Advaxis Inc.
Annual Report 2017

Plain-text annual report

Morningstar® Document Research℠ FORM 10-KAdvaxis, Inc. - ADXSFiled: December 21, 2017 (period: October 31, 2017)Annual report with a comprehensive overview of the companyThe information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The userassumes all risks for any damages or losses arising from any use of this information, except to the extent such damages or losses cannot belimited or excluded by applicable law. Past financial performance is no guarantee of future results. UNITED STATESSECURITIES AND EXCHANGE COMMISSIONWashington, D.C. 20549 FORM 10-K [X] ANNUAL REPORT UNDER SECTION 13 OR 15(d)OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE FISCAL YEAR ENDED - OCTOBER 31, 2017 OR [ ] TRANSITION REPORT UNDER SECTION 13 OR 15 ( d)OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM ______ TO ______ COMMISSION FILE NUMBER 000-28489 ADVAXIS, INC.(Name of Registrant in Its Charter) Delaware 02-0563870(State or Other Jurisdiction of (I.R.S. EmployerIncorporation or Organization) Identification No.) 305 College Road East Princeton, New Jersey 08540(Address of Principal Executive Offices) (Zip Code) (609) 452-9813(Issuer’s Telephone Number) Securities registered under Section 12(b) of the Exchange Act: Common Stock - $.001 par value NASDAQ Capital Market Securities registered under Section 12(g) of the Exchange Act: [None] Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes [ ] No [X] Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Exchange Act. Yes [ ] No [X] Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filingrequirements for the past 90 days. Yes [X] No [ ] Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data Filerequired to be submitted and posted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorterperiod that the registrant was required to submit and post such files). Yes [X] No [ ] Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K (§ 229.405 of this chapter) is not contained herein,and will not be contained, to the best of registrant’s knowledge, in definitive proxy or information statements incorporated by reference in Part III of thisForm 10-K or any amendment to this Form 10-K. [ ] Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, oran emerging growth company. See definition of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company”in Rule 12b-2 of the Exchange Act. Large Accelerated Filer[ ] Accelerated Filer[X]Non-accelerated Filer[ ](Do not check if smaller reporting company)Smaller Reporting Company[ ]Source: Advaxis, Inc., 10-K, December 21, 2017Powered by Morningstar® Document Research℠The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any use of this information,except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results.Emerging growth company[ ] If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new orrevised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. [ ] Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes [ ] No [X] As of April 30, 2017, the aggregate market value of the voting common equity held by non-affiliates was approximately $336,054,000 based on theclosing bid price of the registrant’s Common Stock on the NASDAQ Capital Market. (For purposes of determining this amount, only directors, executiveofficers, and 10% or greater shareholders and their respective affiliates have been deemed affiliates). [X] The registrant had 41,303,988 shares of Common Stock, par value $0.001 per share, outstanding as of December 15, 2017. DOCUMENTS INCORPORATED BY REFERENCE Portions of the Proxy Statement for the registrant’s 2018 Annual Meeting of Stockholders (the “Proxy Statement”) to be filed within 120 days of theend of the fiscal year ended October 31, 2017 are incorporated by reference in Part III hereof. Except with respect to information specifically incorporated byreference in this Form 10-K, the Proxy Statement is not deemed to be filed as a part hereof. Source: Advaxis, Inc., 10-K, December 21, 2017Powered by Morningstar® Document Research℠The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any use of this information,except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results. Table of ContentsForm 10-K Index PART 1 Item 1:Business4Item 1A:Risk Factors16Item 1B:Unresolved Staff Comments28Item 2:Properties28Item 3:Legal Proceedings28Item 4:Mine Safety Disclosures28 PART II Item 5:Market for Registrant’s Common Equity, Related Shareholder Matters and Issuer Purchases of Equity Securities28Item 6:Selected Financial Data30Item 7:Management’s Discussion and Analysis of Financial Condition and Results of Operations31Item 7A:Quantitative and Qualitative Disclosures About Market Risk39Item 8:Financial Statements and Supplementary Data39Item 9:Changes in and Disagreements with Accountants on Accounting and Financial Disclosures39Item 9A:Controls and Procedures39Item 9B:Other Information42 PART III Item 10:Directors, Executive Officers, and Corporate Governance43Item 11:Executive Compensation43Item 12:Security Ownership of Certain Beneficial Owners and Management and Related Shareholder Matters43Item 13:Certain Relationships and Related Transactions, and Director Independence43Item 14:Principal Accounting Fees and Services43 Part IV Item 15:Exhibits, Financial Statements Schedules44 Signatures50 2 Source: Advaxis, Inc., 10-K, December 21, 2017Powered by Morningstar® Document Research℠The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any use of this information,except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results. PART 1 FORWARD LOOKING STATEMENTS This annual report on Form 10-K (“Form 10-K”) includes statements that are, or may be deemed, “forward-looking statements.” In some cases,these forward-looking statements can be identified by the use of forward-looking terminology, including the terms “believes,” “estimates,” “anticipates,”“expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “approximately” or, in each case, their negative or other variations thereon orcomparable terminology, although not all forward-looking statements contain these words. They appear in a number of places throughout this Form 10-Kand include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things, ourongoing and planned discovery and development of drug candidates, the strength and breadth of our intellectual property, our ongoing and plannedpreclinical studies and clinical trials, the timing of and our ability to make regulatory filings and obtain and maintain regulatory approvals for ourproduct candidates, the degree of clinical utility of our product candidates, particularly in specific patient populations, expectations regarding clinicaltrial data, our results of operations, financial condition, liquidity, prospects, growth and strategies, the length of time that we will be able to continue tofund our operating expenses and capital expenditures, our expected financing needs and sources of financing, the industry in which we operate and thetrends that may affect the industry or us. By their nature, forward-looking statements involve risks and uncertainties because they relate to events, competitive dynamics, and healthcare,regulatory and scientific developments and depend on the economic circumstances that may or may not occur in the future or may occur on longer orshorter timelines than anticipated. Although we believe that we have a reasonable basis for each forward-looking statement contained in this Form 10-K,we caution you that forward-looking statements are not guarantees of future performance and that our actual results of operations, financial condition andliquidity, and the development of the industry in which we operate may differ materially from the forward-looking statements contained in this Form 10-K.In addition, even if our results of operations, financial condition and liquidity, and the development of the industry in which we operate are consistent withthe forward-looking statements contained in this Form 10-K, they may not be predictive of results or developments in future periods. Some of the factors that we believe could cause actual results to differ from those anticipated or predicted include: ●the success and timing of our clinical trials, including patient accrual; ●our ability to obtain and maintain regulatory approval and/or reimbursement of our product candidates for marketing; ●our ability to obtain the appropriate labeling of our products under any regulatory approval; ●our plans to develop and commercialize our products; ●the successful development and implementation of our sales and marketing campaigns; ●the change of key scientific or management personnel; ●the size and growth of the potential markets for our product candidates and our ability to serve those markets; ●our ability to successfully compete in the potential markets for our product candidates, if commercialized; ●regulatory developments in the United States and foreign countries; ●the rate and degree of market acceptance of any of our product candidates; ●new products, product candidates or new uses for existing products or technologies introduced or announced by our competitors and the timing ofthese introductions or announcements; ●market conditions in the pharmaceutical and biotechnology sectors; ●our available cash; ●the accuracy of our estimates regarding expenses, future revenues, capital requirements and needs for additional financing; ●our ability to obtain additional funding; ●our ability to obtain and maintain intellectual property protection for our product candidates; ●the success and timing of our preclinical studies including IND enabling studies; ●the ability of our product candidates to successfully perform in clinical trials; ●our ability to obtain and maintain approval of our product candidates for trial initiation; ●our ability to manufacture and the performance of third-party manufacturers; ●the performance of our clinical research organizations, clinical trial sponsors and clinical trial investigators; and ●our ability to successfully implement our strategy. Any forward-looking statements that we make in this Form 10-K speak only as of the date of such statement, and we undertake no obligation to updatesuch statements to reflect events or circumstances after the date of this Form 10-K. You should also read carefully the factors described in the “RiskFactors” section of this Form 10-K to better understand the risks and uncertainties inherent in our business and underlying any forward-lookingstatements. As a result of these factors, we cannot assure you that the forward-looking statements in this Form 10-K will prove to be accurate. This Form 10-K includes statistical and other industry and market data that we obtained from industry publications and research, surveys and studiesconducted by third-parties. Industry publications and third-party research, surveys and studies generally indicate that their information has been obtainedfrom sources believed to be reliable, although they do not guarantee the accuracy or completeness of such information. While we believe these industrypublications and third-party research, surveys and studies are reliable, we have not independently verified such data. We qualify all of our forward-looking statements by these cautionary statements. In addition, with respect to all of our forward-looking statements,we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. 3 Source: Advaxis, Inc., 10-K, December 21, 2017Powered by Morningstar® Document Research℠The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any use of this information,except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results. Item 1. Business. General Advaxis, Inc. (“Advaxis” or the “Company”) is a late-stage biotechnology Company focused on the discovery, development and commercializationof proprietary Lm Technology antigen delivery products based on a platform technology that utilizes live attenuated Listeria monocytogenes (“Lm”)bioengineered to secrete antigen/adjuvant fusion proteins. These Lm-based strains are believed to be a significant advancement in immunotherapy as theyintegrate multiple functions into a single immunotherapy by accessing and directing antigen presenting cells to stimulate anti-tumor T cell immunity,stimulate and activate the immune system with the equivalent of multiple adjuvants, and simultaneously reduce tumor protection in the TumorMicroenvironment (“TME”) to enable the T cells to eliminate tumors. The Company believes that Lm Technology immunotherapies can complement andaddress significant unmet needs in the current oncology treatment landscape. Specifically, their product candidates have the potential to optimizecheckpoint performance, while having a generally well-tolerated safety profile, and most of their product candidates are immediately available for treatmentwith a low cost of goods. The Company’s passion for the clinical potential of Lm Technology is balanced by focus and fiscal discipline and driven towardsincreasing shareholder value. Advaxis is focused on four franchises in various stages of clinical and pre-clinical development, which they believe will provide the greatestopportunity to have a significant impact on patients and their families: ·Human Papilloma Virus (“HPV”)-associated cancers ·Neoantigen therapy ·Disease focused hotspot / cancer antigen therapies ·Prostate cancer All four clinical franchises are anchored in the Company’s Lm TechnologyTM, a unique platform designed for its ability to safely and effectivelytarget various cancers in multiple ways. As an intracellular bacterium, Lm is an effective vector for the presentation of antigens through both the MajorHistocompatibility Complex (“MHC”) I and II pathways, due to its active phagocytosis by Antigen Presenting Cells (“APCs”). Within the APCs, Lm producesvirulence factors which allow survival in the host cytosol and potently stimulate the immune system. Through a license from the University of Pennsylvania, Advaxis has exclusive access to a proprietary formulation of attenuated Lm called LmTechnology. Lm Technology optimizes this natural system, and one of the keys to the enhanced immunogenicity of Lm Technology is the tLLO – fusionprotein, which is made up of tumor associated antigen (“TAA”) fused to a highly immunogenic bacterial protein that triggers potent cellular immunity. ThetLLO-fusion protein also helps to reduce immune tolerance in the TME and promotes antigen spreading, thereby improving activity in the TME. Multiplecopies of the tLLO-fusion protein within each construct may increase antigen presentation and TME impact. As the field of immunotherapy continues to evolve, the flexibility of the Lm Technology platform has allowed Advaxis to develop highlyinnovative products. To date, Lm Technology has demonstrated preclinical synergy with multiple checkpoint inhibitors, co-stimulatory agents and radiationtherapy, with clinical trials currently underway or planned in combination with Merck & Co., Inc. (“Merck”), AstraZeneca PLC (“AstraZeneca”), and Bristol-Myers Squibb Company’s (“BMS”) PD-1/PDL-1 inhibitors. The safety profile of all Lm Technology constructs seen to date has been predictable andmanageable, consisting mostly of mild to moderate flu-like symptoms that have been transient and associated with infusion. The Advaxis Corporate Strategy The Advaxis corporate strategy is to advance the Lm Technology platform and leverage its unique capabilities to design and develop an array ofcancer treatments. The Company and its collaborators are currently conducting or planning clinical studies of Lm Technology immunotherapies in HPV-associated cancers (including cervical and head and neck), prostate cancer, non-small cell lung cancers, and microsatellite stable colorectal cancer. Advaxis’partners and collaborators include Amgen, Inc. (“Amgen”), BMS, Merck, AstraZeneca, the Gynecological Oncology Group (“GOG”) Foundation, Inc. (now amember of NRG Oncology), the European Network for Gynaecological Oncological Trial groups (“ENGOT”), the Parker Institute for Cancer Immunotherapy,Baylor College of Medicine and the Prostate Cancer Foundation. Moving forward, the Company will continue to invest in its core clinical franchises and will also remain opportunistic in evaluating InvestigatorSponsored Trials (“ISTs”) as well as licensing opportunities. The Lm Technology platform is protected by a range of patents, covering both product andprocess, some of which the Company believes can be maintained into 2037. 4 Source: Advaxis, Inc., 10-K, December 21, 2017Powered by Morningstar® Document Research℠The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any use of this information,except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results. Lm Technology and the Immunotherapy Landscape The challenge of cancer immunotherapy has been to find the best overall balance between efficacy and side effects when mobilizing the body’simmune system to fight against cancer. The development of immune checkpoint inhibitors was a significant step forward, and brought with it impressiveclinical activity in many different types of cancers, including melanoma and lung cancer. However, a literature review published in Pharmacy andTherapeutics in 2016 noted that checkpoint inhibitor monotherapy response rates are only in the 15-20% range, and rise to around 50% higher only inselected groups of patients with melanoma or lung cancer. Therefore, for most cancer patients, there is room for improvement. Checkpoint inhibitors canexpand existing cancer fighting cells that may already be present in low numbers and support their activity against cancer cells, but if the right cancer-fighting cells are not present, checkpoint inhibitors may not provide clinical benefit. Similarly, there are many mechanisms of immune tolerance that aredistinct from the checkpoints which, may also be blocking the immune system from fighting cancer. Based on both pre-clinical and early clinical data,Advaxis believes that checkpoint inhibitors, when combined with treatments such as Lm Technology, can have an amplified anti-tumor effect. LmTechnology incorporates several complementary elements that include innate immune stimulation, potent generation of cancer-targeted T cells, ability toboost immunity through multiple treatments, enhancing lymphocyte infiltration into tumors, reduction of non-checkpoint mediated immune tolerance withinthe tumor microenvironment, and promotion of antigen spreading which may amplify the effects of treatment. These results provide rationale for furthertesting of Lm Technology agents in combination with checkpoint inhibitors. Traditional cancer vaccines were another development within immunotherapy and have a history beginning over 30 years ago. Unfortunately, thesevaccines have largely been unsuccessful for a variety of potential reasons. These include poor selection of targets, imbalanced antigen presentation byinclusion of certain immune enhancing agents (adjuvants), failure to consider the blocking actions of immune tolerance, and choice of vaccine vectors. Insome cases, patients may develop neutralizing antibodies, preventing further treatments. In contrast to traditional cancer vaccines, Lm Technology takesadvantage of a natural pathway in the immune system that evolved to protect us against Listeria infections, that also happens to generate the same type ofimmunity that is required when fighting cancer. The live but weakened (attenuated) bacteria stimulate a balanced concert of innate immune triggers andpresent the tumor antigen target precisely where it needs to be to generate potent cancer fighting cells from within the immune system itself. The multitude ofaccompanying signals serves to broadly mobilize most of the immune system in support of fighting what seems to be a Listeria infection, and is then “re-directed” against cancer cell targets. Additionally, the unique intracellular lifecycle of Listeria avoids the creation of neutralizing antibodies, therebyallowing for repeat administration as a chronic therapy with a sustained enhancing of tumor antigen-specific T cell immunity. More recently, a new category of immunotherapies called Adoptive Cell Transfer (“CAR-Ts”, “TCRs”, “TILs”) has provided further evidence of thebenefits of providing an enhanced T cell presence to fight cancer. As published in the Journal of the American Medical Association in November 2017,CAR-T has achieved dramatic results in liquid tumors, and can provoke clinical responses when other treatments stop working. These cells are artificiallyengineered outside the body and early versions have suffered from unanticipated side effects. The therapies are also limited in activity against a specifictarget, and have a limited persistence within the patient. To date, CAR-Ts activity has been limited to liquid tumors and have shown potentially meaningfultoxicity concerns. Moreover, CAR-Ts are complex therapeutic products that are primarily manufactured and released for each patient, leading to costlymanufacturing and a number of treatments. Looking back on the last two decades, there have been promising technology advancements to harness and activate killer T cells against cancersand every day more is learned about the interplay between immunity and cancer that can lead to improved treatments. However there are still significantunmet needs in the immunotherapy landscape that Advaxis feels Lm Technology can address and complement. Specifically, Lm Technology has the potentialto optimize and expand checkpoint inhibitor activity in combination. It also avoids many of the limitations of previous cancer vaccine attempts by tappinginto the pathway reserved for defense against Listeria infection while incorporating the best cancer-targets science can identify, including neoantigens thatresult from mutations in the cancer. To date, Lm Technology products have a generally well-tolerated safety profile, do not generate neutralizing antibodieslending themselves to retreatments, and most of the products are immediately available for treatment without the complication and expense of modifying apatient’s own cells in a laboratory. Lm Technology: An optimized Listeria-based antigen delivery system Advaxis’ Listeria-based immunotherapies are optimized for antigen delivery through a process of insertion of multiple copies of the proprietarytLLO-fusion protein into each extrachromosomal protein expression and secretion plasmid that makes and secretes the target protein right inside the patient’santigen presenting cells to initiate and/or boost their immune response. The tLLO-fusion protein approach was developed at the University of Pennsylvaniaas an improvement over insertion of a single copy of the target gene, as an ACT-A (or other Lm peptide) fusion, within the bacterial genome for four keyreasons: 1.Multiple copies of the DNA in the plasmids per bacteria can result in larger amounts of tLLO- fusion protein being expressed simultaneously, versus asingle copy. This can improve antigen presentation and immunologic priming and increases the number of T cells generated for a particular treatment.2.tLLO expressed on plasmids (with or without a tumor target protein attached) has been shown to reduce numbers and immune suppressive function ofTregs and MDSCs in the tumor microenvironment. Recently presented data demonstrates that Tregs are being destroyed as soon as 5 days after the firstLm Technology treatment in animal models.3.The extrachromosal DNA plasmids themselves also contain CPG sequence patterns that trigger TLR-9, which confers additional innate immunestimulation beyond a listeria without the plasmids.4.The multiple copies of bacterial DNA plasmids (up to 80-100 per bacteria) confers additional stimulation of the STING receptor within APC’s which hasbeen associated with enhancing anti-cancer immunity in patients. Through a license from the University of Pennsylvania, Advaxis has exclusive access to this proprietary formulation of attenuated Lm which furtherenhances this nearly ideal natural system. Clinical application in the Company’s four franchise areas is the core focus of current development efforts. 5 Source: Advaxis, Inc., 10-K, December 21, 2017Powered by Morningstar® Document Research℠The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any use of this information,except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results. Clinical Pipeline Advaxis is focused on the discovery, development and commercialization of proprietary Lm Technology antigen delivery products, with the leadprogram for cervical cancer in Phase 3 development. The Company and its collaborators are currently conducting or planning clinical studies of LmTechnology immunotherapies in four franchises: ·Human Papilloma Virus (“HPV”)-associate cancers ·Neoantigen therapy ·Disease focused hotspot / cancer antigen therapies ·Prostate cancer As a late stage biotechnology company with no commercial products, Advaxis is aware of the need for fiscal responsibility, and is focusing ourinvestment into the four franchises listed above. Additionally, the company will continue to be opportunistic by exploring ISTs, licensing and other externalopportunities. In October of 2015, the Company received notification from the FDA that the INDs for axalimogene filolisbac were put on clinical hold in response to itssubmission of a safety report to the FDA. The clinical hold also included the INDs for ADXS-PSA and ADXS-HER2. Following discussions with the FDA andin accordance with their recommendations, the Company agreed to implement certain risk mitigation measures, including revised trial protocol inclusion /exclusion criteria, post administration antibiotic treatment and patient surveillance and monitoring measures. In December 2015, the FDA notified theCompany that the hold had been lifted with respect to its INDs. Advaxis Pipeline of Product Candidates HPV Related Cancers: Proof of Concept of Lm Technology The Company is developing a franchise in HPV-related cancers including both axalimogene filolisbac and ADXS-DUAL. Axalimogene filolisbac isan Lm–based antigen delivery product directed against HPV and designed to target cells expressing HPV. ADXS-DUAL, the Company’s secondimmunotherapy targeting HPV-associated cancers, builds on the learnings from the clinical development of axalimogene filolisbac and incorporates anadditional HPV target antigen into the Lm Technology vector. The company’s HPV-related products are currently under investigation in two HPV-associatedcancers: cervical cancer and head and neck cancer, either as a monotherapy or in combination. Advaxis has also completed treatment in two Phase 2 studiesof axalimogene filolisbac for the treatment of anal cancer, and is evaluating the potential for collaborative external opportunities to further develop thisprogram. Cervical Cancer: axalimogene filolisbac and ADXS-DUAL HPV is the most common viral infection of the reproductive tract and is the cause of a range of conditions in both females and males. In women,persistent infection with specific oncogenic types of HPV (most frequently alpha7 and alpha9 families) may lead to precancerous lesions which, if untreated,may progress to cervical cancer. There are approximately 527,000 new cases of cervical cancer caused by HPV worldwide every year, and 12,000 new cases inthe U.S. alone, according to the World Health Organization (“WHO”) Human Papillomavirus and Related Cancers in the World Summary Report 2017. Thereare approximately 4,250 deaths from cervical cancer each year according to the National Institutes of Health. Current preventative HPV vaccines such asGardasil® and Cervarix® cannot treat or protect the large population of adults already infected with the virus, leaving several generations of womenvulnerable. Furthermore, challenges with acceptance, accessibility, and compliance have resulted in suboptimal vaccination rates, with approximately 50%of young women and 38% of young men being fully vaccinated in the United States, according to statistics published by the Centers for Disease Control in2017. Vaccination rates are even lower in other countries around the world. Current treatments for metastatic cervical cancer can only extend life for about 6-8 months. Axalimogene filolisbac and ADXS-DUAL are LmTechnology immunotherapies designed to secrete the tLLO-E7 fusion protein to target HPV-positive tumors. 6 Source: Advaxis, Inc., 10-K, December 21, 2017Powered by Morningstar® Document Research℠The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any use of this information,except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results. Axalimogene filolisbac has received FDA orphan drug designation for invasive International Federation of Gynecology and Obstetrics (“FIGO”)Stage II-IV cervical cancer, and has received Fast Track designation from the FDA for the treatment of high-risk locally advanced cervical cancer.Axalimogene filolisbac has also been classified as an advanced-therapy medicinal product (“ATMP”) for the treatment of cervical cancer by the EuropeanMedicines Agency’s (“EMA”) Committee for Advanced Therapies (“CAT”). The CAT is the EMA’s committee responsible for assessing the quality, safetyand efficacy of ATMPs. The Company has completed the CAT certification procedure and the CAT has certified that the preclinical and quality informationhave met the scientific and technical standards for a MAA. Phase 2 Trial Results – axalimogene filolisbac In 2014, the company completed a randomized Phase 2 clinical trial (Lm-LLO-E7-15) in 109 women with recurrent/refractory cervical cancer. Thefinal results were presented at the 2014 American Society of Clinical Oncology (“ASCO”) Annual Meeting, and showed that 32% (35/109) of patients werealive at 12 months, 22% (24/109) of patients were Long-term Survivors (“LTS”) alive greater than 18 months, and 18% (16/91) evaluable with adequatefollow-up of patients were alive for more than 24 months. Of the 109 patients treated in the trial, LTS included not only patients with tumor shrinkage butalso patients who had experienced stable disease or increased tumor burden. 17% (19/109) of the patients in the trial had recurrence of disease after at leasttwo prior treatments for their cervical cancer; these patients comprised 8% (2/24) of LTS. Among the LTS, 25% (3/12) of patients had a baseline EasternCooperative Oncology Group (“ECOG”) performance status of 2, a patient population that is often excluded from clinical trials. Furthermore, a 10%objective response rate (including 5 complete responses and 6 partial responses) and a disease control rate of 38% (42/109) were observed. The addition ofcisplatin chemotherapy to axalimogene filolisbac in this trial did not significantly improve overall survival or objective tumor response (p =0.9981). In this trial, 109 patients received 254 doses of axalimogene filolisbac. Axalimogene filolisbac was found to be well tolerated with 38% (41/109) ofpatients experiencing mild to moderate Grade 1 or 2 transient adverse events associated with infusion; 1 patient experienced a Grade 3 Serious AdverseEvents (“SAE”). All observed treatment-related adverse events either self-resolved or responded readily to symptomatic treatment. Based on these results, the Gynecological Oncology Group (“GOG”) Foundation, Inc. (now a member of NRG Oncology), under the sponsorship ofthe Cancer Therapy Evaluation Program (“CTEP”) of the National Cancer Institute (“NCI”), conducted GOG-0265, an open-label, single arm Phase 2 trial ofaxalimogene filolisbac in persistent or recurrent cervical cancer (patients must have received at least 1 prior chemotherapy regimen for the treatment of theirrecurrent/metastatic disease, not including that administered as a component of primary treatment) at numerous clinical sites in the U.S. The trial was a Simon2-stage design, with the primary efficacy endpoint being 12-month survival, with the objective of the secondary efficacy endpoints to evaluate progression-free survival, overall survival and objective tumor response. The primary safety endpoints were to evaluate the number of patients with dose-limitingtoxicities and the frequency and severity of adverse effects. To evaluate the trial’s primary endpoint of 12-month overall survival rate, the GOG’s protocol featured a prospectively-defined logistic model-basedcalculation of the expected 12-month survival rate using key predictive factors significantly related to survival and derived from 17 serially conductedGOG/NRG 2-stage studies of inactive agents in persistent/recurrent metastatic cervical cancer (“PRmCC”) involving approximately 500 patients. Thisaccumulated data by GOG used a consistent protocol design and a similar data collection methodology resulting in a robust and homogeneous patientdataset for the per protocol analysis of the primary endpoint. Per the trial protocol, this logistic model-based calculation was then used as a comparator forevaluating the 12-month survival rate of axalimogene filolisbac observed in GOG-0265. The first stage of enrollment in GOG-0265 was successfully completed with 26 patients treated and met the predetermined safety and efficacy criteriarequired to proceed into the second stage of patient enrollment. Clinical data from the first stage of GOG-0265 was presented at the American Gynecological& Obstetrical Society (“AGOS”) annual meeting on September 17, 2015. Overall survival at 12 months was 38.5% (10/26) (the predefined criteria for 12-month survival in order to progress to Stage 2 was ≥20%), and, among patients who had received the full treatment regimen of 3 doses of axalimogenefilolisbac, the 12-month survival rate was 55.6% (10/18). The adverse events observed in the first stage of the trial have been consistent with those reported inother clinical studies with axalimogene filolisbac. Stage 2 of the trial began enrollment in February 2015 which included a protocol amendment to allow patients to continue to receive repeat cyclesof therapy until disease progression. Stage 2 enrollment was temporarily suspended with a clinical hold in October 2015 that resolved in mid-December2015. Prior to re-initiating enrollment of a new cohort of Stage 2 patients, Advaxis and the GOG Foundation/NRG Oncology examined the 12-month survivalrate and safety data obtained from the 24 patients who had previously enrolled in Stage 2. The Stage 2 population demonstrated that treatment withaxalimogene filolisbac resulted in a 37.5% (9/24) 12-month survival rate. This data was consistent with the findings in Stage 1 that showed a 38.5% 12-month survival rate, despite a greater proportion of Stage 2 patients having failed bevacizumab treatment. Taken together, the available data from both stagesof GOG-0265 comprise a Phase 2 clinical trial in 50 subjects with a 12 month survival rate of 38% (19/50). The protocol defined logistic model-basedcalculation of the expected 12-month milestone survival rate was calculated to be 24.5% using the key predictors from the patients enrolled in the trial. The12 month survival rate of 38% for patients receiving axalimogene filolisbac in the trial represented a 52% improvement over the expected 12-monthmilestone survival rate of 24.5%. Overall, 28 out of 50 (56%) patients experienced a Grade 1 or Grade 2 TRAE associated with axalimogene filolisbac infusion. The most common(>30%) Grade 1 or Grade 2 TRAEs were fatigue, chills, anemia, nausea and fever. Eighteen (36%) patients experienced a Grade 3 TRAE and two patientsexperienced a Grade 4 AE, including a Klebsiella lung infection in one patient, and hypotension/cytokine related symptoms in another patient, which wereconsidered possibly related to treatment. In October 2016, upon review of these encouraging findings, the Company announced early closure of GOG-0265. Results from the GOG-0265 trialwere presented as an oral late-breaker presentation at the Society of Gynecologic Oncology (“SGO”) annual meeting on March 14, 2017. Based on these data,the Company has made a strategic decision to submit for conditional Marketing Authorization (“MA”) in Europe. 7 Source: Advaxis, Inc., 10-K, December 21, 2017Powered by Morningstar® Document Research℠The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any use of this information,except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results. Advaxis is also conducting an ongoing clinical trial with axalimogene filolisbac through a collaboration agreement with MedImmune, the globalbiologics research and development arm of AstraZeneca. This is a Phase 1/2, open-label, multicenter, dose determination and expansion cohort trial todetermine the recommended Phase 2 dose (“RP2D”) and evaluate the safety and efficacy of axalimogene filolisbac, in combination with MedImmune’sinvestigational anti-PD-L1 immune checkpoint inhibitor, IMFINZITM (“durvalumab”), as a treatment for patients with metastatic squamous or non-squamouscarcinoma of the cervix and metastatic HPV-associated squamous cell carcinoma of the head and neck (“SCCHN”). The dose determination phase of the trialis complete. Two dose cohorts were enrolled. Cohort 1 enrolled 5 patients with metastatic cervical cancer who received 1 x 109 cfu of axalimogene filolisbac+ 3 mg/mg durvalumab. Cohort 2 enrolled 3 patients with metastatic cervical cancer and 2 patients with SCCHN who received 1 x 109 cfu of axalimogenefilolisbac + 10 mg/mg of durvalumab. No dose-limiting toxicities were observed in either cohort. The RP2D was determined to be 1 x 109 cfu foraxalimogene filolisbac + 10 mg/mg for durvalumab. Preliminary data showed that two patients with metastatic cervical cancer achieved a durable completeresponse (with confirmation) and a partial response (without confirmation), respectively. Treatment-related adverse events (“TRAE”) were reported in 91% of patients; the majority were either Grade 1 (64%) or Grade 2 (55%) events. Themost commonly reported TRAEs were chills, fever, nausea and hypotension. Three patients reported Grade 3 TRAEs (1 x 109 + 3 mg/kg rigor/chills; 1 x 109+ 10 mg/kg - rigor/chills; and 1 x 109 + 10 mg/kg - diarrhea and shortness of breath). One patient experienced a grade 4 TRAE of hypotension. The safetyprofile of the combination of axalimogene filolisbac + durvalumab was consistent with previous reported findings for both axalimogene filolisbac anddurvalumab administered as monotherapy. Enrollment in the Part A expansion phase (N = 20 patients with SCCHN) and Part B expansion phase (N=90 patients with metastatic cervical cancer)are open to enrollment. As of the latest data cut-off date of October 18, 2017, 7 patients receiving 1 x 109 axalimogene filolisbac + 10 mg/kg durvalumabhave been enrolled. In the Part B expansion, a total of 32 patients with metastatic cervical cancer were randomized to receive either 10 mg/kg durvalumabalone (N=16 patients) or 1 x 109 axalimogene filolisbac + 10 mg/kg durvalumab (N = 16 patients) expansion phases. The Company expects an interimreadout of the safety and efficacy data from the Part B expansion in 2019. Ongoing Registrational and Phase 3 Studies: ADXS-DUAL and axalimogene filolisbac In evaluating the data from GOG-0265, Advaxis observed that there was a significantly higher representation of alpha7 family viruses in the PRmCCpatient population than are typically seen at an initial diagnosis of cervical cancer. Although axalimogene filolisbac had already been shown to improvesurvival in both alpha7 and alpha9 family cancers, the Company made the decision that late stage, metastatic patients need a potent therapy that presentsantigens to both families, in order to give them the best chance to impede their disease progression. As a result, ADXS-DUAL was developed to have thepotential to be even more potent against the alpha7 family strains found in metastatic cervical cancer. ADXS-DUAL incorporates additional peptides toincrease potency against these alpha7 strains. ADXS-DUAL may give patients the best chance of benefit in the PRmCC setting, especially if combined with acheckpoint inhibitor. To this end, the Company has entered into a clinical development collaboration agreement with BMS to evaluate their PD-1 immune checkpointinhibitor, OPDIVO® (“nivolumab”), in combination with ADXS-DUAL as a potential treatment option for women with PRmCC. Advaxis plans to file an INDapplication for ADXS-DUAL in early 2018. Pending FDA feedback, we plan to initiate a global, randomized, registrational quality trial in 1H 2018 and willevaluate this combination regimen in women with persistent, recurrent or metastatic (squamous or non-squamous cell) carcinoma of the cervix who havefailed at least one prior line of systemic chemotherapy (“ADVANCE” or “ADVAxis Immunotherapy with Nivolumab to Treat Recurrent or MetastaticCErvical Cancer”). Under the terms of the agreement, each party will bear its own internal costs and provide its immunotherapy agents. Advaxis will sponsorthe trial and pay third-party costs. Subject to the positive outcome of this trial, the Company plans to file a Biologics License Application (“BLA”) forapproval of ADXS-DUAL for metastatic cervical cancer in combination treatment. Women who are diagnosed with high risk, locally advanced carcinoma of the cervix (“HRLACC”) face a higher chance that their cancer may recurfollowing initial treatment when compared to earlier stages of the disease. When cervical cancer recurs, there are very few treatment options and the prognosisis dire. To address this unmet need, in 2016 the Company reached an agreement with the FDA, under the Special Protocol Assessment (“SPA”) process, for aPhase 3 trial evaluating axalimogene filolisbac in patients with HRLACC (“AIM2CERV” or “Advaxis Immunotherapy 2 Prevent Cervical Recurrence”) to beconducted in collaboration with the GOG/NRG Oncology. AIM2CERV is a double-blind, randomized, placebo-controlled, Phase 3 trial of adjuvant axalimogene filolisbac following primary chemoradiationtreatment of women with HRLACC. The primary objective of AIM2CERV is to compare the disease free survival of axalimogene filolisbac to placeboadministered in the adjuvant setting following standard concurrent chemotherapy and radiotherapy (“CCRT”) administered with curative intent to patientswith HRLACC. Secondary endpoints include examining overall survival and safety. The company’s goal is to develop a treatment to prevent or reduce therisk of cervical cancer recurrence after primary, standard of care treatment in women who are at high risk of recurrence. The AIM2CERV trial is expected toenroll 450 patients globally and, subject to the positive outcome, is designed to support a BLA submission in the U.S. and in other territories around theworld. The trial is active in ten countries and is currently enrolling. Axalimogene filolisbac EU conditional approval Filing Based on scientific advice provided by the Paul Ehrlich Institute in Germany and the Medical Products Agency in Sweden, the Company has made astrategic decision to submit for conditional Marketing Authorization (“MA”) in Europe. The company plans to file for conditional MA under therequirements in the EMA’s Commission Regulation and Committee for Medicinal Products for Human Use (“CHMP”) Guideline on MAs, which includescriteria such as a positive risk/benefit balance, unmet medical needs being fulfilled, benefits to public health outweighing the additional data required, and ahigh likelihood that comprehensive clinical data will be provided in the future. Progress to date towards submission of the filing includes axalimogene filolisbac’s designation as an ATMP, certification of quality and non-clinicaldata by the CAT, CHMP confirmation of eligibility for Union Marketing Authorization, assignment of EU rapporteurs, and pre-submission meetings heldwith the rapporteurs. Feedback from the rapporteurs advising the provision of additional clinical information in the submission package led to a delay of thefiling which is now planned for Q1 2018. Once the package is submitted, the CHMP review process is expected to take approximately 13 months, and theCompany plans to provide an update at the end of the review.Source: Advaxis, Inc., 10-K, December 21, 2017Powered by Morningstar® Document Research℠The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any use of this information,except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results. 8 Source: Advaxis, Inc., 10-K, December 21, 2017Powered by Morningstar® Document Research℠The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any use of this information,except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results. HPV Franchise Licensing Agreements Biocon Limited (“Biocon”), our co-development and commercialization partner for axalimogene filolisbac in India and key emerging markets, fileda Marketing Authorization Application (“MAA”) for licensure of this immunotherapy in India. The companies are currently evaluating next steps. Especificos Stendhal SA de CV (“Stendhal”), the Company’s co-development and commercialization partner for axalimogene filolisbac in Mexico,Brazil, Colombia and other Latin American countries, will pay $10 million in support payments towards the expense of AIM2CERV over the duration of thetrial, contingent upon Advaxis achieving annual project milestones. Knight Therapeutics Inc. (“Knight”), holds an exclusive license to commercialize axalimogene filolisbac in Canada, as well as our other productcandidates. Advaxis granted Global BioPharma (“GBP”) an exclusive license for the development and commercialization of axalimogene filolisbac for thetreatment of cervical cancer in Asia. GBP is responsible for all development and commercial costs and activities associated with the development in theirterritories. Head and Neck Cancer Squamous Cell Carcinoma of the Head and Neck (“SCCHN”) is the most frequently occurring malignant tumor of the head and neck and is a majorcause of morbidity and mortality worldwide. More than 90% of SCCHNs originate from the mucosal linings of the oral cavity, pharynx, or larynx and 70% ofthese cancers are caused by HPV. According to the American Cancer Society, head and neck cancer accounts for about 3% of all cancers in the United States.But while the Pap smear and other HPV tests have reduced rates of cervical cancer, rates of oral cancer are growing, with 12,000 new cases projected to bediagnosed in the United Stated in 2016 according to the Surveillance, Epidemiology, and End Results (“SEER”) database. A study published in the Annals of Internal Medicine found that 11.5% percent of U.S. men and 3% of women were actively infected with oral HPVbetween 2011 and 2014. That adds up to 11 million men and 3 million women who are at risk for developing SCCHN. SCCHN is typically asymptomaticuntil it has metastasized, and screening options do not exist. The only way to prevent infection is the HPV vaccine, but compliance has been low to date.Another challenge is that preventative vaccines cannot protect those already infected or older than 26, leaving several generations of Americans vulnerableto SCCHN with no way of knowing if cancer is silently growing. The safety and immunogenicity of axalimogene filolisbac is being evaluated in a Phase 2 IST at Mount Sinai and Baylor College of Medicine in apre-surgery “window of opportunity” trial in patients with HPV-positive head and neck cancer. This clinical trial is the first to evaluate the immunologic andpathologic effects of axalimogene filolisbac in patients at the time of initial diagnosis of HPV-associated head and neck cancer. The trial is designed to showthat axalimogene filolisbac is highly immunogenic and worth further investigation if the overall rate of vaccine-induced T-cell responses is 75 percent ormore. Preliminary clinical data from this trial was presented at the American Association of Cancer Research (“AACR”) annual meeting on April 18, 2016.The data from eight of the nine patients enrolled in Stage 1 who were treated with axalimogene filolisbac confirmed that the trial met the target for the overallrate of vaccine-induced T-cell response. The results demonstrated that HPV E7- and/or E6-specific T cell responses increased in the peripheral blood in fiveof the trial patients. Increased infiltration of both CD4+ and CD8+ T cells were observed in the TME of four patients, with a reduction of FOXP3+ regulatoryT cells within the tumors of 3/6 patients. Increased T cell responses to HPV E6 supports enhanced immune activity against additional tumor targets. Changesto the TME included cytotoxic T cell infiltration into the post-resection tumor, increased immune activation, a reduction of regulatory T cells, infiltration ofcytotoxic T cells, and increased expression of inflammatory activation markers. In addition, fluctuations of circulating serum cytokine (IL-15, IL-9, TNFa, IL-2 and MIP-1b) levels were observed potentially suggesting consumption by activated T cells and migration of T cells to the TME. These results confirmedthat the trial met its Stage 1 primary objective which allowed accrual to proceed in the second stage of the trial which is intended. The Stage 2 objective isconsistent with Stage 1 and enrollment is ongoing. As stated above, we have entered into a clinical trial collaboration agreement with MedImmune to collaborate on a Phase 1/2, open-label,multicenter, two part trial to evaluate safety and efficacy of axalimogene filolisbac, in combination with durvalumab (MEDI4736), for patients withmetastatic squamous or non-squamous carcinoma of the cervix and metastatic HPV-associated SCCHN. Part 1 of this trial is complete, and the Company hascommenced enrollment in the Part A (20 patients with SCCHN) and B (90 patients with cervical cancer) expansion phases. We will continue to be opportunistic towards alternative funding approaches for continued development in HPV-positive head and neck cancer, andplan to announce an IST with a prestigious academic institution in 2018. Axalimogene filolisbac has received FDA orphan drug designation for HPV-associated head and neck cancer. 9 Source: Advaxis, Inc., 10-K, December 21, 2017Powered by Morningstar® Document Research℠The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any use of this information,except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results. Anal Cancer According to the American Cancer Society, nearly all squamous cell anal cancers are linked to infection by HPV, the same virus that causes cervicalcancer. According to the SEER database, approximately 7,500 new cases will be diagnosed in the United States in 2016. The safety and efficacy of axalimogene filolisbac is being evaluated in a Phase 2 IST by Brown University in patients with high-risk locallyadvanced anal cancer. As of December 2017, no further enrollment in this trial is planned. 10 patients were treated including one with N2 and four with N3disease. Two patients had grade 3 acute toxicities following the initial dose of axalimogene filolisbac including chills/rigors (n = 2), back pain (n = 1), andhyponatremia (n = 1). All toxicities occurred within 24 hours of administration. There was no apparent increase in chemoradiation toxicities ormyelosuppression. One patient had a Grade 5 cardiopulmonary event shortly after beginning 5-FU treatment. This patient did not receive a dose ofaxalimogene filolisbac. All 9 assessable patients had complete clinical responses by sigmoidoscopy. Eight of the 9 patients (89%) are progression-free at amedian follow-up of 42 months. These data were accepted and published in the International Journal of Radiation Oncology. We conducted a Phase 2 multi-center, open-label, Simon two-stage trial (“FAWCETT” or “Fighting Anal-Cancer with CTL Enhancing TumorTherapy”), testing axalimogene filolisbac in patients with persistent or recurrent metastatic anal cancer. FAWCETT is designed to evaluate the efficacy andsafety of axalimogene filolisbac as a monotherapy in patients with HPV-associated metastatic anal cancer who have received at least one prior treatmentregimen for the advanced disease. Patients will receive intravenous axalimogene filolisbac monotherapy (1x109 CFU) every 3 weeks for ≤ 2 years or until adiscontinuation criterion is met. Stage 1 of the trial targeted enrollment of 36 patients with anal cancer whose disease recurred after receiving treatment, withan interim analysis planned on enrollment of 31 evaluable pts (≥ 1 post-baseline scan) and met the predetermined safety and efficacy criteria required toproceed into the second stage of patient enrollment. Preliminary Stage 1 results from 29 of the planned evaluable patients showed 1 (3.5%) patient had a durable partial response lasting > 6 months(after progression on prior anti-PD-1 therapy) and 7 had stable disease (24%). Disease control rate was 28%. The current Kaplan Meier 6-month PFS estimateis 22%, indicating the trial met the criteria to proceed to Stage 2 of enrollment. Common (≥ 30%) TRAEs were grade 1-2 chills/rigors, fever, hypotension andvomiting. Grade 3 TRAEs of cytokine related symptoms (n=1; SAE), infusion related reactions (n=2; 1 SAE) and hypotension (n=2; 1 SAE) were reported.These results were reported at the annual meeting of the European Society for Medical Oncology (“ESMO”) in September 2017. The Company has decided not to initiate the Stage 2 portion of the trial in order to focus its resources on other clinical priorities at this time. We willcontinue to evaluate alternative funding sources and collaborations to further develop this program. Axalimogene filolisbac has received FDA and EMAorphan drug designation for anal cancer. Neoantigen Therapy (ADXS-NEO) Lm Technology is an effective vector for immunotherapy, and the Company made the decision to branch into the growing field of individualizedcancer treatments with ADXS-NEO. ADXS-NEO is designed to create individualized therapies by activating the patient’s immune system to respond againstmultiple mutations, or neoantigens, identified from an individual patient’s tumor through DNA sequencing. In August 2016, Advaxis entered into a globalagreement with Amgen Inc. (“Amgen”) for the development and commercialization of ADXS-NEO. ADXS-NEO is an individualized Lm Technology antigen delivery product developed using whole-exome sequencing of a patient’s tumor to identifyneoantigens. ADXS-NEO is designed to work by presenting a large payload of neoantigens directly into dendritic cells within the patient’s immune systemand stimulating a T cell response against cancerous cells. The FDA has cleared the initial IND application of ADXS-NEO and we will file an IND amendment in early 2018. This amendment is largely drivenby enhancements to the manufacturing and antigen selection processes. We do not expect this to impact our project timelines, and we plan to initiate a Phase1 trial in first half of 2018. The initial tumor types for the Phase 1 are non-small cell lung cancer, microsatellite stable colorectal cancer, and head and neckcancer. The Company has entered into various research collaborations, including the Parker Institute for Cancer Immunotherapy, to advance the trial ofneoepitope-based, personalized cancer therapy as part of the Tumor neoantigEn SeLection Alliance (“TESLA”) initiative. Disease focused hotspot / cancer antigen therapies (ADXS-HOT) Advaxis is creating a new group of immunotherapy constructs for major cancers that combines our optimized Lm Technology vector with promisingtargets to generate potent anti-cancer immunity. The ADXS-HOT franchise is a series of novel cancer immunotherapies that will target somatic mutations(“hotspots”), cancer testis antigens (“CTAs”) and oncofetal antigens (“OFAs”). These three types of targets form the basis of the ADXS-HOT program becausethey are more capable of generating potent, tumor specific, and high strength killer T cells, versus more traditional over-expressed native sequence TAAs.Most hotspot mutations and OFA/CTA proteins play critical roles in oncogenesis; targeting both at once could significantly impair cancer proliferation. TheADXS-HOT products will combine many of the potential high avidity targets that are expressed in all patients with the target disease into one “off-the-shelf”,ready to administer treatment. The ADXS-HOT technology has a strong Intellectual Property (“IP”) position, with potential protection into 2037, and an IPfiling strategy providing for broad coverage opportunities across multiple disease platforms and combination therapies. The Company is currently prioritizing product development in the most prevalent cancers, with the first indication planned to be Non Small CellLung Cancer (“NSCLC”). Advaxis plans to file multiple ADXS-HOT INDs in 2018, including NSCLC, with our first in human trial in one of the ADXS-HOTproducts to commence in 2018. 10 Source: Advaxis, Inc., 10-K, December 21, 2017Powered by Morningstar® Document Research℠The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any use of this information,except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results. Prostate Cancer (ADXS-PSA) According to the American Cancer Society, prostate cancer is the second most common type of cancer found in American men, and is the secondleading cause of cancer death in men, behind only lung cancer. More than 161,000 men are estimated to be diagnosed with prostate cancer in 2017, with over26,000 deaths each year. Unfortunately, in about 10 – 20% of cases, men with prostate cancer will go on to develop castration-resistant prostate cancer(“CRPC”), which refers to prostate cancer that progresses despite androgen deprivation therapy. Metastatic CRPC (“mCRPC”) occurs when the cancer spreadsto other parts of the body and there is a rising prostate-specific antigen (“PSA”) level. This stage of prostate cancer has an average survival of 9-13 months, isassociated with deterioration in quality of life, and has few therapeutic options available. According to a data review published by MD Anderson Cancer Center in 2016, checkpoint inhibitor monotherapy has not shown significant activityin mCRPC to date. The authors hypothesize that may be due to the inability of the checkpoint inhibitor to infiltrate the tumor microenvironment, and thatcombination therapy with agents that induce T cell infiltration within the tumor may improve performance of checkpoints in prostate cancer. Lm Technology constructs have been shown by multiple labs to reduce number and suppressive function of Tregs and MDSCs in the tumormicroenvironment and cause the destruction of Tregs in the TME as soon as 5 days after dosing in models. This reduction of immune suppression in thetumors has been attributed to our proprietary tLLO-fusion peptides expressed by multiple copies of the plasmids in each bacteria. Advaxis feels that thecombination of ADXS-PSA, our immunotherapy designed to target the PSA antigen, with a checkpoint inhibitor may provide an alternative treatment optionfor patients with mCRPC. Clinical benefit in prostate cancer could be a significant value creator to expand the Lm Technology platform into the prostatecancer market. Advaxis has entered into a clinical trial collaboration and supply agreement with Merck to evaluate the safety and efficacy of ADXS-PSA asmonotherapy and in combination with KEYTRUDA® (“pembrolizumab”), Merck’s anti PD-1 antibody, in a Phase 1/2, open-label, multicenter, dosedetermination and expansion trial in patients with previously treated metastatic, castration-resistant prostate cancer (Keynote-046). For the ADXS-PSAmonotherapy dose escalation and determination portion of the trial, cohorts were started at a dose of 1 x 109 cfu (n=7) and successfully escalated to higherdose levels of 5x109 cfu (n=3) and 1x1010 cfu (n=3) without achieving a maximum tolerated dose. Treatment emergent adverse events noted at these higherdose levels were generally consistent with those observed at the lower dose level (1 x 109 cfu) other than a higher occurrence rate of Grade 2/3 hypotension.The ADXS-PSA monotherapy dose-determination phase of the trial has been completed. The RP2D of ADXS-PSA monotherapy was determined to be 1x 109cfu based on a review of the totality of the clinical data. This dose was used in combination with 200 mg of pembrolizumab in a cohort of 6 patients toevaluate the safety of the combination before moving into an expanded cohort of patients (N=30 patients). The safety of the combination was confirmed andenrollment in the expansion cohort phase was initiated. Enrollment in this phase of the trial was completed in January 2017. Preliminary data correlating clinical observations with immune data in mCRPC patients treated with ADXS-PSA monotherapy were presented at thethird annual CRI-CIMT-EATI-AACR International Cancer Immunotherapy Conference in September 2017. By profiling and quantifying immune-relatedgene expression in patients before and after ADXS-PSA monotherapy, differences were noted between the pre- and post-treatment immune status of stabledisease (“SD”) and non-stable disease patients. 100% of the patients who achieved SD (31%; 4/13) showed expansion of pre-existing, as well as generation ofnew T cells. There were significantly higher expression levels of genes indicative of CD4+ and CD8+ T cell activation and genes supporting M1macrophages, and lower expression levels of immunosuppressive (protumor) genes. Patients with non-stable disease (69%; 9/13) exhibited gene expressionprofiles suggesting a more immunosuppressive myeloid profile with asynchronous and unsustained clonal T cell expansions, and increased expression ofprostate cancer tumor markers in peripheral circulation. Together, these findings suggest that SD patients treated with ADXS-PSA may have a more pro-inflammatory immunologic picture, fewer circulating tumor cells, and potentially less tumor burden. In November 2017 at the Society for Immunotherapy of Cancer (“SITC”), the Company presented additional preliminary data from this monotherapyarm that shows that after administration of ADXS-PSA, all 9 patients who received all three doses saw increasing numbers and strength of T cells targetingPSA, using an ELISpot data analysis. In 56% (5/9) patients, this increase was 3-fold. This data shows, for the first time clinically, that an Lm Technologyconstruct has shown specific T cell generation against a specific target. In addition, the Company evaluated four other markers expressed by prostate cancersand 100% (9/9) patients had an increased frequency of T cells to at least one of these targets, demonstrating that antigen spreading after administration ofADXS-PSA does occur in the clinic and can expand activity. Preliminary safety data shows the most common side effects include chills, fever, rigors, hypertension, fatigue, hypotension and vomiting which areconsistent with cytokine release in response to ADXS-PSA administration. Viewed collectively, the data presented at CRI-CIMT-EATI-AACR 2017 and SITC 2017 is an encouraging signal that ADXS-PSA allows forgeneration of sustained, strengthened T cells against prostate cancer, while weakening the TME and allowing T cells access to the tumor. The Companylooks forward to providing additional data in 2018 from the combination arm of this trial with pembrolizumab. In addition, the Company is actively developing an additional product candidate for prostate cancer, currently in preclinical testing, which couldcomplement ADXS-PSA. Other Lm Technology Products HER2 Expressing Solid Tumors 11 Source: Advaxis, Inc., 10-K, December 21, 2017Powered by Morningstar® Document Research℠The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any use of this information,except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results. HER2 is overexpressed in a percentage of solid tumors including osteosarcoma. According to published literature, up to 60% of osteosarcomas areHER2 positive, and this overexpression is associated with poor outcomes for patients. ADXS-HER2 is an Lm Technology antigen delivery product candidate designed to target HER2 expressing solid tumors including human andcanine osteosarcoma. ADXS-HER2 has received FDA and EMA orphan drug designation for osteosarcoma and has received Fast Track designation from theFDA for patients with newly-diagnosed, non-metastatic, surgically-resectable osteosarcoma. The dose finding phase of a Phase 1b trial in HER2 expressing tumors has been completed. Based on priorities and focus, the Company has decidednot to proceed to the expansion phase of the trial. The Company remains open to investigator-initiated research or licensing proposals for ADXS-HER2. Canine Osteosarcoma On March 19, 2014, we entered into a definitive Exclusive License Agreement (the “Aratana Agreement”) with Aratana Therapeutics Inc.(“Aratana”), where we granted Aratana an exclusive, worldwide, royalty-bearing license, with the right to sublicense, certain of our proprietary technologythat enables Aratana to develop and commercialize animal health products that will be targeted for treatment of osteosarcoma and other cancer indications inanimals. A product license request was filed by Aratana for ADXS-HER2 (also known as AT-014 by Aratana) for the treatment of canine osteosarcoma withthe United States Department of Agriculture (“USDA”). Aratana received communication in December 2017 that the USDA granted Aratana conditionallicensure for AT-014 for the treatment of dogs diagnosed with osteosarcoma, one year of age or older. Aratana plans to conduct an extended field study in aclinical setting and anticipates initiating the study in early 2018, which will be fully funded by Aratana. Initially, Aratana plans to make the therapeuticavailable for purchase at approximately two dozen veterinary oncology practice groups across the United States who participate in the study. Aratana has been granted exclusive worldwide rights by us to develop and commercialize ADXS-HER2 in animals. Aratana is further responsible forthe conduct of clinical research with ADXS-Survivin in canine/feline lymphoma, as well as pending investigations of two additional Advaxis constructs inanimals. Under the terms of the Aratana Agreement, Aratana paid an upfront payment to us in the amount of $1,000,000 upon signing of the AratanaAgreement. Aratana will also pay us (a) up to $36.5 million based on the achievement of milestone relating to the advancement of products through theapproval process with the USDA in the United States and the relevant regulatory authorities in the European Union (“E.U.”) in all four therapeutic areas andup to an additional $15 million in cumulative sales milestones based on achievement of gross sales revenue targets for sales of any and all products for use innon-human animal health applications (the “Aratana Field”) (regardless of therapeutic area), and (b) tiered royalties starting at 5% and going up to 10%,which will be paid based on net sales of any and all products (regardless of therapeutic area) in the Aratana Field in the United States. Royalties for sales ofproducts outside of the United States will be paid at a rate equal to half of the royalty rate payable by Aratana on net sales of products in the United States(starting at 2.5% and going up to 5%). Royalties will be payable on a product-by-product and country-by-country basis from first commercial sale of aproduct in a country until the later of (a) the 10th anniversary of first commercial sale of such product by Aratana, its affiliates or sub licensees in suchcountry or (b) the expiration of the last-to-expire valid claim of our patents or joint patents claiming or covering the composition of matter, formulation ormethod of use of such product in such country. Aratana will also pay us 50% of all sublicense royalties received by Aratana and its affiliates. Corporate Information We were originally incorporated in the State of Colorado on June 5, 1987 under the name Great Expectations, Inc. We were a publicly-traded “shell”company without any business until November 12, 2004 when we acquired Advaxis, Inc., a Delaware corporation, through a Share Exchange andReorganization Agreement, dated as of August 25, 2004, which we refer to as the Share Exchange, by and among Advaxis, the stockholders of Advaxis andus. As a result of the Share Exchange, Advaxis became our wholly-owned subsidiary and our sole operating company. On December 23, 2004, we amendedand restated our articles of incorporation and changed our name to Advaxis, Inc. On June 6, 2006, our stockholders approved the reincorporation of ourcompany from Colorado to Delaware by merging the Colorado entity into our wholly-owned Delaware subsidiary. Our date of inception, for financialstatement purposes, is March 1, 2002 and the Company was uplisted to NASDAQ in 2014. Our principal executive offices and manufacturing facility is located at 305 College Road East, Princeton, New Jersey 08540 and our telephonenumber is (609) 452-9813. We maintain a corporate website at www.advaxis.com which contains descriptions of our technology, our product candidates andthe development status of each drug. We make available free of charge through our Internet website our annual reports on Form 10-K, quarterly reports onForm 10-Q and current reports on Form 8-K, and any amendments to these reports, as soon as reasonably practicable after we electronically file such materialwith, or furnish such material to, the SEC. We are not including the information on our website as a part of, nor incorporating it by reference into, this report.You may read and copy any materials we file at the SEC’s Public Reference Room at 100 F Street, N.E., Washington, D.C. 20549 on official business daysduring the hours of 10:00 a.m. to 3:00 p.m. Please call the SEC at 1-800-SEC-0330 for information on the Public Reference Room. Additionally, the SECmaintains a website that contains annual, quarterly, and current reports, proxy statements, and other information that issuers (including us) file electronicallywith the SEC. The SEC’s website address is http://www.sec.gov. Intellectual Property Protection of our intellectual property is important to our business. We have a robust and extensive patent portfolio that protects our productcandidates and Lm -based immunotherapy technology. Currently, we own or have rights to approximately 433 patents and applications, which are owned,licensed from, or co-owned with University of Pennsylvania (“Penn”) , Merck, National Institute of Health (“NIH”), and/or Augusta University. Wecontinuously grow this portfolio by filing new applications to protect our ongoing research and development efforts. We aggressively prosecute and defendour patents and proprietary technology. Our patents and applications are directed to the compositions of matter, use, and methods thereof, of our Lm -LLOimmunotherapies for our product candidates, including axalimogene filolisbac, ADXS-DUAL, ADXS-PSA, ADXS-NEO, ADXS-HOT, ADXS-HER2. Our approach to the intellectual property portfolio is to create, maintain, protect, enforce and defend our proprietary rights for the products wedevelop from our immunotherapy technology platform. We endeavor to maintain a coherent and aggressive strategic approach to building our patentportfolio with an emphasis in the field of cancer vaccines. 12 Source: Advaxis, Inc., 10-K, December 21, 2017Powered by Morningstar® Document Research℠The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any use of this information,except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results. Issued patents which are directed to axalimogene filolisbac, ADXS-PSA, and ADXS-HER2 in the United States, will expire between 2017 and 2032.Issued patents directed to our product candidates axalimogene filolisbac, ADXS-PSA, and ADXS-HER2 outside of the United States, will expire in 2032.Issued patents directed to our Lm -based immunotherapy platform in the United States, will expire between 2017 and 2031. Issued patents directed to our Lm -based immunotherapy platform outside of the United States, will expire between 2018 and 2033. We have pending patent applications directed to our product candidates axalimogene filolisbac, ADXS-PSA, ADXS-HER2, ADXS-NEO, ADXS-DUAL and ADXS-HOT that, if issued would expire in the United States and in countries outside of the United States between 2020 and 2037. We havepending patent applications directed to methods of using of our product candidates axalimogene filolisbac, ADXS-DUAL, ADXS-PSA, ADXS-NEO, ADXS-HOT, ADXS-HER2 directed to the following indications and others: HPV-related cervical cancer, prostate cancer and her2/neu-expressing cancer, that, ifissued would expire in the United States and in countries outside of the United States between 2020 and 2037, depending on the specific indications. We will be able to protect our technology from unauthorized use by third parties only to the extent it is covered by valid and enforceable patents oris effectively maintained as trade secrets. Patents and other proprietary rights are an essential element of our business. Our success will depend in part on our ability to obtain and maintain proprietary protection for our product candidates, technology, and know-how,to operate without infringing on the proprietary rights of others, and to prevent others from infringing our proprietary rights. Our policy is to seek to protectour proprietary position by, among other methods, filing U.S. and foreign patent applications related to our proprietary technology, inventions, andimprovements that are important to the development of our business. We also rely on trade secrets, know-how, continuing technological innovation, and in-licensing opportunities to develop and maintain our proprietary position. Any patent applications which we have filed or will file or to which we have or will have license rights may not issue, and patents that do issue maynot contain commercially valuable claims. In addition, any patents issued to us or our licensors may not afford meaningful protection for our products ortechnology, or may be subsequently circumvented, invalidated, narrowed, or found unenforceable. Our processes and potential products may also conflictwith patents which have been or may be granted to competitors, academic institutions or others. As the pharmaceutical industry expands and more patents areissued, the risk increases that our processes and potential products may give rise to interferences filed by others in the U.S. Patent and Trademark Office, or toclaims of patent infringement by other companies, institutions or individuals. These entities or persons could bring legal actions against us claiming damagesand seeking to enjoin clinical testing, manufacturing and marketing of the related product or process. In recent years, several companies have been extremelyaggressive in challenging patents covering pharmaceutical products, and the challenges have often been successful. If any of these actions are successful, inaddition to any potential liability for damages, we could be required to cease the infringing activity or obtain a license in order to continue to manufacture ormarket the relevant product or process. We may not prevail in any such action and any license required under any such patent may not be made available onacceptable terms, if at all. Our failure to successfully defend a patent challenge or to obtain a license to any technology that we may require to commercializeour technologies or potential products could have a materially adverse effect on our business. In addition, changes in either patent laws or in interpretationsof patent laws in the United States and other countries may materially diminish the value of our intellectual property or narrow the scope of our patentprotection. We also rely upon unpatented proprietary technology, and in the future may determine in some cases that our interests would be better served byreliance on trade secrets or confidentiality agreements rather than patents or licenses. We may not be able to protect our rights to such unpatented proprietarytechnology and others may independently develop substantially equivalent technologies. If we are unable to obtain strong proprietary rights to our processesor products after obtaining regulatory clearance, competitors may be able to market competing processes and products. Others may obtain patents having claims which cover aspects of our products or processes which are necessary for, or useful to, the development, useor manufacture of our services or products. Should any other group obtain patent protection with respect to our discoveries, our commercialization ofpotential therapeutic products and methods could be limited or prohibited. The Drug Development Process The product candidates in our pipeline are at various stages of preclinical and clinical development. The path to regulatory approval includesmultiple phases of clinical trials in which we collect data that will ultimately support an application to regulatory authorities to allow us to market a productfor the treatment, of a specific type of cancer. There are many difficulties and uncertainties inherent in research and development of new products, resulting inhigh costs and variable success rates. Bringing a drug from discovery to regulatory approval, and ultimately to market, takes many years and significant costs. Clinical testing, known as clinical trials or clinical studies, is either conducted internally by pharmaceutical or biotechnology companies or ismanaged on behalf of these companies by Clinical Research Organizations (“CRO”). The process of conducting clinical studies is highly regulated by theFDA, as well as by other governmental and professional bodies. In a clinical trial, participants receive specific interventions according to the research plan orprotocol created by the study sponsor and implemented by study investigators. Clinical trials may compare a new medical approach to a standard one that isalready available or to a placebo that contains no active ingredients or to no intervention. Some clinical trials compare interventions that are alreadyavailable to each other. When a new product or approach is being studied, it is not usually known whether it will be helpful, harmful, or no different thanavailable alternatives. The investigators try to determine the safety and efficacy of the intervention by measuring certain clinical outcomes in theparticipants. 13 Source: Advaxis, Inc., 10-K, December 21, 2017Powered by Morningstar® Document Research℠The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any use of this information,except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results. Phase 1. Phase 1 clinical trials begin when regulatory agencies allow initiation of clinical investigation of a new drug or product candidate. Theytypically involve testing an investigational new drug on a limited number of patients. Phase 1 studies determine a drug’s basic safety, maximumtolerated dose and how the drug is absorbed by, and eliminated from, the body. Typically, cancer therapies are initially tested on late-stage cancerpatients. Phase 2. Phase 2 clinical trials involve larger numbers of patients that have been diagnosed with the targeted disease or condition. Phase 2 clinicaltrials gather preliminary data on effectiveness (where the drug works in people who have a certain disease or condition) and to determine thecommon short-term side effects and risks associated with the drug. If Phase 2 clinical trials show that an investigational new drug has an acceptablerange of safety risks and probable effectiveness, a company will continue to evaluate the investigational new drug in Phase 3 studies. Phase 3. Phase 3 clinical trials are typically controlled multi-center trials that involve a larger number of patients to ensure the study results arestatistically significant. The purpose is to confirm effectiveness and safety on a large scale and to provide an adequate basis for physician labeling.These trials are generally global in nature and are designed to generate clinical data necessary to submit an application for marketing approval toregulatory agencies. Biologic License Application (BLA). The results of the clinical trials using biologics are submitted to the FDA as part of a BLA. Following thecompletion of Phase 3 studies, if the sponsor of a potential product in the United States believes it has sufficient information to support the safetyand effectiveness of the investigational new drug, the sponsor submits a BLA to the FDA requesting that the investigational new drug be approvedfor marketing. The application is a comprehensive filing that includes the results of all preclinical and clinical studies, information about the drug’scomposition, and the sponsor’s plans for manufacturing, packaging, labeling and testing the investigational new drug. The FDA’s review of anapplication is designated either as a standard review with a target review time of 10 months or a priority review with a target of 6 months. Dependingupon the completeness of the application and the number and complexity of follow-up requests and responses between the FDA and the sponsor, thereview time can take months to many years. Once approved through this process, a drug may be marketed in the United States, subject to anyconditions imposed by the FDA. Government Regulations General Government authorities in the United States and other countries extensively regulate, among other things, the preclinical and clinical testing,manufacturing, labeling, storage, record-keeping, advertising, promotion, import, export, marketing and distribution of drugs. In the United States, the FDAsubjects drugs to rigorous review under the Federal Food, Drug and Cosmetic Act, the Public Health Service Act and other federal statutes and regulations. Orphan Drug Designation Under the Orphan Drug Act (“ODA”), the FDA may grant Orphan Drug Designation (“ODD”) to a drug or biological product intended to treat a raredisease or condition, which means a disease or condition that affects fewer than 200,000 individuals in the United States, or more than 200,000 individuals inthe United States, but for which there is no reasonable expectation that the cost of developing and making a drug or biological product available in theUnited States will be recovered from domestic sales of the product. The benefits of ODD can be substantial, including research and development tax credits and exemption from user fees, enhanced access to advicefrom the FDA while the drug is being developed, and market exclusivity once the product reaches approval and begins sales, provided that the new product isfirst to market and that this new product has not been previously approved for the same orphan disease or condition, with or without orphan drug designation.In order to qualify for these incentives, a company must apply for designation of its product as an “Orphan Drug” and obtain approval from the FDA. Orphanproduct designation does not convey any advantage in or shorten the duration of the regulatory review and approval process; however, an ODD product maybe eligible for priority review. A drug that is approved for the ODD indication is granted seven years of orphan drug exclusivity. During that period, the FDAgenerally may not approve any other application for the same product for the same indication, although there are exceptions, most notably when the laterproduct is shown to be clinically superior to the product with exclusivity. We currently have ODD with the FDA for axalimogene filolisbac for treatment of anal cancer (granted August 2013), HPV-associated head and neckcancer (granted November 2013); and treatment of Stage II-IV invasive cervical cancer (granted May 2014). We also have ODD with the FDA for ADXS-HER2 for the treatment of osteosarcoma (granted May 2014). In Europe, the Committee for Orphan Medicinal Products (“COMP”) issued a positive opinion on the application for ODD of axalimogene filolisbacfor the treatment of anal cancer (December 2015) and on the application for ODD of ADXS-HER2 for osteosarcoma (November 2015). Expedited Programs for Serious Conditions Four FDA programs are intended to facilitate and expedite development and review of new drugs to address unmet medical need in the treatment ofserious or life-threatening conditions: fast track designation, breakthrough therapy designation, accelerated approval, and priority review designation. Weintend to avail ourselves of any and all of these programs as applicable to our products. 14 Source: Advaxis, Inc., 10-K, December 21, 2017Powered by Morningstar® Document Research℠The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any use of this information,except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results. Non-U.S. Regulation Before our products can be marketed outside the United States, they are subject to regulatory approval of the respective authorities in the country inwhich the product should be marketed. The requirements governing the conduct of clinical trials, product licensing, pricing and reimbursement vary widelyfrom country to country. No action can be taken to market any product in a country until an appropriate application has been approved by the regulatoryauthorities in that country. The time spent in gaining approval varies from that required for FDA approval, and in certain countries, the sales price of aproduct must also be approved. The pricing review period often begins after market approval is granted. Even if a product is approved by a regulatoryauthority, satisfactory prices might not be approved for such product. Collaborations, Partnerships and Agreements Collaborations, partnerships and agreements are a key component of Advaxis’ corporate strategy. As a late stage biotechnology company withoutsales revenue, partnerships are an essential part of the ongoing strategy. Additionally, the evolution of the field of immunotherapy has resulted incombination treatments becoming ubiquitous; ongoing clinical studies and agreements with many of the leading, large oncology pharmaceutical companiesand teaching institutions ensures that Lm Technology will be a key component of the cancer treatment protocols of the future. Our collaborators and partners include Amgen, Aratana, AstraZeneca, BMS, Biocon, GBP, Knight, Merck, Sellas Life Science Group, Stendhal, andothers. For more information, see Footnote 9. Collaboration and Licensing Agreements with this Form 10-K and is incorporated herein by reference. We entered into an exclusive worldwide license agreement with Penn, on July 1, 2002 with respect to the innovative work of Yvonne Paterson,Ph.D., Associate Dean for Research at the School of Nursing at Penn, and former Professor of Microbiology at Penn, in the area of innate immunity, or theimmune response attributed to immune cells, including dendritic cells, macrophages and natural killer cells, that respond to pathogens non-specifically(subject to certain U.S. government rights). This agreement was amended and restated as of February 13, 2007, and, thereafter, has been amended from time totime. This license, unless sooner terminated in accordance with its terms, terminates upon the latter of (a) the expiration of the last to expire of the Pennpatent rights; or (b) twenty years after the effective date of the license. Penn may terminate the license agreement early upon the occurrence of certain defaultsby us, including, but not limited to, a material breach by us of the Penn license agreement that is not cured within 60 days after notice of the breach isprovided to us. The license provides us with the exclusive commercial rights to the patent portfolio developed by Penn as of the effective date of the license, inconnection with Dr. Paterson and requires us to pay various milestone, legal, filing and licensing payments to commercialize the technology. In exchange forthe license, Penn received shares of our Common Stock. However, as of October 31, 2016, Penn does not own shares of our Common Stock. In addition, Pennis entitled to receive a non-refundable initial license fee, royalty payments and milestone payments based on net sales and percentages of sublicense fees andcertain commercial milestones. Under the amended licensing agreement, Penn is entitled to receive 2.5% of net sales in the territory. Should annual net salesexceed $250 million, the royalty rate will increase to 2.75%, but only with respect to those annual net sales in excess of $250 million. Additionally, Pennwill receive tiered sales milestone payments upon the achievement of cumulative global sales ranging between $250 million and $2 billion, with themaximum aggregate amounts payable to Penn in the event that maximum sales milestones are achieved is $40 million. Notwithstanding these royalty rates,upon first in-human commercial sale (U.S. & E.U.), we have agreed to pay Penn a total of $775,000 over a four-year period as an advance minimum royalty,which shall serve as an advance royalty in conjunction with the above terms. In addition, under the license, we are obligated to pay an annual maintenancefee of $100,000 commencing on December 31, 2010, and each December 31st thereafter for the remainder of the term of the agreement until the firstcommercial sale of a Penn licensed product. We are responsible for filing new patents and maintaining and defending the existing patents licensed to us andwe are obligated to reimburse Penn for all attorney’s fees, expenses, official fees and other charges incurred in the preparation, prosecution and maintenanceof the patents licensed from Penn. Upon first regulatory approval in humans (US or EU), Penn will be entitled to a milestone payment of $600,000. Furthermore, upon the achievementof the first sale of a product in certain fields, Penn will be entitled to certain milestone payments, as follows: $2.5 million will be due upon the first in-humancommercial sale (US or EU) of the first product in the cancer field and $1.0 million will be due upon the date of first in-human commercial sale (US or EU) ofa product in each of the secondary strategic fields sold. Manufacturing Current Good Manufacturing Practices (“cGMPs”) are the standards identified to conform to requirements by governmental agencies that controlauthorization and licensure for manufacture and distribution of drug products for either clinical investigations or commercial sale. GMPs identify therequirements for procurement, manufacturing, testing, storage, distribution and the supporting quality systems to ensure that a drug product is safe for itsintended application. cGMPs are enforced in the United States by the FDA, under the authorities of the Federal Food, Drug and Cosmetic Act and itsimplementing regulations and use the phrase “current good manufacturing practices” (“cGMP”) to describe these standards. Each of Advaxis’ wholly owned product candidates is manufactured using a platform process, with uniform methods and testing procedures. Thisallows for an accelerated pathway from construct discovery to clinical product delivery, while keeping cost of goods low. The Company intends to add newconstructs to this standardized manufacturing process as their pipeline evolves. 15 Source: Advaxis, Inc., 10-K, December 21, 2017Powered by Morningstar® Document Research℠The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any use of this information,except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results. Advaxis has entered into agreements with multiple third-party organizations (“CMOs”) to handle the manufacturing, testing, and distribution ofproduct candidates. These organizations have extensive experience within the biologics space and with the production of clinical and commercial GMPsupplies. In 2017, the Company expanded and standardized their external clinical manufacturing network in order to access additional manufacture capacityas needed, and reduce their external manufacturing cost structure. In parallel, the Company has also continued to invest in internal process/analytical development, quality systems, manufacturing, and qualitycontrol infrastructure with the goal of accelerating and advancing our pipeline. Advaxis has constructed a state-of-the-art manufacturing facility andlaboratory to develop and manufacture clinical-grade products, supporting the clinical trials and future commercialization of the Company’s therapeutics.Increased manufacturing capability and capacity allows Advaxis to manufacture its own material and reduce reliance on CMOs, and improve supplyflexibility, scalability, lead times, and costs of goods. The Company’s long-term manufacturing strategy is to leverage both their partners’ capabilities andtheir internal capabilities in order to build a supply chain that is reliable, flexible, and cost competitive. In support of future conditional regulatory filing and future launch of axalimogene filolisbac in Europe, the Company has completed a full mappingof supply chain requirements and has established and validated a commercial process and testing in Europe. The Company plans to continue to refine end-to-end product delivery during the ongoing regulatory review process. Competition The biotechnology and biopharmaceutical industries are characterized by rapid technological developments and a high degree of competition. As aresult, our actual or proposed immunotherapies could become obsolete before we recoup any portion of our related research and development expenses.While we believe that our product candidates, technology, knowledge and experience provide us with competitive advantages, we face competition fromestablished and emerging pharmaceutical and biotechnology companies, among others. The biotechnology and biopharmaceutical industries are highlycompetitive, and this competition comes from both biotechnology firms and from major pharmaceutical companies, including: Aduro Biotech, Agenus Inc.,BMS, Celldex Therapeutics, Inovio Pharmaceutical Inc., ISA Pharmaceuticals, AstraZeneca, Merck, Neon Therapeutics, Oncolytics Biotech Inc.,Oncothyreon Inc., et al., each of which is pursuing cancer vaccines and/or immunotherapies. Many of these companies have substantially greater financial, marketing, and human resources than we do (including, in some cases, substantiallygreater experience in clinical testing, manufacturing, and marketing of pharmaceutical products). We also experience competition in the development of ourimmunotherapies from universities and other research institutions and compete with others in acquiring technology from such universities and institutions. Inaddition, certain of our immunotherapies may be subject to competition from investigational new drugs and/or products developed using other technologies,some of which have completed numerous clinical trials. Our competition will be determined in part by the potential indications for which drugs are developed and ultimately approved by regulatoryauthorities. Additionally, the timing of market introduction of some of our potential immunotherapies or of competitors’ products may be an importantcompetitive factor. Accordingly, the speed with which we can develop immunotherapies, complete preclinical testing, clinical trials and approval processesand supply commercial quantities to market are expected to be important competitive factors. We expect that competition among products approved for salewill be based on various factors, including product efficacy, safety, administration, reliability, acceptance, availability, price and patent position. Experience and Expertise Our management team has extensive experience in oncology development, including contract research, development, manufacturing andcommercialization across a board range of science, technologies, and process operations. We have built internal capabilities supporting research, clinical,medical, manufacturing and compliance operations and have extended our expertise with collaborations. Employees As of October 31, 2017, we had 108 employees, all of which were full time employees, 87 of whom were engaged in research and developmentactivities and 21 of whom were engaged in finance, business development, facilities, human resources and administrative support. Of our full-timeemployees, 28 hold Ph.D. degrees. None of our employees are represented by a labor union, and we consider our relationship with our employees to be good. We will continue to rent necessary offices and laboratories to support our growing business. Item 1A: Risk Factors. You should carefully consider the risks described below as well as other information provided to you in this annual report, including informationin the section of this document entitled “Forward-Looking Statements.” The risks and uncertainties described below are not the only ones facing us.Additional risks and uncertainties not presently known to us or that we currently believe are immaterial may also impair our business operations. If any ofthe following risks actually occur, our business, financial condition or results of operations could be materially adversely affected, the value of ourCommon Stock could decline, and you may lose all or part of your investment. 16 Source: Advaxis, Inc., 10-K, December 21, 2017Powered by Morningstar® Document Research℠The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any use of this information,except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results. Risks Related to our Business and Industry We are a clinical stage company. We are a clinical stage biotechnology company with a history of losses and can provide no assurance as to future operating results. As a result oflosses that will continue throughout our clinical stage, we may exhaust our financial resources and be unable to complete the development of our products.We anticipate that our ongoing operational costs will increase significantly as we continue conducting our clinical development program. Our deficit willcontinue to grow during our drug development period. We have sustained losses from operations in each fiscal year since our inception, and we expect losses to continue for the indefinite future due to thesubstantial investment in research and development. As of October 31, 2017, we had an accumulated deficit of $301,142,227 and shareholders’ equity of$54,260,167. We expect to spend substantial additional sums on the continued administration and research and development of proprietary products andtechnologies with no certainty that our immunotherapies will become commercially viable or profitable as a result of these expenditures. If we fail to raise asignificant amount of capital, we may need to significantly curtail operations or cease operations in the near future. If any of our product candidates fail inclinical trials or does not gain regulatory approval, we may never become profitable. Even if we achieve profitability in the future, we may not be able tosustain profitability in subsequent periods. Drug discovery and development is a complex, time-consuming and expensive process that is fraught with risk and a high rate of failure. Product candidates are subject to extensive pre-clinical testing and clinical trials to demonstrate their safety and efficacy in humans. Conductingpre-clinical testing and clinical trials is a lengthy, time-consuming and expensive process that takes many years. We cannot be sure that pre-clinical testing orclinical trials of any of our product candidates will demonstrate the safety, efficacy and benefit-to-risk profile necessary to obtain marketing approvals. Inaddition, product candidates that experience success in pre-clinical testing and early-stage clinical trials will not necessarily experience the same success inlarger or late-stage clinical trials, which are required for marketing approval. Even if we are successful in advancing a product candidate into the clinical development stage, before obtaining regulatory and marketingapprovals, we must demonstrate through extensive human clinical trials that the product candidate is safe and effective for its intended use. Human clinicaltrials must be carried out under protocols that are acceptable to regulatory authorities and to the independent committees responsible for the ethical review ofclinical studies. There may be delays in preparing protocols or receiving approval for them that may delay the start or completion of the clinical trials. Inaddition, clinical practices vary globally, and there is a lack of harmonization among the guidance provided by various regulatory bodies of different regionsand countries with respect to the data that is required to receive marketing approval, which makes designing global trials increasingly complex. There are anumber of additional factors that may cause our clinical trials to be delayed, prematurely terminated or deemed inadequate to support regulatory approval,such as: ●safety issues up to and including patient death (whether arising with respect to trials by third parties for compounds in a similar class as tour productor product candidate), inadequate efficacy, or an unacceptable risk-benefit profile observed at any point during or after completion of the trials; ●slower than expected rates of patient enrollment, which could be due to any number of factors, including failure of our third-party vendors,including our CROs, to effectively perform their obligations to us, a lack of patients who meet the enrollment criteria or competition from clinicaltrials in similar product classes or patient populations, or onerous treatment administration requirements; ●the risk of failure of our clinical investigational sites and related facilities, including our suppliers, to maintain compliance with the FDA’s cGMPregulations or similar regulations in countries outside of the U.S., including the risk that these sites fail to pass inspections by the appropriategovernmental authority, which could invalidate the data collected at that site or place the entire clinical trial at risk; ●any inability to reach agreement or lengthy discussions with the FDA, equivalent regulatory authorities, or ethical review committees on trial designthat we are able to execute; ●changes in laws, regulations, regulatory policy or clinical practices, especially if they occur during ongoing clinical trials or shortly after completionof such trials. ●clinical trial record keeping or data quality and accuracy issues. Any deficiency in the design, implementation or oversight of our development programs could cause us to incur significant additional costs,conduct additional trials, experience significant delays, prevent us from obtaining marketing approval for any product candidate or abandon development ofcertain product candidates, any of which could harm our business and cause our stock price to decline. Our operating history does not afford investors a sufficient history on which to base an investment decision. We commenced our Lm -LLO based immunotherapy development business in February 2002 and today exist as a clinical stage company. We haveno approved products and therefore have not derived any significant revenue from the sales of products and have not yet demonstrated ability to obtainregulatory approval, formulate and manufacture commercial scale products, or conduct sales and marketing activities necessary for successful productcommercialization. Consequently, there is limited information for investors to use as basis for assessing our future viability. Investors must consider the risksand difficulties we have encountered in the rapidly evolving vaccine and immunotherapy industry. Such risks include the following: 17 Source: Advaxis, Inc., 10-K, December 21, 2017Powered by Morningstar® Document Research℠The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any use of this information,except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results. ●difficulties, complications, delays and other unanticipated factors in connection with the development of new drugs; ●competition from companies that have substantially greater assets and financial resources than we have; ●need for acceptance of our immunotherapies; ●ability to anticipate and adapt to a competitive market and rapid technological developments; ●need to rely on outside funding due to the length of drug development cycles and governmental approved protocols associated with thepharmaceutical industry; and ●dependence upon key personnel including key independent consultants and advisors. We cannot be certain that our strategy will be successful or that we will successfully address these risks. In the event that we do not successfullyaddress these risks, our business, prospects, financial condition and results of operations could be materially and adversely affected. We may be required toreduce our staff, discontinue certain research or development programs of our future products and cease to operate. We may face legal claims; litigation is expensive and we may not be able to afford the costs. We may face legal claims involving stockholders, consumers, competitors, regulators and other parties. As described in “Legal Proceedings” in Part IItem 3 of this Form 10-K, we are engaged in a number of legal proceedings. Litigation and other legal proceedings are inherently uncertain, and adverserulings could occur, including monetary damages, or an injunction stopping us from engaging in business practices, or requiring other remedies, such ascompulsory licensing of patents. The costs of litigation or any proceeding relating to our intellectual property or contractual rights could be substantial, even if resolved in our favor.Some of our competitors or financial funding sources have far greater resources than we do and may be better able to afford the costs of complex litigation.Also, a lawsuit, even if frivolous, will require considerable time commitments on the part of management, our attorneys and consultants. Defending thesetypes of proceedings or legal actions involve considerable expense and could negatively affect our financial results. We can provide no assurance of the successful and timely development of new products. Our immunotherapies are at various stages of research and development. Further development and extensive testing will be required to determinetheir technical feasibility and commercial viability. We will need to complete significant additional clinical trials demonstrating that our product candidatesare safe and effective to the satisfaction of the FDA and other non-U.S. regulatory authorities. The drug approval process is time-consuming, involvessubstantial expenditures of resources, and depends upon a number of factors, including the severity of the illness in question, the availability of alternativetreatments, and the risks and benefits demonstrated in the clinical trials. Our success will depend on our ability to achieve scientific and technologicaladvances and to translate such advances into licensable, FDA-approvable, commercially competitive products on a timely basis. Failure can occur at anystage of the process. If such programs are not successful, we may invest substantial amounts of time and money without developing revenue-producingproducts. As we enter a more extensive clinical program for our product candidates, the data generated in these studies may not be as compelling as the earlierresults. The proposed development schedules for our immunotherapies may be affected by a variety of factors, including technological difficulties, clinicaltrial failures, regulatory hurdles, clinical holds, competitive products, intellectual property challenges and/or changes in governmental regulation, many ofwhich will not be within our control. Any delay in the development, introduction or marketing of our products could result either in such products beingmarketed at a time when their cost and performance characteristics would not be competitive in the marketplace or in the shortening of their commerciallives. In light of the long-term nature of our projects, the unproven technology involved and the other factors described elsewhere in this section, there can beno assurance that we will be able to successfully complete the development or marketing of any new products which could materially harm our business,results of operations and prospects. Our research and development expenses are subject to uncertainty. Factors affecting our research and development expenses include, but are not limited to: ●competition from companies that have substantially greater assets and financial resources than we have; ●need for acceptance of our immunotherapies; ●ability to anticipate and adapt to a competitive market and rapid technological developments; ●amount and timing of operating costs and capital expenditures relating to expansion of our business, operations and infrastructure; ●need to rely on multiple levels of outside funding due to the length of drug development cycles and governmental approved protocols associatedwith the pharmaceutical industry; and ●dependence upon key personnel including key independent consultants and advisors. 18 Source: Advaxis, Inc., 10-K, December 21, 2017Powered by Morningstar® Document Research℠The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any use of this information,except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results. There can be no guarantee that our research and development expenses will be consistent from period to period. We may be required to accelerate ordelay incurring certain expenses depending on the results of our studies and the availability of adequate funding. We are subject to numerous risks inherent in conducting clinical trials. We outsource the management of our clinical trials to third parties. Agreements with clinical research organizations, clinical investigators andmedical institutions for clinical testing and data management services, place substantial responsibilities on these parties that, if unmet, could result in delaysin, or termination of, our clinical trials. For example, if any of our clinical trial sites fail to comply with FDA-approved good clinical practices, we may beunable to use the data gathered at those sites. If these clinical investigators, medical institutions or other third parties do not carry out their contractual dutiesor regulatory obligations or fail to meet expected deadlines, or if the quality or accuracy of the clinical data they obtain is compromised due to their failure toadhere to our clinical protocols or for other reasons, our clinical trials may be extended, delayed or terminated, and we may be unable to obtain regulatoryapproval for, or successfully commercialize, our agents. We are not certain that we will successfully recruit enough patients to complete our clinical trials northat we will reach our primary endpoints. Delays in recruitment, lack of clinical benefit or unacceptable side effects would delay or prevent the initiation offuture development of our agents. We or our regulators may suspend or terminate our clinical trials for a number of reasons. We may voluntarily suspend or terminate our clinical trialsif at any time we believe they present an unacceptable risk to the patients enrolled in our clinical trials or do not demonstrate clinical benefit. In addition,regulatory agencies may order the temporary or permanent discontinuation of our clinical trials, or place our products on temporary or permanent hold, at anytime if they believe that the clinical trials are not being conducted in accordance with applicable regulatory requirements or that they present anunacceptable safety risk to the patients enrolled in our clinical trials. Our clinical trial operations are subject to regulatory inspections at any time. If regulatory inspectors conclude that we or our clinical trial sites arenot in compliance with applicable regulatory requirements for conducting clinical trials, we may receive reports of observations or warning letters detailingdeficiencies, and we will be required to implement corrective actions. If regulatory agencies deem our responses to be inadequate, or are dissatisfied with thecorrective actions we or our clinical trial sites have implemented, our clinical trials may be temporarily or permanently discontinued, we may be fined, we orour investigators may be precluded from conducting any ongoing or any future clinical trials, the government may refuse to approve our marketingapplications or allow us to manufacture or market our products, and we may be criminally prosecuted. The lengthy approval process as well as the unpredictability of future clinical trial results may result in our failing to obtain regulatory approval forour product candidates, which would materially harm our business, results of operations and prospects. The successful development of immunotherapies is highly uncertain. Successful development of biopharmaceuticals is highly uncertain and is dependent on numerous factors, many of which are beyond our control.Immunotherapies that appear promising in the early phases of development may fail to reach the market for several reasons including: ●preclinical study results that may show the immunotherapy to be less effective than desired (e.g., the study failed to meet its primary objectives) or tohave harmful or problematic side effects; ●clinical study results that may show the immunotherapy to be less effective than expected (e.g., the study failed to meet its primary endpoint) or tohave unacceptable side effects; ●failure to receive the necessary regulatory approvals or a delay in receiving such approvals. Among other things, such delays may be caused by slowenrollment in clinical studies, length of time to achieve study endpoints, additional time requirements for data analysis, or Biologics LicenseApplication preparation, discussions with the FDA, an FDA request for additional preclinical or clinical data, or unexpected safety or manufacturingissues; ●manufacturing costs, formulation issues, pricing or reimbursement issues, or other factors that make the immunotherapy uneconomical; and ●the proprietary rights of others and their competing products and technologies that may prevent the immunotherapy from being commercialized. Success in preclinical and early clinical studies does not ensure that large-scale clinical studies will be successful. Clinical results are frequentlysusceptible to varying interpretations that may delay, limit or prevent regulatory approvals. The length of time necessary to complete clinical studies and tosubmit an application for marketing approval for a final decision by a regulatory authority varies significantly from one immunotherapy to the next, and maybe difficult to predict. 19 Source: Advaxis, Inc., 10-K, December 21, 2017Powered by Morningstar® Document Research℠The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any use of this information,except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results. Even if we are successful in getting market approval, commercial success of any of our product candidates will also depend in large part on theavailability of coverage and adequate reimbursement from third-party payers, including government payers such as the Medicare and Medicaid programs andmanaged care organizations, which may be affected by existing and future health care reform measures designed to reduce the cost of health care. Third-partypayers could require us to conduct additional studies, including post-marketing studies related to the cost effectiveness of a product, to qualify forreimbursement, which could be costly and divert our resources. If government and other health care payers were not to provide adequate coverage andreimbursement levels for one any of our products once approved, market acceptance and commercial success would be reduced. In addition, if one of our products is approved for marketing, we will be subject to significant regulatory obligations regarding product promotion,the submission of safety and other post-marketing information and reports and registration, and will need to continue to comply (or ensure that our third partyproviders) comply with cGMPs, and Good Clinical Practices (“GCP”), for any clinical trials that we conduct post-approval. In addition, there is always therisk that we or a regulatory authority might identify previously unknown problems with a product post-approval, such as adverse events of unanticipatedseverity or frequency. Compliance with these requirements is costly, and any failure to comply or other issues with our product candidates’ post-marketapproval could have a material adverse effect on our business, financial condition and results of operations. We must comply with significant government regulations. The research and development, manufacturing and marketing of human therapeutic and diagnostic products are subject to regulation, primarily bythe FDA in the United States and by comparable authorities in other countries. These national agencies and other federal, state, local and foreign entitiesregulate, among other things, research and development activities (including testing in animals and in humans) and the testing, manufacturing, handling,labeling, storage, record keeping, approval, advertising and promotion of the products that we are developing. If we obtain approval for any of our productcandidates, our operations will be directly or indirectly through our customers, subject to various federal and state fraud and abuse laws, including, withoutlimitation, the federal Anti-Kickback Statue and the federal False Claims Act, and privacy laws. Noncompliance with applicable laws and requirements canresult in various adverse consequences, including delay in approving or refusal to approve product licenses or other applications, suspension or terminationof clinical investigations, revocation of approvals previously granted, fines, criminal prosecution, civil and criminal penalties, recall or seizure of products,exclusion from having our products reimbursed by federal health care programs, the curtailment or restructuring of our operations, injunctions againstshipping products and total or partial suspension of production and/or refusal to allow a company to enter into governmental supply contracts. The process of obtaining requisite FDA approval has historically been costly and time-consuming. Current FDA requirements for a new humanbiological product to be marketed in the United States include: (1) the successful conclusion of preclinical laboratory and animal tests, if appropriate, to gainpreliminary information on the product’s safety; (2) filing with the FDA of an IND to conduct human clinical trials for drugs or biologics; (3) the successfulcompletion of adequate and well-controlled human clinical trials to establish the safety and efficacy of the investigational new drug for its recommended use;and (4) filing by a company and acceptance and approval by the FDA of a BLA for marketing approval of a biologic, to allow commercial distribution of abiologic product. The FDA also requires that any drug or formulation to be tested in humans be manufactured in accordance with its cGMP regulations. Thishas been extended to include any drug that will be tested for safety in animals in support of human testing. The cGMPs set certain minimum requirements forprocedures, record-keeping and the physical characteristics of the laboratories used in the production of these drugs. A delay in one or more of the proceduralsteps outlined above could be harmful to us in terms of getting our immunotherapies through clinical testing and to market. We can provide no assurance that our clinical product candidates will obtain regulatory approval or that the results of clinical studies will be favorable. We are currently evaluating the safety and efficacy of several of our candidates in a number of ongoing pre-clinical and clinical trials. However,even though the initiation and conduct of the clinical trials is in accordance with the governing regulatory authorities in each country, as with anyinvestigational new drug (under an IND in the United States, or the equivalent in countries outside of the United States), we are at risk of a clinical hold atany time based on the evaluation of the data and information submitted to the governing regulatory authorities. There can be delays in obtaining FDA (U.S.) and/or other necessary regulatory approvals in the United States and in countries outside the UnitedStates for any investigational new drug and failure to receive such approvals would have an adverse effect on the investigational new drug’s potentialcommercial success and on our business, prospects, financial condition and results of operations. The time required to obtain approval by the FDA and non-U.S. regulatory authorities is unpredictable but typically takes many years following the commencement of clinical trials and depends upon numerousfactors, including the substantial discretion of the regulatory authorities. For example, the FDA or non-U.S. regulatory authorities may disagree with thedesign or implementation of our clinical trials or study endpoints; or we may be unable to demonstrate that a product candidate’s clinical and other benefitsoutweigh its safety risks. In addition, the FDA or non-U.S. regulatory authorities may disagree with our interpretation of data from preclinical studies orclinical trials or the data collected from clinical trials of our product candidates may not be sufficient to support the submission of a New Drug Application(“NDA”) or other submission or to obtain regulatory approval in the United States or elsewhere. The FDA or non-U.S. regulatory authorities may fail toapprove the manufacturing processes or facilities of third-party manufacturers with which we contract for clinical and commercial supplies; and the approvalpolicies or regulations of the FDA or non-U.S. regulatory authorities may significantly change in a manner rendering our clinical data insufficient forapproval. 20 Source: Advaxis, Inc., 10-K, December 21, 2017Powered by Morningstar® Document Research℠The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any use of this information,except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results. In addition to the foregoing, approval policies, regulations, or the type and amount of clinical data necessary to gain approval may change duringthe course of a product candidate’s clinical development and may vary among jurisdictions. We have not submitted for nor obtained regulatory approval forany product candidate in-humans (US & EU) and it is possible that none of our existing product candidates or any product candidates we may seek todevelop in the future will ever obtain regulatory approval. We may not obtain or maintain the benefits associated with orphan drug designation, including market exclusivity. Although we have been granted FDA orphan drug designation for axalimogene filolisbac for use in the treatment of anal cancer, HPV-associatedhead and neck cancer, Stage II-IV invasive cervical cancer and for ADXS-HER2 for the treatment of osteosarcoma in the United States, as well as EMA orphandrug designation for axalimogene filolisbac for the treatment of anal cancer and for ADXS-HER2 for the treatment of osteosarcoma in the EU, and intend tocontinue to expand our designation for these uses where applicable , we may not receive the benefits associated with orphan drug designation. This mayresult from a failure to maintain orphan drug status, or result from a competing product reaching the market that has an orphan designation for the samedisease indication. Under U.S. rules for orphan drugs, if such a competing product reaches the market before ours does, the competing product couldpotentially obtain a scope of market exclusivity that limits or precludes our product from being sold in the United States for seven years. Even if we obtainexclusivity, the FDA could subsequently approve the same drug for the same condition if the FDA concludes that the later drug is clinically superior in that itis shown to be safer, more effective or makes a major contribution to patient care. A competitor also may receive approval of different products for the sameindication for which our orphan product has exclusivity, or obtain approval for the same product but for a different indication for which the orphan producthas exclusivity. In addition, if and when we request orphan drug designation in Europe, the European exclusivity period is ten years but can be reduced to six yearsif the drug no longer meets the criteria for orphan drug designation or if the drug is sufficiently profitable so that market exclusivity is no longer justified.Orphan drug exclusivity may be lost if the FDA or EMEA determines that the request for designation was materially defective or if the manufacturer is unableto assure sufficient quantity of the drug to meet the needs of patients with the rare disease or condition. We rely upon patents to protect our technology. We may be unable to protect our intellectual property rights and we may be liable for infringing theintellectual property rights of others. Our ability to compete effectively will depend on our ability to maintain the proprietary nature of our technologies, including the Lm -LLO basedimmunotherapy platform technology, and the proprietary technology of others with whom we have entered into collaboration and licensing agreements. Currently, we own or have rights to approximately 433 patents and applications, which are owned, licensed from, or co-owned with Penn, Merck,NIH, and/or Augusta University. We have obtained the rights to all future patent applications in this field originating in the laboratories of Dr. YvonnePaterson and Dr. Fred Frankel, at the University of Pennsylvania. We own or hold licenses to a number of issued patents and U.S. pending patent applications, as well as foreign patents and foreign counterparts. Oursuccess depends in part on our ability to obtain patent protection both in the United States and in other countries for our product candidates, as well as themethods for treating patients in the product indications using these product candidates. Such patent protection is costly to obtain and maintain, and wecannot guarantee that sufficient funds will be available. Our ability to protect our product candidates from unauthorized or infringing use by third partiesdepends in substantial part on our ability to obtain and maintain valid and enforceable patents. Due to evolving legal standards relating to the patentability,validity and enforceability of patents covering pharmaceutical inventions and the scope of claims made under these patents, our ability to obtain, maintainand enforce patents is uncertain and involves complex legal and factual questions. Even if our product candidates, as well as methods for treating patients forprescribed indications using these product candidates are covered by valid and enforceable patents and have claims with sufficient scope, disclosure andsupport in the specification, the patents will provide protection only for a limited amount of time. Accordingly, rights under any issued patents may notprovide us with sufficient protection for our product candidates or provide sufficient protection to afford us a commercial advantage against competitiveproducts or processes. In addition, we cannot guarantee that any patents will issue from any pending or future patent applications owned by or licensed to us. Even ifpatents have issued or will issue, we cannot guarantee that the claims of these patents are or will be valid or enforceable or will provide us with anysignificant protection against competitive products or otherwise be commercially valuable to us. The laws of some foreign jurisdictions do not protectintellectual property rights to the same extent as in the United States and many companies have encountered significant difficulties in protecting anddefending such rights in foreign jurisdictions. Furthermore, different countries have different procedures for obtaining patents, and patents issued in differentcountries offer different degrees of protection against use of the patented invention by others. If we encounter such difficulties in protecting or are otherwiseprecluded from effectively protecting our intellectual property rights in foreign jurisdictions, our business prospects could be substantially harmed. The patent positions of biotechnology and pharmaceutical companies, including our patent position, involve complex legal and factual questions,and, therefore, validity and enforceability cannot be predicted with certainty. Patents may be challenged, deemed unenforceable, invalidated, orcircumvented as a result of laws, rules and guidelines that are changed due to legislative, judicial or administrative actions, or review, which render ourpatents unenforceable or invalid. Our patents can be challenged by our competitors who can argue that our patents are invalid, unenforceable, lack utility,sufficient written description or enablement, or that the claims of the issued patents should be limited or narrowly construed. Patents also will not protect ourproduct candidates if competitors devise ways of making or using these product candidates without infringing our patents. We will be able to protect our proprietary rights from unauthorized use by third parties only to the extent that our technologies, methods oftreatment, product candidates, and any future products are covered by valid and enforceable patents or are effectively maintained as trade secrets and we havethe funds to enforce our rights, if necessary. 21 Source: Advaxis, Inc., 10-K, December 21, 2017Powered by Morningstar® Document Research℠The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any use of this information,except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results. The expiration of our owned or licensed patents before completing the research and development of our product candidates and receiving allrequired approvals in order to sell and distribute the products on a commercial scale can adversely affect our business and results of operations. Litigation regarding patents, patent applications and other proprietary rights may be expensive and time consuming. If we are involved in such litigation,it could cause delays in bringing product candidates to market and harm our ability to operate. Our success will depend in part on our ability to operate without infringing the proprietary rights of third parties. The pharmaceutical industry ischaracterized by extensive litigation regarding patents and other intellectual property rights. Other parties may obtain patents in the future and allege that theproducts or use of our technologies infringe these patent claims or that we are employing their proprietary technology without authorization. In addition, third parties may challenge or infringe upon our existing or future patents. Proceedings involving our patents or patent applications orthose of others could result in adverse decisions regarding: ●the patentability of our inventions relating to our product candidates; and/or ●the enforceability, validity or scope of protection offered by our patents relating to our product candidates. Even if we are successful in these proceedings, we may incur substantial costs and divert management time and attention in pursuing theseproceedings, which could have a material adverse effect on us. If we are unable to avoid infringing the patent rights of others, we may be required to seek alicense, defend an infringement action or challenge the validity of the patents in court. Patent litigation is costly and time consuming. We may not havesufficient resources to bring these actions to a successful conclusion. In addition, if we do not obtain a license, develop or obtain non-infringing technology,fail to defend an infringement action successfully or have infringed patents declared valid, we may: ●incur substantial monetary damages; ●encounter significant delays in bringing our product candidates to market; and/or ●be precluded from participating in the manufacture, use or sale of our product candidates or methods of treatment requiring licenses. We may be unable to adequately prevent disclosure of trade secrets and other proprietary information. We also rely on trade secrets to protect our proprietary technologies, especially where we do not believe patent protection is appropriate orobtainable. However, trade secrets are difficult to protect. We rely in part on confidentiality agreements with our employees, consultants, outside scientificcollaborators, sponsored researchers, and other advisors to protect our trade secrets and other proprietary information. These agreements may not effectivelyprevent disclosure of confidential information and may not provide an adequate remedy in the event of unauthorized disclosure of confidential information.In addition, others may independently discover our trade secrets and proprietary information. Costly and time-consuming litigation could be necessary toenforce and determine the scope of our proprietary rights, and failure to obtain or maintain trade secret protection could adversely affect our competitivebusiness position. We are dependent upon our license agreement with Penn; if we breach the license agreement and/or fail to make payments due and owing to Penn underour license agreement, our business will be materially and adversely affected. Pursuant to the terms of our license agreement with Penn, which has been amended from time to time, we have acquired exclusive worldwidelicenses for patents and patent applications related to our proprietary Listeria vaccine technology. The license provides us with the exclusive commercialrights to the patent portfolio developed at Penn as of the effective date of the license, in connection with Dr. Paterson and requires us to pay variousmilestone, legal, filing and licensing payments to commercialize the technology. As of October 31, 2017, we had no outstanding payments to Penn. We canprovide no assurance that we will be able to make all future payments due and owing thereunder, that such licenses will not be terminated or expire duringcritical periods, that we will be able to obtain licenses from Penn for other rights that may be important to us, or, if obtained, that such licenses will beobtained on commercially reasonable terms. The loss of any current or future licenses from Penn or the exclusivity rights provided therein could materiallyharm our business, financial condition and operating results. If we are unable to obtain licenses needed for the development of our product candidates, or if we breach any of the agreements under which we licenserights to patents or other intellectual property from third parties, we could lose license rights that are important to our business. If we are unable to maintain and/or obtain licenses needed for the development of our product candidates in the future, we may have to developalternatives to avoid infringing on the patents of others, potentially causing increased costs and delays in drug development and introduction or precludingthe development, manufacture, or sale of planned products. Some of our licenses provide for limited periods of exclusivity that require minimum license feesand payments and/or may be extended only with the consent of the licensor. We can provide no assurance that we will be able to meet these minimum licensefees in the future or that these third parties will grant extensions on any or all such licenses. This same restriction may be contained in licenses obtained in thefuture. 22 Source: Advaxis, Inc., 10-K, December 21, 2017Powered by Morningstar® Document Research℠The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any use of this information,except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results. Additionally, we can provide no assurance that the patents underlying any licenses will be valid and enforceable. To the extent any productsdeveloped by us are based on licensed technology, royalty payments on the licenses will reduce our gross profit from such product sales and may render thesales of such products uneconomical. In addition, the loss of any current or future licenses or the exclusivity rights provided therein could materially harmour business financial condition and our operations. We have limited to no manufacturing, sales, marketing or distribution capability and we must rely upon third parties for such. We currently have agreements with various third party manufacturing facilities for production of many of our immunotherapies for research anddevelopment and testing purposes. While we have built our own manufacturing facility onsite in Princeton to manufacture clinical materials for some of ourproducts, included ADXS-NEO, we depend on third-party manufacturers to supply most of our preclinical and clinical materials and will be reliant on a third-party manufacturer to produce axalimogene filolisbac on a commercial scale, should that product receive regulatory approval. Third-party manufacturersmust be able to meet our deadlines as well as adhere to quality standards and specifications. Our predominant reliance on third parties for the manufacture ofour drug substance, investigational new drugs and, in the future, any approved products, creates a dependency that could severely disrupt our research anddevelopment, our clinical testing, and ultimately our sales and marketing efforts if the source of such supply proves to be unreliable or unavailable. If ourown manufacturing operation or any contracted manufacturing operation is unreliable or unavailable, we may not be able to manufacture clinical drugsupplies of our immunotherapies, and our preclinical and clinical testing programs may not be able to move forward and our entire business plan could fail. Ifwe are able to commercialize our products in the future, there is no assurance that our own manufacturing operation or any third-party manufacturers will beable to meet commercialized scale production requirements in a timely manner or in accordance with applicable standards or current GMP. If we are unable to establish or manage strategic collaborations in the future, our revenue and drug development may be limited. Our strategy includes eventual substantial reliance upon strategic collaborations for marketing and commercialization of our clinical productcandidates, and we may rely even more on strategic collaborations for research, development, marketing and commercialization for some of ourimmunotherapies. To date, we have been heavily reliant upon third party outsourcing for our clinical trials execution and production of drug supplies for usein clinical trials. Establishing strategic collaborations is difficult and time-consuming. Our discussions with potential collaborators may not lead to theestablishment of collaborations on favorable terms, if at all. For example, potential collaborators may reject collaborations based upon their assessment of ourfinancial, clinical, regulatory or intellectual property position. Our current collaborations, as well as any future new collaborations, may never result in thesuccessful development or commercialization of our immunotherapies or the generation of sales revenue. To the extent that we have entered or will enter intoco-promotion or other collaborative arrangements, our product revenues are likely to be lower than if we directly marketed and sold any products that we maydevelop. Management of our relationships with our collaborators will require: ●significant time and effort from our management team; ●financial funding to support said collaboration; ●coordination of our research and development programs with the research and development priorities of our collaborators; and ●effective allocation of our resources to multiple projects. If we continue to enter into research and development collaborations at the early phases of drug development, our success will in part depend on theperformance of our corporate collaborators. We will not directly control the amount or timing of resources devoted by our corporate collaborators to activitiesrelated to our immunotherapies. Our corporate collaborators may not commit sufficient resources to our research and development programs or thecommercialization, marketing or distribution of our immunotherapies. If any corporate collaborator fails to commit sufficient resources, our preclinical orclinical development programs related to this collaboration could be delayed or terminated. Also, our collaborators may pursue existing or otherdevelopment-stage products or alternative technologies in preference to those being developed in collaboration with us. Finally, if we fail to make requiredmilestone or royalty payments to our collaborators or to observe other obligations in our agreements with them, our collaborators may have the right toterminate those agreements. We may incur substantial liabilities from any product liability claims if our insurance coverage for those claims is inadequate. We face an inherent risk of product liability exposure related to the testing of our immunotherapies in human clinical trials, and will face an evengreater risk if the approved products are sold commercially. An individual may bring a liability claim against us if one of the immunotherapies causes, ormerely appears to have caused, an injury. If we cannot successfully defend ourselves against the product liability claim, we will incur substantial liabilities.Regardless of merit or eventual outcome, liability claims may result in: ●decreased demand for our immunotherapies; ●damage to our reputation; ●withdrawal of clinical trial participants; ●costs of related litigation; ●substantial monetary awards to patients or other claimants; ●loss of revenues; ●the inability to commercialize immunotherapies; and ●increased difficulty in raising required additional funds in the private and public capital markets. Source: Advaxis, Inc., 10-K, December 21, 2017Powered by Morningstar® Document Research℠The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any use of this information,except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results. 23 Source: Advaxis, Inc., 10-K, December 21, 2017Powered by Morningstar® Document Research℠The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any use of this information,except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results. We have Product Liability and Clinical Trial Liability insurance coverage for each clinical trial. We do not have product liability insurance for soldcommercial products because we do not have products on the market. We currently are in the process of obtaining insurance coverage and plan to expandsuch coverage to include the sale of commercial products if marketing approval is obtained for any of our immunotherapies. However, insurance coverage isincreasingly expensive and we may not be able to maintain insurance coverage at a reasonable cost and we may not be able to obtain insurance coverage thatwill be adequate to satisfy any liability that may arise. We may incur significant costs complying with environmental laws and regulations. We and our contracted third parties use hazardous materials, including chemicals and biological agents and compounds that could be dangerous tohuman health and safety or the environment. As appropriate, we store these materials and wastes resulting from their use at our or our outsourced laboratoryfacility pending their ultimate use or disposal. We contract with a third party to properly dispose of these materials and wastes. We are subject to a variety offederal, state and local laws and regulations governing the use, generation, manufacture, storage, handling and disposal of these materials and wastes.Compliance with such laws and regulations may be costly. If we use biological materials in a manner that causes injury, we may be liable for damages. Our research and development activities involve the use of biological and hazardous materials. Although we believe our safety procedures forhandling and disposing of these materials complies with federal, state and local laws and regulations, we cannot entirely eliminate the risk of accidentalinjury or contamination from the use, storage, handling or disposal of these materials. We do not carry specific biological waste or pollution liability orremediation insurance coverage, nor do our workers’ compensation, general liability, and property and casualty insurance policies provide coverage fordamages and fines/penalties arising from biological exposure or contamination. Accordingly, in the event of contamination or injury, we could be held liablefor damages or penalized with fines in an amount exceeding our resources, and our clinical trials or regulatory approvals could be suspended or terminated. We need to attract and retain highly skilled personnel; we may be unable to effectively manage growth with our limited resources. As of December 15, 2017, we had 108 employees, all of which were full time employees. Our ability to attract and retain highly skilled personnel iscritical to our operations and expansion. We face competition for these types of personnel from other technology companies and more establishedorganizations, many of which have significantly larger operations and greater financial, technical, human and other resources than we have. We may not besuccessful in attracting and retaining qualified personnel on a timely basis, on competitive terms, or at all. If we are not successful in attracting and retainingthese personnel, or integrating them into our operations, our business, prospects, financial condition and results of operations will be materially adverselyaffected. In such circumstances we may be unable to conduct certain research and development programs, unable to adequately manage our clinical trials andother products, unable to commercialize any products, and unable to adequately address our management needs. We depend upon our senior management and key consultants and their loss or unavailability could put us at a competitive disadvantage. We depend upon the efforts and abilities of our senior executives, as well as the services of several key consultants. The loss or unavailability of theservices of any of these individuals for any significant period of time could have a material adverse effect on our business, prospects, financial condition andresults of operations. We have not obtained, do not own, nor are we the beneficiary of, key-person life insurance. The biotechnology and immunotherapy industries are characterized by rapid technological developments and a high degree of competition. We may beunable to compete with more substantial enterprises. The biotechnology and biopharmaceutical industries are characterized by rapid technological developments and a high degree of competition. As aresult, our actual or proposed immunotherapies could become obsolete before we recoup any portion of our related research and development andcommercialization expenses. Competition in the biopharmaceutical industry is based significantly on scientific and technological factors. These factorsinclude the availability of patent and other protection for technology and products, the ability to commercialize technological developments and the abilityto obtain governmental approval for testing, manufacturing and marketing. We compete with specialized biopharmaceutical firms in the United States,Europe and elsewhere, as well as a growing number of large pharmaceutical companies that are applying biotechnology to their operations. Manybiopharmaceutical companies have focused their development efforts in the human therapeutics area, including cancer. Many major pharmaceuticalcompanies have developed or acquired internal biotechnology capabilities or made commercial arrangements with other biopharmaceutical companies.These companies, as well as academic institutions and governmental agencies and private research organizations, also compete with us in recruiting andretaining highly qualified scientific personnel and consultants. Our ability to compete successfully with other companies in the pharmaceutical field will alsodepend to a considerable degree on the continuing availability of capital to us. 24 Source: Advaxis, Inc., 10-K, December 21, 2017Powered by Morningstar® Document Research℠The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any use of this information,except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results. We are aware of certain investigational new drugs under development or approved products by competitors that are used for the prevention,diagnosis, or treatment of certain diseases we have targeted for drug development. Various companies are developing biopharmaceutical products that havethe potential to directly compete with our immunotherapies even though their approach to may be different. The biotechnology and biopharmaceuticalindustries are highly competitive, and this competition comes from both biotechnology firms and from major pharmaceutical companies, includingcompanies like: Aduro Biotech, Agenus Inc., Celldex Therapeutics, Inovio Pharmaceutical Inc., ISA Pharmaceuticals, MedImmune LLC, Neon Therapeutics,Oncolytics Biotech Inc. and Oncothyreon Inc., each of which is pursuing cancer vaccines and/or immunotherapies. Many of these companies havesubstantially greater financial, marketing, and human resources than we do (including, in some cases, substantially greater experience in clinical testing,manufacturing, and marketing of pharmaceutical products). We also experience competition in the development of our immunotherapies from universitiesand other research institutions and compete with others in acquiring technology from such universities and institutions. In addition, certain of our immunotherapies may be subject to competition from investigational new drugs and/or products developed using othertechnologies, some of which have completed numerous clinical trials. We may not obtain or maintain the benefits associated with breakthrough therapy designation. If we apply for Breakthrough Therapy Designation (“BTD”), we may not be granted BTD, or even if granted, we may not receive the benefitsassociated with BTD. This may result from a failure to maintain breakthrough therapy status if it is no longer considered to be a breakthrough therapy. Forexample, a drug’s development program may be granted BTD using early clinical testing that shows a much higher response rate than available therapies.However, subsequent interim data derived from a larger study may show a response that is substantially smaller than the response seen in early clinicaltesting. Another example is where BTD is granted to two drugs that are being developed for the same use. If one of the two drugs gains traditional approval,the other would not retain its designation unless its sponsor provided evidence that the drug may demonstrate substantial improvement over the recentlyapproved drug. When BTD is no longer supported by emerging data or the designated drug development program is no longer being pursued, the FDA maychoose to send a letter notifying the sponsor that the program is no longer designated as a breakthrough therapy development program. We believe that our immunotherapies under development and in clinical trials will address unmet medical needs in the treatment of cancer. Ourcompetition will be determined in part by the potential indications for which drugs are developed and ultimately approved by regulatory authorities.Additionally, the timing of market introduction of some of our potential products or of competitors’ products may be an important competitive factor.Accordingly, the relative speed with which we can develop immunotherapies, complete preclinical testing, clinical trials and approval processes and supplycommercial quantities to market is expected to be important competitive factors. We expect that competition among products approved for sale will be basedon various factors, including product efficacy, safety, reliability, availability, price and patent position. Approval of our product candidates does not ensure successful commercialization and reimbursement. We are not currently marketing our product candidates, however we are seeking commercial opportunities for axalimogene filolisbac. We cannotassure you that we will be able to commercialize it or any other candidate ourselves or find a commercialization partner or that we will be able to agree toacceptable terms with any partner to launch and commercialize our products. The commercial success of our product candidates is subject to risks in both the United States and European countries. In addition, in Europeancountries, pricing and payment of prescription pharmaceuticals is subject to more extensive governmental control than in the United States. Pricingnegotiations with European governmental authorities can take six to 12 months or longer after the receipt of regulatory approval and product launch. Ifreimbursement is unavailable in any country in which reimbursement is sought, limited in scope or amount, or if pricing is set at or reduced to unsatisfactorylevels, our ability or any potential partner’s ability to successfully commercialize in such a country would be impacted negatively. Furthermore, if thesemeasures prevent us or any potential partner from selling on a profitable basis in a particular country, they could prevent the commercial launch or continuedsale in that country and could adversely impact the commercialization market opportunity in other countries. Moreover, as a condition of approval, the regulatory authorities may require that we conduct post-approval studies. Those studies may reveal newsafety or efficacy findings regarding our drug that could adversely impact the continued commercialization or future market opportunity in other countries. In addition, Advaxis predominantly relies on a network of suppliers and vendors to manufacture its products. Should a regulatory authority makeany significant findings on an inspection of Advaxis’ own operations or the operations of those companies, the ability of Advaxis to continue producing itsproducts could be adversely impacted and further production could cease. Regulatory GMP requirements are extensive and can present a risk of injury orrecall, among other risks, if not manufactured or labeled properly under GMPs. Our potential revenues from the commercialization of our product candidates are subject to these and other factors, and therefore we may never reachor maintain profitability. Risks Related to our Securities The price of our Common Stock and warrants may be volatile. The trading price of our Common Stock and warrants may fluctuate substantially. The price of our Common Stock and warrants that will prevail inthe market may be higher or lower than the price you have paid, depending on many factors, some of which are beyond our control and may not be related toour operating performance. These fluctuations could cause you to lose part or all of your investment in our Common Stock and warrants. Those factors thatcould cause fluctuations include, but are not limited to, the following: 25 Source: Advaxis, Inc., 10-K, December 21, 2017Powered by Morningstar® Document Research℠The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any use of this information,except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results. ●price and volume fluctuations in the overall stock market from time to time; ●fluctuations in stock market prices and trading volumes of similar companies; ●actual or anticipated changes in our net loss or fluctuations in our operating results or in the expectations of securities analysts; ●the issuance of new equity securities pursuant to a future offering, including issuances of preferred stock; ●general economic conditions and trends; ●positive and negative events relating to healthcare and the overall pharmaceutical and biotech sector; ●major catastrophic events; ●sales of large blocks of our stock; ●significant dilution caused by the anti-dilutive clauses in our financial agreements; ●departures of key personnel; ●changes in the regulatory status of our immunotherapies, including results of our clinical trials; ●events affecting Penn or any current or future collaborators; ●announcements of new products or technologies, commercial relationships or other events by us or our competitors; ●regulatory developments in the United States and other countries; ●failure of our Common Stock or warrants to be listed or quoted on The NASDAQ Stock Market, NYSE Amex Equities or other national marketsystem; ●changes in accounting principles; and ●discussion of us or our stock price by the financial and scientific press and in online investor communities. In the past, following periods of volatility in the market price of a company’s securities, securities class action litigation has often been broughtagainst that company. Due to the potential volatility of our stock price, we may therefore be the target of securities litigation in the future. Securitieslitigation could result in substantial costs and divert management’s attention and resources from our business. A limited public trading market may cause volatility in the price of our Common Stock. The quotation of our Common Stock on the NASDAQ does not assure that a meaningful, consistent and liquid trading market currently exists, and inrecent years such market has experienced extreme price and volume fluctuations that have particularly affected the market prices of many smaller companieslike us. Our Common Stock is thus subject to this volatility. Sales of substantial amounts of Common Stock, or the perception that such sales might occur,could adversely affect prevailing market prices of our Common Stock and our stock price may decline substantially in a short time and our shareholderscould suffer losses or be unable to liquidate their holdings. The market prices for our Common Stock may be adversely impacted by future events. Our Common Stock began trading on the over-the-counter-markets on July 28, 2005 and is currently quoted on the NASDAQ Stock Market underthe symbol ADXS. Market prices for our Common Stock and warrants will be influenced by a number of factors, including: ●the issuance of new equity securities pursuant to a future offering, including issuances of preferred stock; ●changes in interest rates; ●significant dilution caused by the anti-dilutive clauses in our financial agreements; ●competitive developments, including announcements by competitors of new products or services or significant contracts, acquisitions, strategicpartnerships, joint ventures or capital commitments; ●variations in quarterly operating results; ●change in financial estimates by securities analysts; ●the depth and liquidity of the market for our Common Stock and warrants; ●investor perceptions of our company and the pharmaceutical and biotech industries generally; and ●general economic and other national conditions. 26 Source: Advaxis, Inc., 10-K, December 21, 2017Powered by Morningstar® Document Research℠The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any use of this information,except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results. If we fail to remain current with our listing requirements, we could be removed from the NASDAQ Capital Market, which would limit the ability of broker-dealers to sell our securities and the ability of shareholders to sell their securities in the secondary market. Companies trading on the NASDAQ Marketplace, such as our Company, must be reporting issuers under Section 12 of the Exchange Act, asamended, and must meet the listing requirements in order to maintain the listing of our Common Stock on the NASDAQ Capital Market. If we do not meetthese requirements, the market liquidity for our securities could be severely adversely affected by limiting the ability of broker-dealers to sell our securitiesand the ability of shareholders to sell their securities in the secondary market. Sales of additional equity securities may adversely affect the market price of our Common Stock and your rights may be reduced. We expect to continue to incur drug development and selling, general and administrative costs, and to satisfy our funding requirements, we willneed to sell additional equity securities, which may be subject to registration rights and warrants with anti-dilutive protective provisions. The sale or theproposed sale of substantial amounts of our Common Stock or other equity securities in the public markets may adversely affect the market price of ourCommon Stock and our stock price may decline substantially. Our shareholders may experience substantial dilution and a reduction in the price that they areable to obtain upon sale of their shares. Also, new equity securities issued may have greater rights, preferences or privileges than our existing Common Stock. Additional authorized shares of Common Stock available for issuance may adversely affect the market price of our securities. We are currently authorized to issue 65,000,000 shares of our Common Stock. As of December 15, 2017, we had 41,303,988 shares of our CommonStock issued and outstanding, excluding shares issuable upon exercise of our outstanding warrants, options, convertible promissory notes and shares ofCommon Stock earned but not yet issued under our director compensation program. Under our 2011 Employee Stock Purchase Plan, or ESPP, our employeescan buy our Common Stock at a discounted price. To the extent the shares of Common Stock are issued, options and warrants are exercised or convertiblepromissory notes are converted, holders of our Common Stock will experience dilution. In the event of any future financing of equity securities or securitiesconvertible into or exchangeable for, Common Stock, holders of our Common Stock may experience dilution. In addition, as of December 15, 2017, we hadoutstanding options to purchase 4,380,557 shares of our Common Stock at a weighted average exercise price of approximately $11.47 per share andoutstanding warrants to purchase 3,092,395 shares of our Common Stock (including the above warrants subject to weighted-average anti-dilutionprotection); and zero shares of our Common Stock are available for grant under the ESPP. We do not intend to pay cash dividends. We have not declared or paid any cash dividends on our Common Stock, and we do not anticipate declaring or paying cash dividends for theforeseeable future. Any future determination as to the payment of cash dividends on our Common Stock will be at our Board of Directors’ discretion and willdepend on our financial condition, operating results, capital requirements and other factors that our Board of Directors considers to be relevant. Our certificate of incorporation, bylaws and Delaware law have anti-takeover provisions that could discourage, delay or prevent a change in control,which may cause our stock price to decline. Our certificate of incorporation, Bylaws and Delaware law contain provisions which could make it more difficult for a third party to acquire us, evenif closing such a transaction would be beneficial to our shareholders. To date, we have not issued shares of preferred stock, however, we are authorized toissue up to 5,000,000 shares of preferred stock. This preferred stock may be issued in one or more series, the terms of which may be determined at the time ofissuance by our Board of Directors without further action by shareholders. The terms of any series of preferred stock may include voting rights (including theright to vote as a series on particular matters), preferences as to dividend, liquidation, conversion and redemption rights and sinking fund provisions. Theissuance of any preferred stock could materially adversely affect the rights of the holders of our Common Stock, and therefore, reduce the value of ourCommon Stock. In particular, specific rights granted to future holders of preferred stock could be used to restrict our ability to merge with, or sell our assetsto, a third party and thereby preserve control by the present management. Provisions of our certificate of incorporation, Bylaws and Delaware law also could have the effect of discouraging potential acquisition proposals ormaking a tender offer or delaying or preventing a change in control, including changes a shareholder might consider favorable. Such provisions may alsoprevent or frustrate attempts by our shareholders to replace or remove our management. In particular, the certificate of incorporation, Bylaws and Delawarelaw, as applicable, among other things; provide the Board of Directors with the ability to alter the Bylaws without shareholder approval, and provide thatvacancies on the Board of Directors may be filled by a majority of directors in office, although less than a quorum. 27 Source: Advaxis, Inc., 10-K, December 21, 2017Powered by Morningstar® Document Research℠The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any use of this information,except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results. We are also subject to Section 203 of the Delaware General Corporation Law, which, subject to certain exceptions, prohibits “businesscombinations” between a publicly-held Delaware corporation and an “interested shareholder,” which is generally defined as a shareholder who becomes abeneficial owner of 15% or more of a Delaware corporation’s voting stock for a three-year period following the date that such shareholder became aninterested shareholder. These provisions are expected to discourage certain types of coercive takeover practices and inadequate takeover bids and to encourage personsseeking to acquire control of our company to first negotiate with its board. These provisions may delay or prevent someone from acquiring or merging withus, which may cause the market price of our Common Stock to decline. Item 1B: Unresolved Staff Comments. None. Item 2. Properties. Our corporate offices and manufacturing facility are located in approximately 48,500 square feet of office space at 305 College Road East,Princeton, New Jersey 08540 which is occupied pursuant to a lease which expires on November 30, 2025. Item 3. Legal Proceedings. The information required under this item is set forth in Footnote 10. Commitments and Contingencies – Legal Proceedings with this Form 10-K andis incorporated herein by reference. Item 4. Mine Safety Disclosures. None. PART II Item 5. Market for Our Common Stock and Related Shareholder Matters. Our common stock is listed on the NASDAQ Global Select Market under the symbol “ADXS”. The following table sets forth for the periodsindicated the high and low sales prices per share of our common stock as reported on the NASDAQ Stock Market: Fiscal 2017 High Low Fourth Quarter $7.41 $3.09 Third Quarter $9.16 $5.94 Second Quarter $9.60 $7.70 First Quarter $10.30 $7.13 Fiscal 2016 High Low Fourth Quarter $15.98 $7.87 Third Quarter $9.66 $7.01 Second Quarter $9.99 $5.46 First Quarter $14.45 $6.64 As of December 15, 2017, there were approximately 98 shareholders of record. Because shares of our Common Stock are held by depositaries,brokers and other nominees, the number of beneficial holders of our shares is substantially larger than the number of shareholders of record. On December 15,2017, the last reported sale price per share for our Common Stock as reported by NASDAQ was $3.14. We have not declared or paid any cash dividends on our Common Stock, and we do not anticipate declaring or paying cash dividends for theforeseeable future. Recent Sales of Unregistered Securities On September 29, 2017, the registrant issued 1,439 shares of Common Stock to its Executive Officers, pursuant to their Employment Agreements. 28 Source: Advaxis, Inc., 10-K, December 21, 2017Powered by Morningstar® Document Research℠The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any use of this information,except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results. On October 24, 2017, the registrant issued 10,000 shares of Common Stock to accredited investors as payment for consulting services. On October 31, 2017 the registrant issued 1,322 shares of Common Stock to its Executive Officers, pursuant to their Employment Agreements. On November 30, 2017 the registrant issued 2,919 shares of Common Stock to its Executive Officers, pursuant to their Employment Agreements. Equity Compensation Plan Information The following table provides information regarding the status of our existing equity compensation plans at October 31, 2017: Plan category Number of shares ofCommon Stock to beissued on exercise ofoutstanding options,warrants and rights Weighted- averageexercise price ofoutstanding options,warrants and rights Number of securitiesremaining available forfuture issuance underequity compensationplans (excludingsecurities reflected in theprevious columns) Equity compensation plans approved by security holders Options 3,893,558 $12.51 N/A Restricted stock 1,363,119 N/A N/A Equity compensation plans not approved by security holders - - - Total 5,256,677 N/A 710,853* * Number of securities remaining can be utilized for either options or restricted stock. Treasury Share Repurchases The following table represents treasury share repurchases during the year ended October 31, 2017: Period (a)Total Numberof SharesPurchased (1) (b)Average PricePaid PerShare (c)Total Numberof SharesPurchased asPart of PubliclyAnnouncedPlans orPrograms (d)MaximumDollar Value ofShares thatMay Yet BePurchased Under theProgramFebruary 1, 2017 – February 29, 2017 9,485 $8.74 N/A N/AJuly 1, 2017 – July 31, 2017 119,128 6.70 N/A N/ATotal 128,613 $6.85 N/A N/A (1) Consists of shares repurchased by the Company for certain employees’ restricted stock units that vested to satisfy minimum tax withholding obligationsthat arose on the vesting of the restricted stock units. 29 Source: Advaxis, Inc., 10-K, December 21, 2017Powered by Morningstar® Document Research℠The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any use of this information,except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results. Common Stock Performance Graph The following graph compares the cumulative total stockholder return on our common stock for the period from October 17, 2013 through October 31, 2017,with the cumulative total return over such period on (i) the U.S. Index of The NASDAQ Stock Market and (ii) the Biotechnology Index of The NASDAQStock Market. The graph assumes an investment of $100 on October 17, 2013, in our common stock (at the closing market price) and in each of the indiceslisted above, and assumes the reinvestment of dividends. COMPARISON OF CUMULATIVE TOTAL RETURN*Among Advaxis, Inc., the NASDAQ Composite Indexand the NASDAQ Biotechnology Index * $100 invested on October 17, 2013 in stock or index, including reinvestment of dividends.Fiscal year ending October 31. ITEM 6. Selected Financial Data. The selected financial data included in this section are not intended to replace the consolidated financial statements included elsewhere in thisAnnual Report on Form 10-K. We derived the selected statements of operations data for the years ended October 31, 2017, 2016 and 2015 and the selectedbalance sheet data at October 31, 2017 and 2016 from our audited financial statements included elsewhere in this report. We derived the selected statementsof operations data for the years ended October 31, 2014 and 2013 and the selected balance sheet data at October 31, 2015, 2014 and 2013 from our auditedfinancial statements which are not included in this Annual Report on Form 10-K. Our historical results are not necessarily indicative of the results that may beexpected in the future. You should read the selected historical consolidated financial data below in conjunction with the section titled “Management’sDiscussion and Analysis of Financial Condition and Results of Operations” and the audited consolidated financial statements included elsewhere in thisreport. Year Ended October 31, 2017 2016 2015 2014 2013 Statements of Operations Data: Revenue $12,031,050 $3,994,856 $- $1,000,000 $- Operating Expenses: Research and Development Expenses 71,900,462 48,774,589 24,455,447 8,862,854 5,621,989 General and Administrative Expenses 38,658,464 31,712,505 24,243,690 11,675,724 9,071,613 Total Operating Expenses 110,558,926 80,487,094 48,699,137 20,538,578 14,693,602 Loss from Operations (98,527,876) (76,492,238) (48,699,137) (19,538,578) (14,693,602) Other Income (Expense): Interest Income 669,759 331,529 114,219 36,305 (987,746)Net Changes in Fair Value of Derivative Liabilities 20,156 69,055 (48,950) 619,089 (1,504,465)(Loss) on Note Retirement - - - - (3,455,327)Other Income (Expense), Net (123) (201) (6,599) 990 (70,876)Net Loss Before Income Tax Benefit (97,838,084) (76,091,855) (48,640,467) (18,882,194) (20,712,016) Income Tax Benefit 4,402,682 2,535,625 1,609,349 2,356,880 725,190 Dividends Attributable to Preferred Shares - - - - (555,000) Source: Advaxis, Inc., 10-K, December 21, 2017Powered by Morningstar® Document Research℠The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any use of this information,except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results.Net Loss Applicable to Common Stock $(93,435,402) $(73,556,230) $(47,031,118) $(16,525,314) $(20,541,826) Net Loss $(93,435,402) $(73,556,230) $(47,031,118) $(16,525,314) $(19,986,826) Net Loss per Common Share, Basic and Diluted $(2.31) $(2.08) $(1.68) $(0.97) $(4.10) Weighted Average Number of Common SharesOutstanding, Basic and Diluted 40,527,844 35,400,980 28,026,197 17,106,577 5,012,105 30 Source: Advaxis, Inc., 10-K, December 21, 2017Powered by Morningstar® Document Research℠The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any use of this information,except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results. October 31, 2017 2016 2015 2014 2013 Balance Sheet Data: Cash and Cash Equivalents and Investments (a) $70,885,113 $152,087,528 $112,156,178 $17,606,860 $20,552,062 Working capital 60,378,526 132,168,809 111,096,966 17,778,325 15,872,461 Total Assets 93,641,778 169,044,060 119,605,693 23,377,813 23,585,921 Common Stock Warrant Liability - 20,156 89,211 32,091 646,734 Accumulated Deficit (301,142,227) (207,706,825) (134,054,259) (86,991,137) (70,465,823)Total Shareholders’ Equity 54,260,167 119,302,194 115,598,875 20,629,986 18,002,142 (a) Includes restricted cash of $587,000 at October 31, 2017. See Note 2. Summary of Significant Accounting Policies with this Form 10-K. ITEM 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations. This Management’s Discussion and Analysis of Financial Conditions and Results of Operations and other portions of this report contain forward-looking information that involves risks and uncertainties. Our actual results could differ materially from those anticipated by the forward-lookinginformation. Factors that may cause such differences include, but are not limited to, availability and cost of financial resources, product demand, marketacceptance and other factors discussed in this report under the heading “Risk Factors”. This Management’s Discussion and Analysis of FinancialConditions and Results of Operations should be read in conjunction with our financial statements and the related notes included elsewhere in this report. Overview Advaxis, Inc. (“Advaxis” or the “Company”) is a late-stage biotechnology Company focused on the discovery, development and commercializationof proprietary Lm Technology antigen delivery products based on a platform technology that utilizes live attenuated Listeria monocytogenes (“Lm”)bioengineered to secrete antigen/adjuvant fusion proteins. These Lm-based strains are believed to be a significant advancement in immunotherapy as theyintegrate multiple functions into a single immunotherapy by accessing and directing antigen presenting cells to stimulate anti-tumor T cell immunity,stimulate and activate the immune system with the equivalent of multiple adjuvants, and simultaneously reduce tumor protection in the TumorMicroenvironment (“TME”) to enable the T cells to eliminate tumors. The Company believes that Lm Technology immunotherapies can complement andaddress significant unmet needs in the current oncology treatment landscape. Specifically, their product candidates have the potential to optimizecheckpoint performance, while having a generally well-tolerated safety profile, and most of their product candidates are immediately available for treatmentwith a low cost of goods. The Company’s passion for the clinical potential of Lm Technology is balanced by focus and fiscal discipline and driven towardsincreasing shareholder value. Advaxis is focused on four franchises in various stages of clinical and pre-clinical development, which they believe will provide the greatestopportunity to have a significant impact on patients and their families: ·Human Papilloma Virus (“HPV”)-associated cancers ·Neoantigen therapy ·Disease focused hotspot / cancer antigen therapies ·Prostate cancer 31 Source: Advaxis, Inc., 10-K, December 21, 2017Powered by Morningstar® Document Research℠The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any use of this information,except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results. All four clinical franchises are anchored in the Company’s Lm TechnologyTM, a unique platform designed for its ability to safely and effectivelytarget various cancers in multiple ways. As an intracellular bacterium, Lm is an effective vector for the presentation of antigens through both the MajorHistocompatibility Complex (“MHC”) I and II pathways, due to its active phagocytosis by Antigen Presenting Cells (“APCs”). Within the APCs, Lm producesvirulence factors which allow survival in the host cytosol and potently stimulate the immune system. Results of Operations Fiscal Year 2017 Compared to Fiscal Year 2016 Revenue Revenue increased $8,036,194 to $12,031,050 for the year ended October 31, 2017 compared to $3,994,856 for the year ended October 31, 2016.The increase was primarily due to a full year recognition of upfront fees received from Amgen in conjunction with the collaboration agreement signed inAugust 2016. Research and Development Expenses We make significant investments in research and development to support our pre-clinical and clinical development programs. Research anddevelopment expenses for the years ended October 31, 2017 and 2016 were categorized as follows: Year ended October 31, 2017 2016 HPV-associated cancers $26,650,340 $12,875,876 Prostate cancer 3,879,894 2,293,549 Neoantigen therapy 2,286,701 1,812,086 Personnel expenses 22,113,902 18,584,165 Professional fees 14,453,151 7,800,517 Laboratory costs 8,610,682 2,751,557 Other clinical trial expenses 1,771,549 1,795,355 Other expenses 2,634,243 861,484 Partner reimbursements (10,500,000) - Total research & development expense $71,900,462 $48,774,589 HPV-Associated Cancer Therapy HPV-associated expenses increased $13,774,464 to $26,650,340 for the year ended October 31, 2017 compared to $12,875,876 for the year endedOctober 31, 2016. The increase resulted primarily from startup activities for additional countries in the Phase 3 AIM2CERV trial, as well as pre-clinicalsupport on ADXS-DUAL. Prostate Cancer Prostate cancer expenses increased $1,586,345 to $3,879,894 for the year ended October 31, 2017 compared to $2,293,549 for the year endedOctober 31, 2016. The increase resulted primarily from higher costs incurred due to the active enrollment of the expansion cohort on the Phase 1/2 trial incombination with Merck’s KEYTRUDA® (pembrolizumab). Neoantigen Therapy Neoantigen therapy expenses increased $474,615 to $2,286,701 for the year ended October 31, 2017 compared to $1,812,086 for the year endedOctober 31, 2016. The increase was a result of Phase 1 startup costs incurred during the year ended October 31, 2017. Personnel Expenses Personnel expenses increased $3,529,737 to $22,113,902 for the year ended October 31, 2017 compared to $18,584,165 for the year ended October31, 2016. The increase relates primarily to a 33% increase in R&D headcount. 32 Source: Advaxis, Inc., 10-K, December 21, 2017Powered by Morningstar® Document Research℠The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any use of this information,except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results. Professional Fees Professional fees increased $6,652,634 to $14,453,151 for the year ended October 31, 2017 compared to $7,800,517 for the year ended October 31,2016. The increase is primarily attributable to an increase in drug manufacturing process validation costs and drug stability studies in support of the MAA. Laboratory Costs Laboratory costs increased $5,859,125 to $8,610,682 for the year ended October 31, 2017 compared to $2,751,557 for the year ended October 31,2016. The increase is primarily attributable to an increase in headcount and laboratory space, as well as support of the MAA. Other Clinical Trial ExpensesClinical trial expenses decreased $23,806 to $1,771,549 for the year ended October 31, 2017 compared to $1,795,355 for the year ended October 31,2016 primarily as a result of the Company decision not to proceed to the expansion phase of the HER2 trial. Other Expenses Other expenses increased $1,772,759 to $2,634,243 for the year ended October 31, 2017 compared to $861,484 for the year ended October 31, 2016.The increase was due to additional infrastructure costs incurred to support the increased headcount and laboratory expansion. Partner Reimbursements Partner reimbursements for the year ended October 31, 2017 were $10,500,000. The Company received clinical development payments from Amgenfor ADXS-NEO totaling $7,500,000 and an additional payment of $3,000,000 from Stendhal to support the AIM2CERV program. General and Administrative Expenses General and administrative expenses primarily include salary and benefit costs for employees included in our finance, legal and administrativeorganizations, outside legal and professional services, and facilities costs. General and administrative expenses increased $6,945,960 to $38,658,464 for theyear ended October 31, 2017, compared with $31,712,505 for the year ended October 31, 2016. The increase is primarily attributable to an increase in stockbased compensation expense and severance associated with the resignation of the Company’s Chief Executive Officer in July, 2017 and increased facilitycosts associated with the facility expansion. These increases were offset by a decrease in consulting fees resulting primarily from non-recurring costsassociated with the collaboration agreement with Amgen which closed in August 2016. We anticipate general and administrative expenses in the near term to remain comparable to current levels, exclusive of the impact of future stockawards, severance and facility expansion expenses. Interest Income Interest income was $669,759 for the year ended October 31, 2017, compared with $331,529 for the year ended October 31, 2016. The increase ininterest income earned was driven primarily by an increase in interest rates as well as a higher investable balance resulting from cash received in fiscal 2016from sales of the Company’s common shares and an up-front cash payment received in conjunction with the collaboration agreement with Amgen. Changes in Fair Values For the year ended October 31, 2017, the Company recorded non-cash income from changes in the fair value of the warrant liability of $20,156 dueto the expiration of all the remaining the liability warrants. For the year ended October 31, 2016, the Company recorded non-cash income from changes in the fair value of the warrant liability of $69,055 dueto a decrease in the fair value of liability warrants as a smaller range of share prices were used in the calculation of the BSM volatility input as well as adecrease in our share price from $11.09 at October 31, 2015 to $8.09 at October 31, 2016. Income Tax Benefit We may be eligible, from time to time, to receive cash from the sale of our Net Operating Losses (“NOLs”) under the State of New Jersey NOLTransfer Program. During the year ended October 31, 2017, the Company recorded Income Tax Receivable of $4,452,682 from the sale of its state NOLs and researchand development tax credits for the period ended October 31, 2016. We paid $50,000 in Taiwanese withholding taxes in connection with the revenuegenerated from an annual exclusive license fee from GBP. During the year ended October 31, 2016, the Company recorded Income Tax Receivable of $2,549,862 from the sale of its state NOLs and researchand development tax credits for the period ended October 31, 2015. In addition, the Company received a net cash amount of $35,764 in excess of what wasrecorded as Income Tax Receivable at October 31, 2015. We paid $50,000 in Taiwanese withholding taxes in connection with the revenue generated from anannual exclusive license fee from GBP. 33 Source: Advaxis, Inc., 10-K, December 21, 2017Powered by Morningstar® Document Research℠The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any use of this information,except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results. Fiscal Year 2016 Compared to Fiscal Year 2015 Revenue During the year ended October 31, 2016, the Company recorded revenue of $3,994,856. The Company recognized $3,744,856 of revenue from thecollaboration agreement with Amgen related to amortization of the upfront fees received. In addition, $250,000 of revenue was due to the receipt of anannual exclusive license fee from GBP for the development and commercialization of axalimogene filolisbac. We did not record any revenue for the year ended October 31, 2015. Research and Development Expenses We make significant investments in research and development in support of our development programs both clinically and pre-clinically. Researchand development costs are expensed as incurred and primarily include salary and benefit costs, third-party grants, fees paid to clinical research organizations,and supply costs. Research and development expenses for the years ended October 31, 2016 and 2015 were categorized as follows: Year ended October 31, 2016 2015 HPV-associated cancers $12,875,876 $7,358,020 Prostate cancer 2,293,549 1,826,978 Neoantigen therapy 1,812,086 172,541 Personnel expenses 18,584,165 8,492,511 Professional fees 7,800,517 3,464,321 Laboratory costs 2,751,557 508,002 Other clinical trial expenses 1,795,355 1,867,831 Other expenses 861,484 765,243 Total research & development expense $48,774,589 $24,455,447 HPV-Associated Cancer Therapy HPV-associated expenses increased $5,517,856 to $12,875,876 for the year ended October 31, 2016 compared to $7,358,020 for the year endedOctober 31, 2015. The increase primarily resulted from the startup costs related to the initiation of the Phase 3 AIMZCERV trial. Prostate Cancer Prostate cancer expenses increased $466,571 to $2,293,549 for the year ended October 31, 2016 compared to $1,826,978 for the year ended October31, 2015. The increase primarily resulted from higher costs incurred due to an increase in enrollment and maintenance costs associated with the Phase 1/2trial in combination with Merck’s KEYTRUDA® (pembrolizumab). Neoantigen Therapy Neoantigen therapy expenses increased $1,639,545 to $1,812,086 for the year ended October 31, 2016 compared to $172,541 for the year endedOctober 31, 2015. The increase was primarily a result of pre-IND activities and startup costs incurred during the year ended October 31, 2016. Personnel Expenses Personnel expenses increased $10,091,654 to $18,584,165 for the year ended October 31, 2016 compared to $8,492,511 for the year ended October31, 2015. The increase primarily relates to a 53% increase in headcount as well as non-cash stock based compensation for past employees. Professional Fees Professional fees increased $4,336,196 to $7,800,517 for the year ended October 31, 2016 compared to $3,464,321 for the year ended October 31,2015. The increase is primarily attributed to an increase in drug manufacturing process validation costs and drug stability studies. Laboratory Costs Laboratory costs increased $2,243,555 to $2,751,557 for the year ended October 31, 2016 compared to $508,002 for the year ended October 31,2015. The increase is primarily attributable to an increase in headcount as well as an expansion of laboratory space. 34 Source: Advaxis, Inc., 10-K, December 21, 2017Powered by Morningstar® Document Research℠The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any use of this information,except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results. Other Clinical Trial Expenses Clinical trial expenses decreased $72,476 to $1,795,355 for the year ended October 31, 2016 compared to $1,867,831 for the year ended October 31,2015. These expenses were related to the HER2 study and were consistent with the comparable prior period. Other Expenses Other expenses increased $96,241 to $861,484 for the year ended October 31, 2016 compared to $765,243 for the year ended October 31, 2015. Theincrease was primarily due to additional infrastructure costs incurred to support the increased headcount and laboratory expansion. General and Administrative Expenses General and administrative expenses primarily include salary and benefit costs for employees included in our finance, legal and administrativeorganizations, outside legal and professional services, and facilities costs. General and administrative expense increased $7,468,815 to $31,712,505 for theyear ended October 31, 2016, compared with $24,243,690 for the year ended October 31, 2015. There was an increase of approximately $6,925,600 incompensation related expense, including a non-cash increase in stock based compensation costs of approximately $2,600,000, attributable to increases in ouremployees, the grant date fair value of stock awards and the number of awards. Costs pertaining to the Company’s infrastructure expansion, including leasedspace and information technology related costs, increased by approximately $1,564,900. Business development costs increased by approximately$1,491,900. This was partially offset by a decrease in non-cash investor relations costs of approximately $2,200,000.We anticipate general and administrative expenses in the near term to remain comparable to current levels, exclusive of the impact of future stockawards and one-time expenses. Interest Income Interest income was $331,529 for the year ended October 31, 2016, compared with $114,219 for the year ended October 31, 2015. The increase ininterest income earned was attributable to an increase in cash resulting from sales of the Company’s common shares. The cash was invested in held-to-maturity investments and a savings account. Changes in Fair Values For the year ended October 31, 2016, the Company recorded non-cash income from changes in the fair value of the warrant liability of $69,055 dueto a decrease in the fair value of liability warrants as a smaller range of share prices were used in the calculation of the BSM volatility input as well as adecrease in our share price from $11.09 at October 31, 2015 to $8.09 at October 31, 2016. For the year ended October 31, 2015, the Company recorded non-cash expense from changes in the fair value of the warrant liability of $48,950 dueto an increase in the fair value of liability warrants primarily resulting from a larger range of share prices used in the calculation of the Black-Scholes Model(“BSM”) volatility input, as well as a significant increase in our share price from $3.18 at October 31, 2014 to $11.09 at October 31, 2015. This was partiallyoffset by the expiration of some warrants. Income Tax Benefit We may be eligible, from time to time, to receive cash from the sale of our Net Operating Losses (“NOLs”) under the State of New Jersey NOLTransfer Program. During the year ended October 31, 2016, the Company recorded Income Tax Receivable of $2,549,862 from the sale of its state NOLs and researchand development tax credits for the period ended October 31, 2015. In addition, the Company received a net cash amount of $35,764 in excess of what wasrecorded as Income Tax Receivable at October 31, 2015. We paid $50,000 in Taiwanese withholding taxes in connection with the revenue generated from anannual exclusive license fee from GBP. During the year ended October 31, 2015, the Company recorded Income Tax Receivable of $1,609,349 from the sale of its state NOLs and researchand development tax credits for the period ended October 31, 2014. Liquidity and Capital Resources Our major sources of cash have been proceeds from various public and private offerings of our common stock, option and warrant exercises, andinterest income. From October 2013 through October 2017, we raised approximately $222.5 million in gross proceeds from various public and privateofferings of our common stock. We have not yet commercialized any drug, and we may not become profitable. Our ability to achieve profitability depends ona number of factors, including our ability to complete our development efforts, obtain regulatory approvals for our drug, successfully complete any post-approval regulatory obligations, successfully compete with other available treatment options in the marketplace, overcome any clinical holds that the FDAmay impose and successfully manufacture and commercialize our drug alone or in partnership. We may continue to incur substantial operating losses evenafter we begin to generate revenues from our drug candidates. As of October 31, 2017, the Company had approximately $70.9 million in cash, restricted cash,cash equivalents and investments on its balance sheet. We believe our current cash position is sufficient to fund our business plan approximately into fiscal2019. The actual amount of cash that we will need to operate is subject to many factors. Since our inception through October 31, 2017, we reported accumulated net losses of approximately $301.1 million and recurring negative cashflows from operations. We anticipate that we will continue to generate significant losses from operations for the foreseeable future. 35 Source: Advaxis, Inc., 10-K, December 21, 2017Powered by Morningstar® Document Research℠The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any use of this information,except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results. Cash Flows Operating Activities Cash used in operating activities for the year ended October 31, 2017 was approximately $76.9 million (including proceeds from the sale of our stateNOLs and Research and Development (R&D) tax credits of approximately $2.5 million) primarily from spending associated with our clinical trial programsand general and administrative spending. Cash used in operating activities for the year ended October 31, 2016 was approximately $9.1 million. Spending associated with our clinical trialprograms and general and administrative spending was partially offset by a $40 million upfront payment received from Amgen in connection with thecollaboration agreement as well as proceeds from the sale of our state NOLs and Research and Development (R&D) tax credits of approximately $1.6 million. Cash used in operating activities for the year ended October 31, 2015 was approximately $24.1 million (including proceeds from the sale of our stateNOLs and R&D tax credits of approximately $1.7 million) primarily from spending associated with our clinical trial programs and general and administrativespending. Investing Activities Cash used in investing activities for the year ended October 31, 2017 was approximately $12.5 million resulting from restricted cash establishedwith letter of credit agreement, held-to-maturity investments, purchases of property and equipment, legal cost spending in support of our intangible assets(patents) and costs paid to Penn for patents. Cash provided by investing activities for the year ended October 31, 2016 was approximately $1.6 million resulting from net proceeds frominvestments in held-to-maturity investments, purchases of property and equipment, construction of cleanroom and laboratory facilities, legal cost spending insupport of our intangible assets (patents) and costs paid to Penn for patents. Cash used in investing activities for the year ended October 31, 2015 was approximately $47.4 million resulting from investments in held-to-maturity investments, purchases of property and equipment to support expansion, legal cost spending in support of our intangible assets (patents) and costspaid to Penn for patents. Financing Activities Cash provided by financing activities for the year ended October 31, 2017 was approximately $528,000, resulting from the sale of 92,145 shares ofour Common Stock in two at-the-market transactions resulting in net proceeds of approximately $656,000 and proceed from the issuance of stock under anemployee stock purchase plan of approximately $251,000. This was partially offset by approximately $357,000 of taxes paid related to the net sharesettlement of equity awards. Cash provided by financing activities for the year ended October 31, 2016 was approximately $53.7 million, resulting from the sale of 3,047,446shares of our Common Stock to Amgen resulting in net proceeds of approximately $25 million and a registered direct offering of 2,244,443 shares of ourCommon Stock resulting in net proceeds of approximately $28.2 million. In addition, approximately $614,000 in proceeds was received on option andwarrant exercises. This was partially offset by approximately $36,000 of taxes paid related to the net share settlement of equity awards. Cash provided by financing activities for the year ended October 31, 2015 was approximately $120.5 million, resulting primarily from registereddirect offerings of 8,806,165 shares of our Common Stock resulting in net proceeds of approximately $63.1 million and a public offering of 2,800,000 sharesof Common Stock resulting in net proceeds of approximately $56.7 million. In addition, the Company received approximately $2.4 million from theproceeds received on option and warrant exercises. This was partially offset by approximately $1.6 million of taxes paid related to the net share settlement ofequity awards. Our capital resources and operations to date have been funded primarily with the proceeds from public, private equity and debt financings, NOL taxsales and income earned on investments and grants. We have sustained losses from operations in each fiscal year since our inception, and we expect losses tocontinue for the indefinite future, due to the substantial investment in research and development. As of October 31, 2017 and October 31, 2016, we had anaccumulated deficit of $301,142,227 and $207,706,825, respectively, and shareholders’ equity of $54,260,167 and $119,302,194, respectively. The Company believes its current cash position is sufficient to fund its business plan approximately into fiscal 2019. We have based this estimate onassumptions that may prove to be wrong, and we could use available capital resources sooner than currently expected. Because of the numerous risks anduncertainties associated with the development and commercialization of our product candidates, we are unable to estimate the amount of increased capitaloutlays and operating expenses associated with completing the development of our current product candidates. The Company recognizes it may need to raise additional capital in order to continue to execute its business plan. There is no assurance thatadditional financing will be available when needed or that management will be able to obtain financing on terms acceptable to the Company or whether theCompany will become profitable and generate positive operating cash flow. If the Company is unable to raise sufficient additional funds, it will have to scaleback its business plan, extend payables and reduce overhead until sufficient additional capital is raised to support further operations. There can be noassurance that such a plan will be successful. 36 Source: Advaxis, Inc., 10-K, December 21, 2017Powered by Morningstar® Document Research℠The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any use of this information,except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results. Tabular Disclosure of Contractual Obligations Payments Due by Period Contractual Obligations Total Less than1 year 1-3 years 3-5 years More than5 years Operating Leases $10,447,167 $1,041,895 $2,340,292 $2,686,459 $4,378,521 Employment Agreements $1,978,225 $1,978,225 Consulting and other Services $2,173,388 $1,877,492 $262,896 $33,000 We enter into agreements in the normal course of business with contract research organizations for clinical trials and with vendors for preclinicalstudies and other services and products for operating purposes which are cancelable at any time by us, generally upon 30 days prior written notice. Thesepayments are not included in this table of contractual obligations. We are obligated to make future payments to third parties under in-license agreements, including sublicense fees, royalties and payments thatbecome due and payable on the achievement of certain development and commercialization milestones. As the amount and timing of sublicense fees and theachievement and timing of these milestones are not probable and estimable, such commitments have not been included on our consolidated balance sheets orin the contractual obligations table above. Off-Balance Sheet Arrangements As of October 31, 2017, we had no off-balance sheet arrangements. Critical Accounting Estimates The preparation of financial statements in accordance with GAAP accepted in the U.S. requires management to make estimates and assumptions thataffect the reported amounts and related disclosures in the financial statements. Management considers an accounting estimate to be critical if: ●it requires assumptions to be made that were uncertain at the time the estimate was made, and While we base our estimates and judgments on our experience and on various other factors that we believe to be reasonable under the circumstances,actual results could differ from those estimates and the differences could be material. The most significant estimates impact the following transactions oraccount balances: stock compensation, warrant liability valuation and impairment of intangibles. Revenue Recognition The Company is expected to derive the majority of its revenue from patent licensing. In general, these revenue arrangements provide for thepayment of contractually determined fees in consideration for the grant of certain intellectual property rights for patented technologies owned or controlledby the Company. The intellectual property rights granted may be perpetual in nature, or upon the final milestones being met, or can be granted for a defined,relatively short period of time, with the licensee possessing the right to renew the agreement at the end of each contractual term for an additional minimumupfront payment. The Company recognizes licensing fees when there is persuasive evidence of a licensing arrangement, fees are fixed or determinable,delivery has occurred and collectability is reasonably assured. Revenue associated with nonrefundable upfront license fees under arrangements where the license fees and research and development activitiescannot be accounted for as separate units of accounting is deferred and recognized as revenue on a straight-line basis over the expected period ofperformance. Revenues from the achievement of research and development milestones, if deemed substantive, are recognized as revenue when the milestones areachieved and the milestone payments are due and collectible. If not deemed substantive, the Company recognizes such milestones as revenue on a straight-line basis over the remaining expected performance period under the arrangement. All such recognized revenues are included in collaborative licensing anddevelopment revenue in the Company’s statements of operations. Milestones are considered substantive if all of the following conditions are met: (1) the milestone is nonrefundable; (2) achievement of themilestone was not reasonably assured at the inception of the arrangement; (3) substantive effort is involved to achieve the milestone; and (4) the amount ofthe milestone appears reasonable in relation to the effort expended, and the other milestones in the arrangement and the related risk associated with theachievement of the milestone and any ongoing research and development or other services are priced at fair value. If product development is successful, the Company will recognize revenue from royalties based on licensees’ sales of its products or products usingits technologies. Royalties are recognized as earned in accordance with the contract terms when royalties from licensees can be reasonably estimated andcollectability is reasonably assured. If royalties cannot be reasonably estimated or collectability of a royalty amount is not reasonably assured, royalties arerecognized as revenue when the cash is received. 37 Source: Advaxis, Inc., 10-K, December 21, 2017Powered by Morningstar® Document Research℠The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any use of this information,except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results. Deferred revenue represents the portion of payments received for which the earnings process has not been completed. Deferred revenue expected tobe recognized within the next 12 months is classified as a current liability. An allowance for doubtful accounts is established based on the Company’s best estimate of the amount of probable credit losses in the Company’sexisting license fee receivables, using historical experience. The Company reviews its allowance for doubtful accounts periodically. Past due accounts arereviewed individually for collectability. Account balances are charged off against the allowance after all means of collection have been exhausted and thepotential for recovery is considered remote. To date, this is yet to occur. Stock Based Compensation We account for stock-based compensation using fair value recognition and record stock-based compensation as a charge to earnings net of theestimated impact of forfeited awards. As such, we recognize stock-based compensation cost only for those stock-based awards that are estimated to ultimatelyvest over their requisite service period, based on the vesting provisions of the individual grants. The process of estimating the fair value of stock-based compensation awards and recognizing stock-based compensation cost over their requisiteservice period involves significant assumptions and judgments. We estimate the fair value of stock option awards on the date of grant using the Black-Scholes option-valuation model for the remaining awards, which requires that we make certain assumptions regarding: (i) the expected volatility in themarket price of our Common Stock; (ii) dividend yield; (iii) risk-free interest rates; and (iv) the period of time employees are expected to hold the award priorto exercise (referred to as the expected holding period). As a result, if we revise our assumptions and estimates, our stock-based compensation expense couldchange materially for future grants. Stock-based compensation for employees, executives and directors is measured based on the fair value of the shares issued on the date of grant and isto be recognized over the requisite service period in both research and development expenses and general and administrative expenses on the statement ofoperations. For non-employees, the fair value of the award is generally measured based on contractual terms. Derivative Financial instruments We do not use derivative instruments to hedge exposures to cash flow, market or foreign currency risks. We evaluate all of our financial instrumentsto determine if such instruments are derivatives or contain features that qualify as embedded derivatives. For derivative financial instruments that areaccounted for as liabilities, the derivative instrument is initially recorded at its fair value and is then re-valued at each reporting date, with changes in the fairvalue reported in the statements of operations. The determination of fair value requires the use of judgment and estimates by management. For stock-basedderivative financial instruments, we used the BSM which approximated the binomial lattice options pricing model to value the derivative instruments atinception and on subsequent valuation dates. The classification of derivative instruments, including whether such instruments should be recorded asliabilities or as equity, is evaluated at the end of each reporting period. Derivative liabilities are classified in the balance sheet as current or non-current basedon whether or not net-cash settlement of the instrument could be required within 12 months of the balance sheet date. The variables used in the model areprojected based on our historical data, experience, and other factors. Changes in any of these variables could result in material adjustments to the expenserecognized for changes in the valuation of the warrant derivative liability. Intangible Assets Intangible assets primarily consist of legal and filing costs associated with obtaining patents and licenses and are amortized on a straight-line basisover their remaining useful lives which are estimated to be twenty years from the effective dates of the University of Pennsylvania (Penn) LicenseAgreements, beginning in July 1, 2002. These legal and filing costs are invoiced to the Company through Penn and its patent attorneys. Management has reviewed its long-lived assets for impairment whenever events and circumstances indicate that the carrying value of an asset mightnot be recoverable and its carrying amount exceeds its fair value, which is based upon estimated undiscounted future cash flows. Net assets are recorded onthe balance sheet for patents and licenses related to axalimogene filolisbac, ADXS-PSA and ADXS-HER2 and other products that are in development.However, if a competitor were to gain FDA approval for a treatment before us or if future clinical trials fail to meet the targeted endpoints, the Companywould likely record an impairment related to these assets. In addition, if an application is rejected or fails to be issued, the Company would record animpairment of its estimated book value. Income Taxes The Company uses the asset and liability method of accounting for income taxes in accordance with ASC Topic 740, “Income Taxes.” Under thismethod, income tax expense is recognized for the amount of: (i) taxes payable or refundable for the current year and (ii) deferred tax consequences oftemporary differences resulting from matters that have been recognized in an entity’s financial statements or tax returns. Deferred tax assets and liabilities aremeasured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered orsettled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in the results of operations in the period that includes theenactment date. A valuation allowance is provided to reduce the deferred tax assets reported if based on the weight of the available positive and negativeevidence, it is more likely than not some portion or all of the deferred tax assets will not be realized. 38 Source: Advaxis, Inc., 10-K, December 21, 2017Powered by Morningstar® Document Research℠The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any use of this information,except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results. ASC Topic 740-10-30 clarifies the accounting for uncertainty in income taxes recognized in an enterprise’s financial statements and prescribes arecognition threshold and measurement attribute for the financial statement recognition and measurement of a tax position taken or expected to be taken in atax return. ASC Topic 740-10-40 provides guidance on de-recognition, classification, interest and penalties, accounting in interim periods, disclosure, andtransition. The Company will classify as income tax expense any interest and penalties. The Company has no material uncertain tax positions for any of thereporting periods presented. The Company files tax returns in U.S. federal and state jurisdictions, including New Jersey, and is subject to audit by taxauthorities beginning with the year ended October 31, 2013. New Accounting Pronouncements See Note 2 to our financial statements that discusses new accounting pronouncements. Item 7A. Quantitative and Qualitative Disclosures About Market Risk. At October 31, 2017, the Company had approximately $70.9 million in cash, restricted cash, cash equivalents and investments, which consistedprimarily of bank deposits, restricted cash, money market funds and short term investments such as certificates of deposit, domestic governmental agencyloans and U.S treasury notes. The Company’s investment policy and strategy are focused on preservation of capital and supporting the Company’s liquidityrequirements. The Company uses a combination of internal and external management to execute its investment strategy and achieve its investmentobjectives. The Company typically invests in highly-rated securities, and its investment policy generally limits the amount of credit exposure to any oneissuer. The policy requires investments generally to be investment grade, with the primary objective of minimizing the potential risk of principal loss. Suchinterest-earning instruments carry a degree of interest rate risk; however, historical fluctuations of interest income have not been significant. We have not been exposed nor do we anticipate being exposed to material risks due to changes in interest rates. A hypothetical 10% change ininterest rates during any of the periods presented would not have had a material impact on our consolidated financial statements. Item 8: Financial Statements and Supplementary Data. The index to Financial Statements appears on the page immediately prior to page F-1, the Report of the Independent Registered Public AccountingFirms appears on page F-1, and the Financial Statements and Notes to Financial Statements appear on pages F-2 to F-26. Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure. Not applicable. Item 9A: Controls and Procedures. Assessment of the Effectiveness of Internal Controls over Financial Reporting Under the supervision and with the participation of our management, including our chief executive officer and chief financial officer, we conductedan evaluation of the effectiveness of our internal control over financial reporting using the criteria set forth by the Committee of Sponsoring Organizations ofthe Treadway Commission (COSO) in Internal Control-Integrated Framework published in 2013. Based on its evaluation, our management concluded thatour internal control over financial reporting was effective as of the end of the period covered by this Annual Report on Form 10-K. (a) Evaluation of Disclosure Controls and Procedures An evaluation was performed under the supervision and with the participation of our management, including our chief executive officer and ourchief financial officer as to the effectiveness of our disclosure controls and procedures (as defined in Rule 13a-15(e) under the Exchange Act) as of the end ofthe period covered by this report. Any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance ofachieving the desired control objectives. Based on that evaluation, the chief executive officer and the chief financial officer of the Company have concludedthat, as of the end of the period covered by this report, our disclosure controls and procedures are effective. (b) Management’s Report on Internal Control over Financial Reporting Our management is responsible for establishing and maintaining adequate internal control over financial reporting to provide reasonable assuranceregarding the reliability of our financial reporting and the preparation of financial statements for external purposes in accordance with generally acceptedaccounting principles in the United States of America. Internal control over financial reporting includes those policies and procedures that: (i) pertain to the maintenance of records that in reasonable detail accurately and fairly reflect the transactions and dispositions of our assets; (ii) provide reasonable assurance that the transactions are recorded as necessary to permit preparation of financial statements in accordance withgenerally accepted accounting principles, and that our receipts and expenditures are being made only in accordance with the authorization of managementand/or our Board of Directors; and 39 Source: Advaxis, Inc., 10-K, December 21, 2017Powered by Morningstar® Document Research℠The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any use of this information,except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results. (iii) provide reasonable assurance regarding the prevention or timely detection of any unauthorized acquisition, use or disposition of our assets thatcould have a material effect on our financial statements. Due to its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluationof effectiveness to future periods are subject to the risk that controls may become inadequate due to changes in conditions, or that the degree of compliancewith the policies or procedures may deteriorate. Marcum LLP, an independent registered public accounting firm, has audited the Consolidated Financial Statements included in this Annual Reporton Form l0-K and, as part of the audit, has issued an attestation report, included herein, on the effectiveness of our internal control over financial reporting.See “Reports of Independent Registered Public Accounting Firm” included in this filling. (c) Changes in Internal Control over Financial Reporting During the quarter ended October 31, 2017, there were no changes in our internal control over financial reporting that have materially affected, orare reasonably likely to materially affect, our internal control over financial reporting. Limitations on the Effectiveness of Controls. Our management, including our Chief Executive Officer and Chief Financial Officer, does not expectthat our disclosure controls and procedures or our internal control over financial reporting will prevent all errors and all fraud. A control system, no matterhow well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. Further, the designof a control system must reflect the fact that there are resource constraints, and the benefits of controls must be considered relative to their costs. Because ofthe inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any,within our company have been detected. 40 Source: Advaxis, Inc., 10-K, December 21, 2017Powered by Morningstar® Document Research℠The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any use of this information,except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results. REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM ON INTERNAL CONTROL OVER FINANCIAL REPORTING To the Audit Committee of theBoard of Directors and Shareholders ofAdvaxis, Inc. We have audited Advaxis, Inc.’s (the “Company”) internal control over financial reporting as of October 31, 2017, based on criteria established in InternalControl-Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission in 2013. The Company’s management isresponsible for maintaining effective internal control over financial reporting, and for its assessment of the effectiveness of internal control over financialreporting, included in the accompanying “Management Annual Report on Internal Control over Financial Reporting”. Our responsibility is to express anopinion on the Company’s internal control over financial reporting based on our audit. We conducted our audit in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those standards require thatwe plan and perform the audit to obtain reasonable assurance about whether effective internal control over financial reporting was maintained in all materialrespects. Our audit of internal control over financial reporting included obtaining an understanding of internal control over financial reporting, assessing therisk that a material weakness exists, and testing and evaluating the design and operating effectiveness of internal control based on the assessed risk. Our auditalso included performing such other procedures as we considered necessary in the circumstances. We believe that our audit provides a reasonable basis forour opinion. A company’s internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reportingand the preparation of financial statements for external purposes in accordance with generally accepted accounting principles. A company’s internal controlover financial reporting includes those policies and procedures that (1) pertain to the maintenance of records that, in reasonable detail, accurately and fairlyreflect the transactions and dispositions of the assets of the company; (2) provide reasonable assurance that transactions are recorded as necessary to permitpreparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the company are beingmade only in accordance with authorizations of management and directors of the company; and (3) provide reasonable assurance regarding prevention ortimely detection of unauthorized acquisition, use, or disposition of the company’s assets that could have a material effect on the financial statements. Because of the inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation ofeffectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that degree of compliancewith the policies or procedures may deteriorate. In our opinion, Advaxis, Inc. maintained, in all material aspects, effective internal control over financial reporting as of October 31, 2017, based on criteriaestablished in Internal Control – Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission in 2013. We have also audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States), the balance sheets as of October31, 2017 and 2016, and the related statements of operations, shareholders’ equity, and cash flows for the years ended October 31, 2017, 2016 and 2015 of theCompany and our report dated December 20, 2017 expressed an unqualified opinion on those financial statements. Marcum llp New York, NY December 20, 2017 41 Source: Advaxis, Inc., 10-K, December 21, 2017Powered by Morningstar® Document Research℠The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any use of this information,except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results. Item 9B: Other Information. None. 42 Source: Advaxis, Inc., 10-K, December 21, 2017Powered by Morningstar® Document Research℠The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any use of this information,except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results. PART III Item 10: Directors, Executive Officers and Corporate Governance. The information required by this Item is incorporated herein by reference from our Proxy Statement for our 2018 Annual Meeting of Stockholders. Item 11: Executive Compensation. The information required by this Item is incorporated herein by reference from our Proxy Statement for our 2018 Annual Meeting of Stockholders. Item 12: Security Ownership of Certain Beneficial Owners and Management and Related Shareholder Matters. The information required by this Item is incorporated herein by reference from our Proxy Statement for our 2018 Annual Meeting of Stockholders. Item 13: Certain Relationships and Related Transactions, and Director Independence. The information required by this Item is incorporated herein by reference from our Proxy Statement for our 2018 Annual Meeting of Stockholders. Item 14: Principal Accountant Fees and Services. The information required by this Item is incorporated herein by reference from our Proxy Statement for our 2018 Annual Meeting of Stockholders. 43 Source: Advaxis, Inc., 10-K, December 21, 2017Powered by Morningstar® Document Research℠The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any use of this information,except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results. PART IV Item 15: Exhibits and Financial Statements Schedules. See Index of Exhibits below. The Exhibits are filed with or incorporated by reference in this report. (a) Exhibits. The following exhibits are included herein or incorporated herein by reference. ExhibitNumber Description of Exhibits 3.1 Amended and Restated Certificate of Incorporation. Incorporated by reference to Annex C to DEF 14A Proxy Statement filed with the SEC onMay 15, 2006. 3.2 Certificate of Designations of Preferences, Rights and Limitations of Series A Preferred Stock of the registrant, dated September 24, 2009.Incorporated by reference to Exhibit 4.1 to Current Report on Form 8-K filed with the SEC on September 25, 2009. 3.3 Certificate of Designations of Preferences, Rights and Limitations of Series B Preferred Stock of the registrant, dated July 19, 2010.Incorporated by reference to Exhibit 4.1 to Current Report on Form 8-K filed with the SEC on July 20, 2010. 3.4 Certificate of Amendment to Amended and Restated Certificate of Incorporation filed with the Delaware Secretary of State on August 16, 2012.Incorporated by reference to Exhibit 3.1 to Current Report on Form 8-K filed with the SEC on August 17, 2012. 3.5 Certificate of Amendment to Amended and Restated Certificate of Incorporation filed with the Delaware Secretary of State on July 11, 2013(reverse stock split). Incorporated by reference to Exhibit 3.1 to Current Report on Form 8-K filed with the SEC on July 15, 2013. 3.6 Certificate of Amendment to Amended and Restated Certificate of Incorporation filed with the Delaware Secretary of State on July 12, 2013(reverse stock split). Incorporated by reference to Exhibit 3.2 to Current Report on Form 8-K filed with the SEC on July 15, 2013. 3.7 Certificate of Amendment to Amended and Restated Certificate of Incorporation filed with the Delaware Secretary of State on July 9, 2014.Incorporated by reference to Exhibit 3.1 to Current Report on Form 8-K filed with the SEC on July 10, 2014. 3.8 Certificate of Amendment to Amended and Restated Certificate of Incorporation filed with the Delaware Secretary of State on March 10, 2016.Incorporated by reference to Exhibit 3.1 to Current Report on Form 8-K filed with the SEC on March 11, 2016. 3.9 Amended and Restated Bylaws. Incorporated by reference to Exhibit 10.4 to Quarterly Report on Form 10-QSB filed with the SEC onSeptember 13, 2006. 4.1 Form of Common Stock Purchase Warrant. Incorporated by reference to Exhibit 4.1 to Current Report on Form 8-K filed with the SEC onAugust 31, 2011. 44 Source: Advaxis, Inc., 10-K, December 21, 2017Powered by Morningstar® Document Research℠The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any use of this information,except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results. ExhibitNumber Description of Exhibits 4.8 Form of Common Stock Purchase Warrant issued to Dr. James Patton. Incorporated by reference to Exhibit 4.23 to Amendment No. 1 toRegistration Statement on Form S-1 (File No. 333-183682) filed with the SEC on September 11, 2012. 4.9 Form of Representative’s Warrant. Incorporated by reference to Exhibit 4.19 to Registration Statement on Form S-1/A (File No. 333-188637)filed with the SEC on September 27, 2013. 4.11 Common Stock purchase warrant, dated as of March 19, 2014, by and between Advaxis, Inc. and Aratana Therapeutics, Inc. Incorporated byreference to Exhibit 4.1 to Quarterly Report on Form 10-Q filed with the SEC on June 10, 2014. 4.12 Form of Representative’s Warrant related to the Underwriting Agreement, dated as of March 31, 2014, by and between Advaxis, Inc. and AegisCapital Group. Incorporated by reference to Exhibit 4.2 to Quarterly Report on Form 10-Q filed with the SEC on June 10, 2014. 10.1 2004 Stock Option Plan of the registrant. Incorporated by reference to Exhibit 4.1 to Report on Form S-8 filed with the SEC on December 1,2005. 10.2 2005 Stock Option Plan of the registrant. Incorporated by reference to Annex A to DEF 14A Proxy Statement filed with the SEC on May 15,2006. 10.3 License Agreement, between the Trustees of the University of Pennsylvania and the registrant dated as of June 17, 2002, as Amended andRestated on February 13, 2007. Incorporated by reference to Exhibit 10.11 to Annual Report on Form 10-KSB filed with the SEC on February13, 2007. 45 Source: Advaxis, Inc., 10-K, December 21, 2017Powered by Morningstar® Document Research℠The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any use of this information,except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results. ExhibitNumber Description of Exhibits 10.4 Amended and Restated 2009 Stock Option Plan of the registrant. Incorporated by reference to Annex A to DEF 14A Proxy Statement filed withthe SEC on April 30, 2010. 10.5 Second Amendment to the Amended and Restated Patent License Agreement between the registrant and the Trustees of the University ofPennsylvania dated as of May 10, 2010. Incorporated by reference to Exhibit 10.1 to Quarterly Report on Form 10-Q filed with the SEC onJune 3, 2010. 10.6 Note purchase agreement, dated as of May 9, 2011, by and between Advaxis, Inc. and each investor identified on the signature pages thereto.Incorporated by reference to Exhibit 10.1 to Amendment to Current Report on Form 8-K/A filed with the SEC on May 12, 2011. 10.7 2011 Omnibus Incentive Plan of registrant. Incorporated by reference to Annex A to DEF 14A Proxy Statement filed with the SEC on August29, 2011. 10.8 2011 Employee Stock Purchase Plan. Incorporated by reference to Annex B to DEF 14A Proxy Statement filed with the SEC on August 29,2011. 10.9 Amendment No. 1 to the Advaxis, Inc. 2011 Employee Stock Purchase Plan. Incorporated by reference to Exhibit 10.1 to Current Report onForm 8-K filed with the SEC on December 20, 2011. 10.10 Exchange Agreement, dated as of May 14, 2012, by and between Advaxis, Inc. and each investor identified on the signature pages thereto.Incorporated by reference to Exhibit 10.1 to Current Report on Form 8-K filed with the SEC on May 18, 2012. 10.11 Amendment, Consent and Waiver Agreement, dated as of May 14, 2012, by and between Advaxis, Inc. and each investor identified on thesignature pages thereto. Incorporated by reference to Exhibit 10.2 to Current Report on Form 8-K filed with the SEC on May 18, 2012. 10.12 Note purchase agreement, dated as of May 14, 2012, by and between Advaxis, Inc. and each investor identified on the signature pages thereto.Incorporated by reference to Exhibit 10.3 to Current Report on Form 8-K filed with the SEC on May 18, 2012. 10.13 Registration Rights Agreement, dated as of May 14, 2012, by and between Advaxis, Inc. and each investor identified on the signature pagesthereto. Incorporated by reference to Exhibit 10.4 to Current Report on Form 8-K filed with the SEC on May 18, 2012. 10.14 Amendment No. 1, dated as of March 26, 2007, to the License Agreement, between the Trustees of the University of Pennsylvania andAdvaxis, Inc. dated as of June 17, 2002, as amended and restated on February 13, 2007. Incorporated by reference to Exhibit 10.1 to QuarterlyReport on Form 10-Q filed with the SEC on June 14, 2012. 10.15 Amendment No. 3, dated as of December 12, 2011, to the License Agreement, between the Trustees of the University of Pennsylvania andAdvaxis, Inc. dated as of June 17, 2002, as amended and restated on February 13, 2007. Incorporated by reference to Exhibit 10.5 to QuarterlyReport on Form 10-Q filed with the SEC on June 14, 2012. 10.16 Amendment No. 1 to 2011 Omnibus Incentive Plan of registrant. Incorporated by reference to Annex B to DEF 14A Proxy Statement filed withthe SEC on July 19, 2012. 46 Source: Advaxis, Inc., 10-K, December 21, 2017Powered by Morningstar® Document Research℠The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any use of this information,except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results. ExhibitNumber Description of Exhibits 10.17 ‡ Employment Agreement by and between Advaxis, Inc. and Daniel J. O’Connor, dated August 19, 2013. Incorporated by reference to Exhibit10.2 to Current Report on Form 8-K filed with the SEC on August 20, 2013. 10.18 Indemnification Agreement. Incorporated by reference to Exhibit 10.3 to Current Report on Form 8-K filed with the SEC on August 20, 2013. 10.19 ‡ Employment Agreement between Advaxis, Inc. and Robert Petit, dated September 26, 2013. Incorporated by reference to Exhibit 10.70 toRegistration Statement on Form S-1/A (File No. 333-188637) filed with the SEC on September 27, 2013. 10.20‡ Employment Agreement by and between Advaxis, Inc. and Gregory T. Mayes, III, dated October 25, 2013. Incorporated by reference to Exhibit10.1 to Current Report on Form 8-K filed with the SEC on October 29, 2013. 10.21‡ Restricted Stock Agreement between Advaxis, Inc. and Gregory T. Mayes, III, dated October 25, 2013. Incorporated by reference to Exhibit10.2 to Current Report on Form 8-K filed with the SEC on October 29, 2013. 10.22 Exclusive License and Technology Transfer Agreement by and between Advaxis, Inc. and Global BioPharma, Inc., dated December 9, 2013.Incorporated by reference to Exhibit 10.79 to Annual Report on Form 10-K/A filed with the SEC on February 6, 2014. 10.23‡ Amendment No. 1, dated as of December 19, 2013, to the Employment Agreement by and between Advaxis, Inc. and Daniel J. O’Connor.Incorporated by reference to Exhibit 10.82 to Annual Report on Form 10-K/A filed with the SEC on February 6, 2014. 10.24‡ Amendment No. 1, dated as of December 19, 2013, to the Employment Agreement by and between Advaxis, Inc. and Gregory T. Mayes, III.Incorporated by reference to Exhibit 10.82 to Annual Report on Form 10-K/A filed with the SEC on February 6, 2014. 10.25‡ Amendment No. 1, dated as of December 19, 2013, to the Employment Agreement by and between Advaxis, Inc. and Mark J. Rosenblum.Incorporated by reference to Exhibit 10.82 to Annual Report on Form 10-K/A filed with the SEC on February 6, 2014. 10.26‡ Amendment No. 1, dated as of December 19, 2013, to the Employment Agreement by and between Advaxis, Inc. and Robert G. Petit.Incorporated by reference to Exhibit 10.82 to Annual Report on Form 10-K/A filed with the SEC on February 6, 2014. 10.27 Distribution and Supply Agreement, dated as of January 20, 2014, by and between Advaxis, Inc. and Biocon, Limited. Incorporated byreference to Exhibit 10.7 to Quarterly Report on Form 10-Q filed with the SEC on March 17, 2014. 10.28 Exclusive License Agreement, dated March 19, 2014, by and between Advaxis, Inc. and Aratana Therapeutics, Inc. Incorporated by referenceto Exhibit 10.1 to Quarterly Report on Form 10-Q filed with the SEC on June 10, 2014. 10.29‡ Employment Agreement, dated March 24, 2014, by and between Advaxis, Inc. and Sara M. Bonstein. Incorporated by reference to Exhibit 10.2to Quarterly Report on Form 10-Q filed with the SEC on June 10, 2014. 10.30‡ Amendment No. 2, dated as of June 5, 2014, to the Employment Agreement by and between Advaxis, Inc. and Daniel J. O’Connor.Incorporated by reference to Exhibit 10.4 to Quarterly Report on Form 10-Q filed with the SEC on June 10, 2014. 10.31‡ Amendment No. 2, dated as of June 5, 2014, to the Employment Agreement by and between Advaxis, Inc. and Gregory T. Mayes. Incorporatedby reference to Exhibit 10.5 to Quarterly Report on Form 10-Q filed with the SEC on June 10, 2014. 47 Source: Advaxis, Inc., 10-K, December 21, 2017Powered by Morningstar® Document Research℠The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any use of this information,except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results. ExhibitNumber Description of Exhibits 10.32‡ Amendment No. 2, dated as of June 5, 2014, to the Employment Agreement by and between Advaxis, Inc. and Robert G. Petit. Incorporated byreference to Exhibit 10.6 to Quarterly Report on Form 10-Q filed with the SEC on June 10, 2014. 10.33‡ Amendment No. 1, dated as of June 5, 2014, to the Employment Agreement by and between Advaxis, Inc. and Sara M. Bonstein. Incorporatedby reference to Exhibit 10.8 to Quarterly Report on Form 10-Q filed with the SEC on June 10, 2014. 10.34‡ Employment Agreement, dated October 20, 2014, by and between Advaxis, Inc. and David J. Mauro. Incorporated by reference to Exhibit 10.1to Current Report on Form 8-K filed with the SEC on October 21, 2014 10.35‡ Form of Restricted Stock Agreement between Advaxis, Inc. and David J. Mauro, dated October 20, 2014. Incorporated by reference to Exhibit10.2 to Current Report on Form 8-K filed with the SEC on October 21, 2014. 10.36 Clinical Trial Collaboration Agreement, dated July 21, 2014, by and between Advaxis, Inc. and MedImmune, LLC. Incorporated by referenceto Exhibit 10.1 to Quarterly Report on Form 10-Q filed with the SEC on September 9, 2014. 10.37 5th Amendment to the Amended & Restated License Agreement, dated July 25, 2014, by and between Advaxis, Inc. and University ofPennsylvania. Incorporated by reference to Exhibit 10.2 to Quarterly Report on Form 10-Q filed with the SEC on September 9, 2014. 10.38 Amendment No. 2 to the Advaxis, Inc. 2011 Omnibus Incentive Plan, effective July 9, 2014. Incorporated by reference to Annex A to CurrentReport on Schedule 14A filed with the SEC on May 20, 2014. 10.39 Amended and Restated 2011 Omnibus Incentive Plan, dated September 8, 2014. Incorporated by reference to Exhibit 10.4 to Quarterly Reporton Form 10-Q filed with the SEC on September 9, 2014. 10.40 Master Services Agreement for Technical Transfer and Clinical Supply, dated February 5, 2014, by and between Advaxis, Inc. and SynCo BioPartners B.V. Incorporated by reference to Exhibit 10.1 to Current Report to Form 8-K filed with the SEC on February 11, 2014. 10.41 Clinical Trial Collaboration and Supply Agreement by and between Advaxis, Inc. and Merck & Co. dated August 22, 2014. Incorporated byreference to Exhibit 10.101 to Annual Report on Form 10-K filed with the SEC on January 6, 2015 10.42‡ Amendment No. 1, dated as of April 17, 2015, to the Employment Agreement by and between Advaxis, Inc and David J. Mauro. Incorporatedby reference to Exhibit 10.2 to Quarterly Report on Form 10-Q filed with the SEC on June 15, 2015. 10.43‡ Amendment No. 2, dated as of April 17, 2015, to the Employment Agreement by and between Advaxis, Inc and Sara M. Bonstein. Incorporatedby reference to Exhibit 10.3 to Quarterly Report on Form 10-Q filed with the SEC on June 15, 2015. 10.44‡ Amendment No. 3, dated as of April 17, 2015, to the Employment Agreement by and between Advaxis, Inc and Daniel J. O’Connor.Incorporated by reference to Exhibit 10.4 to Quarterly Report on Form 10-Q filed with the SEC on June 15, 2015. 10.45‡ Amendment No. 3, dated as of April 17, 2015, to the Employment Agreement by and between Advaxis, Inc and Gregory T. Mayes.Incorporated by reference to Exhibit 10.5 to Quarterly Report on Form 10-Q filed with the SEC on June 15, 2015. 10.46‡ Amendment No. 3, dated as of April 17, 2015, to the Employment Agreement by and between Advaxis, Inc and Robert G. Petit. Incorporatedby reference to Exhibit 10.6 to Quarterly Report on Form 10-Q filed with the SEC on June 15, 2015. 10.47 Exclusive License Agreement, dated August 25, 2015, by and between Advaxis, Inc. and Knight Therapeutics, Inc. Incorporated by referenceto Exhibit 10.57 to Annual Report on Form 10-K filed with the SEC on January 8, 2016. 10.48 Securities Purchase Agreement, dated as of August 25, 2015, between Advaxis, Inc., Knight Therapeutics Inc., and Sectoral Asset Management.Incorporated by reference to Exhibit 10.1 to Current Report on Form 8-K filed with the SEC on August 28, 2015. 10.49‡ Amendment No. 4, dated as of December 31, 2015, to the Employment Agreement by and between Advaxis, Inc and Robert G. Petit.Incorporated by reference to Exhibit 10.58 to Annual Report on Form 10-K filed with the SEC on January 8, 2016. 10.50‡ Amendment No. 3, dated as of December 31, 2015, to the Employment Agreement by and between Advaxis, Inc and Sara M. Bonstein.Incorporated by reference to Exhibit 10.59 to Annual Report on Form 10-K filed with the SEC on January 8, 2016. 10.51‡ Amendment No. 4, dated as of December 31, 2015, to the Employment Agreement by and between Advaxis, Inc and Daniel J. O’Connor.Incorporated by reference to Exhibit 10.60 to Annual Report on Form 10-K filed with the SEC on January 8, 2016. 10.52‡ Amendment No. 4, dated as of December 31, 2015, to the Employment Agreement by and between Advaxis, Inc and Gregory T. Mayes.Incorporated by reference to Exhibit 10.61 to Annual Report on Form 10-K filed with the SEC on January 8, 2016. 10.53 Co-Development and Commercialization Agreement between Advaxis, Inc. and Especificos Stendhal SA de CV dated February 3, 2016.Incorporated by reference to Exhibit 10.1 to Quarterly Report on Form 10-Q filed with the SEC on February 26, 2016. 10.54 Change of Control Plan dated February 24, 2016. Incorporated by reference to Exhibit 10.1 to Quarterly Report on Form 10-Q filed with theSEC on February 26, 2016. Source: Advaxis, Inc., 10-K, December 21, 2017Powered by Morningstar® Document Research℠The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any use of this information,except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results.10.55 License and Collaboration Agreement, dated August 2, 2016, by and between Advaxis, Inc. and Amgen Inc. Incorporated by reference toExhibit 10.57 to Annual Report on Form 10-K filed with the SEC on January 9, 2017. 10.56 Securities Purchase Agreement, dated as of August 1, 2016, between Advaxis, Inc. and Amgen, Inc. Incorporated by reference to Exhibit 10.1to Current Report on Form 8-K filed with the SEC on August 2, 2016. 10.57 Placement Agency Agreement, dated as of August 16, 2016, between Advaxis, Inc. Jefferies LLC and Barclay’s Capital Inc., as representatives.Incorporated by reference to Exhibit 10.1 to Current Report on Form 8-K filed with the SEC on August 16, 2016. 10.58‡ Separation Agreement and General Release, dated July 6, 2017, between Advaxis, Inc. and Daniel J. O’Connor. Incorporated by reference toExhibit 10.1 to Current Report on Form 8-K filed with the SEC on July 7, 2017. 10.59‡ Employment Agreement, dated July 18, 2017, by and between Advaxis, Inc. and Anthony Lombardo. Incorporated by reference to Exhibit10.1 to Current Report on Form 8-K filed with the SEC on July 21, 2017. 48 Source: Advaxis, Inc., 10-K, December 21, 2017Powered by Morningstar® Document Research℠The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any use of this information,except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results. ExhibitNumber Description of Exhibits 14.1 Code of Business Conduct and Ethics dated July 9, 2014. Incorporated by reference to Exhibit 14.1 to Current Report on Form 8-K filed withthe SEC on July 10, 2014. 23.1 Consent of Independent Registered Public Accounting Firm. 31.1* Certification of Chief Executive Officer pursuant to section 302 of the Sarbanes-Oxley Act of 2002 31.2* Certification of Chief Financial Officer pursuant to section 302 of the Sarbanes-Oxley Act of 2002 32.1* Certification of Chief Executive Officer pursuant to section 906 of the Sarbanes-Oxley Act of 2002 32.2* Certification of Chief Financial Officer pursuant to section 906 of the Sarbanes-Oxley Act of 2002 101.INS** XBRL Instance Document 101.SCH** XBRL Taxonomy Extension Schema Document 101.CAL** XBRL Taxonomy Extension Calculation Linkbase Document 101.DEF** XBRL Taxonomy Extension Definitions Linkbase Document 101.LAB** XBRL Taxonomy Extension Label Linkbase Document 101.PRE** XBRL Taxonomy Extension Presentation Linkbase Document *Filed herewith. **Furnished herewith. ‡Denotes management contract or compensatory plan or arrangement. 49 Source: Advaxis, Inc., 10-K, December 21, 2017Powered by Morningstar® Document Research℠The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any use of this information,except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results. SIGNATURE Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this Annual Report to be signed on its behalf by theundersigned, thereunto duly authorized, in Princeton, Mercer County, State of New Jersey, on this 20th day of December 2017. ADVAXIS, INC. By:/s/ Anthony Lombardo Anthony Lombardo, Interim Chief Executive Officer KNOW ALL PERSONS BY THESE PRESENTS, that each person whose signature appears below constitutes and appoints Daniel J. O’Connor and Sara M.Bonstein (with full power to act alone), as his true and lawful attorneys-in-fact and agents, with full powers of substitution and resubstitution, for him and inhis name, place and stead, in any and all capacities, to sign any and all amendments to this Annual Report on Form 10-K and to file the same, with allexhibits thereto, and other documents in connection therewith, with the Securities and Exchange Commission, granting unto said attorneys-in-fact andagents full power and authority to do and perform each and every act and thing requisite or necessary to be done in and about the premises, as fully to allintents and purposes as he might or could do in person, hereby ratifying and confirming all that said attorneys-in-fact and agents, or their substitute orsubstitutes, lawfully do or cause to be done by virtue hereof. Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, this report has been signed by the following persons on behalf of theregistrant and in the capacities and on the dates indicated: SIGNATURE Title DATE /s/ Anthony Lombardi Daniel J. O’Connor Interim Chief Executive Officer December 20, 2017 (Principal Executive Officer) /s/ Sara Bonstein Sara Bonstein Chief Financial Officer, Executive Vice President and Secretary December 20, 2017 (Principal Financial and Accounting Officer) /s/ David Sidransky David Sidransky Chairman of the Board December 20, 2017 /s/ James Patton James Patton Vice Chairman of the Board December 20, 2017 /s/ Richard Berman Richard Berman Director December 20, 2017 /s/ Thomas McKearn Thomas McKearn Director December 20, 2017 /s/ Samir Khleif Samir Khleif Director December 20, 2017 /s/ Roni Appel Roni Appel Director December 20, 2017 /s/ Thomas Ridge Thomas Ridge Director December 20, 2017 50 Source: Advaxis, Inc., 10-K, December 21, 2017Powered by Morningstar® Document Research℠The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any use of this information,except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results. ADVAXIS, INC. FINANCIAL STATEMENTS INDEX Page Report of Independent Registered Public Accounting Firm F-2 Balance Sheets F-3 Statements of Operations F-4 Statements of Shareholders’ Equity F-5 Statements of Cash Flows F-6 Notes to the Financial Statements F-8 F-1Source: Advaxis, Inc., 10-K, December 21, 2017Powered by Morningstar® Document Research℠The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any use of this information,except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results. REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM To the Audit Committee of theBoard of Directors and Shareholders ofAdvaxis, Inc. We have audited the accompanying balance sheets of Advaxis, Inc. (the “Company”) as of October 31, 2017 and 2016, and the related statements ofoperations, shareholders’ equity and cash flows for the years ended October 31, 2017, 2016, and 2015. These financial statements are the responsibility of theCompany’s management. Our responsibility is to express an opinion on these financial statements based on our audits. We conducted our audits in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those standards require thatwe plan and perform the audit to obtain reasonable assurance about whether the consolidated financial statements are free of material misstatement. An auditalso includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements, assessing the accounting principlesused and significant estimates made by management, as well as evaluating the overall financial statement presentation. We believe that our audits provide areasonable basis for our opinion. In our opinion, the financial statements referred to above present fairly, in all material respects, the financial position of Advaxis, Inc. as of October 31, 2017and 2016, and the results of its operations and its cash flows for the years ended October 31, 2017, 2016, and 2015 in conformity with accounting principlesgenerally accepted in the United States of America. We have also audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States), Advaxis Inc.’s internal controlover financial reporting as of October 31,2017, based on the criteria established in Internal Control-Integrated Framework issued by the Committee ofSponsoring Organizations of the Treadway Commission and our report dated December 20, 2017 expressed an unqualified opinion on the effectiveness of theCompany’s internal control over financial reporting. Marcum llp New York, NY December 20, 2017 F-2Source: Advaxis, Inc., 10-K, December 21, 2017Powered by Morningstar® Document Research℠The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any use of this information,except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results. ADVAXIS, INC.BALANCE SHEETS October 31, 2017 2016 ASSETS Current assets: Cash and cash equivalents $23,899,809 $112,750,980 Restricted cash 587,000 - Investments 46,398,304 39,336,548 Income tax receivable 4,452,682 2,549,862 Deferred expenses 2,986,385 4,291,385 Prepaid expenses and other current assets 2,918,644 946,423 Total current assets 81,242,824 159,875,198 Property and equipment (net of accumulated depreciation) 7,111,081 4,389,074 Intangible assets (net of accumulated amortization) 4,856,775 4,329,121 Other assets 431,098 450,667 Total assets $93,641,778 $169,044,060 LIABILITIES AND SHAREHOLDERS’ EQUITY Current liabilities: Accounts payable $5,121,406 $1,720,428 Accrued expenses 8,700,036 10,905,003 Deferred revenue 6,995,336 15,020,576 Other current liabilities 47,520 60,382 Total current liabilities 20,864,298 27,706,389 Deferred revenue 17,478,758 21,234,568 Other liabilities 1,038,555 800,909 Total liabilities 39,381,611 49,741,866 Commitments and contingencies – Note 10 Shareholders’ equity: Preferred stock, $0.001 par value; 5,000,000 shares authorized; Series B Preferred Stock; 0 sharesissued and outstanding at October 31, 2017 and 2016. Liquidation preference of $0 at October31, 2017 and 2016. - - Common stock - $0.001 par value; 65,000,000 shares authorized, 41,206,538 shares issued andoutstanding at October 31, 2017 and 40,057,067 shares issued and 40,041,047 shares outstandingat October 31, 2016. 41,207 40,057 Additional paid-in capital 355,361,187 327,098,749 Treasury stock, at cost, 0 shares at October 31, 2017 and 16,020 shares October 31, 2016 - (129,787)Accumulated deficit (301,142,227) (207,706,825)Total shareholders’ equity 54,260,167 119,302,194 Total liabilities and shareholders’ equity $93,641,778 $169,044,060 The accompanying notes should be read in conjunction with the financial statements. F-3Source: Advaxis, Inc., 10-K, December 21, 2017Powered by Morningstar® Document Research℠The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any use of this information,except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results. ADVAXIS, INC.STATEMENTS OF OPERATIONS Year Ended October 31, 2017 2016 2015 Revenue $12,031,050 $3,994,856 $- Operating expenses: Research and development expenses 71,900,462 48,774,589 24,455,447 General and administrative expenses 38,658,464 31,712,505 24,243,690 Total operating expenses 110,558,926 80,487,094 48,699,137 Loss from operations (98,527,876) (76,492,238) (48,699,137) Other income (expense): Interest income 669,759 331,529 114,219 Net changes in fair value of derivative liabilities 20,156 69,055 (48,950)Other income (expense), net (123) (201) (6,599)Net loss before income tax benefit (97,838,084) (76,091,855) (48,640,467) Income tax benefit 4,402,682 2,535,625 1,609,349 Net loss $(93,435,402) $(73,556,230) $(47,031,118) Net loss per common share, basic and diluted $(2.31) $(2.08) $(1.68) Weighted average number of common shares outstanding, basic and diluted 40,527,844 35,400,980 28,026,197 The accompanying notes should be read in conjunction with the financial statements. F-4Source: Advaxis, Inc., 10-K, December 21, 2017Powered by Morningstar® Document Research℠The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any use of this information,except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results. ADVAXIS, INC.STATEMENTS OF SHAREHOLDERS’ EQUITY Preferred Stock Common Stock AdditionalPaid-In Treasury Stock Accumulated TotalShareholders’ Shares Amount Shares Amount Capital Shares Amount Deficit Equity Balance at October 31,2014 - $- 19,630,139 $19,630 $107,601,493 - $- $(86,991,137) $20,629,986 Stock basedcompensation 1,167,976 1,169 21,374,861 21,376,030 Tax withholdings paidrelated to net sharesettlement of equityawards (1,375,979) (1,375,979)Tax withholdings paidon equity awards (114,445) (1,388,086) (1,388,086)Tax shares sold to payfor tax withholdings onequity awards 16,273 97,526 1,200,325 (32,004) 1,184,594 Common Stock issuedupon exercise of options 65,167 65 58,335 58,400 Common Stock issuedupon exercise ofwarrants 691,268 691 2,341,758 2,342,449 Conversion of notespayable into commonstock 4,104 4 39,928 39,932 Issuance of shares toemployees under ESPPPlan 7,063 7 28,784 28,791 Advaxis registereddirect offerings 8,806,165 8,806 63,046,722 63,055,528 Advaxis Public Offering 3,220,000 3,220 56,675,128 56,678,348 Net Loss (47,031,118) (47,031,118)Balance at October 31,2015 - $- 33,591,882 $33,592 $249,807,303 (16,919) $(187,761) $(134,054,259) $115,598,875 Stock basedcompensation 1,042,527 1,043 23,451,904 23,452,947 Tax withholdings paidrelated to net sharesettlement of equityawards (61,350) (61,350)Tax withholdings paidon equity awards (332,537) (2,729,230) (2,729,230)Tax shares sold to payfor tax withholdings onequity awards 64,110 333,436 2,787,204 (96,336) 2,754,978 Common stock issuedupon exercise ofwarrants 122,661 123 614,245 614,368 Conversion of notespayable into commonstock 1,481 1 29,548 29,549 Issuance of shares toemployees under ESPPPlan 6,627 7 73,237 73,244 Advaxis registereddirect offerings 2,244,443 2,244 28,154,163 28,156,407 Sale of common sharesto Amgen 3,047,446 3,047 24,965,589 24,968,636 Net Loss (73,556,230) (73,556,230)Balance at October 31,2016 - $- 40,057,067 $40,057 $327,098,749 (16,020) $(129,787) $(207,706,825) $119,302,194 Stock basedcompensation 1,030,507 1,031 27,864,642 27,865,673 Tax withholdings paidrelated to net sharesettlement of equityawards (356,949) (356,949)Tax withholdings paidon equity awards (997,029) (128,613) (881,055) (1,878,084)Tax shares sold to payfor tax withholdings onequity awards 843,526 144,633 1,010,842 1,854,368 Common stock issuedupon exercise ofwarrants 225 1,125 1,125 Issuance of shares toemployees under ESPPPlan 26,594 27 251,347 251,374 Advaxis at-the-marketsales 92,145 92 655,776 655,868 Net Loss (93,435,402) (93,435,402)Source: Advaxis, Inc., 10-K, December 21, 2017Powered by Morningstar® Document Research℠The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any use of this information,except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results.Balance at October 31,2017 - $- 41,206,538 $41,207 $355,361,187 - $- $(301,142,227) $54,260,167 The accompanying notes should be read in conjunction with the financial statements. F-5Source: Advaxis, Inc., 10-K, December 21, 2017Powered by Morningstar® Document Research℠The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any use of this information,except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results. ADVAXIS, INC.STATEMENT OF CASH FLOWS Year ended October 31, 2017 2016 2015 OPERATING ACTIVITIES Net loss $(93,435,402) $(73,556,230) $(47,031,118)Adjustments to reconcile net loss to net cash used in operating activities: Stock compensation 27,835,673 23,472,947 21,431,030 Loss (gain) on change in value of warrants and embedded derivative (20,156) (69,055) 48,950 Loss (gain) on disposal of property and equipment 3,187 - (10,000)Warrant expense - - 8,170 Write-off of intangible assets 315,394 - 28,480 Depreciation expense 790,554 283,538 59,033 Amortization expense of intangible assets 329,866 252,654 206,357 Amortization of premium on held to maturity investments 183,947 252,730 60,608 Debt conversion expense - - 6,599 Change in operating assets and liabilities: Prepaid expenses and other current assets (1,972,221) (447,167) (293,096)Income taxes receivable (1,902,820) (940,513) 121,968 Other assets 1,324,569 (3,843,419) 104,529 Accounts payable and accrued expenses 1,159,534 8,354,447 1,094,155 Deferred revenue (11,781,050) 36,255,144 - Other liabilities 244,940 841,135 Net cash used in operating activities (76, 923,985) (9,143,789) (24,164,335) INVESTING ACTIVITIES Restricted cash established with letter of credit agreement (587,000) - - Purchases of investments (71,175,703) (44,524,783) (45,655,103)Proceeds from maturities and redemptions of investments 63,930,000 50,530,000 - Purchase of property and equipment (3,449,271) (3,222,442) (972,859)Cost of intangible assets (1,172,914) (1,226,742) (821,925)Net cash provided by (used in) investing activities (12,454,888) 1,556,033 (47,449,887) FINANCING ACTIVITIES Net proceeds of issuance of common stock 655,868 53,125,043 119,733,876 Proceeds from employee stock purchase plan 251,374 73,244 28,791 Proceeds from exercise of options - - 58,400 Proceeds from the exercise of warrants 1,125 614,368 2,342,449 Tax withholdings paid related to net share settlement of equity awards (356,949) (61,350) (1,375,979)Employee tax withholdings paid on equity awards (1,878,084) (2,729,230) (1,388,086)Tax shares sold to pay for employee tax withholdings on equity awards 1,854,368 2,754,978 1,169,594 Net cash provided by financing activities 527,702 53,777,053 120,569,045 Net increase (decrease) in cash and cash equivalents (88,851,171) 46,189,297 48,954,823 Cash and cash equivalents at beginning of year 112,750,980 66,561,683 17,606,860 Cash and cash equivalents at end of year $23,899,809 $112,750,980 $66,561,683 The accompanying notes should be read in conjunction with the financial statements. F-6Source: Advaxis, Inc., 10-K, December 21, 2017Powered by Morningstar® Document Research℠The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any use of this information,except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results. Supplemental Disclosures of Cash Flow Information Year Ended October 31, 2017 2016 2015 Cash paid for interest $- $- $- Cash paid for taxes $50,000 $50,000 $- Supplemental Schedule of Noncash Investing and Financing Activities Year Ended October 31, 2017 2016 2015 Accounts payable and accrued expenses settled with common stock $75,000 $55,000 $- Conversion of notes payable into common stock $- $29,549 $39,932 Sale of treasury shares pending settlement $- $- $15,000 Property and equipment included in accounts payable and accrued expenses $66,477 $362,926 $- The accompanying notes should be read in conjunction with the financial statements. F-7Source: Advaxis, Inc., 10-K, December 21, 2017Powered by Morningstar® Document Research℠The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any use of this information,except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results. ADVAXIS, INC.NOTES TO FINANCIAL STATEMENTS 1. NATURE OF OPERATIONS AND BASIS OF PRESENTATION Advaxis, Inc. (“Advaxis” or the “Company”) is a late-stage biotechnology Company focused on the discovery, development and commercializationof proprietary Lm Technology antigen delivery products based on a platform technology that utilizes live attenuated Listeria monocytogenes (“Lm”)bioengineered to secrete antigen/adjuvant fusion proteins. These Lm-based strains are believed to be a significant advancement in immunotherapy as theyintegrate multiple functions into a single immunotherapy by accessing and directing antigen presenting cells to stimulate anti-tumor T cell immunity,stimulate and activate the immune system with the equivalent of multiple adjuvants, and simultaneously reduce tumor protection in the TumorMicroenvironment (“TME”) to enable the T cells to eliminate tumors. The Company believes that Lm Technology immunotherapies can complement andaddress significant unmet needs in the current oncology treatment landscape. Specifically, their product candidates have the potential to optimizecheckpoint performance, while having a generally well-tolerated safety profile, and most of their product candidates are immediately available for treatmentwith a low cost of goods. The Company’s passion for the clinical potential of Lm Technology is balanced by focus and fiscal discipline and driven towardsincreasing shareholder value. Advaxis is focused on four franchises in various stages of clinical and pre-clinical development, which they believe will provide the greatestopportunity to have a significant impact on patients and their families: ·Human Papilloma Virus (“HPV”)-associated cancers·Neoantigen therapy·Disease focused hotspot / cancer antigen therapies·Prostate cancer All four clinical franchises are anchored in the Company’s Lm TechnologyTM, a unique platform designed for its ability to safely and effectivelytarget various cancers in multiple ways. As an intracellular bacterium, Lm is an effective vector for the presentation of antigens through both the MajorHistocompatibility Complex (“MHC”) I and II pathways, due to its active phagocytosis by Antigen Presenting Cells (“APCs”). Within the APCs, Lm producesvirulence factors which allow survival in the host cytosol and potently stimulate the immune system. Liquidity and Financial Condition The Company’s products that are being developed have not generated significant revenue. As a result, the Company has suffered recurring losses.These losses are expected to continue for an extended period of time. Our major sources of cash have been proceeds from various public and private offeringsof our common stock, option and warrant exercises, and interest income. From October 2013 through October 2017, we raised approximately $222.5 millionin gross proceeds from various public and private offerings of our common stock. As of October 31, 2017, the Company had approximately $70.9 million in cash, restricted cash, cash equivalents and investments on its balancesheet. The Company plans to continue to be disciplined in regards to its utilization of its capital and anticipates its cash burn will decrease from fiscal 2017.This decrease will largely be due to several one-time items in fiscal 2017 related to the preparation of our MAA filing of axalimogene filolisbac and otherone-time costs that the Company does not anticipate to recur. We believe our current cash position is sufficient to fund our business plan into fiscal 2019.The actual amount of cash that we will need to operate is subject to many factors. The Company also recognizes it may need to raise additional capital in order to continue to execute its business plan. There is no assurance thatadditional financing will be available when needed or that management will be able to obtain financing on terms acceptable to the Company or whether theCompany will become profitable and generate positive operating cash flow. If the Company is unable to raise sufficient additional funds, it will have to scaleback its operations. 2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Estimates The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America (“U.S. GAAP”)requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. Estimates areused when accounting for such items as the fair value and recoverability of the carrying value of property and equipment and intangible assets (patents andlicenses), the fair value of options, the fair value of embedded conversion features, warrants and related disclosure of contingent assets and liabilities. On anon-going basis, the Company evaluates its estimates, based on historical experience and on various other assumptions that it believes to be reasonable underthe circumstances. Actual results may or may not differ from estimates. Reclassification Certain amounts in the prior period financial statements have been reclassified to conform to the presentation of the current period financialstatements. These reclassifications had no effect on the previously reported net loss. F-8Source: Advaxis, Inc., 10-K, December 21, 2017Powered by Morningstar® Document Research℠The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any use of this information,except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results. Collaboration Agreements The Company evaluates whether an arrangement is a collaborative arrangement under the Financial Accounting Standards Board (the “FASB”)Accounting Standards Codification (“ASC”) Topic 808, Collaborative Arrangements, at its inception based on the facts and circumstances specific to thearrangement. The Company also reevaluates whether an arrangement qualifies or continues to qualify as a collaborative arrangement whenever there is achange in either the roles of the participants or the participants’ exposure to significant risks and rewards dependent on the ultimate commercial success ofthe endeavor. For those collaborative arrangements where it is determined that the Company is the principal participant, costs incurred and revenue generatedfrom third parties are recorded on a gross basis in the financial statements. From time to time, the Company enters into collaborative arrangements for the research and development, manufacture and/or commercialization ofproducts and product candidates. These collaborations generally provide for non-refundable, upfront license fees, research and development and commercialperformance milestone payments, cost sharing, royalty payments and/or profit sharing. The Company’s collaboration agreements with third parties areperformed on a ‘‘best efforts’’ basis with no guarantee of either technological or commercial success. Revenue Recognition The Company is expected to derive the majority of its revenue from patent licensing and research and development services associated with patentlicensing. In general, these revenue arrangements provide for the payment of contractually determined fees in consideration for the grant of certainintellectual property rights for patented technologies owned or controlled by the Company. The intellectual property rights granted may be perpetual innature, or upon the final milestones being met, or can be granted for a defined, relatively short period of time, with the licensee possessing the right to renewthe agreement at the end of each contractual term for an additional minimum upfront payment. The Company recognizes licensing fees when there ispersuasive evidence of a licensing arrangement, fees are fixed or determinable, delivery has occurred and collectability is reasonably assured. Revenue associated with nonrefundable upfront license fees under arrangements where the license fees and research and development activitiescannot be accounted for as separate units of accounting is deferred and recognized as revenue on a straight-line basis over the expected period ofperformance. Revenues from the achievement of research and development milestones, if deemed substantive, are recognized as revenue when the milestones areachieved and the milestone payments are due and collectible. If not deemed substantive, the Company recognizes such milestones as revenue on a straight-line basis over the remaining expected performance period under the arrangement. All such recognized revenues are included in collaborative licensing anddevelopment revenue in the Company’s statements of operations. Milestones are considered substantive if all of the following conditions are met: (1) the milestone is nonrefundable; (2) achievement of themilestone was not reasonably assured at the inception of the arrangement; (3) substantive effort is involved to achieve the milestone; and (4) the amount ofthe milestone appears reasonable in relation to the effort expended, and the other milestones in the arrangement and the related risk associated with theachievement of the milestone and any ongoing research and development or other services are priced at fair value. If product development is successful, the Company will recognize revenue from royalties based on licensees’ sales of its products or products usingits technologies. Royalties are recognized as earned in accordance with the contract terms when royalties from licensees can be reasonably estimated andcollectability is reasonably assured. If royalties cannot be reasonably estimated or collectability of a royalty amount is not reasonably assured, royalties arerecognized as revenue when the cash is received. Deferred revenue represents the portion of payments received for which the earnings process has not been completed. Deferred revenue expected tobe recognized within the next 12 months is classified as a current liability. An allowance for doubtful accounts is established based on the Company’s best estimate of the amount of probable credit losses in the Company’sexisting license fee receivables, using historical experience. The Company reviews its allowance for doubtful accounts periodically. Past due accounts arereviewed individually for collectability. Account balances are charged off against the allowance after all means of collection have been exhausted and thepotential for recovery is considered remote. To date, this is yet to occur. Cash and Cash Equivalents The Company considers all highly liquid investments with an original maturity of three months or less from the date of purchase to be cashequivalents. Restricted Cash and Letter of Credit During 2017, the Company established a letter of credit with a financial institution as security for the purchase of custom equipment. The letter ofcredit is collateralized by cash which is unavailable for withdrawal or for usage for general obligations. No amount is outstanding under the letter of credit asof October 31, 2017. F-9Source: Advaxis, Inc., 10-K, December 21, 2017Powered by Morningstar® Document Research℠The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any use of this information,except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results. Concentration of Credit Risk The Company maintains its cash in bank deposit accounts (checking) that at times exceed federally insured limits. Approximately $23.1 million issubject to credit risk at October 31, 2017. However, these cash balances are maintained at creditworthy financial institutions. The Company has notexperienced any losses in such accounts and believes it is not exposed to any significant credit risk. Investments Investment securities consist of certificates of deposit, domestic governmental agency loans, and U.S. treasury notes. The Company classifies thesesecurities as held-to-maturity. Held-to-maturity securities are those securities in which the Company has the ability and intent to hold until maturity. Held-to-maturity securities are recorded at amortized cost, adjusted for the amortization or accretion of premiums or discounts. Premiums and discounts are amortizedor accreted over the life of the related held-to-maturity security as an adjustment to yield using the effective interest method. A decline in the market value of any investment security below cost, that is deemed to be other than temporary, results in a reduction in the carryingamount to fair value. The impairment is charged to operations and a new cost basis for the security is established. Other-than-temporary impairment chargesare included in Other Income (Expense), net. The Company did not recognize any impairment charges during the years ended October 31, 2017, 2016 or2015. Interest income is recognized when earned. Deferred Expenses Deferred expenses consist of advanced payments made on research and development projects. Expense is recognized in the Statement of Operationsas the research and development activity is performed. Property and Equipment Property and equipment is stated at cost. Additions and improvements that extend the lives of the assets are capitalized, while expenditures forrepairs and maintenance are expensed as incurred. Leasehold improvements are amortized on a straight-line basis over the shorter of the asset’s estimateduseful life or the remaining lease term. Depreciation is calculated on a straight-line basis over the estimated useful lives of the assets ranging from three to tenyears. When depreciable assets are retired or sold the cost and related accumulated depreciation are removed from the accounts and any resulting gain orloss is recognized in operations. Intangible Assets Intangible assets are recorded at cost and include patents and patent application costs, licenses and software. Intangible assets are amortized on astraight-line basis over their estimated useful lives ranging from 3 to 20 years. Patent application costs are written-off if the application is rejected, withdrawnor abandoned. Impairment of Long-Lived Assets The company reviews its long-lived assets, including property and equipment and intangible assets, for impairment whenever events andcircumstances indicate that the carrying value of an asset might not be recoverable. Recoverability of assets held and used is measured by comparison of thecarrying amount of an asset to the future undiscounted cash flows expected to be generated from the use of the asset and its eventual disposition. If the totalof the undiscounted future cash flows is less than the carrying amount of those assets, an impairment loss is recognized in the Statement of Operations basedon the excess of the carrying amount over the fair value of the asset. Net Income (Loss) per Share Basic net income or loss per common share is computed by dividing net income or loss available to common shareholders by the weighted averagenumber of common shares outstanding during the period. Diluted earnings per share give effect to dilutive options, warrants, convertible debt and otherpotential Common Stock outstanding during the period. In the case of a net loss the impact of the potential Common Stock resulting from warrants,outstanding stock options and convertible debt are not included in the computation of diluted loss per share, as the effect would be anti-dilutive. In the caseof net income, the impact of the potential Common Stock resulting from these instruments that have intrinsic value are included in the diluted earnings pershare. The table sets forth the number of potential shares of Common Stock that have been excluded from diluted net loss per share. As of October 31, 2017 2016 2015 Warrants 3,092,935 3,110,575 3,241,466 Stock options 3,893,558 3,351,795 1,981,939 Restricted stock units 1,363,119 719,448 1,069,335 Convertible debt (using the if-converted method) - - 1,576 Total 8,349,612 7,181,818 6,294,316 F-10Source: Advaxis, Inc., 10-K, December 21, 2017Powered by Morningstar® Document Research℠The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any use of this information,except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results. Research and Development Expenses Research and development costs are expensed as incurred and include but are not limited to clinical trial and related manufacturing costs, payrolland personnel expenses, lab expenses, and related overhead costs. Stock Based Compensation The Company has an equity plan which allows for the granting of stock options to its employees, directors and consultants for a fixed number ofshares with an exercise price equal to the fair value of the shares at date of grant. The Company measures the cost of services received in exchange for anaward of equity instruments based on the fair value of the award. For employees and directors, the fair value of the award is measured on the grant date and fornon-employees, the fair value of the award is generally measured based on contractual terms. The fair value amount is then recognized over the requisiteservice period, usually the vesting period, in both research and development expenses and general and administrative expenses on the statement ofoperations, depending on the nature of the services provided by the employees or consultants. The process of estimating the fair value of stock-based compensation awards and recognizing stock-based compensation cost over their requisiteservice period involves significant assumptions and judgments. The Company estimates the fair value of stock option awards on the date of grant using theBlack Scholes Model (“BSM”) for the remaining awards, which requires that the Company makes certain assumptions regarding: (i) the expected volatility inthe market price of its Common Stock; (ii) dividend yield; (iii) risk-free interest rates; and (iv) the period of time employees are expected to hold the awardprior to exercise (referred to as the expected holding period). As a result, if the Company revises its assumptions and estimates, stock-based compensationexpense could change materially for future grants. The Company accounts for stock-based compensation using fair value recognition and records forfeitures as they occur. As such, the Companyrecognizes stock-based compensation cost only for those stock-based awards that vest over their requisite service period, based on the vesting provisions ofthe individual grants. Treasury Stock The Company accounts for repurchases of common stock and shares withheld in lieu of taxes when restricted stock vests using the cost method withcommon stock in treasury classified in the balance sheet as a reduction in shareholders’ equity. Fair Value of Financial Instruments The carrying value of financial instruments, including cash and cash equivalents, restricted cash and accounts payable approximated fair value as ofthe balance sheet date presented, due to their short maturities. The carrying amounts of financing arrangements issued approximate fair value as of thebalance sheet date presented, because interest rates on these instruments approximate market interest rates after consideration of stated interest rates, anti-dilution protection and associated warrants. Derivative Financial Instruments The Company does not use derivative instruments to hedge exposures to cash flow, market or foreign currency risks. The Company evaluates all ofits financial instruments to determine if such instruments are derivatives or contain features that qualify as embedded derivatives. For derivative financialinstruments that are accounted for as liabilities, the derivative instrument is initially recorded at its fair value and is then re-valued at each reporting date,with changes in the fair value reported in the statements of operations. For stock-based derivative financial instruments, the Company used the Black Scholesvaluation model which approximated the binomial lattice options pricing model to value the derivative instruments at inception and on subsequentvaluation dates. The classification of derivative instruments, including whether such instruments should be recorded as liabilities or as equity, is evaluated atthe end of each reporting period. Derivative liabilities are classified in the balance sheet as current or non-current based on whether or not net-cash settlementof the instrument could be required within 12 months of the balance sheet date. Income Taxes The Company uses the asset and liability method of accounting for income taxes in accordance with ASC Topic 740, “Income Taxes.” Under thismethod, income tax expense is recognized for the amount of: (i) taxes payable or refundable for the current year and (ii) deferred tax consequences oftemporary differences resulting from matters that have been recognized in an entity’s financial statements or tax returns. Deferred tax assets and liabilities aremeasured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered orsettled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in the results of operations in the period that includes theenactment date. A valuation allowance is provided to reduce the deferred tax assets reported if based on the weight of the available positive and negativeevidence, it is more likely than not some portion or all of the deferred tax assets will not be realized. F-11Source: Advaxis, Inc., 10-K, December 21, 2017Powered by Morningstar® Document Research℠The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any use of this information,except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results. Recent Accounting Pronouncements In May 2014, as part of its ongoing efforts to assist in the convergence of GAAP and International Financial Reporting Standards, the FinancialAccounting Standards Board (the “FASB”) issued Accounting Standards Update (“ASU”) 2014-09, Revenue from Contracts with Customers, which is a newstandard related to revenue recognition. Under the new standard, recognition of revenue occurs when a customer obtains control of promised services orgoods in an amount that reflects the consideration to which the entity expects to receive in exchange for those goods or services. In addition, the standardrequires disclosure of the nature, amount, timing, and uncertainty of revenue and cash flows arising from customer contracts. The standard must be adoptedusing either a full retrospective approach for all periods presented in the period of adoption or a modified retrospective approach. In July 2015, the FASBissued ASU 2015-14, Revenue from Contracts with Customers - Deferral of the Effective Date, which defers the implementation of this new standard to beeffective for fiscal years beginning after December 15, 2017. Early adoption is permitted effective January 1, 2017. In March 2016, the FASB issued ASU2016-08, Principal versus Agent Considerations, which clarifies the implementation guidance on principal versus agent considerations in the new revenuerecognition standard pursuant to ASU 2014-09. In April 2016, the FASB issued ASU 2016-10, Identifying Performance Obligations and Licensing, and inMay 2016, the FASB issued ASU 2016-12, Narrow-Scope Improvements and Practical Expedients, which amend certain aspects of the new revenuerecognition standard pursuant to ASU 2014-09. In December 2016, the FASB issued ASU 2016-20, Technical Corrections and Improvements to Topic 606,Revenue from Contracts with Customers to clarify the codification or to correct unintended application of guidance. In September and November 2017 , theFASB issued ASU 2017-13 , Revenue Recognition (Topic 605), Revenue from Contracts with Customers (Topic 606), Leases (Topic 840), and Leases (Topic842) and ASU 2017-14, Income Statement—Reporting Comprehensive Income (Topic 220), Revenue Recognition (Topic 605), and Revenue from Contractswith Customers (Topic 606) which amends certain aspects of the new revenue recognition standard The Company is currently evaluating which transitionapproach we will utilize and the impact of adopting this accounting standard on the Company’s financial statements. In August 2014, the FASB issued ASU 2014-15, Disclosures of Uncertainties About an Entity’s Ability to Continue as a Going Concern. The newstandard provides guidance around management’s responsibility to evaluate whether there is substantial doubt about an entity’s ability to continue as agoing concern and to provide related footnote disclosures. The new standard is effective for fiscal years, and interim periods within those fiscal years, endingafter December 15, 2016. The Company has adopted this standard effective for the year ending October 31, 2017. There was no impact on the Company’sfinancial statements. In February 2016, the FASB issued ASU 2016-02, Leases (“ASU 2016-02”). The standard amends the existing accounting standards for leaseaccounting, including requiring lessees to recognize most leases on their balance sheets and making targeted changes to lessor accounting. ASU 2016-02 willbe effective beginning in the first quarter of fiscal 2020. Early adoption of ASU 2016-02 is permitted. The new leases standard requires a modifiedretrospective transition approach for all leases existing at, or entered into after, the date of initial application, with an option to use certain transition relief. InSeptember, the FASB issued ASU 2017-13, Revenue Recognition (Topic 605), Revenue from Contracts with Customers (Topic 606), Leases (Topic 840), andLeases (Topic 842) which amends certain aspects of the new lease standard. The Company is currently evaluating the impact of adopting ASU 2016-02 onthe Company’s financial statements. In November 2016, the FASB issued ASU 2016-18, Statement of Cash Flows (Topic 230): Restricted Cash. The new standard changes thepresentation of restricted cash and cash equivalents on the statement of cash flows. Restricted cash and restricted cash equivalents will be included with cashand cash equivalents when reconciling the beginning-of-period and end-of-period total amounts shown on the statement of cash flows. The new standard iseffective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2017. Early adoption is permitted. This ASU is notexpected to have a material impact on the Company’s financial statements. In January 2017, the FASB issued ASU No. 2017-01, “Business Combinations (Topic 805): Clarifying the Definition of a Business.” Theamendments in this Update clarify the definition of a business with the objective of adding guidance to assist entities with evaluating whether transactionsshould be accounted for as acquisitions (or disposals) of businesses. The amendments in this Update provide a screen to determine when a set is not abusiness. If the screen is not met, it (1) requires that to be considered a business, a set must include, at a minimum, an input and a substantive process thattogether significantly contribute to the ability to create output and (2) removes the evaluation of whether a market participant could replace the missingelements. This Update is the final version of Proposed ASU 2015-330 Business Combinations (Topic 805) – Clarifying The Definition of a Business, whichhas been deleted. The amendments in this Update are effective for all entities for annual periods, and interim periods within those annual periods, beginningafter December 15, 2017. Early adoption is permitted. This ASU is not expected to have a material impact on the Company’s financial statements. In May 2017, the FASB issued ASU 2017-09, “Compensation—Stock Compensation (Topic 718): Scope of Modification Accounting” to provideclarity and reduce both (1) diversity in practice and (2) cost and complexity when applying the guidance in Topic 718, Compensation—StockCompensation, to a change to the terms or conditions of a share-based payment award. The amendments in this Update provide guidance about whichchanges to the terms or conditions of a share-based payment award require an entity to apply modification accounting in Topic 718. This Update is the finalversion of Proposed ASU 2016-360—Compensation—Stock Compensation (Topic 718)—Scope of Modification Accounting, which has been deleted. Theamendments in this Update are effective for all entities for annual periods, and interim periods within those annual periods, beginning after December 15,2017. Early adoption is permitted. This ASU is not expected to have a material impact on the Company’s financial statements. Management does not believe that any other recently issued, but not yet effective accounting pronouncements, if adopted, would have a materialimpact on the accompanying consolidated financial statements. F-12 Source: Advaxis, Inc., 10-K, December 21, 2017Powered by Morningstar® Document Research℠The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any use of this information,except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results. 3. INVESTMENTS The following table summarizes the Company’s investment securities at amortized cost as of October 31, 2017 and 2016: October 31, 2017 AmortizedCost,as Adjusted GrossUnrealizedHolding Gains GrossUnrealizedHolding Losses Estimated FairValue Short-term investments: Certificates of Deposit $11,391,147 $- $- $11,391,147 Domestic Governmental Agency Loans 499,957 - 162 499,795 U.S Treasury Notes 34,507,200 - 25,351 34,481,849 Total short-term investment securities $46,398,304 $- $25,513 $46,372,791 October 31, 2016 AmortizedCost,as Adjusted GrossUnrealizedHolding Gains GrossUnrealizedHolding Losses Estimated FairValue Short-term investments: Certificates of Deposit $10,737,563 $- $- $10,737,563 Domestic Governmental Agency Loans 2,500,000 - 250 2,499,750 U.S Treasury Notes 26,098,985 2,404 7,556 26,093,833 Total short-term investment securities $39,336,548 $2,404 $7,806 $39,331,146 All of the Company’s investments mature within the next 12 months. 4. PROPERTY AND EQUIPMENT Property and equipment consists of the following: October 31, 2017 2016 Leasehold improvements $2,167,990 $1,835,602 Laboratory equipment 4,381,428 2,038,704 Furniture and fixtures 728,725 549,025 Computer equipment 394,523 240,910 Construction in progress 645,000 151,368 Total property and equipment 8,317,666 4,815,609 Accumulated depreciation and amortization (1,206,585) (426,535)Net property and equipment $7,111,081 $4,389,074 Depreciation expense for the years ended October 31, 2017, 2016 and 2015 was $790,554, $283,538 and $59,033, respectively. 5. INTANGIBLE ASSETS Intangible assets consist of the following: October 31, 2017 2016 Patents $5,727,298 $4,980,610 License 776,992 776,992 Software 108,604 19,625 Total intangibles 6,612,894 5,777,227 Accumulated amortization (1,756,119) (1,448,106)Net intangible assets $4,856,775 $4,329,121 The expirations of the existing patents range from 2017 to 2038 but the expirations can be extended based on market approval if granted and/orbased on existing laws and regulations. Capitalized costs associated with patent applications that are abandoned without future value are charged to expensewhen the determination is made not to pursue the application. Patent applications having a net book value of $315,394, $0 and $28,480 and were abandonedand were charged to research and development expenses in the Statement of Operations for the years ended October 31, 2017, 2016 and 2015, respectively.Amortization expense for intangible assets is included in general and administrative expenses and aggregated $329,866, $252,654 and $206,357 for theyears ended October 31, 2017, 2016 and 2015, respectively. F-13 Source: Advaxis, Inc., 10-K, December 21, 2017Powered by Morningstar® Document Research℠The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any use of this information,except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results.2018 $365,848 2019 363,448 2020 346,593 2021 329,647 2022 329,647 Thereafter 3,121,592 Total $4,856,775 At October 31, 2017, the estimated amortization expense by fiscal year based on the current carrying value of intangible assets is as follows: 6. ACCRUED EXPENSES: The following table represents the major components of accrued expenses: October 31, 2017 2016 Salaries and other compensation $2,652,583 $2,467,650 Vendors 2,811,956 2,098,792 Professional fees 3,235,497 6,338,561 Total accrued expenses $8,700,036 $10,905,003 7. COMMON STOCK PURCHASE WARRANTS AND WARRANT LIABILITY Warrants A summary of warrant activity was as follows: Shares WeightedAverageExercise Price WeightedAverageRemainingContractual LifeIn Years AggregateIntrinsic Value Outstanding and exercisable warrants at October 31,2014 4,158,092 $5.43 3.94 $9,518 Issued 2,361 7.20 Exercised * (769,349) 5.12 Expired (149,638) 14.61 Outstanding and exercisable warrants at October 31,2015 3,241,466 $5.07 2.90 $19,588,099 Exercised (122,661) 5.01 Expired (8,230) 18.75 Outstanding and exercisable warrants at October 31,2016 3,110,575 $5.04 1.91 $9,558,159 Exercised (225) 5.00 Expired (17,955) 11.43 Outstanding and exercisable warrants at October 31,2017 3,092,395 $5.00 0.92 $- * Includes the cashless exercise of 300,376 warrants that resulted in the issuance of 222,295 shares of common stock. F-14 Source: Advaxis, Inc., 10-K, December 21, 2017Powered by Morningstar® Document Research℠The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any use of this information,except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results. At October 31, 2017, the Company had all of its total 3.09 million outstanding warrants classified as equity (equity warrants). At October 31, 2016,the Company had approximately 3.09 million of its total 3.11 million outstanding warrants classified as equity. At October 31, 2015, the Company hadapproximately 3.22 million of its total 3.24 million outstanding warrants classified as equity. At issuance, equity warrants are recorded at their relative fairvalues, using the Relative Fair Value Method, in the shareholders equity section of the balance sheet. The Company’s equity warrants can only be settledthrough the issuance of shares and are not subject to anti-dilution provisions. Warrant Liability At October 31, 2017, the Company had no warrants classified as liabilities (liability warrants), as all of the liability warrants expired. At October 31,2016, the Company had approximately 18,000 of its total 3.11 million outstanding warrants classified as liabilities. At October 31, 2015, the Company hadapproximately 18,000 of its total 3.24 million outstanding warrants classified as liabilities. The Company utilizes the BSM to calculate the fair value of thesewarrants at issuance and at each subsequent reporting date. For those warrants with exercise price reset features (anti-dilution provisions), the Companycomputes multiple valuations, each quarter, using an adjusted BSM, to account for the various possibilities that could occur due to changes in the inputs tothe BSM as a result of contractually-obligated changes (for example, changes in strike price to account for down-round provisions). The Company effectivelyweights each calculation based on the likelihood of occurrence to determine the value of the warrants at the reporting date. As of October 31, 2015, all of theliability warrants that were subject to weighted-average anti-dilution provisions had expired. The remaining liability warrants contain a cash settlementprovision in the event of a fundamental transaction (as defined in the Common Stock purchase warrant). Any changes in the fair value of the warrant liability(i.e. - the total fair value of all outstanding liability warrants at the balance sheet date) between reporting periods will be reported on the statement ofoperations. At October 31, 2017 and October 31, 2016, the fair value of the warrant liability was $0 and $20,156, respectively and is reflected in other currentliabilities in the Balance Sheet. For the years ended October 31, 2017, 2016 and 2015, the Company reported income of $20,156, income of $69,055 and aloss of $48,950, respectively, due to changes in the fair value of the warrant liability. In fair valuing the warrant liability, at October 31, 2016 and 2015, the Company used the following inputs in its BSM: 10/31/2016 10/31/2015 Exercise price $10.63-18.75 $10.63-18.75 Stock price $8.09 $11.09 Expected term 0.55-0.75 years 1.52-1.76 years Volatility % 81.84%-87.09% 93.87%-95.00%Risk free rate 0.51%-0.66% .075% Warrants with anti-dilution provisions Some of the Company’s warrants contained anti-dilution provisions originally set at an exercise price of $25.00 with a term of five years. As ofOctober 31, 2015, all of these warrants had expired. If the Company had issued any Common Stock, except for exempt issuances as defined in the warrantagreement, for consideration less than the exercise price, then the exercise price and the amount of warrant shares available would have been adjusted to anew price and amount of shares per the “weighted average” formula included in the warrant agreement. For the year ended October 31, 2015, this anti-dilution provision required the Company to issue approximately 2,400 additional warrant shares, and the exercise price to be lowered to $7.20. For those warrants with exercise price reset features (anti-dilution provisions), the Company computed multiple valuations, each quarter, using anadjusted BSM, to account for the various possibilities that could occur due to changes in the inputs to the BSM as a result of contractually-obligated changes(for example, changes in strike price to account for down-round provisions). The Company utilized different exercise prices of $7.20 and $6.00, weightingthe possibility of warrants being exercised at $7.20 between 40% and 50% and warrants being exercised at $6.00 between 50% and 60%. 8. SHARE BASED COMPENSATION The following table summarizes share-based compensation expense included in the Statement of Operations by expense category for the years endedOctober 31, 2017, 2016 and 2015, respectively: Year Ended October 31, 2017 2016 2015 Research and development $5,647,913 $7,985,651 $6,293,791 General and administrative 22,187,760 15,487,296 15,137,239 Total $27,835,673 $23,472,947 $21,431,030 Amendments The Advaxis, Inc. 2015 Incentive Plan (the “2015 Plan”) was originally ratified and approved by the Company’s stockholders on May 27, 2015.Subject to proportionate adjustment in the event of stock splits and similar events, the aggregate number of shares of Common Stock that may be issuedunder the 2015 Plan is 3,600,000 shares, plus a number of additional shares (not to exceed 650,000) underlying awards outstanding as of the effective date ofthe 2015 Plan under the prior plan that thereafter terminate or expire unexercised, or are cancelled, forfeited or lapse for any reason. F-15 Source: Advaxis, Inc., 10-K, December 21, 2017Powered by Morningstar® Document Research℠The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any use of this information,except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results. At the Annual Meeting of Stockholders of the Company held on March 10, 2016, the stockholders ratified and approved an amendment to the 2015Plan to increase the aggregate number of shares of common stock authorized for issuance under such plan from 3,600,000 shares to 4,600,000 shares.Furthermore, the stockholders approved an amendment to the Company’s Certificate of Incorporation to increase the total number of authorized shares ofcommon stock from 45,000,000 shares of common stock to 65,000,000 shares of common stock. At the Annual Meeting of Stockholders of the Company held on April 5, 2017, the stockholders ratified and approved an amendment to the 2015Plan to increase the aggregate number of shares of common stock authorized for issuance under such plan from 4,600,000 shares to 6,100,000 shares. Theamendment also included a provision that provides for pre-defined annual increases in the number of shares available for issuance under the Plan equal to thelesser of: (i) 5% of the total number of shares of Common Stock outstanding, (ii) 2,500,000, or (iii) a lesser number determined by the Board of Directors. Asof October 31, 2017, there were 710,853 shares available for issuance under the 2015 Plan. Restricted Stock Units (RSUs) A summary of the Company’s RSU activity and related information for the year ended October 31, 2017, 2016 and 2015 is as follows: Number ofRSU’s Weighted-AverageGrant Date Fair Value Balance at October 31, 2014: 791,879 $3.81 Granted 864,192 15.14 Vested (583,403) 7.58 Cancelled (3,333) 11.76 Balance at October 31, 2015: 1,069,335 $10.89 Granted 695,040 9.31 Vested (824,317) 8.35 Cancelled (220,610) 15.81 Balance at October 31, 2016 719,448 $10.77 Granted 1,632,134 7.90 Vested (877,383) 9.15 Cancelled (111,080) 8.74 Balance at October 31, 2017 1,363,119 $8.54 The fair value as of the respective vesting dates of RSUs was approximately $6,045,000, $6,643,000 and $7,771,000 for the years ended October 31,2017, 2016 and 2015, respectively. As of October 31, 2017, there was approximately $9,434,000 of unrecognized compensation cost related to non-vested RSUs, which is expected tobe recognized over a remaining weighted average vesting period of approximately 1.99 years. As of October 31, 2017, the aggregate intrinsic value of non-vested RSUs was approximately $4,635,000. Employee Stock Awards Common Stock issued to executives and employees related to vested incentive retention awards, employment inducements, management purchasesand employee excellence awards totaled 878,948 shares (834,600 shares on a net basis after employee taxes), 719,610 shares (712,106 shares on a net basisafter employee taxes), and 506,736 shares (422,781 shares on a net basis after employee taxes) during the years ended October 31, 2017, 2016 and 2015,respectively. Total stock compensation expense associated with these awards for the years ended October 31, 2017, 2016 and 2015 was $8,883,123,$5,458,823 and $5,432,494, respectively. Furthermore, during the year ended October 31, 2015, non-executive employees were entitled to receive a performance-based year-end cash bonus.Several non-executive employees voluntarily requested to be paid all or a portion of their cash bonus in the Company’s common stock instead of cash.During the year ended October 31, 2015, the total fair value of these equity purchases were $102,022, or 9,150 shares of the Company’s Common Stock. Director Stock Awards During the years ended October 31, 2017, 2016 and 2015, common stock issued to the Directors for compensation related to board and committeemembership was 30,000 shares, 152,386 shares and 267,186, respectively. During the years ended October 31, 2017, 2016 and 2015, total stockcompensation expense to the Directors was $403,200, $1,184,780 and $1,223,118, respectively. F-16 Source: Advaxis, Inc., 10-K, December 21, 2017Powered by Morningstar® Document Research℠The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any use of this information,except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results. Stock Options A summary of changes in the stock option plan for the years ended October 31, 2017, 2016 and 2015 is as follows: Shares WeightedAverageExercise Price WeightedAverageRemainingContractual LifeIn Years AggregateIntrinsic Value Outstanding as of October 31, 2014 467,968 $15.51 6.34 $- Granted 1,668,995 13.41 Exercised * (137,667) 12.29 Cancelled or expired (17,357) 36.24 Outstanding as of October 31, 2015 1,981,939 $13.78 8.72 $285,330 Granted 1,385,000 12.81 Cancelled or expired (15,144) 29.69 Outstanding as of October 31, 2016 3,351,795 $13.31 7.82 $61,980 Granted 556,952 7.71 Cancelled or expired (15,189) 14.07 Outstanding as of October 31, 2017 3,893,558 $12.51 5.72 $- Vested and exercisable at October 31, 2017 2,795,826 $13.05 4.80 $- * Includes the cashless exercise of 117,667 options that resulted in the issuance of 45,167 shares of common stock. The following table summarizes information about the outstanding and exercisable options at October 31, 2017; Options Outstanding Options Exercisable Weighted Weighted Weighted Weighted Average Average Average Average Exercise Number Remaining Exercise Intrinsic Number Remaining Exercise Intrinsic Price Range Outstanding Contractual Price Value Exercisable Contractual Price Value $3.63 - $9.99 672,672 6.58 $7.91 $61,980 285,954 4.02 $8.19 $- $10.00 - $14.99 3,006,606 5.63 $13.14 $- 2,295,592 4.95 $13.18 $- $15.01 - $19.99 213,480 4.29 $18.07 $- 213.480 4.29 $18.07 $- $20.00 - $21.25 800 2.60 $21.25 $- 800 2.60 $21.25 $- The fair value of each option granted from the Company’s stock option plans during the years ended October 31, 2017, 2016 and 2015 wasestimated on the date of grant using the Black-Scholes option-pricing model. Using this model, fair value is calculated based on assumptions with respect to(i) expected volatility of the Company’s Common Stock price, (ii) the periods of time over which employees and Board Directors are expected to hold theiroptions prior to exercise (expected lives), (iii) expected dividend yield on the Company’s Common Stock, and (iv) risk-free interest rates, which are based onquoted U.S. Treasury rates for securities with maturities approximating expected lives of the options. The Company used their own historical volatility indetermining the volatility to be used. The expected term of the stock option grants was calculated using the “simplified” method in accordance with the SECStaff Accounting Bulletin 107. The “simplified” method was used since the Company believes its historical data does not provide a reasonable basis uponwhich to estimate expected term and the Company does not have enough option exercise data from its grants issued to support its own estimate as a result ofvesting terms and changes in the stock price. The expected dividend yield is zero as the Company has never paid dividends to common shareholders anddoes not currently anticipate paying any in the foreseeable future. The following table provides the weighted average fair value of options granted to directors and employees and the related assumptions used in theBlack-Scholes model: Year Ended October 31, 2017 October 31, 2016 October 31, 2015 Weighted average fair value of options granted $6.36 $10.71 $17.38 Expected term 5.50-6.50 years 5.51-6.51 years 5-10 years Expected volatility 107.07%-110.93% 109.23%-115.25% 109.26%-154.54%Expected dividends 0% 0% 0%Risk free interest rate 1.26%-1.58% 1.65-2.00% 1.41%-2.27% Total compensation cost related to the Company’s outstanding stock options, recognized in the statement of operations for the years ended October31, 2017, 2016 and 2015 was approximately $17,195,000, $15,223,000 and $9,521,000, respectively. Included in compensation expense is $1,641,000recognized as a result of the modification of certain option agreements associated with the resignation of the Company’s Chief Executive Officer in July2017. Pursuant to the separation agreement all the outstanding options vested immediately and the expiration date was extended until July 5, 2021. F-17 Source: Advaxis, Inc., 10-K, December 21, 2017Powered by Morningstar® Document Research℠The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any use of this information,except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results. During the year ended October 31, 2017, 556,952 options were granted with a total grant date fair value of approximately $3,542,000. During theyear ended October 31, 2016, 1,385,000 options were granted with a total grant date fair value of approximately $14,838,000. During the year ended October31, 2015, 1,668,995 options were granted with a total grant date fair value of approximately $29,014,000. As of October 31, 2017, there was approximately $4,680,000 of unrecognized compensation cost related to non-vested stock option awards, which isexpected to be recognized over a remaining weighted average vesting period of approximately 1.11 years. Shares Issued to Consultants During the year ended October 31, 2017, 165,907 shares of Common Stock valued at $1,384,350 were issued to consultants for services. TheCompany recorded a liability on its balance sheet for $45,000 for shares earned pursuant to consulting agreements but not delivered. The common stockshare values were based on the dates the shares vested. During the year ended October 31, 2016, 168,885 shares of Common Stock valued at $1,565,888 were issued to consultants for services. TheCompany recorded a liability on its balance sheet for $75,000 for shares earned pursuant to consulting agreements but not delivered. The common stockshare values were based on the dates the shares vested. During the year ended October 31, 2015, 378,538 shares of Common Stock valued at $4,707,440 were issued to consultants for services. TheCompany recorded a liability on its balance sheet for $55,000 for shares earned pursuant to consulting agreements but not delivered. The common stockshare values were based on the dates the shares vested. 2011 Employee Stock Purchase Plan The Advaxis, Inc. 2011 Employee Stock Purchase Plan (“ESPP”) was approved by the Company’s shareholders in September 2011. The ESPP allowsemployees to purchase Common Stock of the Company at a 15% discount to the market price on designated exercise dates. Employees were eligible toparticipate in the ESPP beginning December 30, 2011. 40,000 shares of the Company’s Common Stock are reserved for issuance under the ESPP. During the year ended October 31, 2017, 2016 and 2015 shares purchased under the ESPP were 26,594, 6,627 and 7,063 and the Company recordedexpense of $251,374, $73,244 and $28,791 respectively. As of October 31, 2017, 0 shares of Company’s Common Stock remain available for issuance underthe ESPP. 9. COLLABORATION AND LICENSING AGREEMENTS BMS On May 30, 2017, the Company announced a clinical development collaboration with BMS to evaluate ADXS-DUAL, its second investigationalimmunotherapy targeting HPV-associated cancers, and BMS’ PD-1 immune checkpoint inhibitor, Opdivo ® (nivolumab), as a potential combinationtreatment option for women with metastatic cervical cancer. Under the terms of the agreement, each party will bear their own internal costs and provide its immunotherapy agent. The Company will sponsor thetrial and pay third-party costs. Sellas Life Science Group On February 27, 2017, the Company entered into a license agreement with Sellas Life Science Group (“Sellas”) to develop a novel cancerimmunotherapy agent using Advaxis’ proprietary Lm-based antigen delivery product with SELLAS’ patented WT1 targeted heteroclitic peptide antigenmixture (galinpepimut-S)). Pursuant to the agreement, Advaxis will conduct all pre-clinical activities required for an IND filing and Sellas will be responsiblefor all clinical development and commercial activities. Advaxis will receive future payments of up to $358 million from SELLAS if certain development,regulatory, and commercial milestones are met. SELLAS has agreed to pay Advaxis single-digit to low double-digit royalties based on worldwide net salesupon commercialization. If SELLAS sublicenses its rights, Advaxis will receive a percentage of applicable sublicense revenue paid. F-18 Source: Advaxis, Inc., 10-K, December 21, 2017Powered by Morningstar® Document Research℠The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any use of this information,except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results. Amgen On August 1, 2016, the Company entered into a global agreement (the “Amgen Agreement”) with Amgen for the development andcommercialization of the Company’s ADXS-NEO, a novel, preclinical investigational immunotherapy, using the Company’s proprietary Listeriamonocytogenes attenuated bacterial vector which activates a patient’s immune system to respond against unique mutations, or neoepitopes, contained in andidentified from an individual patient’s tumor. Under the terms of the Amgen Agreement, Amgen receives an exclusive worldwide license to develop andcommercialize ADXS-NEO. Amgen made an upfront payment to Advaxis of $40 million and purchased $25 million of Advaxis common stock. Amgen willfund the clinical development and commercialization of ADXS-NEO and Advaxis will retain manufacturing responsibilities. Advaxis and Amgen willcollaborate through a joint steering committee for the development and commercialization of ADXS-NEO. Advaxis will also receive development, regulatoryand sales milestone payments of up to $475 million and high single digit to double digit royalty payments based on worldwide sales. The Company identified the following performance obligations under the agreement: 1) the license, 2) the obligation to provide research activities,3) the obligation to provide clinical supplies, 4) the obligation to perform regulatory functions and 5) the obligation to participate on a Joint ResearchCommittee. The Company considered the provisions of the multiple-element arrangement guidance in determining how to recognize the total consideration ofthe agreement. The Company determined that none of the deliverables have standalone value; all of these obligations will be delivered throughout theestimated period of performance and therefore are accounted for as a single unit of accounting. Accordingly, the Company recorded the $40 million upfrontpayment as deferred revenue on the balance sheet and will recognize revenue on a straight-line basis over the estimated period of performance under theAmgen Agreement. Changes in the estimated period of performance will be accounted for prospectively as a change in estimate. During the years endedOctober 31, 2017 and 2016, the Company recognized revenue from the Amgen Agreement of approximately $11,781,000 and $3,745,000 related toamortization of the upfront fees. In connection with the Amgen Agreement, Amgen purchased directly from Advaxis 3,047,446 shares of the Company’s Common Stock, atapproximately $8.20 per share (representing a purchase at market using a 20 day VWAP methodology). The gross proceeds to Advaxis from the sale of theshares was approximately $25 million. The Company considered the provisions of the research and development and collaboration guidance in determining how to recognize the clinicaldevelopment payments to be received from Amgen. The Company determined the clinical development payments should be accounted for within the scopeof collaboration arrangement accounting guidance. As a result, the Company will account for the clinical development payments as a reduction of researchand development expenses in the Statement of Operations. During the year ended October 31, 2017, the Company received clinical development paymentsfrom Amgen totaling $6,000,000. In addition, the Company recorded an expected clinical development payment of $1,500,000 as prepaid expenses andother current assets on the balance sheet. In November 2017, the Company received the $1,500,000 expected clinical development payment from Amgen. Especificos Stendhal SA de CV On February 3, 2016, the Company entered into a Co-Development and Commercialization Agreement (the “Stendhal Agreement”) with EspecificosStendhal SA de CV (“Stendhal”), for Advaxis’ lead Lm Technology™ immunotherapy, axalimogene filolisbac, in HPV-associated cancers. Under the terms ofthe Stendhal Agreement, Stendhal will pay $10 million (“Support Payments”) towards the expense of AIM2CERV. The Support Payments will be made overthe duration of the trial. Stendhal will also work with the Company to complete the clinical trial of axalimogene filolisbac in Mexico, Brazil, Colombia andother investigational sites in Latin American countries. Stendhal will manage and is responsible for the costs associated with the regulatory approval process,promotion, commercialization and market access for axalimogene filolisbac in these markets. Upon approval and commercialization of axalimogenefilolisbac, Advaxis and Stendhal will share profits on a pre-determined basis. The Company considered the provisions of the research and development and collaboration guidance in determining how to recognize the SupportPayments to be received from Stendhal. The Company determined the Stendhal Agreement should be accounted for within the scope of collaborationarrangement accounting guidance. As a result, the Company will account for the support payments as a reduction of research and development expenses inthe Statement of Operations. During the year ended October 31, 2017, the Company reached the annual project milestones and received a $3,000,000Support Payment from Stendhal. Knight Therapeutics On August 26, 2015, the Company entered into a licensing agreement with Knight Therapeutics Inc. (“Knight”), a Canadian-based specialtypharmaceutical company focused on acquiring, in-licensing, selling and marketing innovative prescription and over-the-counter pharmaceutical products, tocommercialize in Canada the Company’s product candidates. Under the terms of the licensing agreement, Knight will be responsible to conduct and fund allregulatory and commercial activities in Canada. The Company is eligible to receive royalty and sales. In connection with the licensing agreement, theCompany sold directly to Knight 359,454 shares of the common stock at $13.91 per share Under the terms of the agreement, Knight will be responsible to conduct and fund all regulatory and commercial activities in Canada. We areeligible to receive double digit royalty as well as approximately $33 million in cumulative sales milestones. F-19 Source: Advaxis, Inc., 10-K, December 21, 2017Powered by Morningstar® Document Research℠The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any use of this information,except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results. Merck & Co., Inc. On August 22, 2014, the Company entered into a Clinical Trial Collaboration and Supply Agreement (the “Merck Agreement”) with Merck,pursuant to which the parties are collaborating on a Phase 1/2 dose-determination and safety trial. The Phase 1 portion of the trial evaluated the safety of ourLm -LLO based immunotherapy for prostate cancer, ADXS-PSA (the “Advaxis Compound”) as monotherapy and in combination with KEYTRUDA®(pembrolizumab), Merck’s humanized monoclonal antibody against PD-1, (the “Merck Compound”) and has determined a recommended Phase 2combination dose. The Phase 2 portion is evaluating the safety and efficacy of the Advaxis Compound in combination with the Merck Compound. Bothphases of the trial are in patients with previously treated metastatic castration-resistant prostate cancer. A joint development committee, comprised of equalrepresentatives from both parties, is responsible for coordinating all regulatory and other activities under, and pursuant to, the Merck Agreement. Each party is responsible for their own internal costs and expenses to support the trial, while the Company will be responsible for all third party costsof conducting the trial. Merck is responsible for manufacturing and supplying the Merck Compound. The Company is responsible for manufacturing andsupplying the Advaxis Compound. The Company is the sponsor of the trial and hold the IND related to the trial. All data and results generated under the trial (“Collaboration Data”) will be jointly owned by the parties, except that ownership of data andinformation generated from sample analysis to be performed by each party on its respective compound will be owned by the party conducting such testing.All rights to all inventions and discoveries, which claim or cover the combined use of the Advaxis Compound and the Merck Compound shall belong jointlyto the parties. Inventions and discoveries relating solely to the Advaxis Compound, or a live attenuated bacterial vaccine, shall be the exclusive property ofus. Inventions and discoveries relating solely to the Merck Compound, or a PD-1 antagonist, shall be the exclusive property of Merck. The Merck Agreement shall continue in full force and effect until completion of all of the obligations of the parties or a permitted termination. During the years ended October 31, 2017, 2016 and 2015, the Company incurred approximately $2,925,000, $1,587,000 and $1,723,000,respectively, in expenses pertaining to the Merck agreement, and such expenses were a component of research and development expenses in the statement ofoperations. MedImmune/AstraZeneca On July 21, 2014, the Company entered into a Clinical Trial Collaboration Agreement (the “MedImmune Agreement”) with MedImmune, the globalbiologics research and development arm of AstraZeneca, pursuant to which the parties initiated a Phase 1/2 clinical trial in the United States to evaluate thesafety and efficacy of MedImmune’s investigational anti-PD-L1 immune checkpoint inhibitor, MEDI4736, in combination with our investigational Lm -LLOcancer immunotherapy, axalimogene filolisbac , as a combination treatment for patients with advanced, recurrent or refractory cervical cancer and HPV-associated head and neck cancer. A joint steering committee, composed of equal representatives from both parties, is responsible for various mattersassociated with the collaboration, including protocol approval, as well as reviewing and monitoring the progress of the trial. MedImmune is responsible for providing MEDI4736 at no cost, as well as costs related to the proprietary assays performed by MedImmune or a thirdparty on behalf of MedImmune. The Company is the sponsor of the trial and is responsible for the submission of all regulatory filings to support the trial, thenegotiation and execution of the clinical trial agreements associated with each trial site, and the packaging and labelling of the Advaxis and MedImmuneproduct candidates used in the trial and the costs associated therewith. For a period beginning upon the completion of the trial and the receipt byMedImmune of the last final report for the trial and ending one hundred twenty (120) days thereafter (unless extended), MedImmune will be granted first rightto negotiate in good faith in an attempt to enter into an agreement with us with respect to the development, regulatory approval and commercialization ofaxalimogene filolisbac and MEDI4736 to be used in combination with each other for the treatment or prevention of cancer. Neither party is obligated to enterinto such an agreement. In the event the parties do not enter an agreement and we obtain regulatory approval for axalimogene filolisbac in combination withany PD-1 antibody or PD-L1 antibody, we shall pay MedImmune a royalty obligation and one-time payment. All intellectual property rights made, conceived or generated through the clinical trials that relate solely to a MedImmune development productshall be owned solely by MedImmune. All intellectual property rights made, conceived or generated through the clinical trials that relate solely to anAdvaxis development product shall be owned solely by us. All intellectual property rights made, conceived or generated through the clinical trials that relateto the combination of one or more MedImmune development product and one or more Advaxis development product shall be jointly owned by both parties;provided, however that in the event the parties do not enter into a clinical development and commercialization agreement, we will not exploit, commercializeor license the joint inventions, except for the performance of its obligations under the MedImmune Agreement. MedImmune has the sole right to prosecuteand enforce all patents and other intellectual property rights covering all joint inventions and all associated costs will be shared by the parties. The MedImmune Agreement shall remain in effect until the earlier of (i) permitted termination, (ii) the parties entering into a clinical developmentand commercialization agreement or expiration of the negotiation period (unless extended), except with respect to rights that survive termination. Eitherparty may terminate the MedImmune Agreement upon thirty (30) days written notice upon material breach of the other party, unless the breach is cured insuch period or reasonable actions to cure the breach are initiated and pursued (if the breach is not capable of being cured during the 30-day notice period). Inaddition, either party may terminate the MedImmune Agreement immediately if the party determines in good faith that the trials may unreasonably affect thesafety of trial subjects. F-20 Source: Advaxis, Inc., 10-K, December 21, 2017Powered by Morningstar® Document Research℠The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any use of this information,except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results. During the years ended October 31 2017, 2016 and 2015, the Company incurred approximately $2,787,000, $1,978,000 and $1,888,000,respectively, in expenses pertaining to the MedImmune agreement, and such expenses were a component of research and development expenses in theStatement of Operations. Aratana Therapeutics On March 19, 2014, the Company and Aratana entered into a definitive Exclusive License Agreement (the “Aratana Agreement”). Pursuant to theAgreement, Advaxis granted Aratana an exclusive, worldwide, royalty-bearing, license, with the right to sublicense, certain Advaxis proprietary technologythat enables Aratana to develop and commercialize animal health products that will be targeted for treatment of osteosarcoma and other cancer indications inanimals. Under the terms of the Aratana Agreement, Aratana paid an upfront payment to the Company, of $1 million. As this license has stand-alone value toAratana (who has the ability to sublicense) and was delivered to Aratana, upon execution of the Aratana Agreement, the Company recorded the $1 millionpayment as licensing revenue during the 12 months ended October 31, 2014. Aratana will also pay the Company up to an additional $36.5 million based onthe achievement of certain milestones with respect to the advancement of products pursuant to the terms of the Aratana Agreement. In addition, Aratana maypay the Company an additional $15 million in cumulative sales milestones pursuant to the terms of the Aratana Agreement. Advaxis (i) issued and sold 306,122 shares of Advaxis’ Common Stock to Aratana at a price of $4.90 per share, which was equal to the closing priceof the Common Stock on the NASDAQ Capital Market on March 19, 2014, and (ii) issued a ten-year warrant to Aratana giving Aratana the right to purchaseup to 153,061 additional shares of Advaxis’ Common Stock at an exercise price of $4.90 per share. In connection with the sale of the Common Stock andwarrants, Advaxis received aggregate net proceeds of $1,500,000. Biocon Limited On January 20, 2014, we entered into a Distribution and Supply Agreement (“Biocon Agreement”) with Biocon Limited, a company incorporatedunder the laws of India. Pursuant to the Biocon Agreement, we granted Biocon an exclusive license (with a right to sublicense) to (i) use our data from clinical developmentactivities, regulatory filings, technical, manufacturing and other information and know-how to enable Biocon to submit regulatory filings for axalimogenefilolisbac in the following territories: India, Malaysia, Bangladesh, Bhutan, Maldives, Myanmar, Nepal, Pakistan, Sri Lanka, Bahrain, Jordan, Kuwait, Oman,Saudi Arabia, Qatar, United Arab Emirates, Algeria, Armenia, Egypt, Eritrea, Iran, Iraq, Lebanon, Libya, Sudan, Syria, Tunisia and Yemen (collectively, the“Territory”) and (ii) import, promote, market, distribute and sell pharmaceutical products containing axalimogene filolisbac . Global BioPharma Inc. On December 9, 2013, the Company entered into an exclusive licensing agreement for the development and commercialization of axalimogenefilolisbac with Global BioPharma, Inc. (“GBP”), a Taiwanese based biotech company funded by a group of investors led by Taiwan Biotech Co., Ltd (TBC). GBP is planning to conduct a randomized Phase 2, open-label, controlled trial in HPV-associated NSCLC in patients following first-line inductionchemotherapy. GBP has obtained Taiwanese regulatory approval for this trial and plans to initiate this trial in 2018. This trial will be fully fundedexclusively by GBP. GBP will continue to explore the use of our lead product candidate in several other indications including head and neck, and analcancer. GBP also plans to conduct registration trials with axalimogene filolisbac for the treatment of advanced cervical cancer. GBP will pay Advaxis event-based financial milestones, an annual license fee, and annual net sales royalty payments in the high single to doubledigits. In addition, as an upfront payment, GBP made an investment in Advaxis of $400,000 by purchasing from the Company 108,724 shares of its CommonStock at a price of $3.68 per share, GBP also received 100,000 warrants at an exercise price of $5.52 which expire in December 2018. GBP will be responsible for all clinical development and commercialization costs in the GBP territory. GBP will also reimburse Advaxis $2.25million toward AIM2CERV. GBP is committed to establishing manufacturing capabilities for its own. Under the terms of the agreement, we will exclusivelylicense the rights of axalimogene filolisbac to GBP for the Asia, Africa, and former USSR territory, exclusive of India and certain other countries, for all HPV-associated indications. Advaxis will retain exclusive rights to axalimogene filolisbac for the rest of the world. During each of the years ended October 31, 2017 and 2016, the Company recognized revenue of $250,000 for annual license fees. F-21 Source: Advaxis, Inc., 10-K, December 21, 2017Powered by Morningstar® Document Research℠The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any use of this information,except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results. 10. COMMITMENTS AND CONTINGENCIES Legal Proceedings Knoll On August 21, 2015, Knoll Capital Management L.P. (“KCM”) filed a complaint against the Company in the Delaware Court of Chancery. Thecomplaint alleged the existence of an oral agreement for the purchase by Knoll from the Company of 1,666,666.67 shares of Company stock at a price of$3.00 per share. KCM alleged that the Company breached this alleged agreement and sought specific performance or, alternatively, money damages forbreach of contract. KCM served the Company with the complaint on August 31, 2015, and then served an amended complaint on October 16, 2015. TheCompany moved to dismiss the amended complaint on October 26, 2015 and that motion was denied on January 29, 2016. The Company filed an answer tothe amended complaint on February 12, 2016. In lieu of continuing to unnecessarily incur litigation expenses, on April 27, 2017, the Company settled the matter for a non-material amount,predominately reimbursed by the Company’s insurance, and the parties entered into a definitive confidential settlement agreement. The Company expresslydenies any admission or wrongdoing and the settlement was entered into solely for the purpose of avoiding the burden, inconvenience, and expense offurther litigation. On May 11, 2017, following resolution of the matter by the parties, the Court granted a Stipulation Of Dismissal With Prejudice. Bono On August 20, 2015, a derivative complaint was filed by a purported Company shareholder in the United States District Court for the District of NewJersey styled David Bono v. O’Connor, et al., Case No. 3:15-CV-006326-FLW-DEA (D.N.J. Aug. 20, 2015) (the “Bono Action”). The complaint is based ongeneral allegations related to certain stock options granted to the individual defendants and generally alleges counts for breaches of fiduciary duty andunjust enrichment. The complaint also alleges additional claims for violation of Section 14(a) of the Securities Exchange Act of 1934 and for waste ofcorporate assets. The complaint seeks damages and costs of an unspecified amount, disgorgement of compensation obtained by the individual defendants,and injunctive relief. Defendants filed a motion to dismiss the Bono Action. On May 23, 2016, the Court issued an opinion and order granting in part and denying in partdefendants’ motion to dismiss. On October 5, 2016, the Court denied plaintiff’s motion for reconsideration of its May 23 order. On April 13, 2017, the partiesadvised the Court that they had reached a tentative agreement in principle to settle the action, subject to negotiating an award of attorneys’ fees and expensesto plaintiff’s counsel and a stipulation of settlement, and, ultimately, Court approval. The parties subsequently executed the stipulation of settlement onOctober 2, 2017. The Court entered an order preliminarily approving the settlement on November 7, 2017. The final fairness hearing with the Court ispresently scheduled for January 29, 2018. Corporate Office & Manufacturing Facility Lease The Company leases its corporate office and manufacturing facility under an operating lease expiring in November, 2025. Future minimum payments under the Company’s operating leases are as follows: Year ended October 31, 2018 $1,041,895 2019 1,107,385 2020 1,232,907 2021 1,317,640 2022 1,368,819 Thereafter 4,378,521 Total $10,447,167 Rent expense for the years ended October 31, 2017, 2016 and 2015 was $1,188,005, $935,281 and $150,000, respectively. F-22 Source: Advaxis, Inc., 10-K, December 21, 2017Powered by Morningstar® Document Research℠The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any use of this information,except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results. 11. INCOME TAXES: The income tax provision (benefit) consists of the following: October 31, 2017 October 31, 2016 October 31, 2015 Federal Current $- $- $- Deferred (34,296,121) (18,152,484) (14,513,684)State and Local Current (4,452,682) (2,535,625) (1,609,349)Deferred (1,123,593) (3,698,506) (1,840,276)Change in valuation allowance 35,419,714 21,850,990 16,353,960 Income tax provision (benefit) $(4,452,682) $(2,535,625) $(1,609,349) The Company has U.S. federal net operating loss carryovers (“NOLs”) of approximately $187,254,000, $137,082,000 and $100,662,000 at October31, 2017, 2016 and 2015, respectively, available to offset taxable income which expire beginning in 2023. If not used, these NOLs may be subject tolimitation under Internal Revenue Code Section 382 should there be a greater than 50% ownership change as determined under the regulations. In fiscalyears 2017 and 2016, the Company performed a detailed analysis of any historical and/or current Section 382 ownership changes that may limit theutilization of the net operating loss carryovers. From the entire federal NOL of $187,254,000 as of October 31, 2017, approximately $155,930,000 isavailable for immediate use based on Internal Revenue Code Section 382 analysis. The NOL and the deferred tax asset table below does not includeapproximately $24,824,000 of NOL’s that may expire unused. The Company also has New Jersey State Net Operating Loss carryovers of approximately$50,745,000, $66,029,000 and $26,245,000 as of October 31, 2017, 2016 and 2015, respectively, available to offset future taxable income through 2037. In assessing the realization of deferred tax assets, management considers whether it is more likely than not that some portion or all of the deferred taxassets will not be realized. The ultimate realization of deferred tax assets is dependent upon future generation for taxable income during the periods in whichtemporary differences representing net future deductible amounts become deductible. Management considers the scheduled reversal of deferred taxliabilities, projected future taxable income and tax planning strategies in making this assessment. After consideration of all the information available,management believes that significant uncertainty exists with respect to future realization of the deferred tax assets and has therefore established a fullvaluation allowance. The Company evaluated the provisions of ASC 740 related to the accounting for uncertainty in income taxes recognized in an enterprise’s financialstatements. ASC 740 prescribes a comprehensive model for how a company should recognize, present, and disclose uncertain positions that the company hastaken or expects to take in its tax return. For those benefits to be recognized, a tax position must be more-likely-than-not to be sustained upon examinationby taxing authorities. Differences between tax positions taken or expected to be taken in a tax return and the net benefit recognized and measured pursuant tothe interpretation are referred to as “unrecognized benefits.” A liability is recognized (or amount of net operating loss carry forward or amount of taxrefundable is reduced) for unrecognized tax benefit because it represents an enterprise’s potential future obligation to the taxing authority for a tax positionthat was not recognized as a result of applying the provisions of ASC 740. If applicable, interest costs related to the unrecognized tax benefits are required to be calculated and would be classified as “Other Income(Expense)” in the statement of operations. Penalties would be recognized as a component of “General and Administrative Expenses” in the statement ofoperations. No interest or penalties on unpaid tax were recorded during the years ended October 31, 2017, 2016 and 2015, respectively. As of October 31, 2017and 2016, no liability for unrecognized tax benefits was required to be reported. The Company does not expect any significant changes in its unrecognizedtax benefits in the next year. F-23 Source: Advaxis, Inc., 10-K, December 21, 2017Powered by Morningstar® Document Research℠The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any use of this information,except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results. The Company files tax returns in the U.S. federal and state jurisdictions and is subject to examination by tax authorities beginning with the yearended October 31, 2013. The Company’s deferred tax assets (liabilities) consisted of the effects of temporary differences attributable to the following: Years Ended October 31, 2017 October 31, 2016 Deferred Tax Assets Net operating loss carryovers $66,681,000 $51,701,000 Stock-based compensation 21,921,000 15,239,000 Research and development credits 7,293,000 5,672,000 Deferred revenue 9,775,000 - Other deferred tax assets 1,515,000 - Total deferred tax assets $107,185,000 $72,612,000 Valuation allowance (104,738,000) (69,317,000)Deferred tax asset, net of valuation allowance $2,447,000 $3,295,000 Deferred Tax Liabilities Other deferred tax liabilities (2,447,000) (3,295,000)Total deferred tax liabilities $(2,447,000) $(3,295,000)Net deferred tax asset (liability) $- $- The expected tax (expense) benefit based on the statutory rate is reconciled with actual tax expense benefit as follows: Years Ended October 31, 2017 October 31, 2016 October 31, 2015 US Federal statutory rate 34.00% 34.00% 34.00%State income tax, net of federal benefit 1.15 4.86 3.78 Permanent differences (2.30) (2.00) (1.91)Research and development credits 2.36 2.16 2.06 Income tax benefit from sale of New Jersey NOL carryovers 4.55 3.33 3.31 Change in valuation allowance (36.20) (28.72) (33.62)Other 0.99 (10.30) (4.31)Income tax (provision) benefit 4.55% 3.33% 3.31% Sale of Net Operating Losses (NOLs) The Company may be eligible, from time to time, to receive cash from the sale of its Net Operating Losses under the State of New Jersey NOLTransfer Program. In fiscal 1Q 2018, the Company plans to receive a net cash amount of $4,452,682 from the sale of its state NOLs and research anddevelopment tax credits for the period ended October 31, 2016. In November 2016, the Company received a net cash amount of $2,549,862 from the sale ofits state NOLs and research and development tax credits for the period ended October 31, 2015. In December 2015, the Company received a net cash amountof $1,609,349 from the sale of its state NOLs and research and development tax credits for the period ended October 31, 2014. Following the receipt of theNOL and research and development tax credit for the period ending October 31, 2016, the Company will have reached the limit under the NJ NOL programand will no longer be able to participate in future sales. 12. SHAREHOLDERS’ EQUITY: Registered Direct Offerings On August 19, 2016, the Company sold 2,244,443 shares of common stock in a registered direct offering at a per share price of $13.50 for grossproceeds of approximately $30.3 million. The net proceeds to the Company, after deducting the Placement Agents’ fees and other estimated offeringexpenses payable by the Company, were approximately $28.2 million. On February 18, 2015, the Company priced a registered direct offering of 3,068,095 shares of its Common Stock at $7.50 per share. The transactionclosed on February 19, 2015, and the Company received gross proceeds of approximately $23.0 million from the offering. After deducting offering expenses,the net proceeds from the offering were approximately $22.3 million. On December 19, 2014, the Company priced a registered direct offering of 3,940,801 shares of its Common Stock at $4.25 per share. The transactionclosed on December 22, 2014, and the Company received gross proceeds of approximately $16.7 million from the offering. After deducting offeringexpenses, the net proceeds from the offering were approximately $15.8 million. Public Offerings On May 5, 2015, the Company closed on an underwritten public offering of 2,800,000 shares of Common Stock at a public offering price of $19.00per share. On May 20, 2015, the Company closed the underwriters’ overallotment option to purchase 420,000 shares of its Common Stock at a public offeringprice of $19.00 per share. The Company received gross proceeds of approximately $61.2 million from the May 2015 public offerings. After deductingoffering expenses, the net proceeds from the May 2015 public offerings were approximately $56.7 million. F-24 Source: Advaxis, Inc., 10-K, December 21, 2017Powered by Morningstar® Document Research℠The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any use of this information,except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results. 13. EMPLOYEE BENEFIT PLAN The Company sponsors a 401(k) Plan. Employees become eligible for participation upon the start of employment. Participants may elect to have aportion of their salary deferred and contributed to the 401(k) plan up to the limit allowed under the Internal Revenue Code. The Company makes a matchingcontribution to the plan for each participant who has elected to make tax-deferred contributions for the plan year. The Company made matchingcontributions which amounted to $449,086, $172,276 and $51,403 for the years ended October 31, 2017, 2016 and 2015, respectively. These amounts werecharged to the Statement of Operations. The Employer contributions vest immediately. 14. SELECTED QUARTERLY FINANCIAL DATA (UNAUDITED) The following interim financial information presents the Company’s 2017, 2016 and 2015 results of operations on a quarterly basis (in thousands,except per share amounts): Quarter Ended January 31, 2017 April 30, 2017 July 31, 2017 October 31, 2017 Revenue $3,790,842 $3,425,380 $3,051,620 $1,763,208 Net loss (17,081,003) (20,467,655) (32,625,595) (23,261,249)Net loss income per common share, basicand diluted (0.43) (0.51) (0.80) (0.57) Quarter Ended January 31, 2016 April 30, 2016 July 31, 2016 October 31, 2016 Revenue $250,000 $- $- $3,744,856 Net loss (19,844,935) (15,522,450) (16,486,008) (21,702,837)Net loss income per common share, basicand diluted (0.59) (0.45) (0.48) (0.55) Quarter Ended January 31, 2015 April 30, 2015 July 31, 2015 October 31, 2015 Revenue $- $- $- $- Net loss (7,033,870) (13,855,259) (13,562,026) (12,579,963)Net loss income per common share, basicand diluted (0.33) (0.52) (0.44) (0.38) F-25 Source: Advaxis, Inc., 10-K, December 21, 2017Powered by Morningstar® Document Research℠The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any use of this information,except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results. 15. SUBSEQUENT EVENTS On November 2, 2017, the Company granted to executives 300,000 options with an exercise price of $3.19 and 84,000 performance-based RSU’s(“PRSU’s). The options and PRSU’s vest annually in three equal installments beginning on the first anniversaries of the grant date. On November 2, 2017, the Company granted to Directors 180,000 options with an exercise price of $3.19. The options shall vest in one installmenton the first anniversary of the grant date. F-26 Source: Advaxis, Inc., 10-K, December 21, 2017Powered by Morningstar® Document Research℠The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any use of this information,except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results. Source: Advaxis, Inc., 10-K, December 21, 2017Powered by Morningstar® Document Research℠The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any use of this information,except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results. INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM’S CONSENT We consent to the incorporation by reference in the Registration Statement of Advaxis, Inc. on Form S-8 [File Nos. 333-130080 and 333-217218] and FormS-3 [File Nos. 333-194009, 333-203497 and 333-216008] of our report dated December 20, 2017, with respect to our audits of the financial statements ofAdvaxis, Inc. as of October 31, 2017 and 2016 and for the years ended October 31, 2017, 2016 and 2015 and our report dated December 20, 2017 withrespect to our audit of the effectiveness of internal control over financial reporting of Advaxis, Inc. as of October 31, 2017, which reports are included in thisAnnual Report on Form 10-K of Advaxis, Inc. for the year ended October 31, 2017. /s/ Marcum llp Marcum llp New York, NY December 20, 2017 Source: Advaxis, Inc., 10-K, December 21, 2017Powered by Morningstar® Document Research℠The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any use of this information,except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results. Source: Advaxis, Inc., 10-K, December 21, 2017Powered by Morningstar® Document Research℠The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any use of this information,except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results. EXHIBIT 31.1 CERTIFICATION OF PRINCIPAL EXECUTIVE OFFICERPURSUANT TO 18.U.S.C. 7350(SECTION 302 OF THE SARBANES OXLEY ACT OF 2002) I, Anthony Lombardo, certify that: 1.I have reviewed this annual report on Form 10-K for the year ended October 31, 2017 of Advaxis, Inc.; 2.Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make thestatements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; 3.Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects thefinancial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; 4.The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in ExchangeAct Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for theregistrant and have: (a)Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensurethat material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities,particularly during the period in which this report is being prepared; (b)Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under oursupervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for externalpurposes in accordance with generally accepted accounting principles; (c)Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectivenessof the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and (d)Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscalquarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect,the registrant’s internal control over financial reporting; and 5.The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to theregistrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions): (a)All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonablylikely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and (b)Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control overfinancial reporting. December 20, 2017 By:/s/ Anthony Lombardo Name:Anthony Lombardo Title:Interim Chief Executive Officer Source: Advaxis, Inc., 10-K, December 21, 2017Powered by Morningstar® Document Research℠The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any use of this information,except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results. Source: Advaxis, Inc., 10-K, December 21, 2017Powered by Morningstar® Document Research℠The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any use of this information,except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results. EXHIBIT 31.2 CERTIFICATION OF PRINCIPAL FINANCIAL OFFICERPURSUANT TO 18. U.S.C. 7350(SECTION 302 OF THE SARBANES OXLEY ACT OF 2002) I, Sara M. Bonstein, certify that: 1.I have reviewed this annual report on Form 10-K for the year ended October 31, 2017 of Advaxis, Inc.; 2.Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make thestatements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; 3.Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects thefinancial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; 4.The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in ExchangeAct Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for theregistrant and have: (a)Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensurethat material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities,particularly during the period in which this report is being prepared; (b)Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under oursupervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for externalpurposes in accordance with generally accepted accounting principles; (c)Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectivenessof the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and (d)Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscalquarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect,the registrant’s internal control over financial reporting; and 5.The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to theregistrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions): (a)All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonablylikely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and (b)Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control overfinancial reporting. December 20, 2017 By:/s/ Sara M. Bonstein Name:Sara M. Bonstein Title:Chief Financial Officer, Executive Vice President Source: Advaxis, Inc., 10-K, December 21, 2017Powered by Morningstar® Document Research℠The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any use of this information,except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results. Source: Advaxis, Inc., 10-K, December 21, 2017Powered by Morningstar® Document Research℠The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any use of this information,except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results. EXHIBIT 32.1 CERTIFICATION OF CHIEF EXECUTIVE OFFICERPURSUANT TO 18 U.S.C. SECTION 1350,AS ADOPTED PURSUANT TO SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002 In connection with the Annual Report of Advaxis, Inc., a Delaware corporation (the “Company”), on Form 10-K for the year ended October 31, 2017 as filedwith the Securities and Exchange Commission on the date hereof (the “Report”), the undersigned, the Chief Executive Officer, hereby certifies pursuant to 18U.S.C. Sec. 1350 as adopted pursuant to Section 906 of the Sarbanes Oxley Act of 2002 that, to the undersigned’s knowledge: (1) the Report of the Company filed today fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended;and (2) the information contained in the Report fairly presents, in all material respects, the financial condition and results of operation of the Company. A signed original of this written statement required by Section 906 has been provided to the Company and will be retained by the Company and furnished tothe Securities and Exchange Commission or its staff upon request. Date: December 20, 2017By:/s/ Anthony Lombardo Name:Anthony Lombardo Title:Interim Chief Executive Officer Source: Advaxis, Inc., 10-K, December 21, 2017Powered by Morningstar® Document Research℠The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any use of this information,except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results. Source: Advaxis, Inc., 10-K, December 21, 2017Powered by Morningstar® Document Research℠The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any use of this information,except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results. EXHIBIT 32.2 CERTIFICATION OF CHIEF FINANCIAL OFFICERPURSUANT TO 18 U.S.C. SECTION 1350,AS ADOPTED PURSUANT TO SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002 In connection with the Annual Report of Advaxis, Inc., a Delaware corporation (the “Company”), on Form 10-K for the year ended October 31, 2017 as filedwith the Securities and Exchange Commission on the date hereof (the “Report”), the undersigned, the Chief Financial Officer, hereby certifies pursuant to 18U.S.C. Sec. 1350 as adopted pursuant to Section 906 of the Sarbanes Oxley Act of 2002 that, to the undersigned’s knowledge: (1) the Report of the Company filed today fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended;and (2) the information contained in the Report fairly presents, in all material respects, the financial condition and results of operation of the Company. A signed original of this written statement required by Section 906 has been provided to the Company and will be retained by the Company and furnished tothe Securities and Exchange Commission or its staff upon request. Date: December 20, 2017By:/s/ Sara M. Bonstein Name:Sara M. Bonstein Title:Chief Financial Officer, Executive Vice President Source: Advaxis, Inc., 10-K, December 21, 2017Powered by Morningstar® Document Research℠The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any use of this information,except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results. Source: Advaxis, Inc., 10-K, December 21, 2017Powered by Morningstar® Document Research℠The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any use of this information,except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results.Source: Advaxis, Inc., 10-K, December 21, 2017Powered by Morningstar® Document Research℠The information contained herein may not be copied, adapted or distributed and is not warranted to be accurate, complete or timely. The user assumes all risks for any damages or losses arising from any use of this information,except to the extent such damages or losses cannot be limited or excluded by applicable law. Past financial performance is no guarantee of future results.

Continue reading text version or see original annual report in PDF format above