CEL-SCI CORPORATION
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(Exact name of registrant as specified in its charter)
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COLORADO
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84-0916344
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(State or other jurisdiction of incorporation or organization)
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(I.R.S. Employer Identification No.)
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8229 Boone Blvd., Suite 802
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Vienna, Virginia
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22182
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(Address of principal executive offices)
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(Zip Code)
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1)
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Multikine (an investigational immunotherapy under development for the potential treatment of certain head and neck cancers, and anal warts or cervical dysplasia in human immunodeficiency virus, or HIV, and human papillomavirus, or HPV, co-infected patients;
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2)
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L.E.A.P.S. (Ligand Epitope Antigen Presentation System) technology, or LEAPS, with two investigational therapies, LEAPS-H1N1-DC, a product candidate under development for the potential treatment of pandemic influenza in hospitalized patients, and CEL-2000 and CEL-4000, vaccine product candidates under development for the potential treatment of rheumatoid arthritis.
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(1)
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CIZ = low dose (non-chemotherapeutic) of cyclophosphamide, indomethacin and Zinc-multivitamins) all of which are thought to enhance Multikine activity
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Reported improved survival:
In a follow-up analysis of the Phase 2 clinical study population, which used the same dosage and treatment regimen as is being used in the Phase 3 study, head and neck cancer patients with locally advanced primary disease who received the investigational therapy Multikine as first-line investigational therapy followed by surgery and radiotherapy were reported by the clinical investigators to have had a 63.2% overall survival, or OS, rate at a median of 3.33 years from surgery. This percentage of OS was arrived at as follows: of the 21 subjects enrolled in the Phase 2 study, the consent for the survival follow-up portion of the study was received from 19 subjects. OS was calculated using the entire treatment population that consented to the follow-up portion of the study (19 subjects), including two subjects who, as later determined by three pathologists blinded to the study, did not have oral squamous cell carcinoma, or OSCC. These two subjects were thus not evaluable per the protocol and were not included in the pathology portion of the study for purposes of calculating complete response rate, as described below, but were included in the OS calculation. The overall survival rate of subjects receiving the investigational therapy in this study was compared to the overall survival rate that was calculated based upon a review of 55 clinical trials conducted in the same cancer population (with a total of 7,294 patients studied), and reported in the peer reviewed scientific literature between 1987 and 2007. Review of this literature showed an approximate survival rate of 47.5% at 3.5 years from treatment. Therefore, the results of CEL-SCI's final Phase 2 study were considered to be potentially favorable in terms of overall survival recognizing the limitations of this early-phase study. It should be noted that an earlier investigational therapy Multikine study appears to lend support to the overall survival findings described above - Feinmesser et al Arch Otolaryngol. Surg. 2003. However, no definitive conclusions can be drawn from these data about the potential efficacy or safety profile of this investigational therapy. Moreover, further research is required, and these results must be confirmed in the Phase 3 clinical trial of this investigational therapy that is currently in progress. Subject to completion of that Phase 3 clinical trial and the FDA’s review and acceptance of CEL-SCI's entire data set on this investigational therapy, CEL-SCI believes that these early-stage clinical trial results indicate the potential for the Multikine product candidate to become a treatment for advanced primary head and neck cancer, if approved.
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Reported average of 50% reduction in tumor cells in Phase 2 trials (based on 19 patients evaluable by pathology, having OSCC):
The clinical investigators who administered the three week Multikine treatment regimen used in the Phase 2 study reported that, as was determined in a controlled pathology study, Multikine administration appeared to have caused, on average, the disappearance of about half of the cancer cells present at surgery (as determined by histopathology assessing the area of Stroma/Tumor (Mean+/- Standard Error of the Mean of the number of cells counted per filed)) even before the start of standard therapy, which normally includes surgery, radiation and chemotherapy (Timar et al JCO 2005).
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Reported 10.5% complete response in the final Phase II trial (based on 19 patients evaluable by pathology, having OSCC):
The clinical investigators who administered the three-week Multikine investigational treatment regimen used in the Phase 2 study reported that, as was determined in a controlled pathology study, the tumor apparently was no longer present (as determined by histopathology) in approximately 10.5% of evaluable patients with OSCC (Timar et al JCO 2005). In the original study, 21 subjects received Multikine, two of which were later excluded, as subsequent analysis by three pathologists blinded to the study revealed that these two patients did not have OSCC. Two subjects in this study had a complete response, leaving a reported complete response rate of two out of 19 assessable subjects with OSCC (or 10.5%) (Timar et al JCO 2005).
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Adverse events reported in clinical trials:
In clinical trials conducted to date with the Multikine investigational therapy, adverse events which have been reported by the clinical investigators as possibly or probably related to Multikine administration included pain at the injection site, local minor bleeding and edema at the injection site, diarrhea, headache, nausea, and constipation
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$100,000 upon European Medicines Agency ("EMA") grant of Marketing Authorization for Multikine;
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$50,000 upon Croatia’s grant of reimbursement status for Multikine in Croatia; and
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$50,000 upon Serbia’s grant of reimbursement status for Multikine in Serbia.
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continues to undertake preclinical development and clinical trials for product candidates;
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seeks regulatory approvals for product candidates;
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implements additional internal systems and infrastructure; and
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hires additional personnel.
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the rate of progress of, results of and cost of completing Phase 3 clinical development of Multikine for the treatment of certain head and neck cancers;
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the results of the applications to and meetings with the FDA, the EMA and other regulatory authorities and the consequential effect on operating costs;
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assuming favorable Phase 3 clinical results, the cost, timing and outcome of the efforts to obtain marketing approval for Multikine in the United States, Europe and in other jurisdictions, including the preparation and filing of regulatory submissions for Multikine with the FDA, the EMA and other regulatory authorities;
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the scope, progress, results and costs of additional preclinical, clinical, or other studies for additional indications for Multikine, LEAPS and other product candidates and technologies that CEL-SCI may develop or acquire;
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the timing of, and the costs involved in, obtaining regulatory approvals for LEAPS if clinical studies are successful;
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the cost and timing of future commercialization activities for the products if any of the product candidates are approved for marketing, including product manufacturing, marketing, sales and distribution costs;
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the revenue, if any, received from commercial sales of the product candidates for which CEL-SCI receives marketing approval;
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the cost of having the product candidates manufactured for clinical trials and in preparation for commercialization;
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the ability to establish and maintain strategic collaborations, licensing or other arrangements and the financial terms of such agreements;
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the costs involved in preparing, filing and prosecuting patent applications and maintaining, defending and enforcing the intellectual property rights, including litigation costs, and the outcome of such litigation; and
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the extent to which CEL-SCI acquires or licenses other products or technologies.
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decreased demand for Multikine or other product candidates, if approved;
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injury to CEL-SCI’s reputation;
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withdrawal of existing, or failure to enroll additional, clinical trial participants;
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costs to defend any related litigation;
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a diversion of management’s time and the resources;
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substantial monetary awards to trial participants or patients;
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product candidate recalls, withdrawals or labeling, marketing or promotional restrictions;
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loss of revenue;
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inability to commercialize Multikine or the other product candidates; and
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a decline in the price of CEL-SCI’s common stock.
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the efficacy and safety as demonstrated in clinical trials;
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the timing of market introduction of such product candidate as well as competitive products;
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the clinical indications for which the drug is approved;
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the approval, availability, market acceptance and reimbursement for the companion diagnostic;
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acceptance by physicians, major operators of cancer clinics and patients of the drug as a safe and effective treatment;
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the potential and perceived advantages of a product candidate over alternative treatments, especially with respect to patient subsets that are targeted with a product candidate;
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the safety of a product candidate seen in a broader patient group, including its use outside the approved indications;
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the cost of treatment in relation to alternative treatments;
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the availability of adequate reimbursement and pricing by third-party payors and government authorities;
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relative convenience and ease of administration;
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the prevalence and severity of adverse side effects; and
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the effectiveness of sales and marketing efforts.
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the availability of financial resources needed to commence and complete the planned trials;
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obtaining regulatory approval to commence a trial;
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reaching agreement on acceptable terms with prospective contract research organizations, or CROs, and clinical trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and trial sites;
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obtaining Institutional Review Board, or IRB, approval at each clinical trial site;
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recruiting suitable patients to participate in a trial;
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having patients complete a trial or return for post-treatment follow-up;
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clinical trial sites deviating from trial protocol or dropping out of a trial;
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adding new clinical trial sites; or
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manufacturing sufficient quantities of the product candidate for use in clinical trials.
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product design, development and manufacture;
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product application and use
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adverse drug experience;
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product advertising and promotion;
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product manufacturing, including good manufacturing practices
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record keeping requirements;
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registration and listing of the establishments and products with the FDA, EMA and other state and national agencies;
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product storage and shipping;
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drug sampling and distribution requirements;
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electronic record and signature requirements; and
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labeling changes or modifications.
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regulatory authorities may withdraw approvals of such product;
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regulatory authorities may require additional warnings on the label;
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CEL-SCI may be required to create a medication guide outlining the risks of such side effects for distribution to patients;
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CEL-SCI could be sued and held liable for harm caused to patients; and
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its reputation may suffer.
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the federal Anti-Kickback Statute, which prohibits, among other things, persons from knowingly and willfully soliciting, offering, receiving or providing remuneration, directly or indirectly, in cash or in kind, to induce or reward, or in return for, either the referral of an individual for, or the purchase, lease, order or recommendation of, any good, facility, item or service, for which payment may be made, in whole or in part, under federal and state healthcare programs such as Medicare and Medicaid. A person or entity does not need to have actual knowledge of the statute or specific intent to violate it to have committed a violation. In addition, the Affordable Care Act provides that the government may assert that a claim including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the False Claims Act;
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federal civil and criminal false claims laws, including the federal False Claims Act, which impose criminal and civil penalties, including civil whistleblower actions, against individuals or entities for, among other things, knowingly presenting, or causing to be presented, to the federal government, including the Medicare and Medicaid programs, claims for payment that are false or fraudulent or making a false statement to avoid, decrease or conceal an obligation to pay money to the federal government;
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the civil monetary penalties statute, which imposes penalties against any person or entity who, among other things, is determined to have presented or caused to be presented a claim to a federal health program that the person knows or should know is for an item or service that was not provided as claimed or is false or fraudulent;
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the federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, which created new federal criminal statutes that prohibit knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program or obtain, by means of false or fraudulent pretenses, representations or promises, any of the money or property owned by, or under the custody or control of, any healthcare benefit program, regardless of the payor (e.g., public or private), knowingly and willfully embezzling or stealing from a health care benefit program, willfully obstructing a criminal investigation of a healthcare offense and knowingly and willfully falsifying, concealing or covering up by any trick or device a material fact or making any materially false statements in connection with the delivery of, or payment for, healthcare benefits, items or services relating to healthcare matters. A person or entity does not need to have actual knowledge of the statute or specific intent to violate it to have committed a violation;
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HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, or HITECH, and their respective implementing regulations, which impose obligations on covered entities, including healthcare providers, health plans, and healthcare clearinghouses, as well as their respective business associates that create, receive, maintain or transmit individually identifiable health information for or on behalf of a covered entity, with respect to safeguarding the privacy, security and transmission of individually identifiable health information;
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the federal Physician Payments Sunshine Act and its implementing regulations, which imposed annual reporting requirements for certain manufacturers of drugs, devices, biologicals and medical supplies for payments and “transfers of value” provided to physicians and teaching hospitals, as well as ownership and investment interests held by physicians and their immediate family members; and
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analogous state and foreign laws, such as state anti-kickback and false claims laws, which may apply to sales or marketing arrangements and claims involving healthcare items or services reimbursed by non-governmental third-party payors, including private insurers; state laws that require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government or otherwise restrict payments that may be made to healthcare providers; state and foreign laws that require drug manufacturers to report information related to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures; and state and foreign laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and often are not preempted by HIPAA, thus complicating compliance efforts.
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CEL-SCI was the first to make the inventions covered by each of its issued patents and pending patent applications;
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CEL-SCI was the first to file patent applications for these inventions;
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others will independently develop similar or alternative technologies or duplicate any of the technologies;
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any of the pending patent applications will result in issued patents;
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any of the patents will be valid or enforceable;
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any patents issued to CEL-SCI or the collaboration partners will provide CEL-SCI with any competitive advantages, or will be challenged by third parties;
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CEL-SCI will be able to develop additional proprietary technologies that are patentable;
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the U.S. government will exercise any of its statutory rights to CEL-SCI’s intellectual property that was developed with government funding; or
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its business may infringe the patents or other proprietary rights of others.
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actual or anticipated fluctuations in CEL-SCI’s financial condition and operating results;
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actual or anticipated changes in CEL-SCI’s growth rate relative to competitors;
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competition from existing products or new products or product candidates that may emerge;
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development of new technologies that may address the markets and may make CEL-SCI’s technology less attractive;
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changes in physician, hospital or healthcare provider practices that may make CEL-SCI’s product candidates less useful;
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announcements by CEL-SCI, its partners or competitors of significant acquisitions, strategic partnerships, joint ventures, collaborations or capital commitments;
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developments or disputes concerning patent applications, issued patents or other proprietary rights;
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the recruitment or departure of key personnel;
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failure to meet or exceed financial estimates and projections of the investment community or that CEL-SCI provides to the public;
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actual or anticipated changes in estimates as to financial results, development timelines or recommendations by securities analysts;
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variations in the financial results or those of companies that are perceived to be similar to CEL-SCI;
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changes to coverage and reimbursement levels by commercial third-party payors and government payors, including Medicare, and any announcements relating to reimbursement levels;
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general economic, industry and market conditions; and
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the other factors described in this “Risk Factors” section.
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all actions, including federal securities law claims, would be subject to Article X;
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the phrase “a judgment on the merits” means the determination by a court of competent jurisdiction on the matters submitted to the court;
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the phrase “substantially achieves, in both substance and amount” means the plaintiffs in the action would be awarded at least 90% of the relief sought;
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only persons who were stockholders at the time an action was brought would be subject to Article X; and
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only the directors or officers named in the action would be allowed to recover.
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Quarter Ending
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High
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Low
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12/31/13
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$ | 1.80 | $ | 0.53 | ||||
3/31/14
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$ | 1.90 | $ | 0.59 | ||||
6/30/14
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$ | 1.72 | $ | 0.98 | ||||
9/30/14
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$ | 1.30 | $ | 0.75 | ||||
12/31/2014
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$ | 0.91 | $ | 0.54 | ||||
3/31/2015
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$ | 1.23 | $ | 0.59 | ||||
6/30/2015
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$ | 1.09 | $ | 0.59 | ||||
9/30/2015
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$ | 0.80 | $ | 0.48 |
9/10 | 9/11 | 9/12 | 9/13 | 9/14 | 9/15 | |||||||||||||||||||
CEL-SCI Corporation
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100.00 | 56.68 | 53.57 | 26.40 | 14.16 | 9.32 | ||||||||||||||||||
NYSE MKT Composite
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100.00 | 104.37 | 129.03 | 131.42 | 151.13 | 126.81 | ||||||||||||||||||
RDG MicroCap Biotechnology
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100.00 | 72.80 | 121.61 | 108.23 | 79.54 | 50.43 |
Statements of Operations
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2015
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2014
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2013
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2012
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2011
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Grant income and other
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$ | 657,377 | $ | 264,033 | $ | 159,583 | $ | 254,610 | $ | 956,154 | ||||||||||
Operating expenses:
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Research and development
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20,949,208 | 17,000,145 | 12,681,049 | 10,368,695 | 11,745,629 | |||||||||||||||
Depreciation & amortization
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206,750 | 231,752 | 364,124 | 533,468 | 531,316 | |||||||||||||||
General and administrative
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13,797,964 | 10,606,248 | 6,982,686 | 6,595,287 | 6,664,883 | |||||||||||||||
Gain on derivative instruments
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282,616 | 248,767 | 10,750,666 | 1,911,683 | 4,432,148 | |||||||||||||||
Other expenses (3)
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(641,276 | ) | - | - | - | (12,000,000 | ) | |||||||||||||
Interest income
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110,544 | 122,854 | 117,086 | 116,061 | 164,163 | |||||||||||||||
Interest expense
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(129,985 | ) | (163,774 | ) | (170,423 | ) | (262,214 | ) | (322,980 | ) |
Net loss
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(34,674,646 | ) | (27,366,265 | ) | (9,170,947 | ) | (15,477,310 | ) | (25,712,343 | ) | ||||||||||
Issuance of additional shares due to reset provision
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(1,117,447 | ) | - | (250,000 | ) | - | ||||||||||||||
Modification of warrants
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(59,531 | ) | (325,620 | ) | (1,068,369 | ) | ||||||||||||||
Inducement warrants
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- | - | - | (1,593,000 | ) | - | ||||||||||||||
Net loss available to common shareholders
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$ | (34,674,646 | ) | $ | (28,483,712 | ) | $ | (9,230,478 | ) | $ | (17,645,930 | ) | $ | (26,780,712 | ) | |||||
Net loss per common share (1)
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Basic
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$ | (0.42 | ) | $ | (0.48 | ) | $ | (0.30 | ) | $ | (0.70 | ) | $ | (1.28 | ) | |||||
Diluted
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$ | (0.42 | ) | $ | (0.49 | ) | $ | (0.66 | ) | $ | (0.78 | ) | $ | (1.50 | ) | |||||
Weighted average common shares outstanding
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Basic and diluted
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82,519,027 | 58,804,622 | 30,279,442 | 25,183,654 | 20,848,899 | |||||||||||||||
Balance Sheets
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2015 | 2014 | 2013 | 2012 | 2011 | |||||||||||||||
Working capital (deficit)
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$ | 1,982,589 | $ | 8,496,076 | $ | (1,033,370 | ) | $ | 5,529,438 | $ | 1,796,349 | |||||||||
Total assets
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$ | 15,447,603 | $ | 19,230,434 | $ | 10,838,572 | $ | 16,067,450 | $ | 18,625,440 | ||||||||||
Derivative instruments - current (2)
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$ | - | $ | 18,105 | $ | - | $ | - | $ | 5,068,552 | ||||||||||
Derivative instruments – noncurrent (2)
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$ | 13,686,587 | $ | 5,487,141 | $ | 433,024 | $ | 6,983,690 | $ | 2,192,521 | ||||||||||
Total liabilities
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$ | 20,677,846 | $ | 8,787,034 | $ | 4,138,482 | $ | 9,040,018 | $ | 9,546,616 | ||||||||||
Stockholders' (deficit) equity
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$ | (5,230,243 | ) | $ | 10,443,400 | $ | 6,700,090 | $ | 7,027,432 | $ | 9,078,824 |
(1)
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The calculation of diluted earnings per share for the five years in the period ended September 30, 2015 excluded potentially dilutive shares because their effect would have been anti-dilutive.
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(2)
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Included in total liabilities.
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(3)
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The $641,276 loss on debt extinguishment related to the renegotiation of terms on the note payable and is disclosed in the notes to the financial statements for the year ended September 30, 2015. The $12 million other expense in 2011 was the cost of the lawsuit settlement. The detailed terms of the lawsuit settlement and the related agreements and documents were filed as exhibits to CEL-SCI’s report on Form 10-Q for the three months ended March 31, 2011.
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Net Loss Per Share | ||||||||||||
Quarter
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Net loss
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Basic
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Diluted
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12/31/2014
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$ | (7,845,318 | ) | $ | (0.11 | ) | $ | (0.14 | ) | |||
3/31/2015
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$ | (12,556,236 | ) | $ | (0.17 | ) | $ | (0.17 | ) |
6/30/2015
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$ | (4,429,137 | ) | $ | (0.05 | ) | $ | (0.06 | ) | |||
9/30/2015
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$ | (9,843,955 | ) | $ | (0.10 | ) | $ | (0.10 | ) | |||
12/31/2013
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$ | (5,451,865 | ) | $ | (0.11 | ) | $ | (0.15 | ) | |||
3/31/2014
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$ | (13,365,580 | ) | $ | (0.24 | ) | $ | (0.24 | ) | |||
6/30/2014
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$ | (2,444,480 | ) | $ | (0.04 | ) | $ | (0.11 | ) | |||
9/30/2014
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$ | (7,221,787 | ) | $ | (0.11 | ) | $ | (0.13 | ) |
ITEM 7.
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MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
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2015 | 2014 | 2013 | 2012 | 2011 | ||||||||||||||||
MULTIKINE
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$ | 20,455,398 | $ | 16,625,367 | $ | 12,303,564 | $ | 9,977,617 | $ | 11,257,157 | ||||||||||
LEAPS
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493,810 | 374,778 | 377,485 | 391,078 | 488,472 | |||||||||||||||
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TOTAL
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$ | 20,949,208 | $ | 17,000,145 | $ | 12,681,049 | $ | 10,368,695 | $ | 11,745,629 |
Years Ending September 30, | ||||||||||||||||||||||||||||
Total | 2016 | 2017 | 2018 | 2019 | 2020 | 2021 & thereafter | ||||||||||||||||||||||
Operating Leases | $ | 27,117,710 | 1,861,154 | $ | 1,844,807 | $ | 1,848,235 | $ | 1,912,779 | $ | 1,951,756 | $ | 17,698,979 | |||||||||||||||
Related Party Note & Interest | 1,393,872 | 107,646 | 99,365 | 1,186,861 | - | - | - | |||||||||||||||||||||
Total Contractual Obligations | $ | 28,511,582 | $ | 1,968,800 | $ | 1,944,172 | $ | 3,035,096 | $ | 1,912,779 | $ | 1,951,756 | $ | 17,698,979 |
Name
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Age
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Position
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Maximilian de Clara
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85 |
Director and President
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Geert R. Kersten, Esq.
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56 |
Director, Chief Executive Officer and Treasurer
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Patricia B. Prichep
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64 |
Senior Vice President of Operations and Corporate
Secretary
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Dr. Eyal Talor
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59 |
Chief Scientific Officer
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Dr. Daniel H. Zimmerman
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74 |
Senior Vice President of Research, Cellular
Immunology
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John Cipriano
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73 |
Senior Vice President of Regulatory Affairs
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Alexander G. Esterhazy
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74 |
Director
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Dr. Peter R. Young
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70 |
Director
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Bruno Baillavoine
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62 |
Director
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Market-driven.
Compensation programs are structured to be competitive both in their design and in the total compensation that they offer.
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Performance-based.
Certain officers have some portion of their incentive compensation linked to CEL-SCI’s performance. The application of performance measures as well as the form of the reward may vary depending on the employee’s position and responsibilities.
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The salaries paid to employees are consistent with the employees’ duties and responsibilities.
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Employees who have high impact relative to the expectations of their job duties and functions are rewarded.
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CEL-SCI retains employees who have skills critical to its long term success.
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Base Salary
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Long-Term Incentives (“LTIs”) (stock options and/or grants of stock)
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Benefits
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Enhance the link between the creation of shareholder value and long-term executive incentive compensation;
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Provide focus, motivation and retention incentive; and
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Provide competitive levels of total compensation.
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Name and
Principal Position
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Fiscal
Year
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Salary
(1)
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Bonus
(2)
|
Restricted Stock Awards
(3)
|
Option Awards
(4)
|
All Other Compen
-
sation
(5)
|
Total
|
||||||||||||||||||
$ | $ | $ | $ | $ | $ | ||||||||||||||||||||
Maximilian de Clara,
|
2015
|
332,750 | -- | -- | 69,190 | 40,000 | 441,940 | ||||||||||||||||||
President
|
2014
|
393,250 | -- | -- | 298,648 | 73,183 | 765,081 | ||||||||||||||||||
2013
|
332,750 | -- | -- | 306,863 | 40,000 | 679,613 | |||||||||||||||||||
Geert R. Kersten,
|
2015
|
514,083 | -- | 16,050 | -- | 54,981 | 585,114 | ||||||||||||||||||
Chief Executive
|
2014
|
584,621 | -- | 3,236,526 | 82,917 | 57,581 | 3,961,645 | ||||||||||||||||||
Officer and Treasurer
|
2013
|
439,093 | -- | 15,225 | 1,516,692 | 53,514 | 2,024,524 | ||||||||||||||||||
Patricia B. Prichep,
|
2015
|
235,702 | -- | 14,128 | -- | 6,906 | 256,736 | ||||||||||||||||||
Senior Vice President
|
2014
|
247,852 | -- | 1,735,938 | 55,278 | 6,531 | 2,045,599 | ||||||||||||||||||
of Operations and
|
2013
|
202,253 | -- | 13,941 | 485,634 | 5,531 | 707,359 | ||||||||||||||||||
Secretary
|
|||||||||||||||||||||||||
Eyal Talor, Ph.D.
,
|
2015
|
290,983 | -- | 9,600 | -- | 6,031 | 306,613 | ||||||||||||||||||
Chief Scientific Officer
|
2014
|
283,283 | -- | 1,731,290 | 55,278 | 6,031 | 2,075,882 | ||||||||||||||||||
2013
|
272,388 | -- | 9,600 | 460,255 | 6,031 | 748,274 | |||||||||||||||||||
Daniel Zimmerman, Ph.D.,
|
2015
|
219,026 | -- | 13,148 | 52,003 | 6,031 | 290,209 | ||||||||||||||||||
Senior Vice President of
|
2014
|
213,231 | -- | 13,274 | 227,319 | 6,031 | 459,855 | ||||||||||||||||||
Research, Cellular
|
2013
|
205,030 | -- | 12,989 | 87,911 | 6,031 | 311,961 | ||||||||||||||||||
Immunology
|
|||||||||||||||||||||||||
John Cipriano
,
|
2015
|
202,718 | -- | -- | -- | 31 | 202,749 | ||||||||||||||||||
Senior Vice President of
|
2014
|
197,354 | -- | 888,614 | 41,549 | 31 | 1,127,458 | ||||||||||||||||||
Regulatory Affairs
|
2013
|
189,763 | -- | -- | 47,968 | 31 | 237,762 |
(1)
|
The dollar value of base salary (cash and non-cash) earned. The officers of the Company received stock in lieu of salary increases in FY 2015.
|
(2)
|
The dollar value of bonus (cash and non-cash) earned.
|
(3)
|
The fair value of the shares of restricted stock issued during the periods covered by the table is shown as compensation for services to the persons listed in the table. For all persons listed in the table, the shares were issued as CEL-SCI's contribution on behalf of the named officer who participates in CEL-SCI's 401(k) retirement plan and, by far the largest part, restricted shares issued from the 2014 Incentive Stock Bonus Plan that was voted on and passed by the shareholders at the annual meeting on July 22, 2014. These shares are not vested and are held in escrow
.
The shares will only be earned upon the achievement of certain milestones leading to the commercialization of CEL-SCI’s Multikine technology, or specified increases in the market price of CEL-SCI’S stock. If the performance or market criteria are not met as specified in the Incentive Stock Bonus Plan, all or a portion of the awarded shares will be forfeited. The value of all stock awarded during the periods covered by the table is calculated according to ASC 718-10-30-3 which represented the grant date fair value.
|
(4)
|
The fair value of all stock options granted during the periods covered by the table are calculated on the grant date in accordance with ASC 718-10-30-3 which represented the grant date fair value
.
|
(5)
|
All other compensation received that CEL-SCI could not properly report in any other column of the table including the dollar value of any insurance premiums paid by, or on behalf of, CEL-SCI with respect to term life insurance for the benefit of the named executive officer and car allowances paid by CEL-SCI. Includes board of directors fees for Mr. de Clara and Mr. Kersten.
|
Name
|
Paid in Cash
|
Stock
Awards (1)
|
Option
Awards (2)
|
Total
|
||||||||||||
Maximilian de Clara
|
$ | 40,000 | - | $ | 69,190 | $ | 109,190 | |||||||||
Geert Kersten
|
$ | 40,000 | - | - | $ | 40,000 | ||||||||||
Alexander Esterhazy
|
$ | 45,000 | - | $ | 69,190 | $ | 114,190 | |||||||||
Peter R. Young
|
$ | 50,000 | - | $ | 69,190 | $ | 119,190 | |||||||||
Bruno Baillavoine (3)
|
$ | 11,250 | - | $ | 69,190 | $ | 80,440 |
(1)
|
The fair value of stock issued for services.
|
(2)
|
The fair value of options granted computed in accordance with ASC 718-10-30-3 on the date of grant which represents their grant date fair value.
|
(3)
|
Mr. Baillavoine joined the Board of Directors in June 2015. Mr. Baillavoine is the successor to Dr. C. Richard Kinsolving, who passed away in December 2014. Dr. Kinsolving served as a director since February 1999.
|
Name | Grant Date | Options Granted | Price Per Share | Expiration Date | |||||||
Maximilian de Clara
|
6/22/2015
|
125,000 | $ | 0.66 |
6/21/2025
|
||||||
Daniel Zimmerman
|
6/25/2015
|
100,000 | $ | 0.62 |
6/24/2025
|
||||||
Alexander Esterhazy
|
6/22/2015
|
125,000 | $ | 0.66 |
6/21/2025
|
||||||
Bruno Baillavoine
|
6/22/2015
|
125,000 | $ | 0.66 |
6/21/2025
|
||||||
Peter Young
|
6/22/2015
|
125,000 | $ | 0.66 |
6/21/2025
|
|
Weighted Average
|
Weighted Average
Remaining Contractual
|
|
Employee
|
Total Options
|
Exercise
Price
|
Term (Years)
|
Date of
|
Shares Acquired
|
Value
|
|
Name
|
Exercise
|
On Exercise
|
Realized
|
Shares underlying unexercised
|
|||||||||||||
Option which are:
|
Exercise
|
Expiration
|
|||||||||||
Name
|
Exercisable
|
Unexercisable
|
Price
|
Date
|
|||||||||
Maximilian de Clara
|
10,000 | 5.80 |
09/12/16
|
||||||||||
20,000 | 6.30 |
09/13/17
|
|||||||||||
20,000 | 6.20 |
03/04/18
|
|||||||||||
143,625 | (1) | 2.50 |
04/23/19
|
||||||||||
16,667 | (2) | 3.80 |
07/06/19
|
||||||||||
25,000 | 3.80 |
07/20/19
|
|||||||||||
25,000 | 4.80 |
07/20/20
|
|||||||||||
25,000 | 6.90 |
04/14/21
|
|||||||||||
47,200 | 3.20 |
12/01/16
|
|||||||||||
37,500 | 3.90 |
05/17/22
|
|||||||||||
40,000 | 2.80 |
12/17/22
|
|||||||||||
25,000 | 2.10 |
06/30/23
|
|||||||||||
25,000 | 1.09 |
02/25/24
|
|||||||||||
100,000 | 1.10 |
08/05/24
|
|||||||||||
150,000 | 1.08 |
08/25/24
|
|||||||||||
---------- | |||||||||||||
709,992 | |||||||||||||
33,333 | (2) | 3.80 |
07/06/19
|
||||||||||
60,000 | 2.80 |
12/17/22
|
|||||||||||
12,500 | 2.10 |
06/30/23
|
|||||||||||
50,000 | 1.09 |
02/25/24
|
|||||||||||
125,000 | 0.66 |
06/21/25
|
|||||||||||
---------- | |||||||||||||
280,833 |
Shares underlying unexercised
|
|||||||||||||
Option which are:
|
Exercise
|
Expiration
|
|||||||||||
Name
|
Exercisable
|
Unexercisable
|
Price
|
Date
|
|||||||||
Geert R. Kersten
|
20,000 | 5.80 |
09/12/16
|
||||||||||
20,000 | 6.30 |
09/13/17
|
|||||||||||
20,000 | 6.20 |
03/04/18
|
|||||||||||
183,861 | (1) | 2.50 |
04/23/19
|
||||||||||
133,334 | (2) | 3.80 |
07/06/19
|
||||||||||
30,000 | 3.80 |
07/20/19
|
|||||||||||
30,000 | 4.80 |
07/20/20
|
|||||||||||
30,000 | 6.90 |
04/14/21
|
|||||||||||
125,440 | 3.20 |
12/01/16
|
|||||||||||
45,000 | 3.90 |
05/17/22
|
|||||||||||
189,000 | 2.80 |
12/17/17
|
|||||||||||
114,140 | 2.80 |
12/17/22
|
|||||||||||
30,000 | 2.10 |
06/30/23
|
|||||||||||
30,000 | 1.09 |
02/25/24
|
|||||||||||
---------- | |||||||||||||
1,000,775 | |||||||||||||
266,666 | (2) | 3.80 |
07/06/19
|
||||||||||
385,860 | 2.80 |
12/17/22
|
|||||||||||
15,000 | 2.10 |
06/30/23
|
|||||||||||
60,000 | 1.09 |
02/25/24
|
|||||||||||
---------- | |||||||||||||
727,526 | |||||||||||||
Patricia B. Prichep
|
9,000 | 5.80 |
09/12/16
|
||||||||||
10,000 | 6.30 |
09/13/17
|
|||||||||||
10,000 | 6.20 |
03/04/18
|
|||||||||||
71,710 | (1) | 2.50 |
04/23/19
|
||||||||||
100,000 | (2) | 3.80 |
07/06/19
|
||||||||||
15,000 | 3.80 |
07/20/19
|
|||||||||||
15,000 | 4.80 |
07/20/20
|
|||||||||||
15,000 | 6.90 |
04/14/21
|
|||||||||||
38,520 | 3.20 |
12/01/16
|
|||||||||||
30,000 | 3.90 |
05/17/22
|
|||||||||||
58,000 | 2.80 |
12/17/17
|
|||||||||||
46,780 | 2.80 |
12/17/22
|
|||||||||||
20,000 | 2.10 |
06/30/23
|
|||||||||||
20,000 | 1.09 |
02/25/24
|
|||||||||||
---------- | |||||||||||||
459,010 | |||||||||||||
200,000 | (2) | 3.80 |
07/06/19
|
||||||||||
103,220 | 2.80 |
12/17/22
|
|||||||||||
10,000 | 2.10 |
06/30/23
|
|||||||||||
40,000 | 1.09 |
02/25/24
|
|||||||||||
---------- | |||||||||||||
353,220 |
Shares underlying unexercised
|
|||||||||||||
Option which are:
|
Exercise
|
Expiration
|
|||||||||||
Name
|
Exercisable
|
Unexercisable
|
Price
|
Date
|
|||||||||
Eyal Talor, Ph.D
|
8,000 | 5.80 |
09/12/16
|
||||||||||
10,000 | 6.30 |
09/13/17
|
|||||||||||
10,000 | 6.20 |
03/04/18
|
|||||||||||
24,082 | (1) | 2.50 |
04/23/19
|
||||||||||
100,000 | (2) | 3.80 |
07/06/19
|
||||||||||
15,000 | 3.80 |
07/20/19
|
|||||||||||
15,000 | 4.80 |
07/20/20
|
|||||||||||
15,000 | 6.90 |
04/14/21
|
|||||||||||
27,773 | 3.20 |
12/01/16
|
|||||||||||
30,000 | 3.90 |
05/17/22
|
|||||||||||
37,417 | 2.80 |
12/17/17
|
|||||||||||
46,780 | 2.80 |
12/17/22
|
|||||||||||
20,000 | 2.10 |
06/30/23
|
|||||||||||
20,000 | 1.09 |
02/25/24
|
|||||||||||
---------- | |||||||||||||
379,052 | |||||||||||||
200,000 | (2) | 3.80 |
07/06/19
|
||||||||||
103,220 | 2.80 |
12/17/22
|
|||||||||||
10,000 | 2.10 |
06/30/23
|
|||||||||||
40,000 | 1.09 |
02/25/24
|
|||||||||||
---------- | |||||||||||||
353,220 | |||||||||||||
Daniel Zimmerman, Ph.D
|
6,000 | 5.80 |
09/12/16
|
||||||||||
7,500 | 6.30 |
09/13/17
|
|||||||||||
7,500 | 6.20 |
03/04/18
|
|||||||||||
20,000 | 3.80 |
07/15/14
|
|||||||||||
15,000 | 4.80 |
07/20/20
|
|||||||||||
15,000 | 6.90 |
04/14/21
|
|||||||||||
25,200 | 3.20 |
12/01/16
|
|||||||||||
22,500 | 3.90 |
05/17/22
|
|||||||||||
39,200 | 2.80 |
12/17/17
|
|||||||||||
15,000 | 2.10 |
06/30/23
|
|||||||||||
15,000 | 1.09 |
02/25/24
|
|||||||||||
66,667 | 1.10 |
08/05/24
|
|||||||||||
---------- | |||||||||||||
254,567 | |||||||||||||
7,500 | 2.10 |
06/30/23
|
|||||||||||
30,000 | 1.09 |
02/25/24
|
|||||||||||
133,333 | 1.10 |
08/05/24
|
|||||||||||
100,000 | 0.62 |
06/25/25
|
|||||||||||
---------- | |||||||||||||
270,833 |
(1)
|
Options awarded to employees who did not collect a salary, or reduced or deferred their salary between September 15, 2008 and June 30, 2009. For example, Mr. de Clara, Mr. Kersten and Ms. Prichep did not collect any salary between September 30, 2008 and June 30, 2009.
|
(2)
|
Long-term performance options: The Board of Directors has identified the successful Phase III clinical trial for Multikine to be the most important corporate event to create shareholder value. Therefore, one third of the options can be exercised when the first 400 patients are enrolled in CEL-SCI's Phase III head and neck cancer clinical trial. One third of the options can be exercised when all of the patients have been enrolled in the Phase III clinical trial. One third of the options can be exercised when the Phase III trial is completed. The grant-date fair value of these options awarded to the senior management of the Company amounts to $3.3 million in total.
|
Name of Plan
|
Total Shares Reserved
Under Plans
|
Shares Reserved for Outstanding
Options
|
Shares Issued
|
Remaining Options/Shares
Under Plans
|
||||||||||||
Incentive Stock Option Plans
|
1,960,000 | 1,690,665 | N/A | 6,635 | ||||||||||||
Non-Qualified Stock Option
Plans
|
7,680,000 | 5,849,103 | N/A | 1,219,479 | ||||||||||||
Bonus Plans
|
3,594,000 | N/A | 1,643,714 | 1,949,459 | ||||||||||||
Stock Compensation Plan
|
3,350,000 | N/A | 1,423,999 | 1,892,950 | ||||||||||||
Incentive Stock Bonus Plan
|
16,000,000 | N/A | 15,600,000 | 400,000 |
Plan category
|
Number of Securities to be Issued Upon Exercise of Outstanding
Options (a)
|
Weighted-Average Exercise Price of Outstanding
Options
|
Number of Securities Remaining Available For Future Issuance Under Equity Compensation Plans, Excluding Securities
Reflected in Column (a)
|
|||||||||
Incentive Stock Option Plans
|
1,690,665 | $ | 3.03 | 6,635 | ||||||||
Non-Qualified Stock Option Plans
|
5,849,103 | $ | 2.62 | 1,219,479 |
Name and Address | Number of Shares (1) | Percent of Class (2) | ||||||
Maximilian de Clara
Bergstrasse 79
6078 Lungern,
Obwalden, Switzerland
|
780,115 | 0.6 | % | |||||
Geert R. Kersten
8229 Boone Blvd., Suite 802
Vienna, VA 22182
|
15,043,056 | (3) | 11.0 | % | ||||
Patricia B. Prichep
8229 Boone Blvd., Suite 802
Vienna, VA 22182
|
3,763,883 | 2.9 | % | |||||
Eyal Talor, Ph.D.
8229 Boone Blvd., Suite 802
Vienna, VA 22182
|
3,632,514 | 2.8 | % | |||||
Daniel H. Zimmerman, Ph.D.
8229 Boone Blvd., Suite 802
Vienna, VA 22182
|
363,891 | 0.3 | % | |||||
John Cipriano
8229 Boone Blvd., Suite 802
Vienna, VA 22182
|
1,744,718 | 1.3 | % | |||||
Alexander G. Esterhazy
20 Chemin du Pre-Poiset
CH- 1253 Vandoeuvres
Geneve, Switzerland
|
440,549 | 0.3 | % | |||||
Peter R. Young, Ph.D.
208 Hewitt Drive, Suite 103-143
Waco, TX 76712
|
456,610 | 0.4 | % | |||||
Bruno Baillavoine
8229 Boone Blvd., Suite 802
Vienna, VA 22182
|
0 | 0.0 | % | |||||
All Officers and Directors
as a Group (9 persons)
|
26,225,336 | 18.9 | % |
(1)
|
Includes shares issuable prior to February 28, 2016 upon the exercise of options or warrants granted to the following persons:
|
Name
|
Options or Warrants Exercisable
Prior to February 28, 2016
|
|||
Maximilian de Clara
|
754,992 | |||
Geert R. Kersten, Esq.
|
6,197,093 | (3) | ||
Patricia B. Prichep
|
513,417 | |||
Eyal Talor, Ph.D.
|
433,459 | |||
Daniel Zimmerman, Ph.D.
|
269,567 | |||
John Cipriano
|
130,100 | |||
Alexander G. Esterhazy
|
417,233 | |||
Peter R. Young, Ph.D.
|
426,834 | |||
Bruno Baillavoine
|
0 |
(2)
|
Amount includes shares referred to in (1) above but excludes shares which may be issued upon the exercise or conversion of other options, warrants and other convertible securities previously issued by CEL-SCI.
|
(3)
|
Amount includes shares held in trust for the benefit of Mr. Kersten's children and warrants held in the de Clara Trust, of which Mr. Kersten is the trustee and a beneficiary. Mr. Kersten is the stepson of Maximilian de Clara.
|
Year Ended September 30,
|
||||||||
2015
|
2014
|
|||||||
Audit Fees
|
$ | 362,000 | $ | 397,000 | ||||
Audit Related Fees
|
- | - | ||||||
Tax Fees
|
- | - | ||||||
All Other Fees
|
- | - |
Exhibits
|
||||
3(a)
|
Articles of Incorporation
|
Incorporated by reference to Exhibit 3(a) of CEL-SCI's combined Registration Statement on Form S-1 and Post-Effective Amendment ("Registration Statement"), Registration Nos. 2-85547-D and 33-7531.
|
||
3(b)
|
Amended Articles
|
Incorporated by reference to Exhibit 3(a) of CEL-SCI's Registration Statement on Form S-1, Registration Nos. 2-85547-D and 33-7531.
|
||
3(c)
|
Amended Articles (Name change only)
|
Filed as Exhibit 3(c) to CEL-SCI's Registration Statement on Form S-1 Registration Statement (No. 33-34878).
|
||
3(d)
|
Bylaws
|
Incorporated by reference to Exhibit 3(b) of CEL-SCI's Registration Statement on Form S-1, Registration Nos. 2-85547-D and 33-7531.
|
||
3(e)
|
Amended Bylaws
|
Incorporated by reference to Exhibit 3(ii) of CEL-SCI’s report on Form 8-K dated March 16, 2015.
|
||
4
|
Shareholders Rights Agreement, as Amended
|
__________________
|
||
4(b)
|
Incentive Stock Option Plan
|
Incorporated by reference to Exhibit 4 (b) filed on September 25, 2012 with the Company’s registration statement on Form S¬8 (File number 333-184092.
|
||
4(c)
|
Non-Qualified Stock Option Plan
|
Incorporated by reference to Exhibit 4 (b) filed on August 19, 2014 with the Company’s registration statement on Form S¬8 (File number 333-198244).
|
||
4(d)
|
Stock Bonus Plan
|
Incorporated by reference to Exhibit 4 (d) filed on September 25, 2012 with the Company’s registration statement on Form S¬8 (File number 333-184092.
|
||
4(e)
|
Stock Compensation Plan
|
Incorporated by reference to Exhibit 4 (e) filed on September 25, 2012 with the Company’s registration statement on Form S¬8 (File number 333-184092.
|
||
4(f)
|
2014 Incentive Stock Bonus Plan
|
Filed with this Amendment No. 2 to the Company’s annual report on Form 10-K for the year ended September 30, 2014.
|
||
10(d)
|
Employment Agreement with Maximilian de Clara
|
Incorporated by reference to Exhibit 10(d) of CEL-SCI’s report on Form 8-K (dated April 21, 2005) and Exhibit 10(d) to CEL-SCI’s report on Form 8-K dated September 8, 2006.
|
||
10(f)
|
Securities Purchase Agreement (together with schedule required by Instruction 2 to Item 601 of Regulation S-K) pertaining to Series K notes and warrants, together with the exhibits to the Securities Purchase Agreement
|
Incorporated by reference to Exhibit 10 to CEL-SCI’s report on Form 8-K dated August 4, 2006.
|
Exhibits
|
||||
10(g)
|
Subscription Agreement (together with Schedule required by Instruction 2 toItem 601 of Regulation S-K) pertaining to April 2007 sale of 20,000,000 shares of CEL-SCI’s common stock, 10,000,000 Series L warrants and 10,000,000 Series M Warrants
|
Incorporated by reference to Exhibit 10 of CEL-SCI’s report on Form 8-K dated April 18, 2007
|
||
10(h)
|
Warrant Adjustment Agreement with Laksya Ventures
|
Incorporated by reference to Exhibit 10(i) of CEL-SCI’s report on Form 8-K dated August 3, 2010
|
||
10(i)
|
Employment Agreement with Patricia Prichep (2013-2016)
|
Incorporated by reference to Exhibit 10(j) of CEL-SCI’s report on Form 8-K dated August 30, 2013
|
||
10(j)
|
Employment Agreement with Eyal Taylor (2013-2016)
|
Incorporated by reference to Exhibit 10(k) of CEL-SCI’s report on Form 8-K dated August 30, 2013.
|
||
10(k)
|
Amendment to Employment Agreement with Maximilian de Clara
|
Incorporated by reference to Exhibit 10(l) of CEL-SCI’s report on Form 8-K dated August 30, 2010 and Exhibit 10(l) of CEL-SCI’s report on Form 8-K dated August 30, 2013.
|
||
10(l)
|
First Amendment to Development Supply and Distribution Agreement with Orient Europharma.
|
Incorporated by reference to Exhibit 10(m) filed with CEL-SCI’s 10-K report for the year ended September 30, 2010.
|
||
10(m)
|
Exclusive License and Distribution Agreement with Teva Pharmaceutical Industries Ltd.
|
Incorporated by reference to Exhibit 10(n) filed with CEL-SCI’s 10-K report for the year ended September 30, 2010.
|
||
10(n)
|
Lease Agreement
|
Incorporated by reference to Exhibit 10(o) filed with CEL-SCI’s 10-K report for the year ended September 30, 2010.
|
||
10(o)
|
Promissory Note with Maximilian de Clara, together with Amendments 1 and 2
|
Incorporated by reference to Exhibit 10(p) filed with CEL-SCI’s 10-K report for the year ended September 30, 2010.
|
||
10(p)
|
Licensing Agreement with Byron Biopharma
|
Incorporated by reference to Exhibit 10(i) of CEL-SCI’s report on Form 8-K dated March 27, 2009
|
||
10(q)
|
At Market Issuance Sales Agreement with McNicoll, Lewis & Vlak LLC
|
Incorporated by reference to Exhibit 10(r) filed with CEL-SCI’s 10-K report for the year ended September 30, 2010
|
||
10(z)
|
Development, Supply and Distribution Agreement with Orient Europharma
|
Incorporated by reference to Exhibit 10(z) filed with CEL-SCI’s report on Form 10-K for the year ended September 30, 2003.
|
||
10(za)
|
Employment Agreement with Geert Kersten. Amendment to Employment Agreement
|
Incorporated by reference to Exhibit 10(za) to CEL-SCI’s report on Form 8-K dated September 1, 2011 and Exhibit 10(za) of CEL-SCI’s report on Form 8-K dated August 30, 2013.
|
||
10(aa)
|
Securities Purchase Agreement and form of the Series F warrants, which is and exhibit to the Securities Purchase Agreement
|
Incorporated by reference to Exhibit 10(aa) of CEL-SCI’s report on Form 8-K dated October 3, 2011.
|
||
10(bb)
|
Placement Agent Agreement
|
Incorporated by reference to Exhibit 10(bb) of CEL-SCI’s report on Form 8-K dated October 3, 2011.
|
||
10(cc)
|
Securities Purchase Agreement, together with the form of the Series H warrant, which is an exhibit to the securities Purchase Agreement
|
Incorporated by reference to Exhibit 10(cc) of CEL-SCI’s report on Form 8-K dated January 25, 2012.
|
||
10(dd)
|
Placement Agent Agreement
|
Incorporated by reference to Exhibit 10(dd) of CEL-SCI’s report on Form 8-K dated January 25, 2012.
|
||
10(ee) | Warrant Amendment Agreement, together with the form of the Series P warrant, which is an exhibit to the Warrant Amendment Agreement | Incorporated by reference to Exhibit 10(ee) of CEL-SCI’s report on Form 8-K dated February 10, 2012. | ||
10(ff) | Placement Agent Agreement | Incorporated by reference to Exhibit 10(ff) of CEL-SCI’s report on Form 8-K dated February 10, 2012. | ||
10(gg) | Securities Purchase Agreement and the form of the Series Q warrant, which is an exhibit to the Securities Purchase Agreement | Incorporated by reference to Exhibit 10(gg) of CEL-SCI’s report on Form 8-K dated June 18, 2012. | ||
10(hh) | Placement Agent Agreement | Incorporated by reference to Exhibit 10(hh) of CEL-SCI’s report on Form 8-K dated June 18, 2012. | ||
10 (ii) | Securities Purchase Agreement and the form of the Series R warrant, which is an exhibit to the Securities Purchase Agreement | Incorporated by reference to Exhibit 10(ii) of CEL-SCI’s report on Form 8-K dated December 5, 2012. | ||
10 (jj) | Placement Agent Agreement | Incorporated by reference to Exhibit 10(jj) of CEL-SCI’s report on Form 8-K dated December 5, 2012. |
Exhibits | ||||
10 (nn) | Underwriting Agreement, together with the form of Series S warrant which is an exhibit to the underwriting agreement | Incorporated by reference to Exhibit 1.1 of CEL-SCI’s report on Form 8-K dated October 8, 2013. | ||
10 (oo) | Underwriting Agreement, together with the form of Series S warrant which is an exhibit to the underwriting agreement | Incorporated by reference to Exhibit 1.1 of CEL-SCI’s report on Form 8-K dated December 19, 2013. | ||
10 (pp) | Underwriting Agreement, together with the form of Series T warrant which is an exhibit to the warrant agent agreement | Incorporated by reference to Exhibit 1.1 of CEL-SCI’s report on Form 8-K dated April 15, 2014. | ||
10 (qq) | Underwriting Agreement, together with the form of Series S warrant which is an exhibit to the warrant agent agreement | Incorporated by reference to Exhibit 1.1 of CEL-SCI’s report on Form 8-K dated October 23, 2014. | ||
10 (rr) | Assignment and Assumption Agreement with Teva Pharmaceutical Industries, Ltd. and GCP Clinical Studies, Ltd. | Incorporated by reference to Exhibit 10(rr) of CEL-SCI’s report on Form 10-K/A report for the year ended September 30, 2014 dated April 17, 2015. | ||
10 (ss) | Service Agreement with GCP Clinical Studies, Ltd., together with Amendment 1 thereto* | Incorporated by reference to Exhibit 10(ss) of CEL-SCI’s first amendment to its Form 10-K report for the year ended September 30, 2014 dated April 17, 2015. | ||
10 (tt) | Joinder Agreement with PLIVA Hrvatska d.o.o. | Incorporated by reference to Exhibit 10(tt) of CEL-SCI’s first amendment to its Form 10-K report for the year ended September 30, 2014 dated April 17, 2015. | ||
10 (uu) | Master Service Agreement with Ergomed Clinical Research, Ltd., and Clinical Trial Orders thereunder | Incorporated by reference to Exhibit 10(uu) of CEL-SCI’s first amendment to its Form 10-K report for the year ended September 30, 2014 dated April 17, 2015. | ||
10 (vv) | Co-Development and Revenue Sharing Agreement with Ergomed Clinical Research Ltd., dated April 19, 2013, as amended | Incorporated by reference to Exhibit 10(vv) of CEL-SCI’s first amendment to its Form 10-K report for the year ended September 30, 2014 dated April 17, 2015. | ||
10 (ww) | Co-Development and Revenue Sharing Agreement II: Cervical Intraepithelial Neoplasia in HIV/HPV co-infected women, with Ergomed Clinical Research Ltd., dated October 10, 2013, as amended | Incorporated by reference to Exhibit 10(ww) of CEL- first amendment to its Form 10-K report for the year ended September 30, 2014 dated April 17, 2015. | ||
10 (xx) | Co-Development and Revenue Sharing Agreement III: Anal warts and anal intraepithelial neoplasia in HIV/HPV co-infected patients, with Ergomed Clinical Research Ltd., dated October 24, 2013 | Incorporated by reference to Exhibit 10(xx) of CEL-SCI’s first amendment to its Form 10-K report for the year ended September 30, 2014 dated April 17, 2015. | ||
10 (yy) | Master Services Agreement with Aptiv Solutions, Inc. | Incorporated by reference to Exhibit 10(yy) of CEL-SCI’s first amendment to its Form 10-K report for the year ended September 30, 2014 dated April 17, 2015. | ||
10 (zz) | Project Agreement Number 1 with Aptiv Solutions, Inc. together with Amendments 1 and 2 thereto* | Incorporated by reference to Exhibit 10(zz) of CEL-SCI’s first amendment to its Form 10-K report for the year ended September 30, 2014 dated April 17, 2015. | ||
10 (aaa) | Second Amendment to Development Supply and Distribution Agreement with Orient Europharma | Incorporated by reference to Exhibit 10(aaa) of CEL-SCI’s first amendment to its Form 10-K report for the year ended September 30, 2014 dated April 17, 2015. | ||
10 (bbb) | Amended and Restated Promissory Note with Maximilian de Clara | Incorporated by reference to Exhibit 10(bbb) of CEL-SCI’s report on Form 10-K/A report for the year ended September 30, 2014 dated April 17, 2015. | ||
10 (ccc) | Placement Agent Agreement dated May 22, 2015 by and among CEL-SCI Corporation and Dawson James Securities, Inc. | Incorporated by reference to Exhibit 1.1 of CEL-SCI’s report on Form 8-K filed on May 26, 2015. | ||
10 (ddd) | Warrant Agent Agreement (as amended), Series V warrants | Incorporated by reference to Exhibit 10 (ccc) of CEL-SCI’s report on Form 8-K filed on May 29, 2015. | ||
10 (eee) | Assignment of Proceeds and Investment Agreement between CEL-SCI Corporation and Lake Whillans Vehicle 1. | Incorporated by reference to Exhibit 10 (ddd) of CEL-SCI’s report on Form 8-K filed on October 16, 2015. | ||
10 (fff) | Placement Agent Agreement dated October 22, 2015 by and among CEL-SCI Corporation and Dawson James Securities, Inc. | Incorporated by reference to Exhibit 1.1 of CEL-SCI’s report on Form 8-K filed on October 23, 2015. | ||
10 (ggg) | Warrant Agent Agreement, Series W warrants | Incorporated by reference to Exhibit 10 (eee) of CEL-SCI’s report on Form 8-K filed on October 23, 2015. | ||
10 (hhh) | Amendment to Promissory Note held by the de Clara Trust | ____________________ | ||
10 (iii) | Amendment to Co-Development and Revenue Sharing Agreement with Ergomed Clinical Research, Ltd., dated September 15, 2015 | ____________________ | ||
23.1 | Consent of BDO USA, LLP | |||
31 | Rule 13a-14(a) Certifications | |||
32 | Section 1350 Certifications |
*
|
Portions of this exhibit have been omitted pursuant to a request for confidential treatment filed with the Commission under Rule 24b-2 of the Securities Exchange Act of 1934. The omitted confidential material has been filed separately with the Commission. The location of the omitted confidential information is indicated in the exhibit with asterisks (*)
|
Page | |
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
|
F- 2
|
FINANCIAL STATEMENTS FOR THE YEARS
ENDED SEPTEMBER 30, 2015, 2014 and 2013:
|
|
Balance Sheets
|
F- 3
|
Statements of Operations
|
F- 4
|
Statements of Stockholders’ (Deficit) Equity
|
F- 5
|
Statements of Cash Flows
|
F- 6
|
Notes to Financial Statements
|
F- 8
|
CEL-SCI CORPORATION
|
||||||||||||||||||||
STATEMENTS OF STOCKHOLDERS' (DEFICIT) EQUITY
|
||||||||||||||||||||
YEARS ENDED SEPTEMBER 30, 2015, 2014 and 2013
|
||||||||||||||||||||
Additional
|
||||||||||||||||||||
Common
|
Stock
|
Paid-In
|
Accumulated
|
|||||||||||||||||
Shares
|
Amount
|
Capital
|
Deficit
|
Total
|
||||||||||||||||
BALANCE, OCTOBER 1, 2012
|
27,312,492 | 273,125 | 209,743,928 | (202,989,621 | ) | 7,027,432 | ||||||||||||||
Sale of stock
|
3,500,000 | 35,000 | 9,753,769 | - | 9,788,769 | |||||||||||||||
Issuance of warrants in connection with
|
||||||||||||||||||||
sale of common stock
|
- | - | (4,200,000 | ) | - | (4,200,000 | ) | |||||||||||||
401(k) contributions paid
|
||||||||||||||||||||
in common stock
|
74,230 | 742 | 158,114 | - | 158,856 | |||||||||||||||
Stock issued to nonemployees for service
|
138,297 | 1,383 | 359,542 | - | 360,925 | |||||||||||||||
Equity based compensation - employees
|
- | - | 2,636,905 | - | 2,636,905 | |||||||||||||||
Equity based compensation - non-employees
|
- | - | 98,150 | - | 98,150 | |||||||||||||||
Net loss
|
- | - | - | (9,170,947 | ) | (9,170,947 | ) | |||||||||||||
BALANCE, SEPTEMBER 30, 2013
|
31,025,019 | 310,250 | 218,550,408 | (212,160,568 | ) | 6,700,090 | ||||||||||||||
Sale of stock
|
31,755,494 | 317,555 | 28,129,691 | - | 28,447,246 | |||||||||||||||
Issuance of warrants in connection with
|
||||||||||||||||||||
sale of common stock
|
- | - | (7,791,448 | ) | - | (7,791,448 | ) | |||||||||||||
401(k) contributions paid
|
||||||||||||||||||||
in common stock
|
164,787 | 1,647 | 153,787 | - | 155,434 | |||||||||||||||
Exercise of warrants
|
2,668,508 | 26,686 | 4,253,632 | - | 4,280,318 | |||||||||||||||
Conversion of warrant liability to equity
|
- | - | 1,308,528 | - | 1,308,528 | |||||||||||||||
Stock issued to nonemployees for service
|
579,968 | 5,800 | 621,318 | - | 627,118 | |||||||||||||||
Stock issued for patents
|
8,695 | 87 | 9,912 | - | 9,999 | |||||||||||||||
Modification of options issued to consultants
|
- | - | 76,991 | - | 76,991 | |||||||||||||||
Issuance of restricted stock
|
15,700,000 | 157,000 | (157,000 | ) | - | - | ||||||||||||||
Equity based compensation - employees
|
- | - | 3,958,637 | - | 3,958,637 | |||||||||||||||
Equity based compensation - non-employees
|
- | - | 36,752 | - | 36,752 | |||||||||||||||
Net loss
|
- | - | - | (27,366,265 | ) | (27,366,265 | ) | |||||||||||||
BALANCE, SEPTEMBER 30, 2014
|
81,902,471 | 819,025 | 249,151,208 | (239,526,833 | ) | 10,443,400 | ||||||||||||||
Sale of stock
|
29,467,901 | 294,679 | 20,853,699 | 21,148,378 | ||||||||||||||||
Issuance of warrants in connection with
|
||||||||||||||||||||
sale of common stock
|
- | - | (8,463,957 | ) | (8,463,957 | ) | ||||||||||||||
401(k) contributions paid
|
||||||||||||||||||||
in common stock
|
243,178 | 2,432 | 163,214 | 165,646 | ||||||||||||||||
Stock issued to nonemployees for service
|
739,968 | 7,400 | 526,576 | 533,976 | ||||||||||||||||
Modification of warrants
|
- | - | 475,333 | 475,333 | ||||||||||||||||
Forfeiture of unvested restricted stock
|
(100,000 | ) | (1,000 | ) | 1,000 | - | ||||||||||||||
Equity based compensation - employees
|
107,050 | 1,070 | 5,104,757 | 5,105,827 | ||||||||||||||||
Equity based compensation - non-employees
|
- | - | 35,800 | 35,800 | ||||||||||||||||
Net loss
|
- | - | - | (34,674,646 | ) | (34,674,646 | ) | |||||||||||||
BALANCE, SEPTEMBER 30, 2015
|
112,360,568 | $ | 1,123,606 | $ | 267,847,630 | $ | (274,201,479 | ) | $ | (5,230,243 | ) |
CEL-SCI CORPORATION
|
||||||||||||
STATEMENTS OF CASH FLOWS
|
||||||||||||
YEARS ENDED SEPTEMBER 30, 2015, 2014 and 2013
|
||||||||||||
2015
|
2014
|
2013
|
||||||||||
CASH FLOWS FROM OPERATING ACTIVITIES:
|
||||||||||||
Net loss
|
$ | (34,674,646 | ) | $ | (27,366,265 | ) | $ | (9,170,947 | ) | |||
Adjustments to reconcile net loss to
|
||||||||||||
net cash used in operating activities:
|
||||||||||||
Depreciation and amortization
|
206,750 | 231,752 | 364,124 | |||||||||
Amortization of debt premium
|
(20,819 | ) | - | - | ||||||||
Issuance of common stock, warrants and options for services
|
565,915 | 694,955 | 454,855 | |||||||||
Modification of warrants issued to consultants
|
- | 76,991 | - | |||||||||
Equity based compensation
|
5,105,827 | 3,958,637 | 2,636,905 | |||||||||
Common stock contributed to 401(k) plan
|
165,646 | 155,434 | 158,856 | |||||||||
Impairment loss on abandonment of patents
|
- | 1,182 | 22,628 | |||||||||
Loss on retired equipment
|
313 | 268 | 4,350 | |||||||||
Gain on derivative instruments
|
(282,616 | ) | (248,767 | ) | (10,750,666 | ) | ||||||
Loss on debt extinguishment
|
641,276 | - | - | |||||||||
(Increase)/decrease in assets:
|
||||||||||||
Receivables
|
(5,394 | ) | (7,557 | ) | 84,351 | |||||||
Deferred rent
|
745,673 | 769,159 | 544,028 | |||||||||
Prepaid expenses
|
(68,268 | ) | (158,088 | ) | 529,738 | |||||||
Inventory used for R&D and manufacturing
|
50,181 | (435,392 | ) | 367,856 | ||||||||
Deposits
|
150,000 | (200,000 | ) | (400,000 | ) | |||||||
Increase/(decrease) in liabilities:
|
||||||||||||
Accounts payable
|
3,981,886 | (751,971 | ) | 1,316,964 | ||||||||
Accrued expenses
|
(458,633 | ) | 433,712 | 101,995 | ||||||||
Deferred revenue
|
48 | 46 | 45 | |||||||||
Due to employees
|
57,170 | (78,376 | ) | 186,446 | ||||||||
Deferred rent liability
|
6,358 | (3,739 | ) | (108 | ) | |||||||
Net cash used in operating activities
|
(23,833,333 | ) | (22,928,019 | ) | (13,548,580 | ) | ||||||
CASH FLOWS FROM INVESTING ACTIVITIES:
|
||||||||||||
Purchases of equipment
|
(73,399 | ) | (103,977 | ) | (102,033 | ) | ||||||
Expenditures for patent costs
|
(20,132 | ) | (34,887 | ) | (30,728 | ) | ||||||
Net cash used in investing activities
|
(93,531 | ) | (138,864 | ) | (132,761 | ) | ||||||
CASH FLOWS FROM FINANCING ACTIVITIES:
|
||||||||||||
Proceeds from issuance of common stock and warrants
|
21,148,378 | 28,428,641 | 9,788,769 | |||||||||
Proceeds from exercise of warrants
|
- | 3,118,387 | - | |||||||||
Payments on obligations under capital lease
|
(8,452 | ) | (8,137 | ) | (6,858 | ) | ||||||
Net cash provided by financing activities
|
21,139,926 | 31,538,891 | 9,781,911 | |||||||||
NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS
|
(2,786,938 | ) | 8,472,008 | (3,899,430 | ) | |||||||
CASH AND CASH EQUIVALENTS, BEGINNING OF YEAR
|
8,513,620 | 41,612 | 3,941,042 | |||||||||
CASH AND CASH EQUIVALENTS, END OF YEAR
|
$ | 5,726,682 | $ | 8,513,620 | $ | 41,612 |
Warrants
|
Issue Date
|
Shares Issuable upon Exercise of
Warrants
|
Exercise
Price
|
Expiration Date
|
Refer
-ence
|
|||||||||
Series N
|
8/18/08
|
2,844,627 | 0.53 |
8/18/17
|
1 | |||||||||
Series Q
|
6/21/12
|
1,200,000 | 5.00 |
12/22/15
|
1 | |||||||||
Series R
|
12/6/12
|
2,625,000 | 4.00 |
12/6/16
|
1 | |||||||||
Series S
|
10/11/13- 10/24/14
|
25,928,010 | 1.25 |
10/11/18
|
1 | |||||||||
Series U
|
4/17/14
|
445,514 | 1.75 |
10/17/17
|
1 | |||||||||
Series V
|
5/28/15
|
20,253,164 | 0.79 |
5/28/20
|
1 | |||||||||
Series P
|
2/10/12
|
590,001 | 4.50 |
3/6/17
|
2 | |||||||||
Consultants
|
10/14/05 – 7/1/15
|
238,000 | 0.66 – 20.00 |
10/14/15 - 6/30/18
|
3 |
1.
|
Derivative Liabilities
|
2015
|
2014
|
|||||||
Series A through E warrants
|
$ | - | $ | 6,105 | ||||
Series H warrants
|
- | 12,000 | ||||||
Series Q warrants
|
- | 12,000 | ||||||
Series R warrants
|
- | 157,500 | ||||||
Series S warrants
|
7,363,555 | 5,197,352 | ||||||
Series U warrants
|
44,551 | 120,289 | ||||||
Series V warrants
|
6,278,481 | - | ||||||
|
||||||||
Total derivative liabilities
|
$ | 13,686,587 | $ | 5,505,246 |
Warrant Series
|
2015
|
2014
|
2013
|
|||||||||
Series A - E
|
$ | 6,105 | $ | 1 | $ | 780,883 | ||||||
Series F and G
|
- | 12,667 | 1,634,000 | |||||||||
Series H
|
12,000 | 24,000 | 1,764,000 | |||||||||
Series N
|
- | (1,404,027 | ) | 788,533 | ||||||||
Series Q
|
12,000 | 36,000 | 1,872,000 | |||||||||
Series R
|
157,500 | 131,250 | 3,911,250 |
Series S
|
(1,705,466 | ) | 1,098,787 | - | ||||||||
Series T
|
- | 276,122 | - | |||||||||
Series U
|
75,738 | 73,967 | - | |||||||||
Series V
|
1,724,739 | - | - | |||||||||
|
||||||||||||
Net gain
|
$ | 282,616 | $ | 248,767 | $ | 10,750,666 |
2.
|
Equity Warrants
|
3.
|
Options and Shares Issued to Consultants
|
2015 | 2014 | |||||||
Research equipment
|
$ | 3,268,757 | $ | 3,230,882 | ||||
Furniture and equipment
|
141,347 | 141,269 | ||||||
Leasehold improvements
|
131,910 | 131,910 | ||||||
3,542,014 | 3,504,061 | |||||||
Accumulated depreciation and amortization
|
(3,234,548 | ) | (3,101,057 | ) | ||||
Net research and office equipment
|
$ | 307,466 | $ | 403,004 |
2015 | 20 14 | |||||||
Patents
|
$ | 1,525,791 | $ | 1,517,344 | ||||
Accumulated amortization
|
(1,234,227 | ) | (1,193,756 | ) | ||||
Net Patents
|
$ | 291,564 | $ | 323,588 |
Years ending September 30,
|
||||
2016
|
$ | 36,547 | ||
2017
|
36,547 | |||
2018
|
36,213 | |||
2019
|
34,510 | |||
2020
|
31,317 | |||
Thereafter
|
116,430 | |||
$ | 291,564 |
2015 | 2014 | |||||||
Net operating loss carryforwards
|
$ | 61,363,080 | $ | 55,229,799 | ||||
R&D credit
|
1,221,487 | 1,221,487 | ||||||
Stock-based compensation
|
5,854,794 | 4,054,450 | ||||||
Fixed assets and intangibles
|
41,018 | 26,329 | ||||||
Capitalized R&D
|
15,081,545 | 9,897,041 | ||||||
Vacation and other
|
114,625 | 108,891 | ||||||
Loan modification
|
56,779 | - | ||||||
Total deferred tax assets
|
83,733,328 | 70,537,997 | ||||||
|
||||||||
Valuation
allowance
|
(83,733,328 | ) | (70,537,9977 | ) | ||||
Net deferred tax asset
|
$ | - | $ | - |
2015 | 2014 | 2013 | ||||||||||
Federal Rate
|
34.00 | % | 34.00 | % | 34.00 | % | ||||||
State tax rate, net of federal benefit
|
5.12 | 5.15 | 4.97 | |||||||||
State tax rate change
|
(0.15 | ) | 0.93 | (3.77 | ) | |||||||
Other adjustments
|
(0.21 | ) | 0.00 | 0.00 | ||||||||
Expired tax attributes
|
0.00 | 0.00 | (87.87 | ) | ||||||||
Adjustment to deferreds
|
0.00 | 19.13 | 14.30 | |||||||||
Permanent differences
|
(0.71 | ) | (0.43 | ) | (1.59 | ) | ||||||
Change in valuation allowance
|
(38.05 | ) | (58.78 | ) | 39.96 | |||||||
Effective tax rate
|
0.00 | % | 0.00 | % | 0.00 | % |
Year Ended September 30, | ||||||||||||
2015
|
2014
|
2013
|
||||||||||
Employees
|
$ | 5,105,827 | $ | 3,958,637 | $ | 2,636,905 | ||||||
Non-employees
|
$ | 565,915 | $ | 771,946 | $ | 454,855 |
2015
|
2014
|
2013
|
||||||||||
Expected stock price volatility
|
73.38 – 86.19 | % | 72.81 – 86.87 | % | 84.41-92.28 | % | ||||||
Risk-free interest rate
|
0.93 – 2.35 | % | 0.59 – 2.65 | % | 0.75-2.73 | % | ||||||
Expected life of options
|
3.0 – 9.76 Years
|
3.0 – 9.76 Years
|
4.85-9.77 | |||||||||
Expected dividend yield
|
- | - | - |
Outstanding
|
Exercisable
|
|||||||||||||||||||||||||||||||
Number of
Shares
|
Weighted
Average
|
Weighted
Ave
|
Aggregate
Intrinsic
|
Number of
Shares
|
Weighted
Average
|
Weighted
Ave
|
Aggregate
Intrinsic
|
|||||||||||||||||||||||||
Outstanding at October 1, 2013
|
5,188,141 | $ | 3.62 | 6.53 | $ | 133 | 2,422,997 | $ | 4.00 | 4.95 | $ | 133 | ||||||||||||||||||||
Vested
|
1,094,803 | $ | 2.14 | |||||||||||||||||||||||||||||
Granted (a)
|
1,723,240 | $ | 1.09 | |||||||||||||||||||||||||||||
Exercised
|
||||||||||||||||||||||||||||||||
Forfeited
|
6,316 | $ | 1.60 | |||||||||||||||||||||||||||||
Expired
|
73,916 | $ | 4.29 | 73,916 | $ | 4.29 | ||||||||||||||||||||||||||
Cancelled
|
||||||||||||||||||||||||||||||||
Outstanding at September 30, 2014
|
6,831,149 | $ | 2.98 | 6.55 | $ | 3,600 | 3,443,884 | $ | 3.40 | 5.49 | $ | 3,600 | ||||||||||||||||||||
Vested
|
1,153,357 | $ | 2.48 | |||||||||||||||||||||||||||||
Granted (b)
|
893,700 | $ | 0.66 | |||||||||||||||||||||||||||||
Exercised
|
||||||||||||||||||||||||||||||||
Forfeited
|
116,665 | $ | 1.87 | |||||||||||||||||||||||||||||
Expired
|
70,499 | $ | 4.15 | 70,499 | $ | 4.15 | ||||||||||||||||||||||||||
Cancelled
|
||||||||||||||||||||||||||||||||
Outstanding at September 30, 2015
|
7,537,685 | $ | 2.71 | 5.98 | $ | 50 | 4,526,742 | $ | 3.15 | 5.01 | $ | 0 |
(a)
|
Includes 80,000 stock options granted to consultants
|
(b)
|
Includes 90,000 stock options granted to consultants
|
Number of
Shares
|
Weighted Average
Grant Date
Fair Value
|
|||||||
Unvested at October 1, 2013
|
2,765,144 | $ | 2.79 | |||||
Vested
|
(1,094,803 | ) | ||||||
Granted
|
1,723,240 | |||||||
Forfeited
|
(6,316 | ) | ||||||
Unvested at September 30, 2014
|
3,387,265 | $ | 2.15 | |||||
Vested
|
(1,153,357 | ) | ||||||
Granted
|
893,700 | |||||||
Forfeited
|
(116,665 | ) | ||||||
Unvested at September 30, 2015
|
3,010,943 | $ | 1.72 |
Number of Shares
|
Weighted Average Grant Date Fair Value
|
|||||||
Unvested at October 1, 2013
|
- | - | ||||||
Vested
|
- | |||||||
Granted
|
15,700,000 | |||||||
Forfeited
|
- | |||||||
Unvested at September 30, 2014
|
15,700,000 | $ | 0.55 | |||||
Vested
|
(500,000 | ) | ||||||
Granted
|
- | |||||||
Forfeited
|
(100,000 | ) | ||||||
Unvested at September 30, 2015
|
15,100,000 | $ | 0.55 |
Years Ending September 30 , | ||||
2016
|
$ | 1,861,154 | ||
2017
|
1,844,807 | |||
2018
|
1,848,235 | |||
2019
|
1,912,779 | |||
2020
|
1,951,756 | |||
Thereafter
|
17,698,979 | |||
Total minimum lease payments:
|
$ | 27,117,710 |
o
|
Level 1 – Observable inputs such as quoted prices in active markets for identical assets or liabilities
|
o
|
Level 2 – Inputs other than quoted prices that are observable for the asset or liability, either directly or indirectly. These include quoted prices for similar assets or liabilities in active markets, quoted prices for identical or similar assets or liabilities in markets that are not active and amounts derived from valuation models where all significant inputs are observable in active markets
|
o
|
Level 3 – Unobservable inputs that reflect management’s assumptions
|
Quoted Prices in
Active Markets
for Identical Assets or
Liabilities (Level 1)
|
Significant
Other
Observable
Inputs (Level 2)
|
Significant
Unobservable
Inputs (Level 3)
|
Total | |||||||||||||
Derivative Instruments | $ | 7,363,555 | $ | - | $ | 6,323,032 | $ | 13,686,587 |
Quoted Prices in
Active Markets
for Identical Assets or
Liabilities (Level 1)
|
Significant
Other
Observable
Inputs (Level 2)
|
Significant
Unobservable
Inputs (Level 3)
|
Total | |||||||||||||
Derivative Instruments | $ | 5,197,352 | $ | - | $ | 307,894 | $ | 5,505,246 |
2015
|
2014
|
|||||||
Beginning balance
|
$ | 307,894 | $ | 433,024 | ||||
Issuances
|
8,003,220 | 7,791,448 | ||||||
Settlements
|
- | (1,445,528 | ) | |||||
Transfers to Level 1
|
- | (7,321,071 | ) | |||||
Net realized and unrealized derivative (gain)/loss
|
(1,988,082 | ) | 850,021 | |||||
Ending balance
|
$ | 6,323,032 | $ | 307,894 |
2015 | 2014 | 2013 | ||||||||||
Net loss available to
|
||||||||||||
common shareholders
|
$ | (34,674,646 | ) | $ | (28,483,712 | ) | $ | (9,230,478 | ) | |||
Less: Gain on derivative
|
||||||||||||
Instruments
|
- | (248,767 | ) | (10,750,666 | ) | |||||||
Net loss - diluted
|
$ | (34,674,646 | ) | $ | (28,732,479 | ) | $ | (19,981,144 | ) | |||
Weighted average number of
|
||||||||||||
shares - basic and diluted
|
82,519,027 | 58,804,622 | 30,279,442 | |||||||||
Loss per share - basic
|
$ | (0.42 | ) | $ | (0.48 | ) | $ | (0.30 | ) | |||
Loss per share - diluted
|
$ | (0.42 | ) | $ | (0.49 | ) | $ | (0.66 | ) |
Fiscal 2015
|
||||||||||||||||||||
Three months
ended
December 31
2014
|
Three months
ended
March 31,
2015
|
Three months
ended
June 30,
2015
|
Three months
Ended
September 30,
2015
|
Year ended
September 30,
2015
|
||||||||||||||||
Grant income and other
|
$ | 136,838 | $ | 197,620 | $ | 389,223 | $ | (66,304 | ) | $ | 657,377 | |||||||||
Operating expenses
|
10,132,579 | 7,956,963 | 8,590,698 | 8,273,682 | 34,953,922 | |||||||||||||||
Non-operating (expense) income, net
|
(12,547 | ) | (14,097 | ) | (15,166 | ) | 22,369 | (19,441 | ) | |||||||||||
Gain (loss) on derivative instruments
|
2,162,970 | (4,782,796 | ) | 4,428,780 | (1,526,338 | ) | 282,616 | |||||||||||||
Loss on debt extinguishment
|
- | - | (641,276 | ) | - | (641,276 | ) | |||||||||||||
Net loss available to
|
||||||||||||||||||||
common shareholders
|
$ | (7,845,318 | ) | $ | (12,556,236 | ) | $ | (4,429,137 | ) | $ | (9,843,955 | ) | $ | (34,674,646 | ) | |||||
Net loss per share-basic
|
$ | (0.11 | ) | $ | (0.17 | ) | $ | (0.05 | ) | $ | (0.10 | ) | $ | (0.42 | ) | |||||
Net loss per share-diluted
|
$ | (0.14 | ) | $ | (0.17 | ) | $ | (0.06 | ) | $ | (0.10 | ) | $ | (0.42 | ) | |||||
Weighted average shares:
|
||||||||||||||||||||
Basic
|
73,260,783 | 75,847,869 | 83,796,311 | 97,040,004 | 82,519,027 | |||||||||||||||
Diluted
|
73,260,783 | 75,847,869 | 85,134,107 | 97,040,004 | 82,519,027 |
Fiscal 2014
|
||||||||||||||||||||
Three months
|
Three months
|
Three months
|
Th
ree months
|
|
||||||||||||||||
ended
December 31
2013
|
ended
March 31,
2014
|
ended
June 30,
2014
|
Ended
September 30,
2014
|
Year ended
September 30,
2014
|
||||||||||||||||
Grant income and other
|
$ | 113,144 | $ | 67,157 | $ | 15,914 | $ | 67,818 | $ | 264,033 | ||||||||||
Operating expenses
|
6,047,454 | 6,293,592 | 6,917,243 | 8,579,856 | 27,838,145 | |||||||||||||||
Non-operating expenses, net
|
(10,925 | ) | (6,797 | ) | (10,927 | ) | (12,271 | ) | (40,920 | ) | ||||||||||
Gain (loss) on derivative instruments
|
1,610,817 | (7,132,348 | ) | 4,467,776 | 1,302,522 | 248,767 | ||||||||||||||
Net loss
|
(4,334,418 | ) | (13,365,580 | ) | (2,444,480 | ) | (7,221,787 | ) | (27,366,265 | ) |
Issuance of shares due to reset provisions
|
(1,117,447 | ) | - | - | - | (1,117,447 | ) | |||||||||||||
Net loss available to
|
||||||||||||||||||||
common shareholders
|
$ | (5,451,865 | ) | $ | (13,365,580 | ) | $ | (2,444,480 | ) | $ | (7,221,787 | ) | $ | (28,483,712 | ) | |||||
Net loss per share-basic
|
$ | (0.11 | ) | $ | (0.24 | ) | $ | (0.04 | ) | $ | (0.11 | ) | $ | (0.48 | ) | |||||
Net loss per share-diluted
|
$ | (0.15 | ) | $ | (0.24 | ) | $ | (0.11 | ) | $ | (0.13 | ) | $ | (0.49 | ) | |||||
Weighted average shares-basic and diluted
|
48,215,919 | 56,239,562 | 64,664,274 | 66,091,826 | 58,804,622 |
CEL-SCI CORPORATION | |||
By:
|
/s/ Maximilian de Clara | ||
Maximilian de Clara, President | |||
Signature
|
Title
|
Date
|
/s/ Maximilian de Clara
|
Director
|
December 11, 2015
|
Maximilian de Clara
|
||
/s/ Geert R. Kersten
|
Chief Executive, Principal
|
|
Geert R. Kersten
|
Accounting, Principal Financial
|
|
Officer and a Director
|
December 11, 2015
|
|
/s/ Alexander G. Esterhazy
|
Director
|
December 11, 2015
|
Alexander G. Esterhazy
|
||
/s/Peter R. Young
|
Director
|
December 11, 2015
|
Dr. Peter R. Young
|
||
/s/ Bruno Baillavoine
|
Director
|
December 11, 2015
|
Bruno Baillavoine
|
SECTION | PAGE | |||
1 |
Certain Definitions
|
1 | ||
2
|
Appointment of Rights Agent
|
5
|
||
3
|
Issue of Right Certificates
|
5
|
||
4
|
Form of Right Certificates
|
7
|
||
5
|
Countersignature and Registration
|
8
|
||
6 |
Transfer, Split-Up, Combination and Exchange
of Rights Certificates; Lost, Stolen, Destroyed
or Mutilated Right Certificates
|
8
|
||
7 |
Exercise of Rights; Purchase Price; Expiration
Date of Rights
|
9
|
||
8
|
Cancellation and Destruction of Right Certificates
|
10
|
||
9
|
Reservation and Availability of Common Shares
|
11
|
||
10
|
Common Shares Record Date
|
12
|
||
11 |
Adjustment of Purchase Price, Number and Kind of
Shares or Number of Rights
|
12
|
||
12 |
Certificate of Adjusted Purchase Price or
Number of Shares
|
22
|
||
13 |
Consolidation, Merger, Statutory Share Exchange or
Sale or Transfer of Assets or Earning Power
|
22
|
||
14
|
Fractional Rights and Fractional Shares
|
25
|
||
15
|
Rights of Action
|
26
|
||
16
|
Agreement of Right Holders
|
26
|
||
17
|
Right Certificate Holder Not Deemed a Shareholder
|
27
|
||
18
|
Concerning the Rights Agent
|
28
|
||
19 |
Merger or Consolidation or Change of Name of
Rights Agent
|
28
|
||
20
|
Duties of Rights Agent
|
29
|
||
21
|
Change of Rights Agent
|
31
|
||
22
|
Issuance of New Right Certificates
|
32
|
||
23
|
Redemption
|
32
|
||
24
|
Exchange
|
33
|
||
25
|
Notice of Certain Events
|
34
|
||
26
|
Notices
|
35
|
||
27
|
Supplements and Amendments
|
36
|
||
28
|
Successors
|
36
|
||
29
|
Benefits of this Agreement
|
36
|
||
30
|
Severability
|
37
|
||
31
|
Governing Law
|
38
|
||
32
|
Counterparts
|
37
|
||
33
|
Descriptive Headings
|
37
|
Certificate No. R- | Rights |
Certificate No. R- | Rights |
|
(i)
|
Co-Development and Revenue Sharing Agreement (Co-Development Agreement) pursuant to which they have undertaken to jointly develop and commercialized a compound known as Multikine;
|
1.1.
|
The Parties would like to delete Section 3.1 of the Co-Development Agreement in its entirety and replace it with the following:
|
|
“3.1
|
With respect to the Product, Ergomed shall invest up to Twelve Million US dollars ($12 million) toward the clinical and regulatory costs for the conduct the Co-Developed Clinical Trial for the Product in Europe, Russia, India, and North America (the actual amount of such investment, determined in accordance with Section 6. The Ergomed Co-Development Investment shall not exceed US$12,000,000 Twelve million dollars), (the “Ergomed Co-Development Investment Cap”).”
|
1.2
|
The Parties would like to delete Section 6.1 of the Co-Development Agreement in its entirety and replace it with the following:
|
|
“6.1
|
CEL-SCI shall make payments to Ergomed for invoices submitted by Ergomed for Egromed’s activities on each Co-Developed Clinical Trial in accordance within the terms stipulated in the MSA and the relevant related CTOs and any annex thereto; provided, however, that Ergomed’s invoices for each Co-Developed Clinical Trial will be reduced by 30% (thirty percent) from the costs set forth in the relevant CTO, and any annex thereto (“Ergomed Invoiced Costs”). The 30% reduction described in the
|
2.1.
|
All other provisions of the Co-Development Agreement remain unchanged, valid and in force.
|
2.2.
|
This Annex is being executed in 2 (two) may be executed in two or more counterparts, each of which shall be deemed an original and all of which shall together be deemed to constitute one agreement. The parties agree that execution of this Annex by industry standard electric signature software and /or by exchanging PDF signatures shall have the same legal force and effect as the exchange of original signatures, and that in any proceeding arising under or relating to this Annex, each party hereby waives any right to raise any defense or waiver based upon execution of this Annex by means of such electronic signatures or maintenance of the executed agreement electronically.
|
ERGOMED: | CEL-SCI: | |
/s/ M. Reljanovic
|
/s/ Geert Kersten
|
|
Printed Name
|
Printed Name
|
|
CEO
|
CEO
|
|
Title
|
Title
|
|
15 September 2015
|
15 September 2015
|
|
Date
|
Date
|
1)
|
Effective July 7, 2015, interest on the Note will be at an annual rate of 9% and will be payable monthly.
|
2)
|
The maturity date of the Note is extended to July 6, 2017.
|
3)
|
The Note, in whole or in part, will be convertible at the Holder’s option into shares of the Company’s common stock at a price of $0.59 per share, subject to the customary adjustments. The Company agrees to deliver the shares within 3 trading days of a conversion notice.
|
1)
|
The maturity date of the Note is extended to July 6, 2018.
|
December 11, 2015
|
By:
|
/s/ Geert R. Kersten | |
Geert R. Kersten | |||
Principal Executive Officer
|
December 11, 2015
|
By:
|
/s/ Geert R. Kersten | |
Geert R. Kersten | |||
Principal Financial Officer
|
(1)
|
The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
|
(2)
|
The information contained in the Report fairly presents, in all material respects the financial condition and results of the Company.
|
December 11, 2015
|
By:
|
/s/ Geert R. Kersten | |
Geert Kersten, Chief Executive and Principal
Financial and Accounting Officer
|