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What changed in CEL SCI CORP's 10-K — 2024 vs 2025

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Paragraph-level year-over-year comparison of CEL SCI CORP's 2024 and 2025 10-K annual filings, covering the Business, Risk Factors, Legal Proceedings, Cybersecurity, MD&A and Market Risk sections. Every new, removed and edited paragraph is highlighted side-by-side so you can see exactly what management changed in the 2025 report.

+133 added−122 removedSource: 10-K (2025-12-29) vs 10-K (2025-01-13)

Top changes in CEL SCI CORP's 2025 10-K

133 paragraphs added · 122 removed · 100 edited across 5 sections

Item 1. Business

Business — how the company describes what it does

68 edited+17 added−15 removed136 unchanged
Biggest changeMultikine’s proposed indication is a pre-surgical treatment in head & neck cancer, where no drug is currently approved. · Multikine’s Target Population : The confirmatory registration study will focus on newly diagnosed locally advanced primary head and neck cancer patients with no lymph node involvement (determined via PET scan) and with low PD-L1 tumor expression (determined via biopsy). · FDA pathway : CEL-SCI is aiming to begin enrollment for a 212-patient confirmatory registration study in Q1 2025, with full enrollment expected in Q2 2026 with the potential to seek early approval after full enrollment.
Biggest changeThe Hazard ratio is 0.35 with an upper limit (95% Confidence interval) of 0.66. · Addressing an unmet medical need : Multikine focuses on the 70% of patients (based on our 928 patient Phase III study) not well served by Keytruda or by other immune checkpoint inhibitors, at present. · Multikine’s Target Population : The confirmatory registration study will focus on newly diagnosed locally advanced primary head and neck cancer patients with no lymph node involvement (determined via PET scan) and with low PD-L1 tumor expression (determined via biopsy). · FDA pathway : CEL-SCI’s goal is to begin the 212-patient confirmatory registration study as soon as the needed capital has been raised, with full enrollment about 15 months later with the potential to seek early approval after full enrollment. 11 CORPORATE HISTORY CEL-SCI was formed as a Colorado corporation in 1983.
The planned confirmatory study will be much smaller—less than a quarter the size of the prior study— and will focus on the patients who saw the greatest survival benefit when treated with Multikine. Why Do We Believe Our Confirmatory Study Will Be Successful? 10 An “unmet need” is a factor for approval considered by all major regulatory bodies worldwide.
The planned confirmatory study will be much smaller—less than a quarter the size of the prior study— and will focus on the patients who saw the greatest survival benefit when treated with Multikine. 10 Why Do We Believe Our Confirmatory Study Will Be Successful? An “unmet need” is a factor for approval considered by all major regulatory bodies worldwide.
Source: Adapted from Timar et al., Journal of Clinical Oncology 23(15) May 20, 2005 12 The first indication CEL-SCI is pursuing for its investigational drug product candidate Multikine is an indication for the neoadjuvant therapy in patients with squamous cell carcinoma of the head and neck, or SCCHN (hereafter also referred to as advanced primary head and neck cancer).
Source: Adapted from Timar et al., Journal of Clinical Oncology 23(15) May 20, 2005 The first indication CEL-SCI is pursuing for its investigational drug product candidate Multikine is an indication for the neoadjuvant therapy in patients with squamous cell carcinoma of the head and neck, or SCCHN (hereafter also referred to as advanced primary head and neck cancer).
Multiple Phase II clinical trials may be conducted to obtain information prior to beginning larger and more expensive Phase III clinical trials. 19 · Phase III — The investigational product is administered to an expanded patient population to further evaluate dosage, to provide statistically significant evidence of clinical efficacy and to further test for safety, generally at multiple geographically dispersed clinical trial sites.
Multiple Phase II clinical trials may be conducted to obtain information prior to beginning larger and more expensive Phase III clinical trials. · Phase III — The investigational product is administered to an expanded patient population to further evaluate dosage, to provide statistically significant evidence of clinical efficacy and to further test for safety, generally at multiple geographically dispersed clinical trial sites.
The work was performed in conjunction with researchers at Rush University Medical Center, Chicago, Illinois and was funded by the SBIR Phase 2 Grant. 15 In July 2019, one of CEL-SCI’s collaborators from Rush, Dr. Adrienn Markovics presented new LEAPS data at i-Chem2019, International Conference on Immunity and Immunochemistry.
The work was performed in conjunction with researchers at Rush University Medical Center, Chicago, Illinois and was funded by the SBIR Phase 2 Grant. In July 2019, one of CEL-SCI’s collaborators from Rush, Dr. Adrienn Markovics presented new LEAPS data at i-Chem2019, International Conference on Immunity and Immunochemistry.
The goal is to help the intact immune system recognize and kill the tumor micro metastases that usually cause recurrence of the cancer. In short, CEL-SCI believes that the local administration of Multikine before weakening of the immune system by surgery and radiation will result in better anti-tumor response than if Multikine were administered after surgery and radiation.
The goal is to help the intact immune system recognize and kill the tumor micro metastases that usually cause recurrence of the cancer. In short, CEL-SCI believes that the local administration of Multikine before weakening of the immune system by surgery and radiation (+/- chemotherapy) will result in better anti-tumor response than if Multikine were administered after surgery and radiation.
FDA, Health Canada, European Medicine Agency (EMA) and the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom (UK) all have conditional approval pathways designed for situations where the target population has not been fully tested prospectively and there is strong data supporting clinical benefit for patients.
FDA, Health Canada, European Medicines Agency (EMA) and the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom (UK) all have conditional approval pathways designed for situations where the target population has not been fully tested prospectively and there is strong data supporting clinical benefit for patients.
The reason is that regulators understand that in many cases patients should not have to wait for additional data before being offered the chance to benefit from a new drug, especially if the drug has shown to be safe. Every situation is different and depends on the specific facts.
The reason is that regulators understand that in many cases patients should not have to wait for additional data before being offered the chance to benefit from a new drug, especially if the drug has been shown to be safe. Every situation is different and depends on the specific facts.
As part of the follow-up to the grant funded work, CEL-SCI published a review comparing CEL-4000 and the new LEAPS peptide CEL-5000 to both the Janus kinase (JAK) inhibitors and disease modifying anti-rheumatic drugs (DMARDs) in use for RA and autoimmune arthritis.
As part of the follow-up to the grant funded work, CEL-SCI published a review comparing CEL-4000 and the new LEAPS peptide CEL-5000 to both the Janus kinase (JAK) inhibitors and disease modifying anti-rheumatic drugs (DMARDs) in use for Rheumatoid Arthritis (RA) and autoimmune arthritis.
Under the goals and policies agreed to by the FDA under the Prescription Drug User Fee Act, or PDUFA, for original BLAs, the FDA’s goal is to review the BLA within ten months after it accepts the application for filing, or, if the product relates to an unmet medical need in a serious or life-threatening indication and has received a priority review designation, six months after the FDA accepts the application for filing. 20 After filing the marketing application, the FDA reviews a BLA to determine, among other things, whether a product is safe, pure and potent and the facility in which it is manufactured, processed, packed, or held meets standards designed to assure the product’s continued safety, purity and potency.
Under the goals and policies agreed to by the FDA under the Prescription Drug User Fee Act, or PDUFA, for original BLAs, the FDA’s goal is to review the BLA within ten months after it accepts the application for filing, or, if the product relates to an unmet medical need in a serious or life-threatening indication and has received a priority review designation, six months after the FDA accepts the application for filing. 21 After filing the marketing application, the FDA reviews a BLA to determine, among other things, whether a product is safe, pure and potent and the facility in which it is manufactured, processed, packed, or held meets standards designed to assure the product’s continued safety, purity and potency.
Therefore, no bias was found, which supports confidence in Multikine’s efficacy results. 8 These positive survival outcomes—increased overall survival, reduced risk of death, widely separated Kaplan-Meier curves with early separation, low hazard ratio, low p-values, low confidence intervals—CEL-SCI believes were driven by high PSR/PSD rates in the target population, as shown in the graphic below: CEL-SCI relies on all of these data together to support its plan to request accelerated/conditional approval in the new target population without waiting until the completion of another clinical trial.
Therefore, no bias was found, which supports confidence in Multikine’s efficacy results. 9 These positive survival outcomes—increased overall survival, reduced risk of death, widely separated Kaplan-Meier curves with early separation, low hazard ratio, low p-values, low confidence intervals—CEL-SCI believes were driven by high PSR/PSD rates in the target population, as shown in the graphic below: CEL-SCI relies on all of these data together to support its plan to request accelerated/conditional approval in the new target population without waiting until the completion of another clinical trial.
The likelihood of living at least five years is shown in the graphic below for patients with PSR (blue), patients with PSD (orange) and control patients who did not receive Multikine (gray). 6 Multikine cut the 5-year risk of death in half in the target population.
The likelihood of living at least five years is shown in the graphic below for patients with PSR (blue), patients with PSD (orange) and control patients who did not receive Multikine (gray). Multikine cut the 5-year risk of death in half in the target population.
Orphan Drug Designation Under the Orphan Drug Act, the FDA may grant orphan drug designation to drugs or biologics intended to treat a rare disease or condition that affects fewer than 200,000 individuals in the United States, or if it affects more than 200,000 individuals in the United States and there is no reasonable expectation that the cost of developing and making the drug for this type of disease or condition will be recovered from sales in the United States. 23 In the United States, orphan drug designation entitles a party to financial incentives such as opportunities for grant funding towards clinical trial costs, tax advantages and user-fee waivers.
Orphan Drug Designation Under the Orphan Drug Act, the FDA may grant orphan drug designation to drugs or biologics intended to treat a rare disease or condition that affects fewer than 200,000 individuals in the United States, or if it affects more than 200,000 individuals in the United States and there is no reasonable expectation that the cost of developing and making the drug for this type of disease or condition will be recovered from sales in the United States. 24 In the United States, orphan drug designation entitles a party to financial incentives such as opportunities for grant funding towards clinical trial costs, tax advantages and user-fee waivers.
The target population is newly diagnosed advanced primary head and neck cancer patients with no lymph node involvement (determined via PET imaging) and with low PD-L1 tumor expression (determined via biopsy), two features that physicians routinely assess at baseline as part of standard practice. 3 CEL-SCI completed a bias analysis for the target population in the 928 patient Phase III study in preparation for submission of data to regulatory agencies including the FDA for confirmatory registration study.
The target population is newly diagnosed advanced primary head and neck cancer patients with no lymph node involvement (determined via PET imaging), and with low PD-L1 tumor expression (determined via biopsy), two features that physicians routinely assess at baseline as part of standard practice. 3 CEL-SCI completed a bias analysis for the target population in the Phase III study in preparation for submission of data to regulatory agencies, including the FDA, for a confirmatory registration study.
CEL-SCI considers this to be its best protection from competitors. LEAPS is protected by patents in the United States issued between January 2019 and June 2021. The LEAPS patents, which expire between 2027 and 2032, include overlapping claims, with composition of both matter (new chemical entity), process and methods-of-use, to maximize and extend the coverage in their current format.
CEL-SCI considers this to be its best protection from competitors. LEAPS is protected by patents in the United States issued between January 2019 and June 2021. The LEAPS patents, which expire between 2027 and 2031, include overlapping claims, with composition of both matter (new chemical entity), process and methods-of-use, to maximize and extend the coverage in their current format.
If CEL-SCI is not able to comply with these requirements, the FDA may, among other things, take enforcement action or seek sanctions against use, impose restrictions on a product or its manufacturer, require CEL-SCI to recall a product from distribution, or withdraw approval of the BLA. 22 The FDA may withdraw approval if compliance with regulatory requirements and standards is not maintained or if problems occur after the product reaches the market.
If CEL-SCI is not able to comply with these requirements, the FDA may, among other things, take enforcement action or seek sanctions against use, impose restrictions on a product or its manufacturer, require CEL-SCI to recall a product from distribution, or withdraw approval of the BLA. 23 The FDA may withdraw approval if compliance with regulatory requirements and standards is not maintained or if problems occur after the product reaches the market.
If CEL-SCI develops Multikine for other oncology indications and Teva indicates a desire to participate, the parties have agreed to negotiate in good faith with respect to Teva’s participation and contribution in future clinical trials. 13 Teva has agreed to use all reasonable efforts to obtain regulatory approval to market and sell Multikine in its territory at its own cost and expense.
If CEL-SCI develops Multikine for other oncology indications and Teva indicates a desire to participate, the parties have agreed to negotiate in good faith with respect to Teva’s participation and contribution in future clinical trials. 14 Teva has agreed to use all reasonable efforts to obtain regulatory approval to market and sell Multikine in its territory at its own cost and expense.
The taller blue columns show PSR and PSD rates in all 529 Multikine-treated patients in the Phase III trial, and the gray columns show PSR and PSD rates for all 394 control patients. 5 It was not enough for us to show that Multikine likely leads to PSRs and PSDs as compared to a control group, CEL-SCI also had to test if PSRs and PSDs lead to improved survival.
The taller blue columns show PSR and PSD rates in all 529 Multikine-treated patients in the Phase III trial, and the gray columns show PSR and PSD rates for all 394 control patients. 6 It was not enough for us to show that Multikine likely leads to PSRs and PSDs as compared to a control group, CEL-SCI also had to test if PSRs and PSDs lead to improved survival.
CEL-SCI’s regulatory strategy going forward is to seek approval of Multikine following full enrollment of our confirmatory study wherever possible. CEL-SCI applied to the FDA for a 212-patient randomized controlled confirmatory registration study focusing only on those patients in the target population, which accounts for approximately 100,000 patients worldwide per year.
CEL-SCI’s regulatory strategy going forward is to seek approval of Multikine following full enrollment of its confirmatory study wherever possible. CEL-SCI applied to the FDA for a 212-patient randomized controlled confirmatory registration study focusing only on those patients in the target population, which accounts for approximately 100,000 patients worldwide per year.
Multikine on the other hand is administered locally to treat tumors and their microenvironment before any other therapy has been administered because it is believed that this is the time when the immune system would be strongest and most amenable to activation against the tumor.
Multikine on the other hand is administered locally to treat tumors and their microenvironment before any other therapy has been given to the patients because it is believed that this is the time when the immune system would be strongest and most amenable to activation against the tumor.
Development Agreements for Multikine In August 2008, CEL-SCI signed an agreement with Teva Pharmaceutical Industries Ltd., or Teva, that gives Teva the exclusive right and license to market, distribute and sell Multikine, if approved, in Israel and Turkey for treatment of head and neck cancer.
In August 2008, CEL-SCI signed an agreement with Teva Pharmaceutical Industries Ltd., or Teva, that gives Teva the exclusive right and license to market, distribute and sell Multikine, if approved, in Israel and Turkey for treatment of head and neck cancer.
The article reviewed the mechanism of action and targets with pictorial graphics in the journal Biomedicines and can be found online at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8772713/ . In May 2019, CEL-SCI announced that a newly discovered LEAPS conjugate acts alone and can complement CEL-4000 therapeutically when administered in combination to an animal model of Rheumatoid Arthritis (RA).
The article reviewed the mechanism of action and targets with pictorial graphics in the journal Biomedicines and can be found online at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8772713/. 16 In May 2019, CEL-SCI announced that a newly discovered LEAPS conjugate acts alone and can complement CEL-4000 therapeutically when administered in combination to an animal model of RA.
The process required by the FDA before biological product candidates may be marketed in the United States generally involves the following: · completion of preclinical laboratory tests and animal studies performed in accordance with the FDA’s Good Laboratory Practice, or GLP, regulations; · submission to the FDA of an investigational new drug application, or IND, which must become effective before clinical trials may begin and must be updated annually; · approval by an independent Institutional Review Board, or IRB, or ethics committee at each clinical site before the trial is initiated; · performance of adequate and well-controlled human clinical trials in compliance with Good Clinical Practice, or GCP, regulations to establish the safety, purity and potency of the proposed biologic product candidate for its intended purpose; · preparation of and submission to the FDA of a Biologics License Application, or BLA, after completion of clinical trials; · satisfactory completion of an FDA Advisory Committee review, if applicable; · a determination by the FDA within 60 days of its receipt of a BLA to file the application for review; · satisfactory completion of an FDA pre-approval inspection of the manufacturing facility or facilities at which the proposed product is produced to assess compliance with current Good Manufacturing Practice, or cGMP, requirements and to assure that the facilities, methods and controls are adequate to preserve the biological product’s continued safety, purity and potency, and of selected clinical investigations to assess compliance with GCPs; and · FDA review and approval of the BLA to permit commercial marketing of the product for particular indications for use in the United States. 18 Prior to commencing the first clinical trial with a product candidate in the U.S., CEL-SCI must submit an IND to the FDA.
The process required by the FDA before biological product candidates may be marketed in the United States generally involves the following: · completion of preclinical laboratory tests and animal studies performed in accordance with the FDA’s Good Laboratory Practice, or GLP, regulations; · submission to the FDA of an investigational new drug application, or IND, which must become effective before clinical trials may begin and must be updated annually; · approval by an independent Institutional Review Board, or IRB, or ethics committee at each clinical site before the trial is initiated; · performance of adequate and well-controlled human clinical trials in compliance with Good Clinical Practice, or GCP, regulations to establish the safety, purity and potency of the proposed biologic product candidate for its intended purpose; · preparation of and submission to the FDA of a Biologics License Application, or BLA, after completion of clinical trials; 19 · satisfactory completion of an FDA Advisory Committee review, if applicable; · a determination by the FDA within 60 days of its receipt of a BLA to file the application for review; · satisfactory completion of an FDA pre-approval inspection of the manufacturing facility or facilities at which the proposed product is produced to assess compliance with current Good Manufacturing Practice, or cGMP, requirements and to assure that the facilities, methods and controls are adequate to preserve the biological product’s continued safety, purity and potency, and of selected clinical investigations to assess compliance with GCPs; and · FDA review and approval of the BLA to permit commercial marketing of the product for particular indications for use in the United States.
Link to poster: https://cel-sci.com/wp-content/uploads/2023/10/ESMO-2023-Poster_893P_FINAL.pdf Previously, CEL-SCI published two abstracts and presented a poster related to its pivotal Phase III Multikine head and neck cancer clinical trial at the American Society of Clinical Oncology (ASCO) in June 2022.
Link to poster: https://cel-sci.com/wp-content/uploads/2023/10/ESMO-2023-Poster_893P_FINAL.pdf Previously, CEL-SCI published an abstract and presented a poster related to its pivotal Phase III Multikine head and neck cancer clinical trial at the American Society of Clinical Oncology (ASCO) in June 2022.
The pro-inflammatory cytokine mixture includes interleukins, interferons, chemokines and colony-stimulating factors, which contain elements of the body’s natural mix of defenses against cancer. Multikine is designed to be used in a different way than cancer immunotherapy is generally being used.
The pro-inflammatory cytokine mixture includes interleukins, interferons, chemokines and colony-stimulating factors, which contain elements of the body’s natural mix of defenses against cancer. 12 Multikine is designed to be utilized in a different way than cancer immunotherapy is generally being administered.
In February 2024, CEL-SCI announced that the commissioning of the manufacturing facility had been completed, a significant milestone toward a planned Biologics License Application (BLA) with several regulatory agencies for approval of Multikine in the treatment of head and neck cancer.
This expansion was completed at the end of 2021. In February 2024, CEL-SCI announced that the commissioning of the manufacturing facility had been completed, a significant milestone toward a planned Biologics License Application (BLA) with several regulatory agencies for approval of Multikine in the treatment of head and neck cancer.
The abstract titles and corresponding links are as follows: · “Leukocyte interleukin injection (LI) immunotherapy extends overall survival (OS) in treatment-naive low-risk (LR) locally advanced primary squamous cell carcinoma of the head and neck: The IT-MATTERS study.” o Link to abstract: https://meetings.asco.org/abstracts-presentations/207201 o Link to poster: https://cel-sci.com/wp-content/uploads/2022/06/CEL-SCI-ASCO-2022-Poster-6032-June-6-Head-and-Neck-Cancer-1.pdf · “Novel algorithm for assigning risk/disease-directed treatment (DDT) choice in locally advanced primary squamous cell carcinoma of the head and neck (SCCHN): Using pretreatment data only.” o Link to abstract: https://meetings.asco.org/abstracts-presentations/207202/ Ultimately, the decision as to whether CEL-SCI’s drug product candidate is safe and effective can only be made by the FDA and/or by other regulatory authorities based upon an assessment of all of the data from an entire drug development program submitted as part of an application for marketing approval.
The abstract titles and corresponding link is as follows: · “Leukocyte interleukin injection (LI) immunotherapy extends overall survival (OS) in treatment-naive low-risk (LR) locally advanced primary squamous cell carcinoma of the head and neck: The IT-MATTERS study.” o Link to abstract: https://meetings.asco.org/abstracts-presentations/207201 o Link to poster: https://cel-sci.com/wp-content/uploads/2022/06/CEL-SCI-ASCO-2022-Poster-6032-June-6-Head-and-Neck-Cancer-1.pdf Ultimately, the decision as to whether Multikine is safe and effective can only be made by the FDA and/or by other regulatory authorities based upon an assessment of all of the data from an entire drug development program submitted as part of an application for marketing approval.
Composition-of-matter patents for Multikine have been issued in Japan (issued in November 2012 and currently set to expire in 2025) and three in Europe (issued in September 2015, May 2016 and October 2017, currently set to expire in 2025 and 2026).
Composition-of-matter patents for Multikine have been issued in Japan (issued in November 2012 and expired in 2025) and three in Europe (issued in September 2015, May 2016 and October 2017, two of which expired in 2025 and one set to expire in May 2026).
For a fast track product, the FDA may consider sections of the BLA for review on a rolling basis before the complete application is submitted if relevant criteria are met.
For a fast track product, the FDA may consider sections of the BLA for review on a rolling basis before the complete application is submitted if relevant criteria are met. A fast track designated product candidate may also qualify for priority review.
Since the completion of commissioning of the manufacturing facility, CEL-SCI undertook qualification of the manufacturing environment and validation of the manufacturing process in the updated manufacturing facility, aiming to complete the clinical lot in time for the initiation of the confirmatory study. CEL-SCI’s lease on the manufacturing facility expires on October 31, 2028.
Since the completion of commissioning of the manufacturing facility, CEL-SCI undertook qualification of the manufacturing environment and validation of the manufacturing process in the updated manufacturing facility. CEL-SCI completed its first clinical lot in time for the initiation of the confirmatory study. CEL-SCI’s lease on the manufacturing facility expires on October 31, 2028.
As of December 15, 2024, there were no contested proceedings and/or third-party claims with respect to CEL-SCI’s patents or patent applications. 17 MANUFACTURING FACILITY Before starting the Phase III clinical trial, for reasons related to regulatory considerations, CEL-SCI built a dedicated manufacturing facility to produce its investigational biological product candidate Multikine.
As of the date of this annual report, there were no contested proceedings and/or third-party claims with respect to CEL-SCI’s patents or patent applications. 18 MANUFACTURING FACILITY Before starting the Phase III clinical trial, for reasons related to regulatory considerations, CEL-SCI built a dedicated manufacturing facility to produce its investigational biological product candidate Multikine.
(It should be noted that immune checkpoint inhibitors like Keytruda and Opdivo appear to work best in patients with tumors having high PD-L1 expression). · Second, the Multikine target population can now be readily identified upon diagnosis, prior to surgery, using tests that physicians routinely use in cancer screenings. · Third, Multikine patients in the target population saw a significant increase in 5-year overall survival, from 45% for control patients who did not receive Multikine to 73% for Multikine-treated patients.
(It should be noted that immune checkpoint inhibitors like Keytruda and Opdivo appear to work best in patients with tumors having high PD-L1 expression). · Second, the Multikine target population can now be readily identified upon diagnosis, prior to surgery, using tests that physicians routinely use in cancer screenings. · Third, Multikine patients in the target population saw a significant increase in 5-year overall survival, from 45% for control patients who did not receive Multikine to 73% for Multikine-treated patients. · Multikine treated subjects demonstrated a significant (p=0.002) shift in AJCC downstage from baseline to surgery in the LI+CIZ+SOC vs SOC.
A fast track designated product candidate may also qualify for priority review. 21 Under the accelerated approval program, the FDA may approve a BLA on the basis of either a surrogate endpoint that is reasonably likely to predict a clinical benefit, or on a clinical endpoint that can be measured earlier than irreversible morbidity or mortality, that is reasonably likely to predict an effect on irreversible morbidity or mortality or other clinical benefit, taking into account the severity, rarity, or prevalence of the condition and the availability or lack of alternative treatments.
Under the accelerated approval program, the FDA may approve a BLA on the basis of either a surrogate endpoint that is reasonably likely to predict a clinical benefit, or on a clinical endpoint that can be measured earlier than irreversible morbidity or mortality, that is reasonably likely to predict an effect on irreversible morbidity or mortality or other clinical benefit, taking into account the severity, rarity, or prevalence of the condition and the availability or lack of alternative treatments.
CORPORATE HISTORY CEL-SCI was formed as a Colorado corporation in 1983. CEL-SCI’s principal office is located at 8229 Boone Boulevard, Suite 802, Vienna, VA 22182. CEL-SCI’s telephone number is 703-506-9460 and its website is www.cel-sci.com . CEL-SCI does not incorporate the information on its website into this report, and you should not consider it part of this report.
CEL-SCI’s principal office is located at 8229 Boone Boulevard, Suite 802, Vienna, VA 22182. CEL-SCI’s telephone number is 703-506-9460 and its website is www.cel-sci.com . CEL-SCI does not incorporate the information on its website into this report, and you should not consider it part of this report.
Multikine is the trademark that CEL-SCI has registered for this investigational therapy, and this proprietary name is subject to review by the FDA, in connection with CEL-SCI’s future anticipated regulatory submission for approval in the United States.
Multikine is the trademark that CEL-SCI has registered for this investigational therapy, and this proprietary name is subject to FDA review under CEL-SCI’s future anticipated regulatory submission for approval.
CEL-SCI published its data as abstracts and posters at the annual conferences for the 2022 American Society of Clinical Oncology (ASCO), 2022, 2023 European Society for Medical Oncology (ESMO), the 2023 European Head and Neck Society’s (EHNS’s) annual European Conference On Head And Neck Oncology (ECHNO), the 2023 European Society for Therapeutic Radiology and Oncology (ESTRO) and the 2023 American Head and Neck society (AHNS).
CEL-SCI published its data as abstracts and posters at the annual conferences for the 2022 American Society of Clinical Oncology (ASCO), 2022 and 2023 European Society for Medical Oncology (ESMO), the 2023 European Head and Neck Society’s (EHNS’s) annual European Conference on Head and Neck Oncology (ECHNO), the 2023 European Society for Therapeutic Radiology and Oncology (ESTRO), the 2023 American Head and Neck Society (AHNS), 2024 ESMO Congress and in the peer reviewed journal Pathology Oncology Research (POR) 2025.
CEL-SCI observed statistically significant pre-surgical responses after Multikine treatment, and therefore CEL-SCI believes in the following: ➢ Multikine causes pre-surgical responses; ➢ Pre-surgical responses lead to longer life; ➢ Therefore, selecting more patients predicted to have a pre-surgical response should lead to much better survival in the target population. A “pre-surgical response” is a significant change in disease before surgery.
Multikine works by inducing pre-surgical responses. CEL-SCI observed statistically significant pre-surgical responses after Multikine treatment, and therefore CEL-SCI believes in the following: ➢ Multikine causes pre-surgical responses; ➢ Pre-surgical responses lead to longer life; ➢ Therefore, selecting more patients predicted to have a pre-surgical response should lead to much better survival in the target population.
PSDs were seen in 22% of Multikine patients as compared to 13% in the control group. Because Multikine was the only therapy given to these patients before surgery, it is CEL-SCI’s strong belief that Multikine had to be the cause of the higher rates of PSR and PSD. These data are presented visually below.
Because Multikine was the only therapy given to these patients before surgery, it is CEL-SCI’s strong belief that Multikine had to be the cause of the higher rates of PSR and PSD. These data are presented visually below.
For purposes of approval of a Biologics License Application, or BLA, human clinical trials are typically conducted in three or four sequential phases that may overlap. · Phase I — The investigational product is initially introduced into healthy human subjects or patients with the target disease or condition.
There are also requirements governing the reporting of ongoing clinical studies and clinical study results to public registries. 20 For purposes of approval of a Biologics License Application, or BLA, human clinical trials are typically conducted in three or four sequential phases that may overlap. · Phase I — The investigational product is initially introduced into healthy human subjects or patients with the target disease or condition.
There can be no assurance that these approvals will be granted. 16 INTELLECTUAL PROPERTY Patents and other proprietary rights are essential to CEL-SCI’s business. CEL-SCI files patent applications to protect its technologies, inventions and improvements that CEL-SCI considers important to the development of its business.
INTELLECTUAL PROPERTY Patents and other proprietary rights are essential to CEL-SCI’s business. CEL-SCI files patent applications to protect its technologies, inventions and improvements that CEL-SCI considers important to the development of its business.
If commercial approval is obtained, CEL-SCI intends to manufacture Multikine in a proprietary manner in CEL-SCI’s manufacturing facility near Baltimore, Maryland, USA. CEL-SCI spent many years and more than $200 million developing and validating the manufacturing process for Multikine.
Multikine is an immunotherapy product candidate comprised of a patented defined mixture of 14 human natural cytokines. If commercial approval is obtained, CEL-SCI intends to manufacture Multikine in a proprietary manner in CEL-SCI’s manufacturing facility near Baltimore, Maryland, USA. CEL-SCI spent many years and more than $200 million developing and validating the manufacturing process for Multikine.
The United States and some foreign jurisdictions are considering or have enacted a number of legislative and regulatory proposals to change the healthcare system in ways that could affect CEL-SCI’s ability to sell its products profitably.
Reimbursement may not be available or sufficient to allow CEL-SCI to sell its products on a competitive and profitable basis. 25 The United States and some foreign jurisdictions are considering or have enacted a number of legislative and regulatory proposals to change the healthcare system in ways that could affect CEL-SCI’s ability to sell its products profitably.
ABOUT LEAPS CEL-SCI’s patented T-cell Modulation Process, referred to as LEAPS (Ligand Epitope Antigen Presentation System), uses “heteroconjugates” to direct the body to choose a specific immune response.
Sales revenues will be divided equally between CEL-SCI and Byron. 15 ABOUT LEAPS CEL-SCI’s patented T-cell Modulation Process, referred to as LEAPS (Ligand Epitope Antigen Presentation System), uses “heteroconjugates” to direct the body to choose a specific immune response.
CEL-SCI is currently focused on the development of the following product candidates and technologies: 1) Multikine, an investigational immunotherapy under development for the potential treatment of certain head and neck cancers; and 2) L.E.A.P.S. (Ligand Epitope Antigen Presentation System) technology, or LEAPS, with several product candidates under development for the potential treatment of rheumatoid arthritis.
CEL-SCI is currently focused on the development of the following product candidates and technologies with an emphasis on Multikine: 1) Multikine, an investigational Phase 3 immunotherapy under development for the potential treatment of certain head and neck cancers; and 2) L.E.A.P.S.
Lastly, no definitive conclusions can be drawn from the early-phase, preclinical-trials data involving these investigational products. Before obtaining marketing approval from the FDA in the United States, and by comparable agencies in most foreign countries, these product candidates must undergo rigorous preclinical and clinical testing which is costly and time consuming and subject to unanticipated delays.
Before obtaining marketing approval from the FDA in the United States, and by comparable agencies in most foreign countries, these product candidates must undergo rigorous preclinical and clinical testing which is costly and time consuming and subject to unanticipated delays. There can be no assurance that these approvals will be granted.
If Multikine is approved for sale in South Africa, CEL-SCI will be responsible for manufacturing the product, while Byron will be responsible for sales in South Africa. Sales revenues will be divided equally between CEL-SCI and Byron.
Pursuant to the agreement, Byron will be responsible for registering Multikine in South Africa. If Multikine is approved for sale in South Africa, CEL-SCI will be responsible for manufacturing the product, while Byron will be responsible for sales in South Africa.
CEL-SCI saw two kinds of responses in the Phase III trial. First, there were “reductions” in the size of the tumor—a reduction of 30% or more qualified as a “pre-surgical reduction,” or “PSR” for short. Second, there were disease “downstages,” (e.g., the disease improved from Stage IV to Stage III) pre-surgery.
A “pre-surgical response” is a significant change in disease before surgery. CEL-SCI saw two kinds of responses in the Phase III trial. First, there were “reductions” in the size of the tumor—a reduction of 30% or more qualified as a “pre-surgical reduction,” or “PSR” for short.
The article is entitled “Rheumatoid arthritis vaccine therapies: perspectives and lessons from therapeutic Ligand Epitope Antigen Presentation System vaccines for models of rheumatoid arthritis” and was published in Expert Review of Vaccines 1 - 18 and can be found online at http://www.ncbi.nlm.nih.gov/pubmed/25787143 .
The article is entitled “Rheumatoid arthritis vaccine therapies: perspectives and lessons from therapeutic Ligand Epitope Antigen Presentation System vaccines for models of rheumatoid arthritis” and was published in Expert Review of Vaccines 1 - 18 and can be found online at http://www.ncbi.nlm.nih.gov/pubmed/25787143 . 17 Accordingly, even though the various LEAPS candidates have not yet been given to humans, they have been tested in vitro with human cells.
In the United States, the pharmaceutical industry has been a particular focus of these efforts and has been significantly affected by major legislative initiatives. 24 Foreign Regulation In addition to regulations in the United States, CEL-SCI will be subject to a variety of foreign regulations governing clinical trials and commercial sales and distribution of its products to the extent CEL-SCI chooses to develop or sell any products outside of the United States.
Foreign Regulation In addition to regulations in the United States, CEL-SCI will be subject to a variety of foreign regulations governing clinical trials and commercial sales and distribution of its products to the extent CEL-SCI chooses to develop or sell any products outside of the United States.
An IND is a request for authorization from the FDA to administer an investigational product to humans. The central focus of an IND submission is on the general investigational plan and the protocol(s) for human studies.
Prior to commencing the first clinical trial with a product candidate in the U.S., CEL-SCI must submit an IND to the FDA. An IND is a request for authorization from the FDA to administer an investigational product to humans. The central focus of an IND submission is on the general investigational plan and the protocol(s) for human studies.
Among policy makers and payors in the United States and elsewhere, there is significant interest in promoting changes in healthcare systems with the stated goals of containing healthcare costs, improving quality and/or expanding access.
Among policy makers and payors in the United States and elsewhere, there is significant interest in promoting changes in healthcare systems with the stated goals of containing healthcare costs, improving quality and/or expanding access. In the United States, the pharmaceutical industry has been a particular focus of these efforts and has been significantly affected by major legislative initiatives.
CEL-SCI makes its electronic filings with the Securities and Exchange Commission (SEC), including its annual reports on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K and amendments to these reports.
CEL-SCI makes its electronic filings with the Securities and Exchange Commission (SEC), including its annual reports on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K and amendments to these reports. These filings are available on its website free of charge as soon as practicable after they are filed or furnished to the SEC.
CEL-SCI expects to initiate the confirmatory study in Q1 2025 and reach full enrollment in Q2 2026. · If approved as a pre-surgical treatment, CEL-SCI believes Multikine should be added to the standard of care for the target population in this unmet medical need. · CEL-SCI believes that the confirmatory study has a high likelihood of success based on the large survival benefit that has already been observed in the target population from the completed Phase III study.
CEL-SCI is moving forward with a Phase III confirmatory registration study of Multikine in the target population. · The confirmatory study will be a randomized controlled trial with two arms: Multikine treatment plus standard of care versus standard of care alone. · If approved as a pre-surgical treatment, CEL-SCI believes Multikine should be added to the standard of care for the target population in this unmet medical need. · CEL-SCI believes that the confirmatory study has a high likelihood of success based on the large survival benefit that has already been observed in the target population from the completed Phase III study.
CEL-SCI believes that patients with tumors having low PD-L1 would be more likely to respond to Multikine because their tumors have lower defenses against the patient’s immune system. CEL-SCI estimates that patients with tumors having low PD-L1 represent about 70% of locally advanced primary SCCHN patients. Targeting low PD-L1 also differentiates Multikine from other immunotherapies.
CEL-SCI believes that patients with tumors having low PD-L1 would be more likely to respond to Multikine because their tumors have lower defenses against the patient’s immune system.
In the case of Multikine, statistically speaking, there is a 95% chance that the hazard ratio would fall between 0.18 and 0.66 if Multikine were tested in the target population in another study.
It is also important to note that the hazard ratio’s 95% confidence interval remained far below 1.0 (which would mean parity between the compared groups). In the case of Multikine, statistically speaking, there is a 95% chance that the hazard ratio would fall between 0.18 and 0.66 if Multikine were tested in the target population in another study.
After the 20-year period has expired, the agreement will be automatically extended for successive two-year periods, unless either party gives notice of its intent not to extend the agreement. 14 Pursuant to the agreement, Byron will be responsible for registering Multikine in South Africa.
This license will terminate 20 years after marketing approval in South Africa or after the bankruptcy or uncured material breach by either party. After the 20-year period has expired, the agreement will be automatically extended for successive two-year periods, unless either party gives notice of its intent not to extend the agreement.
Data from CEL-SCI’s clinical trials suggest that Multikine may help the immune system “see” the tumor and then attack it, enabling the body’s own anti-tumor immune response to fight the tumor.
MORE ABOUT MULTIKINE CEL-SCI’s lead investigational therapy, Multikine, is being developed as a potential therapeutic agent directed at using the immune system to produce an anti-tumor immune response. Data from CEL-SCI’s clinical trials suggest that Multikine may help the immune system “see” the tumor and then attack it, enabling the body’s own anti-tumor immune response to fight the tumor.
A hazard ratio of 0.66 as the “so-called worst-case scenario” (the upper limit of the 95% confidence interval - for the hazard ration - in this case) is still below (better) than the hazard ratio required for most drug approvals.
A hazard ratio of 0.66 as the “so-called worst-case scenario” (the upper limit of the 95% confidence interval - for the hazard ration - in this case) is still below (better) than the hazard ratio required for most drug approvals. 8 CEL-SCI completed a bias analysis for the target population in the Phase III study in preparation for submission of data to regulatory agencies including the FDA for a confirmatory registration study.
After approval, some types of changes to the approved product, such as adding new indications, manufacturing changes and additional labeling claims, are subject to further testing requirements and FDA review and approval.
After approval, some types of changes to the approved product, such as adding new indications, manufacturing changes and additional labeling claims, are subject to further testing requirements and FDA review and approval. 22 Expedited Review and Approval A sponsor may seek approval of its product candidate under programs designed to accelerate the FDA’s review and approval of new drugs and biological products that meet certain criteria.
None of the LEAPS investigational products have been approved for sale, barter or exchange by the FDA or any other regulatory agency for any use to treat disease in animals or humans. The safety or efficacy of these products has not been established for any use.
They have also shown some level of activity in animals in two autoimmune conditions, curtailing and sometimes preventing disease progression in arthritis and myocarditis animal models. None of the LEAPS investigational products have been approved for sale, barter or exchange by the FDA or any other regulatory agency for any use to treat disease in animals or humans.
It is time consuming and expensive for CEL-SCI to seek reimbursement from third-party payors. Reimbursement may not be available or sufficient to allow CEL-SCI to sell its products on a competitive and profitable basis.
It is time consuming and expensive for CEL-SCI to seek reimbursement from third-party payors.
CEL-SCI’s physician consultants tell CEL-SCI that the early separation of these two survival curves (e.g., at 12 months) adds validation to the potential positive effects of Multikine. 7 Another measure of survival benefit is called the “hazard ratio,” which compares the rate of an event (chances) of dying between two different groups.
These results had a low (log rank) p-value of 0.0015, which is very significant as a statistical matter. 7 CEL-SCI’s physician consultants tell CEL-SCI that the early separation of these two survival curves (e.g., at 12 months) adds validation to the potential positive effects of Multikine.
CEL-SCI calls this a “pre-surgical downstaging” or “PSD” for short. CEL-SCI’s 2022 ESMO cancer conference presentation reported on PSR, and CEL-SCI’s new 2023 ESMO presentation reported on PSD. Across the whole Phase III trial, PSRs were seen in 8.5% of Multikine patients compared to none in the control group.
Second, there were disease “downstages,” (e.g., the disease improved from Stage IV to Stage III) pre-surgery. CEL-SCI calls this a “pre-surgical downstaging” or “PSD” for short. CEL-SCI’s 2022 ESMO cancer conference presentation reported on PSR, and CEL-SCI’s new 2023 ESMO presentation reported on PSD and POR 2025.
CEL-SCI completed a bias analysis for the target population in the Phase III study in preparation for submission of data to regulatory agencies including the FDA for confirmatory registration study. The detailed data on parameters including patient age, sex, race, tumor locations, and staging demonstrate balance between the treatment and control arms.
The detailed data on parameters including patient age, sex, race, tumor locations, and staging demonstrate balance between the treatment and control arms.
The LEAPS candidates have demonstrated protection against lethal herpes simplex virus (HSV1) and H1N1 influenza infection, as a prophylactic or therapeutic agent in animals. They have also shown some level of activity in animals in two autoimmune conditions, curtailing and sometimes preventing disease progression in arthritis and myocarditis animal models.
They have induced similar cytokine responses that were seen in these animal models, which may indicate that the LEAPS technology might translate to humans. The LEAPS candidates have demonstrated protection against lethal herpes simplex virus (HSV1) and H1N1 influenza infection, as a prophylactic or therapeutic agent in animals.
Here, in the Multikine target population, the hazard ratio was 0.35, which means that deaths occurred in the Multikine group about one-third as frequently as in the control group. It is also important to note that the hazard ratio’s 95% confidence interval remained far below 1.0 (which would mean parity between the compared groups).
Another measure of survival benefit is called the “hazard ratio,” which compares the rate of an event (chances) of dying between two different groups. Here, in the Multikine target population, the hazard ratio was 0.35, which means that deaths occurred in the Multikine group about one-third as frequently as in the control group.
These checkpoint inhibitors appear to act best when tumors express high levels of PD-L1 receptors (usually TPS >20 to TPS >50).
These checkpoint inhibitors appear to act best when tumors express high levels of PD-L1 receptors (usually TPS >20 to TPS >50). Keytruda was approved by FDA in June 2025 as a perioperative (before and after surgery) treatment for resectable locally advanced head and neck cancer patients whose tumors express PD-L1 at a positive level.
Multikine (Leukocyte Interleukin, Injection) is the full name of this investigational therapy, which, for simplicity, is referred to in this report as Multikine. Multikine is the trademark that CEL-SCI has registered for this investigational therapy, and this proprietary name is subject to FDA review under CEL-SCI’s future anticipated regulatory submission for approval.
(Ligand Epitope Antigen Presentation System) technology, or LEAPS, with several product candidates under development for the potential treatment of rheumatoid arthritis. Multikine (Leukocyte Interleukin, Injection) is the full name of this investigational therapy, which, for simplicity, is referred to in this report as Multikine.
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While none of these drugs are currently approved as a first-line treatment before surgery, even if such approvals were to come in the future, we believe the large majority of patients having low PD-L1 would still be expected to need Multikine. 4 CEL-SCI believes Multikine leads to longer survival with no safety issues.
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CEL-SCI estimates that patients with tumors having low PD-L1 represent about 70% of locally advanced primary patients with squamous cell carcinoma of the head and neck, or SCCHN (hereafter also referred to as advanced primary head and neck cancer). Targeting low PD-L1 also differentiates Multikine from other immunotherapies.
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These publications can be accessed at http://www.cel-sci.com . Multikine works by inducing pre-surgical responses.
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In Merck’s Phase III KEYNOTE-689 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.
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These results had a low (log rank) p-value of 0.0015, which is very significant as a statistical matter.
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Patients with low to zero levels of PD-L1 did not benefit from Keytruda. 4 In contrast to the results of the KEYNOTE-689, CEL-SCI’s Phase III study showed that Multikine treated patients whose tumors expressed low (Tumor Proportion Score [TPS CEL-SCI believes Multikine leads to longer survival with no safety issues.
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In May 2024, CEL-SCI announced that the FDA indicated CEL-SCI may move forward with a confirmatory registration study of Multikine in the target population. 9 · The confirmatory study will be a randomized controlled trial with two arms: Multikine treatment plus standard of care versus standard of care alone.
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In March 2025, CEL-SCI published a comprehensive presentation of results from the Phase 3 trial in the peer reviewed journal Pathology and Oncology Research (POR).
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The Hazard ratio is 0.35 with an upper limit (95% Confidence interval) of 0.66. · Addressing an unmet medical need : Multikine focuses on the 70% of patients not well served by the two leading approved drugs for head and neck cancer, Keytruda and Opdivo.
Added
The article is titled “Neoadjuvant Leukocyte Interleukin Injection Immunotherapy Improves Overall Survival in Low-risk Locally Advanced Head and Neck Squamous Cell Carcinoma -The IT-MATTERS Study” and included new data on quality of life, in addition to improved overall survival (OS) in the Multikine-treated low-risk with a 46.5 months median OS advantage over low-risk control (treated with standard of care only, SOC). · Quality of life improvements included reduction in or cessation of pain in the head and neck area, improvement or complete restoration in ability to eat, drink, and swallow, ability for selfcare including walking and using the toilet, and improved emotional wellbeing. · Complete responders to Multikine treatment reported a 100% (wherein all respondents scored the highest possible improvement from baseline) on 60% (39/65) quality of life measures. · 89.4% of partial responders to Multikine reported improved quality of life measures.
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These filings are available on its website free of charge as soon as practicable after they are filed or furnished to the SEC. 11 MORE ABOUT MULTIKINE CEL-SCI’s lead investigational therapy, Multikine, is being developed as a potential therapeutic agent directed at using the immune system to produce an anti-tumor immune response.
Added
These Quality of Life (QoL) improvements were self-reported by study participants and were sustained throughout the 3-years follow-up post SOC administration in which data on quality of life was systematically measured by EORTC validated QoL instruments specifically designed to measure QoL in Head and Neck Cancer patients. 5 These publications can be accessed at http://www.cel-sci.com .

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Item 1C. Cybersecurity

Cybersecurity — threats and controls disclosure

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Biggest changeUsing various monitoring and detection tools implemented into CEL-SCI’s internal technology systems, they can identify cybersecurity threats and report such risks to CEL-SCI’s management team. CEL-SCI’s management team oversees efforts to prevent, detect, mitigate, and remediate cybersecurity risks and incidents through various means, which includes oversight over its third-party IT consultant, monitoring systems and employee engagement.
Biggest changeUsing various monitoring and detection tools implemented into CEL-SCI’s internal technology systems, they can identify cybersecurity threats and report such risks to CEL-SCI’s management team. 52 CEL-SCI’s management team oversees efforts to prevent, detect, mitigate, and remediate cybersecurity risks and incidents through various means, which includes oversight over its third-party IT consultant, monitoring systems and employee engagement.
ITEM 1C. CYBERSECURITY CEL-SCI recognizes the importance of assessing, identifying, and managing material risks from cybersecurity threats. CEL-SCI’s policies, standards and procedures for assessing, identifying, and managing material risks from cybersecurity threats are integrated into our overall risk management system.
ITEM 1C. CYBERSECURITY CEL-SCI recognizes the importance of assessing, identifying, and managing material risks from cybersecurity threats. CEL-SCI’s policies, standards and procedures for assessing, identifying, and managing material risks from cybersecurity threats are integrated into its overall risk management system.

Item 2. Properties

Properties — owned and leased real estate

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Biggest changeThe lease allows CEL-SCI, at its election, to extend the lease for two ten-year periods or to purchase the building at the end of the 20-year lease. 51 In August 2020, the Company entered into an amendment to the San Tomas lease agreement under which the landlord agreed to allow the Company to substantially upgrade the manufacturing facility in preparation for the potential commercial production of Multikine.
Biggest changeIn August 2020, the Company entered into an amendment to the San Tomas lease agreement under which the landlord agreed to allow the Company to substantially upgrade the manufacturing facility in preparation for the potential commercial production of Multikine. The total cost of the upgrades was $11.1 million.
The lease expires on October 31, 2028 and required annual base rent payments of approximately $2.7 million during the twelve months ended September 30, 2024. The annual base rent escalates each year at 3% beginning on November 1st.
The lease expires on October 31, 2028 and required annual base rent payments of approximately $2.7 million during the twelve months ended September 30, 2025. The annual base rent escalates each year at 3% beginning on November 1st.
ITEM 2. PROPERTIES CEL-SCI leases approximately 3,700 square feet of office space at 8229 Boone Blvd., Suite 802, Vienna, Virginia at a monthly rental of approximately $8,000. The lease on the office space expires on November 30, 2025. CEL-SCI believes this arrangement is adequate for the conduct of its present business.
ITEM 2. PROPERTIES CEL-SCI leases approximately 3,700 square feet of office space at 8229 Boone Blvd., Suite 802, Vienna, Virginia at a monthly rental of approximately $8,000. In October 2025, the lease on the office space was extended and expires on May 31, 2031. CEL-SCI believes this arrangement is adequate for the conduct of its present business.
CEL-SCI has a 17,900 square foot laboratory located in Baltimore, Maryland. The laboratory is leased by CEL-SCI at a cost of approximately $22,000 per month. During the period ended September 30, 2021, the laboratory lease was extended ten years and expires on February 29, 2032. In August 2007, CEL-SCI leased a building near Baltimore, Maryland (the San Tomas lease).
CEL-SCI has a 17,900 square foot laboratory located in Baltimore, Maryland. The laboratory is leased by CEL-SCI at a cost of approximately $22,000 per month. The laboratory lease expires on February 29, 2032. In August 2007, CEL-SCI leased a building near Baltimore, Maryland (the San Tomas lease).
CEL-SCI is also required to pay all real estate and personal property taxes, insurance premiums, maintenance expenses, repair costs and utilities, which were approximately $76,000 per month as of September 30, 2024.
CEL-SCI is also required to pay all real estate and personal property taxes, insurance premiums, maintenance expenses, repair costs and utilities, which were approximately $86,000 per month as of September 30, 2025. The lease allows CEL-SCI, at its election, to extend the lease for two ten-year periods or to purchase the building at the end of the 20-year lease.
The total cost of the upgrades was $11.1 million. The landlord agreed to finance the final $2.4 million of the costs incurred. The Company started repaying these costs on March 1, 2021 through increased lease payments which will continue over the remaining lease term.
The landlord agreed to finance the final $2.4 million of the costs incurred. The Company started repaying these costs on March 1, 2021 through increased lease payments which will continue over the remaining lease term. The repayment includes a base rent which escalates at 3% each year plus interest that accrues at 13.75% per year on the $2.4 million financed.
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The repayment includes a base rent which escalates at 3% each year plus interest that accrues at 13.75% per year on the $2.4 million financed.

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

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Biggest changeThe issuance of preferred stock with such rights may make more difficult the removal of management even if such removal would be considered beneficial to shareholders generally, and will have the effect of limiting shareholder participation in certain transactions such as mergers or tender offers if such transactions are not favored by incumbent management. 52 The market price of CEL-SCI’s common stock, as well as the securities of other biopharmaceutical and biotechnology companies, have historically been highly volatile, and the market has from time to time experienced significant price and volume fluctuations that are unrelated to the operating performance of particular companies.
Biggest changeThe issuance of preferred stock with such rights may make more difficult the removal of management even if such removal would be considered beneficial to shareholders generally, and will have the effect of limiting shareholder participation in certain transactions such as mergers or tender offers if such transactions are not favored by incumbent management.
Factors such as fluctuations in CEL-SCI’s operating results, announcements of technological innovations or new therapeutic products by CEL-SCI or its competitors, governmental regulation, developments in patent or other proprietary rights, public concern as to the safety of products which may be developed by CEL-SCI or other biotechnology and pharmaceutical companies, and general market conditions may have a significant effect on the market price of CEL-SCI’s common stock.
Factors such as fluctuations in CEL-SCI’s operating results, announcements of technological innovations or new therapeutic products by CEL-SCI or its competitors, governmental regulation, developments in patent or other proprietary rights, public concern as to the safety of products which may be developed by CEL-SCI or other biotechnology and pharmaceutical companies, and general market conditions may have a significant effect on the market price of CEL-SCI’s common stock. 54
ITEM 5. MARKET FOR CEL-SCI'S COMMON EQUITY AND RELATED STOCKHOLDER MATTERS. As of September 30, 2024, there were approximately 465 record holders of CEL-SCI’s common stock. CEL-SCI’s common stock is traded on the NYSE American under the symbol “CVM”.
ITEM 5. MARKET FOR CEL-SCI'S COMMON EQUITY AND RELATED STOCKHOLDER MATTERS. As of September 30, 2025, there were approximately 425 record holders of CEL-SCI’s common stock. CEL-SCI’s common stock is traded on the NYSE American under the symbol “CVM”.
Quarter Ending High Low 12/31/2022 $ 3.68 $ 1.88 3/31/2023 $ 3.33 $ 2.15 6/30/2023 $ 2.94 $ 1.86 9/30/2023 $ 2.99 $ 1.08 12/31/2023 $ 3.23 $ 1.04 3/31/2024 $ 3.08 $ 1.63 6/30/2024 $ 2.39 $ 1.10 9/30/2024 $ 2.22 $ 1.02 Holders of common stock are entitled to receive dividends as may be declared by CEL-SCI’s Board of Directors out of legally available funds and, in the event of liquidation, to share pro rata in any distribution of CEL-SCI’s assets after payment of liabilities.
Quarter Ending High Low 12/31/2023 $ 96.91 $ 31.20 3/31/2024 $ 92.41 $ 48.90 6/30/2024 $ 71.71 $ 33.00 9/30/2024 $ 66.60 $ 30.60 12/31/2024 $ 33.90 $ 11.10 3/31/2025 $ 20.41 $ 6.65 6/30/2025 $ 9.60 $ 1.98 9/30/2025 $ 13.48 $ 2.21 Holders of common stock are entitled to receive dividends as may be declared by CEL-SCI’s Board of Directors out of legally available funds and, in the event of liquidation, to share pro rata in any distribution of CEL-SCI’s assets after payment of liabilities.
Shown below are the range of high and low quotations for CEL-SCI’s common stock for the periods indicated as reported by the NYSE American.
As a result of the reverse stock split, the number of the Company’s outstanding shares of common stock decreased from 94,037,256 (pre-split) shares to 3,135,021 (post-split) shares Shown below are the range of high and low quotations for CEL-SCI’s common stock for the periods indicated as reported by the NYSE American.
Added
On May 19, 2025, the Company’s shareholders approved a reverse split of the Company’s common stock which became effective on the NYSE American on May 20, 2025. On that date, every thirty issued and outstanding shares of the Company’s common stock automatically converted into one outstanding share. No fractional shares were issued in the reverse split.
Added
Any fractional shares were rounded up to one whole share.
Added
The market price of CEL-SCI’s common stock, as well as the securities of other biopharmaceutical and biotechnology companies, have historically been highly volatile, and the market has from time to time experienced significant price and volume fluctuations that are unrelated to the operating performance of particular companies.

Item 7. Management's Discussion & Analysis

Management's Discussion & Analysis (MD&A) — revenue / margin commentary

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Biggest changeThis decrease is primarily due to a decrease in employee stock compensation expense of approximately $0.5 million and a decrease in other net general and administrative expenses of approximately $0.3 million. Net interest expense decreased by approximately $0.1 million for the year ended September 30, 2024 compared to the year ended September 30, 2023.
Biggest changeInterest Expense, Net Net interest expense decreased by approximately $0.1 million for the year ended September 30, 2025 compared to the year ended September 30, 2024. This decrease is primarily due to less interest paid on leases as higher principal balances have been paid over the last year.
The inability of CEL-SCI to conduct clinical trials or research, whether due to a lack of capital or regulatory approval, will prevent CEL-SCI from completing the studies and research required to obtain regulatory approval for any products which CEL-SCI is developing. Without regulatory approval, CEL-SCI will be unable to sell any of its products.
The inability of CEL-SCI to conduct clinical trials or research, whether due to a lack of capital or regulatory approval, will prevent CEL-SCI from completing the studies and research required to obtain regulatory approval for any products which CEL-SCI is developing. Without regulatory approval, CEL-SCI will be unable to sell any of its products.
The total compensation cost will be expensed over the estimated requisite service period.
The total compensation cost will be expensed over the estimated requisite service period. 59
The fair value of stock options is calculated using the Black-Scholes option pricing model. The Black-Scholes model requires five input variables: the strike price of an option, the current stock price, the time to expiration, the risk-free rate and the volatility. The share-based compensation cost is recognized using the straight-line method as expense over the requisite service or vesting period.
The Black-Scholes model requires six input variables: the strike price of an option, the current stock price, the time to expiration, the risk-free rate, the dividend yield and the volatility. The share-based compensation cost is recognized using the straight-line method as expense over the requisite service or vesting period.
Since all of CEL-SCI’s projects are under development, CEL-SCI cannot predict with any certainty the funds required for future research and clinical trials, the timing of future research and development projects, or when it will be able to generate any revenue from the sale of any of its products.
Ultimately, CEL-SCI must complete the development of its products, obtain appropriate regulatory approvals and obtain sufficient revenues to support its cost structure. 58 Since all of CEL-SCI’s projects are under development, CEL-SCI cannot predict with any certainty the funds required for future research and clinical trials, the timing of future research and development projects, or when it will be able to generate any revenue from the sale of any of its products.
The lease expires on October 31, 2028, and required annual base rent payments of approximately $2.6 million during the twelve months ended September 30, 2024. See Item 2 of this report for more information concerning the terms of this lease. During the year ended September 30, 2024, 5,680,000 pre-funded warrants were exercised.
The lease expires on October 31, 2028, and required annual base rent payments of approximately $2.7 million during the twelve months ended September 30, 2025. See Item 2 of this report for more information concerning the terms of this lease. 57 During the fiscal years ended September 30, 2025 and 2024, 733,834 and 189,335 pre-funded warrants were exercised, respectively.
Primarily as a result of CEL-SCI’s losses incurred to date, its expected continued future losses, and limited cash balances, CEL-SCI has included a disclosure in its financial statements expressing substantial doubt about its ability to continue as a going concern. 55 Future Capital Requirements CEL-SCI’s material capital commitments include funding operating losses, funding its research and development program and making required lease payments.
Primarily as a result of CEL-SCI’s losses incurred to date, its expected continued future losses, and limited cash balances, CEL-SCI has included a disclosure in its financial statements expressing substantial doubt about its ability to continue as a going concern.
Capital has also been used for patent applications, debt repayment, research and development, administrative costs, and for CEL-SCI’s laboratory and manufacturing facilities. CEL-SCI does not anticipate realizing significant revenues until it enters into licensing arrangements regarding its technology and know-how or until it receives regulatory approval to sell its products (which could take a number of years).
CEL-SCI does not anticipate realizing significant revenues until it enters into licensing arrangements regarding its technology and know-how or until it receives regulatory approval to sell its products (which could take a number of years).
For information on employment contracts, see Item 11 of this report. CEL-SCI will need to raise additional funds, either through debt or equity financings or a partnering arrangement, to bring Multikine to market.
Future Capital Requirements CEL-SCI’s material capital commitments include funding operating losses, funding its research and development program and making required lease payments. For information on employment contracts, see Item 11 of this report. CEL-SCI will need to raise additional funds, either through debt or equity financings or a partnering arrangement, to bring Multikine to market.
In addition, CEL-SCI has utilized short-term loans to meet its capital requirements. Capital raised by CEL-SCI has been used to acquire an exclusive worldwide license to use, and later purchase, certain patented and unpatented proprietary technology and know-how relating to the human immunological defense system and for clinical trials.
Capital raised by CEL-SCI has been used to acquire an exclusive worldwide license to use, and later purchase, certain patented and unpatented proprietary technology and know-how relating to the human immunological defense system and for clinical trials. Capital has also been used for patent applications, debt repayment, research and development, administrative costs, and for CEL-SCI’s laboratory and manufacturing facilities.
The determination of the incremental borrowing rates for new and modified lease contracts is a critical accounting estimate.
The determination of the incremental borrowing rates for new and modified lease contracts is a critical accounting estimate. Significant judgment is required by management to develop inputs and assumptions used to determine the incremental borrowing rate for lease contracts.
As a result, CEL-SCI cannot predict when it will be able to generate any revenue from the sale of any of its products. Since inception, CEL-SCI has financed its operations through the issuance of equity securities, convertible notes, loans and certain research grants.
As a result, CEL-SCI cannot predict when it will be able to generate any revenue from the sale of any of its products.
Results of Operations The Company incurred a net operating loss of approximately $26.4 million for the twelve months ended September 30, 2024. This net operating loss consists of significant non-cash expenses accounting for approximately 30% of the operating loss. The non-cash operating expenses include approximately $4.3 million in stock-based employee compensation and approximately $4.0 million in depreciation and amortization expense.
Results of Operations and Financial Condition The Company incurred a net operating loss of approximately $24.8 million for the twelve months ended September 30, 2025. This net operating loss consists of significant non-cash expenses accounting for approximately 27% of the operating loss.
The table below shows the research and development expenses associated with each project during the reporting periods. Year ended September 30, 2024 2023 Multikine $ 18,072,573 $ 22,098,222 LEAPS 88,878 373,274 Total research and development $ 18,161,451 $ 22,471,496 CEL-SCI’s Phase III clinical trial began in December 2010 after the completion and validation of CEL-SCI’s dedicated manufacturing facility.
Year Ended September 30, 2025 2024 Multikine $ 16,389,249 $ 18,072,573 LEAPS (502,272 ) 88,878 Total research and development $ 15,886,977 $ 18,161,451 56 CEL-SCI’s Phase III clinical trial began in December 2010 after the completion and validation of CEL-SCI’s dedicated manufacturing facility.
Ultimately, CEL-SCI must complete the development of its products, obtain appropriate regulatory approvals and obtain sufficient revenues to support its cost structure.
The ability of the Company to complete the necessary clinical trials and obtain FDA approval for the sale of products to be developed on a commercial basis is uncertain. Ultimately, the Company must complete the development of its products, obtain the appropriate regulatory approvals and obtain sufficient revenues to support its cost structure.
Significant judgment is required by management to develop inputs and assumptions used to determine the incremental borrowing rate for lease contracts. 56 Share-based Compensation –Compensation cost for all share-based awards is measured at fair value as of the grant date in accordance with the provisions of ASC 718, Compensation – Stock Compensation (“ASC 718”).
Share-based Compensation – Compensation cost for all share-based awards is measured at fair value as of the grant date in accordance with the provisions of ASC 718, Compensation – Stock Compensation (“ASC 718”). The fair value of stock options is calculated using the Black-Scholes option pricing model.
During fiscal year 2024 and 2023, CEL-SCI raised net proceeds of approximately $21.2 million and $6.3 million, respectively, through a combination of the sale of common stock and the exercise of warrants. 54 In August 2007, CEL-SCI leased a building near Baltimore, Maryland.
During fiscal years 2025 and 2024, CEL-SCI raised net proceeds of approximately $25.0 million and $21.2 million, respectively, through a combination of the sale of common stock and the exercise of warrants. The cost of the confirmatory registration study is estimated to be about $30 million.
Since all of CEL-SCI’s projects are under development, CEL-SCI cannot predict when it will be able to generate any revenue from the sale of any of its products. Liquidity and Capital Resources CEL-SCI has relied primarily upon capital generated from the public and private offerings of its common stock and convertible notes.
Since all of CEL-SCI’s projects are under development, CEL-SCI cannot predict when it will be able to generate any revenue from the sale of any of its products. General and Administrative Expenses During the year ended September 30, 2025, general and administrative expenses increased by approximately $0.7 million, or 9%, compared to the year ended September 30, 2024.
Supplies are purchased for use in the Company’s manufacturing and R&D efforts. During the year ended September 30, 2024, the supplies increased by approximately $0.2 million in support of the work to validate and prepare the manufacturing facility to produce Multikine for the confirmatory registration study and before the Company’s Biologics License Application (BLA) can be submitted to the FDA.
Supplies are purchased for use in the Company’s manufacturing and R&D efforts. During the year ended September 30, 2025, the supplies decreased by approximately $1.0 million primarily due to supplies used in the manufacturing of the clinical lot in the third quarter of the current fiscal year.
Removed
During the year ended September 30, 2024, research and development expenses decreased by approximately $4.3 million, or 19%, compared to the year ended September 30, 2023. Major components of this decrease include an approximately $1.6 million decrease in employee stock compensation expense and a decrease of approximately $3.3 million in costs related to its clinical study activities.
Added
In August 2025, CEL-SCI filed a Breakthrough Medicine Designation application with the Saudi Food and Drug Authority (SFDA) for Multikine in the Kingdom of Saudi Arabia by one of the Kingdom’s premier pharmaceutical and healthcare companies, Dallah Pharma. Since inception, CEL-SCI has financed its operations through the issuance of equity securities, convertible notes, loans and certain research grants.
Removed
These decreases were offset by an increase of approximately $0.6 million in other research and development costs. 53 During the year ended September 30, 2024, general and administrative expenses decreased by approximately $0.8 million, or 9%, compared to the year ended September 30, 2023.
Added
The non-cash operating expenses include approximately $2.7 million in stock-based compensation to employees and non-employees and approximately $3.9 million in depreciation and amortization expense.
Removed
This decrease is primarily due to the Company earning approximately $0.2 million less in interest income and approximately $0.1 million less in interest expense from its finance leases during the year ended September 30, 2024 compared to the year ended September 30, 2023. Research and Development Expenses CEL-SCI’s research and development efforts involved Multikine and LEAPS.
Added
Research and Development Expenses Research and development expenses consist primarily of costs incurred for our research activities, including the development of our products, and include: · employee‑related expenses, including salaries, related benefits and stock‑based compensation expense for employees engaged in research and development functions; · fees paid to consultants for services directly related to our product development and regulatory efforts; · expenses incurred under agreements with Clinical Research Organizations, or CROs, and consultants that conduct and provide supplies for our clinical studies and clinical trials; · costs associated with clinical activities and development activities; and · costs related to compliance with regulatory requirements. 55 The following table summarizes our research and development expenses for the years ended September 30, 2025 and 2024: Year Ended September 30, (in thousands) 2025 2024 Clinical trial expense $ 615 $ 315 Supplies & materials 2,267 2,098 Personnel-related expenses 5,900 6,050 Stock-based compensation 832 2,896 Depreciation and amortization expense 3,846 3,925 Other expenses 2,427 2,877 Total research and development expenses $ 15,887 $ 18,161 During the year ended September 30, 2025, research and development expenses decreased by approximately $2.3 million, or 13%, compared to the year ended September 30, 2024.
Removed
During the year ended September 30, 2023, the following chart lists the warrants that were exercised and the proceeds received. Fiscal Year 2023 Warrants Warrants Exercised Exercise Price Proceeds Series RR 17,752 $ 1.65 $ 29,291 Series SS 200,000 $ 2.09 418,000 217,752 $ 447,291 During the year ended September 30, 2024, the Company’s cash increased by approximately $0.6 million.
Added
A major component of the decrease in research and development expenses over the prior period included an approximate $2.1 million decrease in employee stock compensation expense.
Removed
During the year ended September 30, 2023, the Company’s cash decreased by approximately $18.5 million. The significant component of this decrease included cash used to fund the Company’s regular operations of approximately $22.8 million, which includes the approximate $2.3 million deposit made to the Company’s landlord as a result of falling below certain cash requirements per the San Tomas lease.
Added
The decrease in employee stock compensation expense is due to options issued in prior periods having a higher fair value because of the Company’s stock price and the forfeiture of stock options during fiscal year ended September 30, 2025 which resulted in the reversal of approximately $0.6 million in research and development expense.
Removed
Other components of this decrease include approximately $0.4 million used to make leasehold improvements and acquire research and development equipment, and approximately $1.6 million in payments on the Company’s finance leases. These decreases were offset by approximately $5.8 million and $0.5 million of cash received from issuance of common stock and exercise of warrants, respectively.
Added
Additionally there was an approximate $0.5 million net decrease of other research and development expenses, offset by an increase of $0.3 million in costs incurred related to its clinical study activities. CEL-SCI’s research and development efforts involved Multikine and LEAPS. The table below shows the research and development expenses associated with each project during the reporting periods.
Added
The major components of general and administrative expenses include an approximate increase of $0.7 million in public relations costs during the current year, and an approximate increase of $0.4 million in legal and accounting fees primarily due to out of scope work, offset by an approximate $0.3 million decrease of employee stock compensation expense due to options issued in the prior period having a higher fair value because of the Company’s stock price, and an approximate $0.1 million decrease in other general and administrative expenses.
Added
Liquidity and Capital Resources CEL-SCI has relied primarily upon capital generated from the public and private offerings of its common stock. In addition, CEL-SCI has utilized short-term loans to meet its capital requirements.
Added
The Company will be required to raise additional capital or find additional long-term financing to continue with its research efforts. The ability to raise capital may be dependent upon market conditions that are outside the control of the Company.
Added
However, there can be no assurance that the Company will be able to raise sufficient capital to support its operations. Due to recurring losses from operations and future liquidity needs, there is substantial doubt about the Company’s ability to continue as a going concern. In August 2007, CEL-SCI leased a building near Baltimore, Maryland.
Added
During the year ended September 30, 2025, the Company’s cash increased by approximately $6.2 million.
Added
The significant component of this increase included gross proceeds from the financings during the year ended September 30, 2025 of approximately $28.3 million offset by cash used to fund the Company’s regular operations of approximately $17.0 million, approximately $3.1 million in payments for costs to issue common stock and approximately $2.0 million in payments on the Company’s finance lease obligations.
Added
During the year ended September 30, 2024, the Company’s cash increased by approximately $0.6 million.

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