering in the amount of $4.999442 million.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 7,552,500
Price\Range: $0.31
Discount Per Security: $0.0217
Security Name: Pre-Funded Warrants
Security Type: Equity Warrant
Securities Offered: 8,577,500
Price\Range: $0.3099
Discount Per Security: $0.02169 Announcement • Dec 31
CEL-SCI Corporation announced delayed annual 10-K filing On 12/30/2024, CEL-SCI Corporation announced that they will be unable to file their next 10-K by the deadline required by the SEC. Announcement • Dec 28
CEL-SCI Corporation has filed a Follow-on Equity Offering. CEL-SCI Corporation has filed a Follow-on Equity Offering.
Security Name: Common Stock
Security Type: Common Stock
Security Name: Pre-Funded Warrants
Security Type: Equity Warrant Announcement • Dec 13
CEL-SCI Corporation Highlights Biological Rationale for the Use of Multikine in the Confirmatory Registration Head and Neck Cancer Study CEL-SCI Corporation highlights strong biological rationale for the use of Multikine in the confirmatory registration head and neck cancer study. This study of 212 newly diagnosed locally advanced, resectable head and neck cancer patients was given the go-ahead as a confirmatory registration study by FDA and will focus on those patients who showed a 73% survival with Multikine vs. a 45% for the control patients not treated with Multikine in the prior Phase 3 study. Following these positive results, CEL-SCI conducted a 928-patient randomized controlled Phase 3 clinical trial to confirm Multikine's ability to cause tumor regressions prior to surgery, confirm its safety profile and ultimately longer overall survival versus the standard of care. After this analysis was done and the evidence collected, CEL-SCI presented these selection criteria to FDA. The study will include patients with newly diagnosed locally advanced primary (disease stage III and IVa) head and neck cancer presenting with: No lymph node involvement (N0) (determined via PET imaging) and having low PD-L1 tumor expression (determined via biopsy). Strong statistical significance: Clinical trials are typically designed to detect effects in the overall population, not within subgroups. Multiple comparisons require a higher level of significance. Criticism: When multiple subgroups are analyzed, the probability of finding a significant result by chance increases. It should be noted that at the time of Phase 3 study initiation PD-L1 was not available. However, as the study progressed, the statistical analysis plan (SAP) was updated to specify analysis by cellular markers including tumor PD-L1. Response: The subgroup analyses in the Phase 3 study were pre-specified in the original protocol including analysis of cellular markers; for markers not available at the time of study initiation, analysis by these markers was pre-specified in the SAP (signed and issued prior to database lock). This biological basis is evidenced by the Phase 3 clinical trial results, which showed a higher rate of pre-surgical responses among subjects with lower disease burden. Multikine (Leukocyte Interleukin, Injection), a true first-line cancer therapy, 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. Based on the very strong data from the completed randomized controlled Phase 3 study, the FDA concurred with CEL-SCI's target patient selection criteria and gave the go-ahead to conduct a small, focused, confirmatory Registration Study which will enroll 212 patients. Factors that could cause or contribute to such differences include an inability to duplicate the clinical 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 but but but not only only only only for the control patients who showed a73% survival with Multikine's mechanism of action (MOA). New Risk • Dec 06
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of American stocks, typically moving 10% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risk Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (US$20m net loss in 2 years). Share price has been volatile over the past 3 months (10% average weekly change). Shareholders have been diluted in the past year (28% increase in shares outstanding). Market cap is less than US$100m (US$35.8m market cap). Announcement • Nov 17
CEL-SCI Corporation Names Patricia B. Prichep as Chief Financial Officer CEL-SCI Corporation announced that Patricia B. Prichep, CEL-SCI’s current senior Vice President of Operations, has assumed the duties of CEL-SCI’s Chief Financial and Operations Officer, effective November 13, 2024. Information concerning Ms. Prichep can be found in CEL-SCI’s Proxy Statement relating to its 2024 Annual Meeting of Shareholders, which can be reviewed on the website of the Securities and Exchange Commission. Announcement • Nov 08
U.S. FDA and CEL-SCI Corporation Agree on Use of PD-L1 Biomarker to Select Head and Neck Cancer Patients for Marketing Registration Study to Commence First Quarter 2025 CEL-SCI Corporation announced that in a recent meeting the U.S. Food and Drug Administration (FDA) concurred with the Company’s approach to patient selection using low PD-L1 tumor expression in its confirmatory Registration Study for Multikine (Leukocyte Interleukin, Injection). This study will focus on the treatment of newly diagnosed locally advanced primary head and neck cancer patients with no lymph node involvement and low (TPS <10) PD-L1 tumor expression. This Registration Study, slated to commence in the first quarter of 2025, will enroll approximately 212 patients and prospectively confirm the favorable safety profile and the very favorable efficacy results demonstrated in the target population in CEL-SCI’s prior Phase 3 randomized study of 928 patients. PD-L1 is a widely used biomarker for cancer patient selection for checkpoint inhibitors, a class of cancer drugs representing a $48 billion global market in 2023, led by pembrolizumab (Keytruda) which is the top selling drug in the world with $27 billion in estimated 2024 sales. While checkpoint inhibitors such as nivolumab (Opdivo) and Keytruda appear to work best for patients with high PD-L1 expression, CEL-SCI’s Multikine has been shown to be more effective in patients with low PD-L1 expression, thereby uniquely positioning Multikine as potentially a more effective drug for head and neck patients, in whom about 70% have been shown to have low PD-L1 expression. Since PD-L1 acts as a brake on the immune system, Multikine can activate the immune system to fight cancer better without the interference of PD-L1. Announcement • Sep 16
CEL-SCI Corporation Reports New Data from Its Concluded Phase 3 Study of Multikine® (Leukocyte Interleukin, Injection) CEL-SCI Corporation reported new data from its concluded Phase 3 study of Multikine® (Leukocyte Interleukin, Injection) that were presented at the European Society for Medical Oncology (ESMO) 2024 Congress on September 14, 2024 in a poster titled Prognostic significance of diagnostic staging in treatment naive, resectable locally advanced primary oral cavity squamous cell carcinoma for neoadjuvant Leukocyte Interleukin Injection immunotherapy. This data is highly relevant to CEL-SCI's 212 patient confirmatory Registration Study which has received the U.S. Food and Drug Administration's (FDA) go-ahead and is currently under preparation. Summary of Phase 3 Study: Multikine-treated patients who were recommended treatment of surgery and radiotherapy had a nearly 4-year survival benefit over control group. As previously reported, CEL-SCI’s completed Phase 3 study of 923 patients showed that newly diagnosed head and neck cancer patients who were deemed at low risk for recurrence after surgery (and therefore recommended to receive only radiotherapy after surgery) had a median overall survival (OS) benefit of 46.5-months, almost 4-years, over control patients. However, patients who were deemed to be high risk for recurrence after surgery (and therefore recommended to have chemotherapy added to the radiotherapy after surgery) showed no survival benefit. Upcoming FDA Confirmatory Registration Study: Since the completed Phase 3 study showed clear survival benefit for some, but not all of the patients, the FDA requested that CEL-SCI conduct a confirmatory Registration Study focusing on the patients who showed the best survival benefit. Based on the data, CEL-SCI determined this target population to be patients with newly diagnosed locally advanced primary head and neck cancer with no lymph node involvement and with low PD-L1 tumor expression. Applying these selection criteria to the completed Phase 3 study of 923 patients resulted in the target population (n=114) having a 73% survival at 5 years vs a 45% survival at 5 years for the control patients, log rank p=0.0015. The hazard ratio was an exceptional 0.34, with a 95% confidence interval upper limit of 0.65; Wald p=0.0012 and achieving a 66% reduction in the overall risk of death. Summary of New Data Presented at ESMO: The new data presented at ESMO includes a further analysis of the 114 patients in the completed Phase 3 study who met these target population selection criteria and form the basis for the confirmatory study. Specifically, the new analysis focused on those patients who were deemed low risk for recurrence (recommended to be given only radiotherapy – but no chemotherapy, per National Comprehensive Cancer Network “NCCN” guidelines) following surgery (n=79) as opposed to the selected patients who were deemed high risk for recurrence and who were recommended to have chemotherapy added to their treatment following surgery per the same guidelines (n=35). While the overall survival benefit was clear and statistically significant (log rank p=0.0015) for the entire target population (n=114), the 79 patients who were recommended to receive only radiotherapy benefited to an even greater degree from pre-surgery treatment with Multikine than the group of 114 as a whole. This target low risk population (n=38) had a 5-year overall survival of 82.6% when treated with Multikine vs. 47.3% when treated with standard of care alone (n=41), without overlap in their respective 95% confidence intervals. More recent analysis for the target low risk population (n=79) showed a hazard ratio of 0.27 (95% CI [0.12, 0.64], Wald p=0.0027) achieving a 73% reduction in overall risk of death. Announcement • Sep 05
The UK’s Medicines & Healthcare Products Regulatory Agency Grants CEL-SCI Corporation A Pediatric Waiver, Bringing Multikine One Step Closer to Future Marketing Clearance CEL-SCI Corporation reported it has received a decision letter from the United Kingdom’s Healthcare Products Regulatory Agency granting Multikine (Leukocyte Interleukin, Injection) a product specific waiver for the treatment of head and neck cancer in a pediatric population of people up to 18 years of age. As a result, CEL-SCI will not be required to evaluate Multikine in a pediatric population as part of license and marketing clearance review in the UK. Announcement • Jul 30
CEL-SCI Corporation has completed a Follow-on Equity Offering in the amount of $10.7737 million. CEL-SCI Corporation has completed a Follow-on Equity Offering in the amount of $10.7737 million.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 3,715,000
Price\Range: $1
Discount Per Security: $0.07
Security Name: Pre-Funded Warrants
Security Type: Equity Warrant
Securities Offered: 7,130,000
Price\Range: $0.99
Discount Per Security: $0.07 Announcement • Jul 27
CEL-SCI Corporation has filed a Follow-on Equity Offering in the amount of $10.845 million. CEL-SCI Corporation has filed a Follow-on Equity Offering in the amount of $10.845 million.
Security Name: Common Stock
Security Type: Common Stock
Security Name: Pre-Funded Warrants
Security Type: Equity Warrant Announcement • Jul 26
CEL-SCI Corporation Announces Phase 3 Population Analysis for Upcoming Confirmatory Registration Study in Head & Neck Cancer CEL-SCI Corporation reported positive results from a bias analysis conducted for its concluded Phase 3 study of Multikine (Leukocyte Interleukin, Injection) in the treatment of head and neck cancer. Conducting a bias analysis is a standard process used to identify, assess, and address potential sources of bias that could influence the outcomes and interpretations of study results. The goal of a bias analysis is to ensure that the trial's findings are reliable, the conclusions are valid, and to minimize the risk that bias has distorted the results. As such, the study data are reliably interpretable, statistically significant and have been shown to support the clinical effect of neoadjuvant (pre-surgery) Multikine immunotherapy in extending the life of these patients in the Phase 3 study. This is critically important information because CEL-SCI, with the FDA's agreement, will be conducting a 212-patient confirmatory registration study for Multikine. The target population for the confirmatory study shows a 5-year survival in advanced primary head and neck cancer of 73% in Multikine treated patients vs. 45% survival in the control. The bias analysis was conducted for the entire Phase 3 study population of 923 patients with newly diagnosed resesectable, locally advanced primary head and neck cancer, as well as the subgroup of 114 patients who had no lymph node involvement and had low PD-L1 tumor expression (determined via biopsy), the target population for CEL-SCI's upcoming confirmatory registration study. Announcement • Jul 08
CEL-SCI Corporation Appoints Robert Watson as Chairperson of the Board CEL-SCI Corporation announced that Robert Watson, who has served as a Director of the Company since 2017, has been appointed Chairperson of the Board. Bob is an accomplished business leader who began his career as an investment banker. With over four decades of experience across various healthcare markets, Bob brings extensive expertise in capital formation strategies and partnerships to drive an efficient capital structure. During his career as CEO or President of private and publicly traded companies in the healthcare sector, Bob negotiated over a half dozen exits and more than $750 million in capital transactions including IPOs, secondary offerings, and debt instruments. Based on robust efficacy and safety data in over 750 patients for its immunotherapy drug, Multikine, CEL-SCI received the U.S. Food and Drug Administration’s go-ahead to conduct a confirmatory Registration Study for the treatment of newly diagnosed advanced primary head and neck cancer. Multikine, a true first-line cancer therapy, significantly extended life in its target patient population demonstrating a 73% survival rate with Multikine vs. only 45% without at 5 years after treatment. The small, focused, confirmatory Registration Study will enroll only 212 patients with a high unmet need for an estimated 100,000 patients annually. Announcement • Jul 03
CEL-SCI Corporation(NYSEAM:CVM) dropped from Russell 3000E Value Index CEL-SCI Corporation(NYSEAM:CVM) dropped from Russell 3000E Value Index New Risk • May 17
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$20m 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$20m free cash flow). Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (US$22m net loss in 2 years). Share price has been volatile over the past 3 months (11% average weekly change). Shareholders have been diluted in the past year (21% increase in shares outstanding). Market cap is less than US$100m (US$75.6m market cap). Board Change • Apr 30
Less than half of directors are independent Following the recent departure of a director, there is only 1 independent director on the board. The company's board is composed of: 1 independent director. 3 non-independent directors. Independent Director Bruno Baillavoine was the last independent director to join the board, commencing their role in 2015. The company's minority of independent directors is a risk according to the Simply Wall St Risk Model. Breakeven Date Change • Apr 15
No longer forecast to breakeven The 2 analysts covering CEL-SCI no longer expect the company to break even during the foreseeable future. The company was expected to make a profit of US$473.6m in 2026. New consensus forecast suggests the company will make a loss of US$17.5m in 2026. New Risk • Mar 23
New minor risk - Market cap size The company's market capitalization is less than US$100m. Market cap: US$98.8m This is considered a minor risk. Companies with a small market capitalization are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. Currently, the following risks have been identified for the company: Major Risk Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable next year (US$34m net loss next year). Shareholders have been diluted in the past year (23% increase in shares outstanding). Market cap is less than US$100m (US$98.8m market cap). Announcement • Mar 08
CEL-SCI Corporation, Annual General Meeting, Apr 19, 2024 CEL-SCI Corporation, Annual General Meeting, Apr 19, 2024, at 10:00 US Eastern Standard Time. Location: Hilton McLean Tysons Corner located at 7920 Jones Branch Drive McLean, VA 22102 Mc Lean Virginia United States Agenda: To consider election of the directors who shall constitute company’s board of directors for the ensuing year; to consider and approve the adoption of company’s 2024 non-qualified stock option plan; to ratify the appointment of bdo usa, p.c. as company’s independent registered public accounting firm for the fiscal year ending September 30, 2024; and to consider other matters. Announcement • Feb 09
CEL-SCI Corporation has filed a Follow-on Equity Offering in the amount of $7.75 million. CEL-SCI Corporation has filed a Follow-on Equity Offering in the amount of $7.75 million.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 3,875,000
Price\Range: $2
Discount Per Security: $0.14 Announcement • Nov 21
CEL-SCI Corporation has completed a Follow-on Equity Offering in the amount of $4.98 million. CEL-SCI Corporation has completed a Follow-on Equity Offering in the amount of $4.98 million.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 2,490,000
Price\Range: $2
Discount Per Security: $0.14 Announcement • Nov 18
CEL-SCI Corporation has filed a Follow-on Equity Offering in the amount of $4.98 million. CEL-SCI Corporation has filed a Follow-on Equity Offering in the amount of $4.98 million.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 2,490,000
Price\Range: $2
Discount Per Security: $0.14 Announcement • Oct 26
CEL-Sci Corporation Releases Video Detailing Recent Phase 3 Findings & Its Plans to Seek Immediate Regulatory Approvals CEL-SCI Corporation released a video presentation in which the Company's CEO, Geert Kersten, shares the most recent data presented at the European Society for Medical Oncology (ESMO) Congress and the data's impact on propelling the Company's immunotherapy drug Multikine (Leukocyte Interleukin, Injection) toward regulatory approval for the treatment of newly diagnosed, advanced squamous cell carcinoma of the head and neck (SCCHN). Mr. Kersten carefully explains how it is that patients in the target group who were treated with Multikine had a 5-year survival rate of 73% as compared to only 45% for those who did not receive Multikine, cutting the risk of death by half. He goes on to present CEL-SCI's regulatory submissions plan and timelines based on these compelling findings for a patient population that has not had a new treatment approved in the U.S. in many decades. Summary of Multikine Results in the Target Population: 73% survival for Multikine vs 45% in the control at 5 years; 28% absolute survival benefit; Statistically significant p=.0015 and hazard ratio = 0.35; Tumor reduction rate >13% and tumor downstaging >35%; No safety signals or toxicities vs standard of care; Target population of an estimated 145,000 patients (global, annual) who present with: No nodal involvement and no extracapsular spread; Low PD-L1 tumor expression (different from high PD-L1 targeted by checkpoint inhibitors); Physicians routinely assess these features at baseline; no extra tests needed; These features make it easy to write a label for the approval of Multikine, which is essential for drug approval. Announcement • Oct 24
CEL-SCI Presents the Data for the First Time at the European Society for Medical Oncology Congress in Spain CEL-SCI presented the data for the first time at the European Society for Medical Oncology (ESMO) Congress in Spain on October 22, 2023. The selection criteria for this target population were developed based on the completed Phase 3 randomized controlled trial, advice from regulators, and advice from physician consultants associated with the University of California San Diego Cancer Center and Yale Medical School, recognized as among the nation's most esteemed immuno-oncologists in head and neck cancer. This is a new sign of hope for head and neck cancer patients and a critical milestone for Multikine towards achieving regulatory approval. Because Multikine is a neoadjuvant (pre-surgical) immunotherapy, identifying patients who benefit from Multikine upon diagnosis was very difficult, and welcomed the assistance of regulators and expert physician consultants to help. Patients with this disease have a clear unmet medical need for better outcomes. Multikine's demonstrated effects in the new intended target population are overwhelmingly large and strong as a statistical matter and support the observed Multikine efficacy. While Multikine has not yet been tested prospectively in the new target population, the Phase 3 data present a compelling case for immediate patient access to Multikine because the Phase 3 study results showed prospectively that Multikine led to pre-surgical responses which in turn led to longer life. Regulators understand that patients should not have to wait before gaining access to these benefits, particularly given Multikine's safety profile and data that mechanistically and empirically supports the target population definition. There are specific pathways in Europe, the UK, Canada, and the U.S. for such approvals, and are currently working towards this goal. Most other cancer immunotherapies are administered only after conventional therapies have been tried and/or failed. Multikine (Leukocyte Interleukin, Injection) received Orphan Drug designation from the FDA for neoadjuvant therapy in patients with squamous cell carcinoma (cancer) of the head and neck. Multikine is designed to help the immune system "target" the tumor at a time when the immune system is still relatively intact and thereby thought to be better able to mount an attack on the tumor. CEL-SCI has completed a 928 patient Phase 3 clinical trial in locally advanced primary head and neck cancer patients. The Company has operations in Vienna, Virginia, and near/in Baltimore, Maryland. Such statements include, but are not limited to, statements about the terms, expected proceeds, use of proceeds, use of proceeds and closing of the offering. Factors that could cause or contribute to such differences include an inability to duplicate the clinical 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 for the year ended September 30, 2022. 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 unmet medical need for the approval of Multikine. New Risk • Oct 24
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of American stocks, typically moving 16% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. 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$23m free cash flow). Share price has been highly volatile over the past 3 months (16% average weekly change). Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (US$24m net loss in 2 years). Shareholders have been diluted in the past year (9.0% increase in shares outstanding). Market cap is less than US$100m (US$71.4m market cap). Announcement • Oct 06
Cel-Sci Files Request with the Uk's Mhra Regarding Path to Approval for Multikine in the Treatment of Head & Neck Cancer CEL-SCI Corporation reported it has filed a request with the United Kingdom's Medicines and Healthcare Products Regulatory Agency (MHRA) to discuss a pathway for approval of Multikine (Leukocyte Interleukin, Injection) immunotherapy for the treatment of newly diagnosed head and neck cancer. At the meeting, CEL-SCI will present MHRA with new results that demonstrate pre-surgical response rates and overall survival advantages that are superior to those published by CEL-SCI previously. These new results arose from an improved selection algorithm of the Multikine target population. The improvements in the selection algorithm were based on discussions and feedback from regulators and consultants. This pathway would allow CEL-SCI to request immediate approval based on the data generated to date, and any additional studies if needed would be done post-market. With the European Medicines Agency and the MHRA, company hope to do the same. The company's pivotal Phase 3 study tested Multikine in newly diagnosed locally advanced head and neck cancer patients. The study demonstrated a nearly 4-year median overall survival benefit for Multikine treated patients who were treated with surgery and radiotherapy versus the control group who did not receive Multikine. The dire need for a new and effective treatment for newly diagnosed locally advanced primary head and neck cancer is widely recognized in the medical community. Announcement • Sep 27
Cel-Sci Submits Scientific Advice Filing to European Medicines Agency (Ema) for Multikine in the Treatment of Head & Neck Cancer CEL-SCI Corporation reported it has filed a request for Scientific Advice regarding Multikine* (Leukocyte Interleukin, Injection) immunotherapy for the treatment of newly diagnosed locally advanced squamous cell carcinoma of the head and neck (SCCHN) with the European Medicines Agency’s (EMA’s) Scientific Advice Working Group. Europe is a high priority market for CEL-SCI, as Europe has 150,000 new annual cases of head and neck cancer, more than twice the 68,000 cases diagnosed each year in the U.S. Announcement • Jul 13
CEL-SCI Corporation Reports Phase 3 Tumor PD-L1 Biomarker Data Demonstrate Multikine’s Increased Efficacy and Points to Potential for Combination with Checkpoint Inhibitors for Head & Neck Cancer CEL-SCI Corporation announced new data from a biomarker analysis of its pivotal Phase 3 study in newly diagnosed locally advanced squamous cell carcinoma of the head and neck (SCCHN) at the American Head and Neck Cancer Society’s (AHNS) 11th Annual International Conference on Head and Neck Cancer on July 10, 2023 in Montreal, Canada, in the presentation titled “Tumor cell PD-L1 biomarker confirms Leukocyte Interleukin Injection (LI) treatment (Tx) survival outcome advantage in naïve locally advanced primary head & neck squamous cell carcinoma (SCCHN), the IT-MATTERS Study”. The Leukocyte Interleukin Injection (LI) [aka Multikine*] talk, was delivered by Philip Lavin, PhD, lead biostatistician for over 80 regulatory approvals/clearances who has also served on multiple U.S. Food and Drug Administration (FDA) review panels. Dr. Lavin is the lead biostatistician for CEL-SCI’s IT-MATTERS study. Tumor cell PD-L1, also known as PD-L1 (Programmed Death-Ligand 1), a protein that plays a crucial role in immune system regulation, is a target pathway for immune checkpoint inhibitors, a major class of oncology drugs. These work by blocking the interaction between tumor cell PD-L1 and the PD-1 receptor. The global PD-L1/PD-1 therapeutics market was valued at $34.8 billion in 2022 and includes two drugs approved for head and neck cancer, specifically unresectable recurrent or metastatic SCCHN, Keytruda and Opdivo. While pembrolizumab (Keytruda) and nivolumab (Opdivo) are approved for use in recurrent and metastatic head and neck cancer, CEL-SCI’s Phase 3 data showed that Multikine prolonged overall survival in the lower risk for recurrence advanced primary head and neck cancer patients and more so in a subset comprising >70% of the lower-risk patients (all had low levels (defined as TPS<10) of tumor cell PD-L1 expression). The AHNS presentation focused on biomarker analysis, specifically featuring tumor cell PD-L1, from tumor specimens that were collected from nearly half of the patients in CEL-SCI’s pivotal Phase 3 study. In June of 2021, a Multikine study reported a statistically significant 14.1% absolute 5-year overall survival benefit in the intent to treat (ITT; n=923) subjects who were categorized as lower risk for recurrence (LR; n=380) per National Comprehensive Cancer Network (NCCN) guidelines and received Multikine followed by surgery and radiotherapy, as compared to control LR subjects who received only standard of care (SOC) (surgery plus radiotherapy), resulting in a near 4-year median overall survival advantage over control (101.7 vs 55.2 months). The Company is pursuing paths to marketing approval for Multikine in the treatment of head and neck cancer in the USA, Canada, the UK and the European Union. Highlights of the data they presented at AHNS conference include: A Kaplan-Meier lifetable for low tumor cell PD-L1 (defined as TPS <10) demonstrated a significant log rank test (2-sided p=0.034) favoring the Multikine plus Standard of care (SOC) group vs SOC alone; there was an absolute 20% survival advantage at 5-year favoring both Multikine plus SOC (~60% alive) vs SOC alone (~40% alive). The PD-L1 low subgroup represents >70% of all LR subjects. Two-way and three-way interaction models for the LR population confirmed statistical significance favoring Multikine treatment regimen plus SOC vs SOC alone with a 0.6 hazard ratio for 3-way interaction and a 0.55 hazard ratio for the 2-way interaction vs 0.68 hazard ratio for the study LR population that contained all patients, not just those with low PD-L1 (TPS <10). The data suggest potential benefits for combining Multikine with checkpoint inhibitors to further improve overall survival outcome in this hard-to-treat patient population. New Risk • Jun 28
New minor risk - Market cap size The company's market capitalization is less than US$100m. Market cap: US$99.7m This is considered a minor risk. Companies with a small market capitalization are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. 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$23m free cash flow). Earnings are forecast to decline by an average of 3.1% per year for the foreseeable future. Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$56m net loss in 3 years). Share price has been volatile over the past 3 months (11% average weekly change). Shareholders have been diluted in the past year (3.2% increase in shares outstanding). Market cap is less than US$100m (US$99.7m market cap). Announcement • Jun 24
CEL-SCI Corporation to Present Novel Data at AHNS 11th International Conference on Head and Neck Cancer--New Patent to Be Filed CEL-SCI Corporation announced it will present the new data from its pivotal Phase 3 study, the largest study ever conducted in newly diagnosed locally advanced squamous cell carcinoma of the head and neck (SCCHN), at the American Head and Neck Cancer Society’s (AHNS) 11th Annual International Conference on Head and Neck Cancer on July 8-12, 2023 in Montreal, Canada. CEL-SCI’s IT-MATTERS pivotal Phase 3 study reported a statistically significant 14.1% absolute 5-year overall survival (OS) benefit in the intent to treat (ITT) subjects who received Multikine followed by surgery and radiotherapy, as compared to control subjects who received only standard of care (SOC) (surgery plus radiotherapy). The Company is pursuing marketing approval for Multikine in the treatment of head and neck cancer in the U.S., Canada and the European Union. Announcement • May 16
CEL-SCI Corporation Announces Latest Results from Its Pivotal Phase 3 Study of Multikine CEL-SCI Corporation announced that the latest results from its pivotal Phase 3 study of Multikine, a presurgical cancer immunotherapy, were presented at the European Society for Radiotherapy and Oncology (ESTRO) 2023 Congress in Vienna, Austria in a poster presentation titled “Histopathology population (HPP) confirms Multikine* [Leukocyte Interleukin Injection (LI)] treatment (Tx) outcome in naïve locally advanced primary head & neck squamous cell carcinoma SCCHN)” during the Head & Neck Cancer Session on May 13, 2023. CEL-SCI’s IT-MATTERS pivotal Phase 3 study, the largest study ever conducted in newly diagnosed locally advanced squamous cell carcinoma of the head and neck, reported a statistically significant 14.1% absolute 5-year overall survival benefit in the intent to treat (ITT) subjects who were categorized as lower risk to recurrence (LR) per National Comprehensive Cancer Network (NCCN) guidelines and received Multikine followed by surgery and radiotherapy, as compared to control LR subjects who received only standard of care (SOC) (surgery plus radiotherapy). The ESTRO presentation focused on pathology analysis of Phase 3 patients’ tumors at surgery. In summary, it confirmed that Multikine pre-surgery treatment led to significant changes in the tumors of the patients treated with Multikine and that these changes were not seen in control patients who did not get Multikine. The tumor tissue and biomarker analyses demonstrated that these changes were statistically significant and important in bringing about the beneficial responses seen. The tumor and tumor microenvironment changes induced by Multikine explain the increased survival, improved progression free survival, and improved local regional control, as well as the significantly lowered death rate compared to control subjects in the study. These findings from the Phase 3 study also confirm Multikine’s mechanism of action which was previously determined from samples collected during Phase 2 studies from Multikine treated subjects. The results from the Phase 2 studies were previously reported in the Journal of Clinical Oncology(Timar et al). The ESTRO presentation reported that patient responses to Multikine were determined following 3 weeks of Multikine treatment by comparing baseline tumor/lymph node measurements at screening (per RECIST) with tumor/lymph node measurements made just prior to and confirmed by pathology following surgery. Histopathology (HP) samples (n=453), were representative of the study ITT population (n=923) in all manner of subjects’ characteristics, and showed that: Multikine treated subjects had a different tumor and tumor microenvironment cellular profile at surgery than that exhibited by SOC (control) treated subjects. This was determined by pathologists who were blinded to the study using predefined low/high thresholds for 20 biomarkers (5 tumor, 15 tumor microenvironment). The histopathology analysis showed association with improved overall survival, progression free survival and local regional control that significantly favored Multikine-treated [(61/279 or 21.9% >> 2.5% by chance alone) vs SOC-treated (5/279 (or 1.9% < 2.5% by chance alone)] (conditional binomial; p<0.0001). HP LR Multikine-treated vs HP LR SOC 5-year efficacy measures of success were: Overall Survival of 63.9% vs 44.4% (hazard ratio: 0.64 [95% CI 0.41, 1.01]), Progression Free Survival of 56.9% vs 41.1% (hazard ratio 0.67 [95% CI 0.44, 1.02]), Local Regional Control of 73.1% vs 63.6% (hazard ratio 0.62 [95% CI 0.35,1.09]), HP LR Multikine-treated subjects had a significantly lower (39.1% [45/115]) death rate versus a 53.7% (51/95) death rate for HP LR SOC alone (two-sided Fisher Exact Test p=0.038), These statistical results for the HP LR analyzed subjects are supportive of the efficacy advantages demonstrated for LR Multikine-treated vs LR SOC alone treated patients in the Phase 3 study. Breakeven Date Change • Feb 28
No longer forecast to breakeven The 2 analysts covering CEL-SCI no longer expect the company to break even during the foreseeable future. The company was expected to make a profit of US$143.7m in 2024. New consensus forecast suggests the company will make a loss of US$61.9m in 2025. Breakeven Date Change • Feb 19
Forecast breakeven date moved forward to 2023 The analyst covering CEL-SCI previously expected the company to break even in 2024. New forecast suggests the company will make a profit of US$17.1m in 2023. Price Target Changed • Feb 17
Price target decreased by 23% to US$11.50 Down from US$15.00, the current price target is an average from 2 analysts. New target price is 278% above last closing price of US$3.04. Stock is down 43% over the past year. The company is forecast to post earnings per share of US$0.29 next year compared to a net loss per share of US$0.87 last year. Major Estimate Revision • Jan 04
Consensus revenue estimates fall by 33% The consensus outlook for revenues in 2023 has deteriorated. 2023 revenue forecast decreased from US$30.4m to US$20.4m. Forecast loss of -US$0.19, down from profit of US$0.02 per share profit previously. Biotechs industry in the US expected to see average net income decline 82% next year. Consensus price target down from US$15.00 to US$14.50. Share price rose 13% to US$2.56 over the past week. Breakeven Date Change • Dec 29
Forecast breakeven date pushed back to 2024 The 2 analysts covering CEL-SCI previously expected the company to break even in 2023. New consensus forecast suggests losses will reduce by 20% to 2023. The company is expected to make a profit of US$143.3m in 2024. Average annual earnings growth of 64% is required to achieve expected profit on schedule. Price Target Changed • Nov 16
Price target increased to US$15.00 Up from US$12.00, the current price target is an average from 2 analysts. New target price is 372% above last closing price of US$3.18. Stock is down 71% over the past year. The company is forecast to post a net loss per share of US$0.83 next year compared to a net loss per share of US$0.90 last year. Breakeven Date Change • Aug 25
Forecast breakeven date pushed back to 2024 The 2 analysts covering CEL-SCI previously expected the company to break even in 2023. New consensus forecast suggests losses will reduce by 46% per year to 2023. The company is expected to make a profit of US$144.1m in 2024. Average annual earnings growth of 71% is required to achieve expected profit on schedule. Price Target Changed • Apr 27
Price target increased to US$15.00 Up from US$12.00, the current price target is an average from 2 analysts. New target price is 447% above last closing price of US$2.74. Stock is down 89% over the past year. The company is forecast to post a net loss per share of US$0.60 next year compared to a net loss per share of US$0.90 last year. Board Change • Apr 27
Insufficient new directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 2 experienced directors. 2 highly experienced directors. Independent Director Bob Watson was the last director to join the board, commencing their role in 2017. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model. Recent Insider Transactions • Oct 22
Chief Scientific Officer recently sold US$169k worth of stock On the 19th of October, Eyal Talor sold around 15k shares on-market at roughly US$11.25 per share. This was the largest sale by an insider in the last 3 months. Insiders have been net sellers, collectively disposing of US$218k more than they bought in the last 12 months. Price Target Changed • Aug 24
Price target decreased to US$12.00 Down from US$18.50, the current price target is provided by 1 analyst. New target price is 20% above last closing price of US$10.02. Stock is down 23% over the past year. Breakeven Date Change • Jul 01
Forecast breakeven pushed back to 2023 The analyst covering CEL-SCI previously expected the company to break even in 2022. New forecast suggests losses will reduce by 34% per year to 2022. The company is expected to make a profit of US$43.8m in 2023. Average annual earnings growth of 101% is required to achieve expected profit on schedule. Recent Insider Transactions • Apr 24
Insider recently sold US$244k worth of stock On the 22nd of April, John Cipriano sold around 10k shares on-market at roughly US$24.38 per share. This was the largest sale by an insider in the last 3 months. Insiders have been net sellers, collectively disposing of US$307k more than they bought in the last 12 months. Is New 90 Day High Low • Jan 28
New 90-day high: US$26.54 The company is up 111% from its price of US$12.55 on 29 October 2020. The American market is up 21% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Biotechs industry, which is up 28% over the same period. Analyst Estimate Surprise Post Earnings • Dec 31
Earnings beat expectations, revenue disappoints Revenue missed analyst estimates by 6.9%. Earnings per share (EPS) exceeded analyst estimates by 6.5%. Over the next year, revenue is forecast to grow 1,636%, compared to a 509% growth forecast for the Biotechs industry in the US. Reported Earnings • Dec 31
Full year 2020 earnings released: US$0.82 loss per share Full year 2020 results: Net loss: US$30.3m (loss widened 37% from FY 2019). Over the last 3 years on average, earnings per share has increased by 38% per year but the company’s share price has increased by 84% per year, which means it is tracking significantly ahead of earnings growth. Recent Insider Transactions Derivative • Nov 18
Insider notifies of intention to sell stock John Cipriano intends to sell roughly 10.00k shares in the next 90 days after lodging an Intent To Sell Form on the 13th of November. If the sale is conducted around the recent share price of US$12.80, it would amount to US$128k. Since December 2019, John has owned 83.11k shares directly. Company insiders have collectively bought US$67k more than they sold, via options and on-market transactions, in the last 12 months. Recent Insider Transactions • Nov 18
Insider recently sold US$127k worth of stock On the 13th of November, John Cipriano sold around 10k shares on-market at roughly US$12.73 per share. This was the largest sale by an insider in the last 3 months. Despite this recent sale, insiders have collectively bought US$67k more than they sold in the last 12 months. Is New 90 Day High Low • Nov 03
New 90-day low: US$11.56 The company is down 4.0% from its price of US$12.04 on 04 August 2020. The American market is flat over the last 90 days, indicating the company underperformed over that time. However, its price trend is similar to the Biotechs industry, which is also down 4.0% over the same period. Is New 90 Day High Low • Oct 08
New 90-day high: US$14.51 The company is up 1.0% from its price of US$14.30 on 10 July 2020. The American market is up 7.0% over the last 90 days, indicating the company underperformed over that time. However, it outperformed the Biotechs industry, which is down 3.0% over the same period.