UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q

(Mark One)

[X] QUARTERLY REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended July 31, 20172018

[  ]TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from ___________________ to ___________________

Commission file number000-28489001-36138

ADVAXIS, INC.

(Exact name of registrant as specified in its charter)

305 College Road East, Princeton, NJ 08540

(Address of principal executive offices)

(609) 452-9813

(Registrant’s telephone number)

(Former name, former address and former fiscal year, if changed since last report)

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 of 1934 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 filing requirements 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,website, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (Section 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files). Yes [X] No [  ]

Indicate by check markcheckmark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an 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.

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 or revised 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]

The number of shares of the registrant’s Common Stock, $0.001 par value, outstanding as of August 31, 20172018 was 41,065,835.52,828,483.

INDEXTABLE OF CONTENTS

All other items called for by the instructions to Form 10-Q have been omitted because the items are not applicable or the relevant information is not material.

Cautionary Note Regarding Forward Looking StatementsCAUTIONARY NOTE REGARDING FORWARD LOOKING STATEMENTS

This quarterly report on Form 10-Q (“Form 10-Q”) 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 or comparable terminology, although not all forward-looking statements contain these words. They appear in a number of places throughout this Form 10-Q and include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things, our ongoing and planned discovery and development of drug candidates, the strength and breadth of our intellectual property, our ongoing and planned preclinical studies and clinical trials, the timing of and our ability to make regulatory filings and obtain and maintain regulatory approvals for our product candidates, the degree of clinical utility of our product candidates, particularly in specific patient populations, expectations regarding clinical trial data, our results of operations, financial condition, liquidity, prospects, growth and strategies, the length of time that we will be able to continue to fund our operating expenses and capital expenditures, our expected financing needs and sources of financing, the industry in which we operate and the trends 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 or shorter timelines than anticipated. Although we believe that we have a reasonable basis for each forward-looking statement contained in this Form 10-Q, we caution you that forward-looking statements are not guarantees of future performance and that our actual results of operations, financial condition and liquidity, and the development of the industry in which we operate may differ materially from the forward-looking statements contained in this Form 10-Q. In addition, even if our results of operations, financial condition and liquidity, and the development of the industry in which we operate are consistent with the forward-looking statements contained in this Form 10-Q, 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:

Any forward-looking statements that we make in this Form 10-Q speak only as of the date of such statement, and we undertake no obligation to update such statements to reflect events or circumstances after the date of this Form 10-Q. You should also read carefully the factors described in the “Risk Factors” section of the Company’s annual report on Form 10-K for the year ended October 31, 2016,2017, as filed with the SEC on January 9,December 21, 2017, to better understand the risks and uncertainties inherent in our business and underlying any forward-looking statements. As a result of these factors, we cannot assure you that the forward-looking statements in this Form 10-Q will prove to be accurate.

This Form 10-Q includes statistical and other industry and market data that we obtained from industry publications and research, surveys and studies conducted by third-parties. Industry publications and third-party research, surveys and studies generally indicate that their information has been obtained from sources believed to be reliable, although they do not guarantee the accuracy or completeness of such information. While we believe these industry publications 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

PART I - FINANCIAL INFORMATION

ITEMItem 1. FINANCIAL STATEMENTSFinancial Statements

ADVAXIS, INC.

CONDENSED BALANCE SHEETS (Unaudited)

(In thousands, except share and per share data)

The accompanying notes are an integral part of these condensedshould be read in conjunction with the financial statements.

ADVAXIS, INC.

CONDENSED STATEMENTS OF OPERATIONS (Unaudited)

(unaudited)(In thousands, except share and per share data)

The accompanying notes are an integral part of these condensedshould be read in conjunction with the financial statements.

ADVAXIS, INC.

CONDENSED STATEMENTS OF CASH FLOWS (Unaudited)

(unaudited)(in thousands)

The accompanying notes are an integral part of these condensedshould be read in conjunction with the financial statements.

Supplemental Disclosures of Cash Flow Information

Supplemental Schedule of Non-Cash Investing and Financing Activities

The accompanying notes are an integral part of these condensed financial statements.

ADVAXIS, INC.

NOTES TO THE CONDENSED FINANCIAL STATEMENTS

(unaudited)(Unaudited)

1. NATURE OF OPERATIONS

Advaxis, Inc. (“Advaxis” or the “Company”) is a late-stage biotechnology company focused on the discovery, development and commercialization of proprietaryLm-based antigen delivery products. These immunotherapies are based on a platform technology that utilizes live attenuatedListeria monocytogenes (“Lm” or “) based antigen delivery products. The Company is using itsLmTechnology^TM”) bioengineered platform directed against tumor-specific targets in order to secrete antigen/adjuvant fusion proteins. Theseengage the patient’s immune system to destroy tumor cells. Through a license from the University of Pennsylvania, Advaxis has exclusive access to this proprietary formulation of attenuatedLm-based strains are believed to be calledLm Technology. Advaxis’ proprietary approach deploys a significant advancement in immunotherapy as they integrate multiple functions into a single immunotherapy as they access and direct antigen presenting cells to stimulate anti-tumor T-cell immunity, stimulate and activateunique mechanism of action that redirects the immune system to attack cancer in three distinct ways by:

Advaxis’ proprietaryLm platform technology has been clinically validated and dosed in over 500 patients across multiple adjuvants,clinical trials and simultaneously reducein various tumor protectiontypes. The Company believes thatLm Technology immunotherapies can complement and address significant unmet needs in the tumor microenvironmentcurrent oncology treatment landscape. Specifically, our product candidates have the potential to enable the T-cells to eliminate tumors.

Advaxis has developed a strong foothold in the development ofwork synergistically with other immunotherapies, including both axalimogene filolisbac and ADXS-DUAL (ADXS-602) for HPV-related cancers. Axalimogene filolisbac is anLm–based antigen delivery product directed against the Human Papilloma Virus (“HPV”) and designed to target cells expressing the HPV. ADXS-DUAL, the Company’s second immunotherapy targeting HPV-associated cancers, is anLm-based immunotherapy that secretescheckpoint inhibitors, while having a fusion protein containing E7 protein antigens from both major families of HPV.

The Company completed a randomized Phase 2 study in 110 patients with recurrent metastatic cervical cancer that was shown to have a manageablegenerally well-tolerated safety profile, apparent improved survival and objective tumor responses. In addition, the Gynecologic Oncology Group (“GOG”) Foundation, Inc., now part of NRG Oncology, conducted a cooperative group / Company sponsored Phase 2 open-label clinical study of axalimogene filolisbac in patients with persistent or recurrent metastatic cervical cancer with documented disease progression. The study, known as GOG-0265, has successfully completed the first and second stages in its Simon 2-stage design. Upon early closure of this study, the results from both stages totaling 50 patients dosed resulted in a 12-month survival rate of 38.0% with a manageable safety profile. The Company has initiated a registrational Phase 3 clinical trial for the adjuvant treatment of women with high-risk locally advanced cervical cancer and, pending FDA feedback, is planning to initiate a global, randomized, registrational quality clinical trial in 1H 2018 in the metastatic cervical cancer setting with ADXS-DUAL in combination with Bristol-Myers Squibb’s (“BMS”) PD-1 immune checkpoint inhibitor, OPDIVO^® (nivolumab). The Company also plans to pursue registrational opportunities in Europe in 2017 for the metastatic cervical cancer setting as a monotherapy with axalimogene filolisbac.

Axalimogene filolisbac has received United States Food and Drug Administration (“FDA”) orphan drug designation for three HPV-associated cancers: cervical, head and neck, and anal cancer, and has received European Medicines Agency (“EMA”) orphan drug designation for anal cancer. Axalimogene filolisbac has been designated by the FDA as a Fast Track product for adjuvant therapy for high-risk locally advanced cervical cancer patients. It has also been classified as an advanced-therapy medicinal product (“ATMP”) for the treatment of cervical cancer by the European Medicines Agency’s Committee for Advanced Therapies (“CAT”). Axalimogene filolisbac is subject to an agreement with the FDA, under the Special Protocol Assessment (“SPA”) process, for the Phase 3 AIM2CERV trial in patients with high-risk, locally advanced cervical cancer. It is also being evaluated in Company-sponsored trials executed under an Investigational New Drug (“IND”) which include the following: (i) a Phase 1/2 clinical trial alone and in combination with MedImmune, LLC’s (“MedImmune”) investigational anti-PD-L1 immune checkpoint inhibitor, durvalumab (MEDI4736), in patients with previously treated metastatic cervical cancer or patients with HPV-associated head and neck cancer; and (ii) a single arm Phase 2 monotherapy study in patients with metastatic anal cancer. In addition to the Company-sponsored trials, axalimogene filolisbac is also being evaluated in two investigator-initiated clinical trials as follows: neoadjuvant treatment of HPV-positive head and neck cancer (Mount Sinai & Baylor College of Medicine), and locally advanced high risk anal cancer (Brown University).

ADXS-PSA (ADXS31-142) is the Company’sLm–based product candidate designed to target the Prostate Specific Antigen (“PSA”) associated with prostate cancer which is being evaluated in a Phase 1/2 clinical trial alone and in combination with KEYTRUDA^®(pembrolizumab), Merck & Co.’s (“Merck”) humanized monoclonal antibody against PD-1, in patients with previously treated metastatic castration-resistant prostate cancer.

ADXS-HER2 (ADXS31-164) is the Company’sLm-based product candidate designed for the treatment of Human Epidermal Growth Factor Receptor 2 (“HER2”) expressing cancers, including human and canine osteosarcoma. ADXS-HER2 was evaluated in a Phase 1b clinical trial in patients with metastatic HER2 expressing solid tumors. The Company has evaluated the data, and based on the Company’s priorities, has determined not to pursue further clinical study of ADXS-HER2 at this time but remains open to investigator-initiated research or licensing proposals. Clinical research with ADXS-HER2 in canine osteosarcoma is being developed by the Company’s pet therapeutic partner, Aratana Therapeutics Inc. (“Aratana”), who holds exclusive rights to develop and commercialize ADXS-HER2 and three otherLm -LLO immunotherapies for pet health applications. Aratana has announced that a product license application for use of ADXS-HER2 in the treatment of canine osteosarcoma has been filed with the United States Department of Agriculture (“USDA”). Aratana received communication from the USDA in March 2015 stating that the previously submitted efficacy data for product licensure for AT-014 (ADXS-HER2), the cancer immunotherapy for canine osteosarcoma, was accepted and that it provides a reasonable expectation of efficacy that supports conditional licensure. While additional steps need to be completed, including in the areas of manufacturing and safety, Aratana anticipates that AT-014 could receive conditional licensure from the USDA in 2017.

ADXS-NEO is the Company’s individualLm-based antigen delivery product combined with a fusion protein based on information captured by comparing a patient’s own DNA with the DNA from that patient’s tumor. The FDA has cleared the Company’s IND application for clinical investigation of a new precision immunotherapy for the treatment of cancers. The Company plans to initiate a Phase 1 study in first half of 2018.

The Company has focused its development efforts on establishing a drug development pipeline that incorporates this technology into therapeutic cancer immunotherapies, with clinical trials currently targeting HPV-associated cancers (cervical cancer, head and neck cancer, and anal cancer), prostate cancer, and canine osteosarcoma. Although no immunotherapies have been commercialized to date, the Company continues to invest in research and development to advance the technology and make it available to patients with many different types of cancer. Pipeline development and the further exploration of the technology for advancement entails risk and expense. The Company anticipates that its ongoing operational costs will increase significantly as it continues conducting and expanding its clinical development programs. In addition to its existing single antigen vectors that target one tumor associated antigen, the Company is actively engaged in the development of new constructs that will address multiple targets that are common to tumor types, as well as mutation-associated epitopes that are specific to an individual patient’s tumor. The Company is also leveraging itsLm Technology™ to target common (public or shared) mutations (hotspots) in tumor driver genes, which it refers to as ADXS-HOT. Lastly, the Company completed construction for its pilot plant at the state-of-the-art manufacturing facility in Princeton, NJ, to produce supplies for its neoepitope and other development programs.

LiquidityGoing Concern and Financial ConditionManagements Plans

The Company’s products that are being developed and have not generated significant revenues. revenue. As a result, the Company has suffered recurring losses and requires significant cash resources to execute its business plans. These losses are expected to continue for an extended period of time. The aforementioned factors raise substantial doubt about the Company’s ability to continue as a going concern. The accompanying condensed consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. The financial statements do not include any adjustments relating to the recoverability and classification of asset amounts or the classification of liabilities that might be necessary should the Company be unable to continue as a going concern within one year after the date the financial statements are issued.

Historically, our major sources of cash have comprised proceeds from various public and private offerings of our common stock, option and warrant exercises, and interest income. From October 2013 through August 2018, we raised approximately $245 million in gross proceeds from various public and private offerings of our common stock.

As of July 31, 2017,2018 and August 31, 2018, the Company had approximately $89.4$40.4 million and $36.3 million, respectively, in cash, restricted cash and cash equivalents. Management’s plans to mitigate an expected shortfall of capital, to support future operations, include raising additional funds. On September 7, 2018 the Company announced the pricing of an underwritten public offering which is expected to gross $20 million in cash, cash equivalents and investmentsproceeds. It is the belief of the Company, that should the financing close on its balance sheet. TheSeptember 11, 2018 the Company believes its current cash position isexpects to have sufficient capital to fund its obligations, as they become due, in the ordinary course of business plan into approximately fiscalthrough September 2019. The estimate is based on assumptions that may prove to be wrong, and the Company could use available capital resources sooner than currently expected. Because of the numerous risks and uncertainties associated with the development and commercialization of its product candidates, the Company is unable to estimate theactual amount of increased capital outlays and operating expenses associated with completing the development of its current product candidates.cash that it will need to operate, is subject to many factors.

The Company also recognizes it maywill need to raise additional capital in order to continue to execute its business plan.plan in the future. There is no assurance that additional financing will be available when needed or that management will be able to obtain financing on terms acceptable to the Company or whether the Company will become profitable and generate positive operating cash flow. If the Company is unable to raise sufficient additional funds, it will have to scale back its business plan.operations.

2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES AND BASIS OF PRESENTATION

Basis of Presentation - Unaudited Interim Financial InformationPresentation/Estimates

The accompanying unaudited interim condensed financial statements and related notes have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) for interim financial information, and in accordance with the rules and regulations of the SEC with respect to Form 10-Q and Rule 10-01 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by U.S. GAAP for complete financial statements and the accompanying unaudited condensed balance sheet as of October 31, 2017 has been derived from the Company’s October 31, 2017 audited financial statements. TheIn the opinion of management, the unaudited interim condensed financial statements furnished reflectinclude all adjustments (consisting of normal recurring accruals) which are, in the opinion of management, necessary to representfor a fair statement of the results for the interim periods presented. InterimCertain reclassifications have been made to prior year financial statements to conform to classifications used in the current year.

Operating results for interim periods are not necessarily indicative of the results to be expected for the full year. These unaudited interim condensed financial statements should be read in conjunction with the financial statements of the Company for the year ended October 31, 2016 and notes thereto contained in the Company’s annual report on Form 10-K for the year ended October 31, 2016, as filed with the SEC on January 9, 2017.

The information presented in the accompanying unaudited condensed balance sheet as of October 31, 2016 has been derived from the Company’s October 31, 2016 audited financial statements.

Estimates

The preparation of financial statements in accordance with U.S. GAAP involves the use ofrequires management to make estimates and assumptions that affect the recordedreported amounts of assets, liabilities, revenues, expenses, and liabilities as ofthe related disclosures at the date of the financial statements and the reported amounts of revenue and expenses during the reporting period. Actual results may differ substantially from these estimates. Significant estimates include the timelines associated with revenue recognition on upfront payments received, the fair value and recoverability of the carrying value of property and equipment and intangible assets, (patents and licenses), the grant date fair value of stock options, the fair value of embedded conversion features, warrantsdeferred tax assets and any related valuation allowance and related disclosure of contingent assets and liabilities. On an on-going basis, the Company evaluates its estimates, based on historical experience and on various other assumptions that it believes to be reasonable under the circumstances. Actual results maycould materially differ from these estimates.

Reclassifications

Certain amountsThese unaudited interim condensed financial statements should be read in conjunction with the financial statements of the Company for the year ended October 31, 2017 and notes thereto contained in the prior period financial statements have been reclassified to conform toCompany’s annual report on Form 10-K for the presentation ofyear ended October 31, 2017, as filed with the current period financial statements. These reclassifications had no effectSEC on the previously reported net loss.

Collaboration AgreementsDecember 21, 2017.

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 the arrangement. The Company also reevaluates whether an arrangement qualifies or continues to qualify as a collaborative arrangement whenever there is a change in either the roles of the participants or the participants’ exposure to significant risks and rewards dependent on the ultimate commercial success of the endeavor. For those collaborative arrangements where it is determined that the Company is the principal participant, costs incurred and revenue generated from 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 of products and product candidates. These collaborations generally provide for non-refundable, upfront license fees, research and development and commercial performance milestone payments, cost sharing, royalty payments and/or profit sharing. The Company’s collaboration agreements with third parties are performed 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 patent licensing. In general, these revenue arrangements provide for the payment of contractually determined fees in consideration for the grant of certain intellectual property rights for patented technologies owned or controlled by 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 minimum upfront 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 activities cannot be accounted for as separate units of accounting is deferred and recognized as revenue on a straight-line basis over the expected period of performance.

Revenues from the achievement of research and development milestones, if deemed substantive, are recognized as revenue when the milestones are achieved 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 and development 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 the milestone was not reasonably assured at the inception of the arrangement; (3) substantive effort is involved to achieve the milestone; and (4) the amount of the milestone appears reasonable in relation to the effort expended, and the other milestones in the arrangement and the related risk associated with the achievement 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 using its technologies. Royalties are recognized as earned in accordance with the contract terms when royalties from licensees can be reasonably estimated and collectability is reasonably assured. If royalties cannot be reasonably estimated or collectability of a royalty amount is not reasonably assured, royalties are recognized 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 to be 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’s existing license fee receivables, using historical experience. The Company reviews its allowance for doubtful accounts periodically. Past due accounts are reviewed individually for collectability. Account balances are charged off against the allowance after all means of collection have been exhausted and the potential 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 when purchased to be cash equivalents. As of July 31, 2017 and October 31, 2016, the Company had approximately $8.3 million and $106.7 million, respectively, in cash equivalents.

Concentration of Credit Risk

TheFinancial instruments which potentially subject the Company maintains itsto concentration of credit risk, consist principally of cash and cash equivalents. All of the Company’s cash and cash equivalents are deposited in bank deposit accounts (checking)with financial institutions that management believes are of high credit quality and at times exceed the federally insured limits. Approximately $13.7 million is subject to credit risk at July 31, 2017. However, these cash balances are maintained at creditworthy financial institutions. The Company hashad not experienced any losses in such accounts and believes it is not exposed to any significant credit risk.

Fair ValueRestricted Cash and Letters of Financial InstrumentsCredit

During July 2017 and January 2018, the Company established two letters of credit with a financial institution as security for the purchase of custom equipment and as security for application fees associated with the Company’s Marketing Authorization Application (“MAA”) in Europe. The carrying amountsletters of financial instruments, includingcredit are collateralized by cash accounts payable and accrued expenses approximated fair valuewhich is unavailable for withdrawal or for usage for general obligations. No amount is outstanding under either letter of credit as of the balance sheet date presented, because of the relatively short maturity dates on these instruments. The carrying amounts of the financing arrangements issued approximate fair value as of the balance 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.July 31, 2018.

Net LossIncome (Loss) per Share

Basic net income or loss per common share is computed by dividing net income or loss available to common shareholdersstockholders by the weighted average number of common shares outstanding during the period. Diluted earnings per share give effect to dilutive options, warrants, convertible debtrestricted stock units and other potential Common Stockcommon stock outstanding during the period. In the case of a net loss, the impact of the potential Common Stockcommon 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 case of net income, the impact of the potential Common Stockcommon stock resulting from these instruments that have intrinsic value are included in the diluted earnings per share. The table sets forth the number of potential shares of Common Stockcommon stock that have been excluded from diluted net loss per share.

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 of shares 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 an award 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 for non-employees, the fair value of the award is generally measured based on contractual terms. The fair value amount is then recognized over the requisite service period, usually the vesting period, in both research and development expenses and general and administrative expenses on the statement of operations, 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 requisite service period involves significant assumptions and judgments. The Company estimates the fair value of stock option awards on the date of grant using the Black Scholes Model (“BSM”) for the remaining awards, which requires that the Company makes certain assumptions regarding: (i) the expected volatility in the 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 award prior to exercise (referred to as the expected holding period). As a result, if the Company revises its assumptions and estimates, stock-based compensation expense could change materially for future grants.

The Company accounts for stock-based compensation using fair value recognition and records stock-based compensation as a charge to earnings net of forfeited awards. As such, the Company recognizes stock-based compensation cost only for those stock-based awards that vest over their requisite service period, based on the vesting provisions of the individual grants.

Recent Accounting PronouncementsStandards

In May 2014, as part of its ongoing efforts to assist in the convergence of GAAP and International Financial Reporting Standards, the FASB issued ASU No. 2014-09, Revenue from Contracts with Customers (Topic 606) (“ASU 2014-09”), which is a new standard related toamends the existing accounting standards for revenue recognition. UnderASU 2014-09 is based on principles that govern the new standard, recognition of revenue occurs when a customer obtains control of promised services or goods inat an amount that reflects the consideration to which thean entity expects to receive in exchange for those goods or services. In addition, the standard requires disclosure of the nature, amount, timing, and uncertainty of revenue and cash flows arising from customer contracts. The standard must be adopted using either a full retrospective approach for all periods presented in the period of adoption or a modified retrospective approach. In July 2015,entitled when products are transferred to customers.

Subsequently, the FASB has issued the following standards related to ASU 2015-14,2014-09: ASU No. 2016-08, Revenue from Contracts with Customers - Deferral of the Effective Date, which defers the implementation of this new standard to be effective for fiscal years beginning after December 15, 2017. Early adoption is permitted effective January 1, 2017. In March 2016, the FASB issued ASU 2016-08,(Topic 606): Principal versus Agent Considerations which clarifies the implementation guidance on principal versus agent considerations in the new revenue recognition standard pursuant to (“ASU 2014-09. In April 2016, the FASB issued2016-08”); ASU No. 2016-10, Revenue from Contracts with Customers (Topic 606): Identifying Performance Obligations and Licensing in May 2016, the FASB issued (“ASU 2016-10”); ASU No. 2016-12, Revenue from Contracts with Customers (Topic 606): Narrow-Scope Improvements and Practical Expedients (“ASU 2016-12”); and in December 2016 the FASB issued ASU No. 2016-20, Technical Corrections and Improvements to Topic 606, Revenue from Contracts with Customers which amend certain aspects(“ASU 2016-20”). The Company must adopt ASU 2016-08, ASU 2016-10, ASU 2016-12 and ASU 2016-20 with ASU 2014-09 (collectively, the “new revenue standards”). The new revenue standards may be applied retrospectively to each prior period presented or retrospectively with the cumulative effect recognized as of the new revenue recognition standard pursuant to ASU 2014-09.date of adoption. We are currently evaluating which transition approach we will utilize and the impact of adopting this accounting standard on the Company’sour unaudited condensed financial statements. This update will be effective for the Company beginning in the first quarter of fiscal 2019.

In February 2016, the FASB issued ASU 2016-02, Leases“Leases (“Topic 842”) (“ASU 2016-02”). The standard amends the existing accounting standards for lease accounting, including requiring lessees to recognize most leases on their balance sheets and making targeted changes to lessor accounting. ASU 2016-02 will be effective beginning in the first quarter of 2019.fiscal 2020. Early adoption of ASU 2016-02 is permitted. The new leases standard requires a modified retrospective transition approach for all leases existing at, or entered into after, the date of initial application, with an option to use certain transition relief. The Company is currently evaluating the impact of adopting ASU 2016-02 on the Company’s financial statements.

In June 2016, the FASB issued ASU 2016-13, “Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments.” The standard significantly changes how entities will measure credit losses for most financial assets and certain other instruments that aren’t measured at fair value through net income. The standard will replace today’s “incurred loss” approach with an “expected loss” model for instruments measured at amortized cost. For available-for-sale debt securities, entities will be required to record allowances rather than reduce the carrying amount, as they do today under the other-than-temporary impairment model. It also simplifies the accounting model for purchased credit-impaired debt securities and loans. This ASU is effective for annual periods beginning after December 15, 2019, and interim periods therein. Early adoption is permitted for annual periods beginning after December 15, 2018, and interim periods therein. This ASU is not expected 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.” The amendments in this Update clarify the definition of a business with the objective of adding guidance to assist entities with evaluating whether transactions should be accounted for as acquisitions (or disposals) of businesses. The amendments in this Update provide a screen to determine when a set is not a business. 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 that together significantly contribute to the ability to create output and (2) removes the evaluation of whether a market participant could replace the missing elements. This Update is the final version of Proposed ASU 2015-330 Business Combinations (Topic 805) – Clarifying The Definition of a Business, which has been deleted. The amendments 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.

In May 2017, the FASB issued ASU 2017-09, “Compensation—Stock Compensation (Topic 718): Scope of Modification Accounting” to provide clarity and reduce both (1) diversity in practice and (2) cost and complexity when applying the guidance in Topic 718, Compensation—Stock Compensation, to a change to the terms or conditions of a share-based payment award. The amendments in this Update provide guidance about which changes 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 final version of Proposed ASU 2016-360—Compensation—Stock Compensation (Topic 718)—Scope of Modification Accounting, which has been deleted. The amendments 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 material impact on the accompanying condensed financial statements.

3. INVESTMENTSSHORT-TERM INVESTMENT SECURITIES

The following table summarizes the Company’s short-term investment securities at amortized cost as of October 31, 2017 (in thousands):

As of July 31, 2017 and October 31, 2016:

All2018, all of the Company’s investments mature within the next 12 months.

short-term investment securities have matured.

4. PROPERTY AND EQUIPMENT

Property and equipment, net consists of the following:following (in thousands):

Depreciation expense for the three and nine months ended July 31, 2018 and 2017 was approximately $0.3 million, $0.8 million, $0.2 million and 2016 was $216,376, $553,779, $68,457 and $163,581,$0.6 million, respectively.

5. INTANGIBLE ASSETS

Pursuant to our license agreement with the University of Pennsylvania (“Penn”), the Company is billed actual patent expenses as they are passed through from Penn and are billed directly from our patent attorney. The following is a summary of intangibleIntangible assets, as of the endnet consist of the following fiscal periods:(in thousands):

The expirations of the existing patents range from 20172018 to 20372038 but the expirations can be extended based on market approval if granted and/or based on existing laws and regulations. Capitalized costs associated with patent applications that are abandoned without future value are charged to expense when the determination is made not to pursue the application. Patent applications having a net book value of $17,745approximately $0.1 million, $0.4 million, $0.02 million and $107,626$0.1 million were abandoned and were charged toResearch research and Development Expensesdevelopment expenses in the statementStatement of operationsOperations for the three and nine months ended July 31, 2017. No patent applications were abandoned during the three or nine months ended July 31, 2016.2018 and 2017, respectively. Amortization expense for intangible assets is included in researchaggregated approximately $0.1 million, $0.3 million, $0.1 million and development expenses and aggregated $87,000, $239,155, $64,440 and $183,184$0.2 million for the three and nine months ended July 31, 2018 and 2017, and 2016, respectively.

At July 31, 2017,2018, the estimated amortization expense by fiscal year based on the current carrying value of intangible assets is as follows:follows (in thousands):

6. ACCRUED EXPENSES:

The following table represents the major components of accrued expenses:expenses (in thousands):

7. DERIVATIVE INSTRUMENTSWARRANTS

Warrants

A summary of changes in warrants for the nine months ended July 31, 2017 is as follows:

At July 31, 20172018 and October 31, 2016,2017, the Company had 3,092,395 warrants outstanding at a weighted average exercise price of $5.00 and 3,092,619a weighted average remaining contractual life of 0.17 and 0.92 years, respectively. At July 31, 2018 and October 31, 2017, all of the Company’s outstanding warrants were classified as equity (equity warrants) out of it total 3,094,173 and 3,110,575 warrants, respectively.. At issuance, equity warrants are recorded at their relative fair values, using the Relative Fair Value Method,relative fair value method, in the shareholders’stockholders’ equity section of the balance sheet. The Company’s equity warrants can only be settled through the issuance of shares and are not subject to anti-dilution provisions.

Warrant Liability

At July 31, 2017, the Company had approximately 2,000 of its total approximately 3.09 million outstanding warrants classified as liabilities (liability warrants). At October 31, 2016, the Company had approximately 18,000 of its total approximately 3.11 million outstanding warrants classified as liabilities (liability warrants). The Company utilizes the BSM to calculate the fair value of these warrants at issuance and at each subsequent reporting date. The liability warrants contain a cash settlement provision 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 of operations.

At July 31, 2017 and October 31, 2016, the fair value of the warrant liability was $0 and $20,156, respectively. For the three months ended July 31, 2017 and 2016, the Company reported a gain of $0 and $6,340, respectively, due to changes in the fair value of the warrant liability. For the nine months ended July 31, 2017 and 2016, the Company reported a gain of $20,156 and $56,214, respectively, due to changes in the fair value of the warrant liability. In determining the fair value of the warrant liability at July 31, 2017 and October 31, 2016, the Company used the following inputs in its BSM:

8. SHARE BASED COMPENSATION

The following table summarizes share-based compensation expense included in the Statement of Operations (in thousands):

Restricted Stock Units (RSUs)

A summary of the Company’s RSU activity and related information for the nine months ended July 31, 20172018 is as follows:

As of July 31, 2017,2018, there was approximately $11,266,000$3.2 million of unrecognized compensation cost related to non-vested RSUs, which is expected to be recognized over a remaining weighted average vesting period of approximately 2.181.57 years.

As of July 31, 2017,2018, the aggregate intrinsic value of non-vested RSUs was approximately $9,884,000.

$1.0 million.

Employee Stock Awards

Common Stock issued to executives and employees related to vested incentive retention awards, employment inducements, management purchases and employee excellence awards totaled 215,267 shares (190,247 shares on a net basis after employee taxes) and 463,985 shares (452,084 shares on a net basis after employee taxes) and 152,056 shares (149,833 shares on a net basis after employee taxes) forduring the three months ended July 31, 20172018 and 2016,2017 respectively. Total stock compensation expense associated with theseemployee awards for the three months ended July 31, 2018 and 2017 was approximately $0.9 and 2016 was $4,259,656 and $1,220,832 respectively.$4.3 million, respectively

Common Stock issued to executives and employees related to vested incentive retention awards, employment inducements, management purchases and employee excellence awards totaled 717,505669,044 shares (674,543(623,687 shares on a net basis after employee taxes) and 539,512717,505 shares (532,933(674,543 shares on a net basis after employee taxes) during the nine months ended July 31, 20172018 and 2016,2017 respectively. Total stock compensation expense associated with theseemployee awards for the nine months ended July 31, 2018 and 2017 was approximately $2.9 million and 2016 was $7,328,591 and $4,075,393,$7.3 million, respectively.

Furthermore, employees were entitled to receive a performance-based year-end cash bonus. Several employees voluntarily requested to be paid all or a portion of their cash bonusIncluded in compensation expense for the Company’s Common Stock instead of cash. During thethree and nine months ended July 31, 2016,2018 is approximately $110,000 and $320,000, respectively, recognized as a result of the total fair valuemodification of these equity purchases were $102,022, or 9,150 sharescertain RSU’s associated with the resignation of the Company’s Common Stock.Chief Financial Officer in April 2018 and Chief Operating Officer in June 2018. Pursuant to the separation agreements, the vesting was accelerated on all of the outstanding RSU’s.

Director Stock Awards

Common stock issued to Directors for compensation related to board and committee membership totaled 0 shares45,000 and 31,7670 shares for the three months ended July 31, 2018 and 2017, and 2016, respectively. Total Director stock compensation expense forDuring the three months ended July 31, 2018 and 2017, total stock compensation expense associated with Director awards was approximately $71,000 and 2016 was $101,628 and $311,205,$102,000, respectively.

Common stock issued to Directors for compensation related to board and committee membership totaled 30,00075,000 and 125,50130,000 shares for the nine months ended July 31, 2018 and 2017, and 2016, respectively. Total Director stock compensation expense forDuring the nine months ended July 31, 2018 and 2017, total stock compensation expense associated with Director awards was approximately $178,000 and 2016 was $301,572 and $933,615,$302,000, respectively.

Stock Options

A summary of changes in the stock option plan for the nine months ended July 31, 20172018 is as follows:

Total compensation cost related to the Company’s outstanding stock options, recognized in the statement of operations for the three months ended July 31, 20172018 and 2016,2017 was approximately $9,698,000$0.9 million and $3,108,000,$9.7 million, respectively. For the nine months ended July 31, 20172018 and 2016,2017, compensation cost related to the Company’s outstanding stock options was approximately $15,889,000$2.9 million and $13,060,000,$15.9 million, respectively. Included in compensation expense for the three and nine months ended July 31, 2018 is approximately $0 and $77,000, respectively, recognized as a result of the modification of certain option agreements associated with two Board members that decided not to run for re-election in March 2018. For the modified options, the vesting was accelerated and the expiration dates were changed to the earlier of the original expiration date or March 21, 2023.

During the nine months ended July 31, 2018, 2,473,460 options were granted with a total grant date fair value of approximately $4.0 million. During the nine months ended July 31, 2017, 556,952 options were granted with a total grant date fair value of approximately $3,542,000. During the nine months ended July 31, 2016, 1,385,000 options were granted with a total grant date fair value of approximately $14,838,000.$3.5 million.

As of July 31, 2017,2018, there was approximately $6,342,000$3.4 million of unrecognized compensation cost related to non-vested stock option awards, which is expected to be recognized over a remaining weighted average vesting period of approximately 1.292.19 years.

As of July 31, 2017,2018, the aggregate intrinsic value of vested and exercisable options was approximately $27,000.

$0.

In determining the fair value of the stock options granted during the nine months ended July 31, 20172018 and 2016,2017, the Company used the following inputs in its BSM:

Shares Issued to Consultants2018 Employee Stock Purchase Plan – update with ’18 Plan

During the three months ended July 31, 2017, 48,737 shares of Common Stock valued at $416,000 were issued to consultants for services, of which $247,100 represented shares issued for amounts previously accrued. The Company recorded a liability on its balance sheet for $141,800 for shares earned pursuant to consulting agreements but not delivered. During the three months ended July 31, 2016, 31,030 shares of Common Stock valued at $252,000 were issued to consultants for services. The common stock share values were based on the dates the shares vested.

During the nine months ended July 31, 2018, the Company issued 10,681 shares that were purchased in fiscal 2017 125,549 shares of Commonunder the 2011 Employee Stock valued at $1,108,950 were issued to consultants for services, of which $75,000 represented shares issued for amounts previously accrued. The Company recorded a liability on its balance sheet for $141,800 for shares earned pursuant to consulting agreements but not delivered. During the nine months ended July 31, 2016, 120,047 shares of Common Stock valued at $1,097,088 were issued to consultants for services. The common stock share values were based on the dates the shares vested.Purchase Plan (“ESPP”).

The following table summarizes share-based compensation expense included inAdvaxis, Inc. 2018 ESPP was approved by the StatementCompany’s shareholders on March 21, 2018. The ESPP allows eligible employees to purchase shares of Operations by expense categoryour common stock at a 15% discount to the closing market price on designated exercise dates. 1,000,000 shares of the Company common stock are reserved for issuance under the three and nine months ended July 31, 2017 and 2016, respectively:

9. COLLABORATION AND LICENSING AGREEMENTS

AmgenESPP.

On August 1, 2016, the Company entered into a global agreement (the “Amgen Agreement”) with Amgen for the development and commercialization of the Company’s ADXS-NEO, a novel, preclinical investigational immunotherapy, using the Company’s proprietary Listeria monocytogenes attenuated bacterial vector which activates a patient’s immune system to respond against unique mutations, or neoepitopes, contained in and identified from an individual patient’s tumor. Under the terms of the Amgen Agreement, Amgen receives an exclusive worldwide license to develop and commercialize ADXS-NEO. Advaxis and Amgen will collaborate through a joint steering committee for the development and commercialization of ADXS-NEO. Under the Amgen Agreement, Amgen will fund the clinical development and commercialization of ADXS-NEO and Advaxis will retain manufacturing responsibilities. The Company considered the provisions of the research and development and collaboration guidance in determining how to recognize the clinical development payments to be received from Amgen. The Company determined the clinical development payments should be accounted for within the scope of collaboration arrangement accounting guidance. As a result, the Company will account for the clinical development payments as a reduction ofResearch and Development Expenses in the statement of operations. During the nine months ended July 31, 2017, the Company received clinical development payments from Amgen totaling $4,500,000. In addition, the Company recorded an expected clinical development payment of $1,500,000 asOther Receivableson the balance sheet. In August 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 Especificos Stendhal SA de CV (“Stendhal”), for Advaxis’ leadLm Technology™ immunotherapy, Axalimogene filolisbac , in HPV-associated cancers. Under the terms of the Stendhal Agreement, Stendhal will pay $10 million (“Support Payments”) towards the expense of AIM2CERV over the duration of the trial. Certain internal expenses of Stendhal up to $1 million shall be counted towards the $10 million in Support Payments. The Support Payments are contingent upon Advaxis achieving annual project milestones. The Company considered the provisions of the research and development and collaboration guidance in determining how to recognize the Support Payments to be received from Stendhal. The Company determined the Stendhal Agreement should be accounted for within the scope of collaboration arrangement accounting guidance. Furthermore, the Company determined that Advaxis is the principal in the Stendhal Agreement. As a result, the Company will account for the Support Payments as a reduction ofResearch and Development Expenses in the statement of operations. During the nine months ended July 31, 2017, the Company reached the annual project milestones and received a $3,000,000 Support Payment from Stendhal.

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 cancer immunotherapy agent using Advaxis’ proprietaryLm-based antigen delivery product with SELLAS’ patented WT1 targeted heteroclitic peptide antigen mixture (galinpepimut-S)). Pursuant to the agreement, Advaxis will conduct all pre-clinical activities required for an IND filing and Sellas will be responsible for 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 sales upon commercialization. If SELLAS sublicenses its rights, Advaxis will receive a percentage of applicable sublicense revenue paid.

10.9. COMMITMENTS AND CONTINGENCIES :

Legal Proceedings

Knoll

On August 21, 2015, Knoll Capital Management L.P. filed a complaint against the Company in the Delaware Court of Chancery. 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 expressly denies any admission or wrongdoing and the settlement was entered into solely for the purpose of avoiding the burden, inconvenience, and expense of further 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 shareholderstockholder in the United States District Court for the District of New Jersey 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 iswas based on general allegations related to certain stock options granted to the individual defendants and generally allegesalleged counts for breaches of fiduciary duty and unjust enrichment. The complaint also allegesalleged additional claims for violation of Section 14(a) of the Securities Exchange Act of 1934 and for waste of corporate assets. The complaint seekssought 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 United States District Court for the District of New Jersey issued an opinion and order granting in part and denying in part defendants’ motion to dismiss. Specifically, the court denied the motion to dismiss as to the breach of fiduciary duty claim and unjust enrichment claim against the three members of the Compensation Committee, but dismissed without prejudice the breach of fiduciary duty and unjust enrichment claims against the other eight individual defendants [O’Connor, Khleif, McKearn, Patton, Bonstein, Mauro, Mayes, and Petit]. The court dismissed without prejudice the Section 14(a) disclosure claim and waste claims against all defendants. On October 5, 2016, the courtCourt denied plaintiff’s motion for reconsideration of its May 23 order. On April 13, 2017, the parties advised the Court that they had reached a tentative agreement in principle to settle the action, which is still subject to negotiating an award of attorneys’ fees and expenses to Plaintiffs’plaintiff’s counsel and a stipulation of settlement, and, ultimately, Court approval. The parties subsequently executed the stipulation of settlement on October 2, 2017. The Court entered an order preliminarily approving the settlement on November 7, 2017. The final fairness hearing was held January 29, 2018, and the Order and Final Judgment approving the settlement and dismissing the action with prejudice was entered on January 29, 2018. This matter is now concluded.

GeneralCorporate Office & Manufacturing Facility Lease

The Company is from time to time involvedleases its corporate office and manufacturing facility under an operating lease expiring in legal proceedings in the ordinary course of its business. The Company does not believe that any of these claims and proceedings against it is likely to have, individually or in the aggregate, a material adverse effect on its financial condition or results of operations.

Operating LeasesNovember 2025.

The Company’s corporate offices are currently located at 305 College Road East, Princeton, New Jersey 08540.

At July 31, 2017 futureFuture minimum lease payments by fiscal year ofunder the Company’s operating leases are as follows:follows (in thousands):

10. INCOME TAXES

On December 22, 2017, the U.S. government enacted comprehensive tax legislation commonly referred to as the Tax Cuts and Jobs Act (the “Tax Act”). The Tax Act significantly revises U.S. corporate income taxation by, among other things, lowering the U.S. corporate income tax rate from 35.0 % to 21.0% effective January 1, 2018. The decrease in the U.S. federal corporate tax rate from 35.0% to 21.0% will result in a blended statutory tax rate of 23.2% for the fiscal year ending October 31, 2018. The Company does not anticipate any impact to tax expense due to the full valuation allowance of the Company and believes that the most significant impact on its financial statements will be reduction of approximately $32.7 million for the deferred tax assets related to net operating losses and other assets. Such reduction is offset by changes to the Company’s valuation allowance.

In December 2017, the Securities and Exchange Commission issued Staff Accounting Bulletin 118, which allows a measurement period, not to exceed one year, to finalize the accounting for the income tax impacts of the Tax Act. Until the accounting for the income tax impacts of the Tax Act is complete, the reported amounts are based on reasonable estimates, are disclosed as provisional and reflect any adjustments in subsequent periods as they refine their estimates or complete their accounting of such tax effects.

11. STOCKHOLDERS’ EQUITY

During the nine months ended July 31, 2018, the Company sold 881,629 shares of its common stock at-the-market transactions resulting in net proceeds of approximately $2.7 million.

During February 2018, the Company issued 10,000,000 shares of the Company’s common stock in a public offering at $2.00 per share, less underwriting discounts and commissions. The net proceeds to the Company from the transaction was approximately $18.4 million.

On March 21, 2018, the Company’s shareholders approved an amendment to the Company’s Amended and Restated Certificate of Incorporation to increase our authorized shares of common stock by 30,000,000 to 95,000,000.

12. SUBSEQUENT EVENTS

On September 4, 2018, The Company granted a license to OS Therapies LLC for the use of ADXS31-164, also known as ADXS-HER2, for evaluation in the treatment of osteosarcoma in humans. Under the terms of the license agreement, OS Therapies LLC, in collaboration with the Children’s Oncology Group, will be responsible for the conduct and funding of a clinical study evaluating ADXS-HER2 in recurrent, completely resected osteosarcoma. The Company will receive an upfront payment, reimbursement for product supply and other support, clinical, regulatory, and sales-based milestone payments, and royalties on future product sales.

On September 7, 2018, the Company announced the pricing of an underwritten public offering of 16,666,666 shares of its common stock and warrants to purchase up to 14,166,666 shares of common stock. Each share of common stock is being sold together in a fixed combination with a warrant to purchase 0.85 shares of common stock. The warrants will be exercisable immediately, will expire six years from the date of issuance and will have an exercise price of $1.50 per share, subject to anti-dilution adjustments. The gross proceeds of the offering to the Company are expected to be approximately $20 million, before deducting the underwriting discounts and commissions and other estimated offering expenses, and excluding the exercise of any warrants. The closing of the offering is expected to occur on or about September 11, 2018, subject to the satisfaction of customary closing conditions.

The shares of common stock will be sold pursuant to an effective shelf registration statement on Form S-3 (No. 333- 226988) filed with the Securities and Exchange Commission on August 23, 2018 and declared effective on August 30, 2018.

ITEMItem 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONSManagement’s Discussion and Analysis of Financial Condition and Results of Operations

The following discussion and analysis contains forward-looking statements about our plans and expectations of what may happen in the future. Forward-looking statements are based on a number of assumptions and estimates that are inherently subject to significant risks and uncertainties, and our results could differ materially from the results anticipated by our forward-looking statements as a result of many known or unknown factors, including, but not limited to, those factors discussed in “Risk Factors” and incorporated by reference herein. See also the “Special Cautionary Notice Regarding Forward-Looking Statements” set forth at the beginning of this report.

You should read the following discussion and analysis in conjunction with the unaudited financial statements, and the related footnotes thereto, appearing elsewhere in this report, and in conjunction with management’s discussion and analysis and the audited financial statements included in our annual report on Form 10-K for the year ended October 31, 2016.2017. In addition, we intend to use our media and investor relations website (http:// http://ir.advaxis.com/), SEC filings, press releases, public conference calls and webcasts as well as social media to communicate with our subscribers and the public about Advaxis, its services and other issues. It is possible that the information we post on social media could be deemed to be material information. Therefore, in light of the SEC’s guidance, we encourage investors, the media, and others interested in Advaxis to review the information we post on the U.S. social media channels listed on our website.

Overview

Advaxis, Inc. is a late-stage biotechnology company focused on the discovery, development and commercialization of proprietaryListeria monocytogenes (“Lm-based”) based antigen delivery productsproducts. The Company is using itsLm platform directed against tumor-specific targets in order to engage the patient’s immune system to destroy tumor cells. Through a license from the University of Pennsylvania, Advaxis has exclusive access to this proprietary formulation of attenuatedLm calledLm Technology. Advaxis’ proprietary approach deploys a unique mechanism of action that redirects the immune system to attack cancer in three distinct ways by:

During the second fiscal quarter, the Company began assessing the clinical and commercial viability of its R&D programs in order to determine which were best suited for internal development and which were better suited for external development opportunities, while determining other ways to reduce operating expenses, in order to maximize stockholder value. In particular, we took the following actions:

In addition, in June 2018, the Company announced that it implemented a reduction in force to align its staffing needs with its new strategy. The reduction involved the elimination of approximately 24% of the Company’s work force. Overall the cost of separation payments were slightly higher than the savings of the work force reduction in the third quarter by approximately $0.14 million. Beginning with the leadCompany’s fourth quarter, results of operations net of quarterly savings will be approximately $1.2 million, or a total annualized workforce payroll savings of approximately $4.6 million. The net savings generated by the elimination of these positions, in conjunction with the reduction in clinical expenditures, will significantly lower the Company’s operating expenses and align its operations to focus on priority programs.

As previously reported, the Company’s clinical trial collaboration agreement with MedImmune, the global biologics research and development arm of AstraZeneca, related to the Phase 1/2, open-label, multicenter, two-part study to evaluate the safety and efficacy of axalimogene filolisbac in combination with MedImmune’s investigational anti-PD-L1 immune checkpoint inhibitor, durvalumab, as a combination treatment for patients with metastatic squamous or non-squamous carcinoma of the cervix and metastatic HPV-associated squamous cell carcinoma of the head and neck was placed on clinical hold by FDA on March 9, 2018 following its review of a safety report regarding a Grade 5 Serious Adverse Event occurring on February 27, 2018 and involving respiratory failure which followed a sixth combination cycle (11^th dose of axalimogene filolisbac, 21^st dose of durvalumab) in the trial. As of the end of 2017, over 430 patients have received axalimogene filolisbac, and approximately 1,260 doses have been delivered across multiple trials in HPV-associated cancers, to date, and this is the first time we have seen this type of event. On July 13, 2018, the Company announced that it received notification from the FDA that the clinical hold has been lifted. New guidelines for the early detection and treatment of such rare events were agreed to with the FDA and have been implemented for this combination study and will be implemented across the portfolio as needed. Enrollment and dosing in all other Advaxis and durvalumab clinical programs were not affected by the clinical hold.

ADXS-HOT

Utilizing ADXS-HOT, a program that leveragesLmTechnology to target hotspot neoantigens and other proprietary tumor associated antigens that commonly occur in Phase 3 development. These immunotherapies are based onspecific cancer types, the Company is currently prioritizing product development in the most prevalent cancers, with the first tumor type to be NSCLC. On July 30, 2018, the Company announced FDA’s allowance of its ADXS-HOT IND in NSCLC. We plan to commence a platform technology that utilizes live attenuatedfirst-in-human trial in NSCLC in 2018. Going forward, the Company plans to submit additional INDs for drug candidates from its ADXS-HOT program for prostate cancer by the end of 2018, for bladder cancer by the first quarter of 2019 and for one of breast, colorectal, ovarian or head and neck candidates by the third quarter of 2019.

ADXS-HOT preclinical data was presented in a poster presentation at the 2018 AACR Annual Meeting. The study, entitled “Targeting Shared Hotspot Cancer Mutations with aListeria monocytogenes bioengineeredImmunotherapy Induce Potent Anti-Tumor Immunity” demonstrated that the ADXS-HOT platform could effectively target common (public or shared) mutations (hotspots) and control tumor growth with both single and multi-target constructs.

In June 2018, we announced plans to secrete antigen/adjuvant fusion proteins. Theseincrease our internal investment in the ADXS-HOT program.

ADXS-NEO

Preclinical findings in the ADXS-NEO personalizedLm-based strains are believedimmunotherapy program were discussed in poster presentations at the 2018 American Association for Cancer Research (AACR) Annual Meeting. Additionally, portions of these data were presented by Amgen, the Company’s partner in the development and commercialization of the ADXS-NEO program, at a podium presentation during the European Neoantigen Summit 2018.

The first study, as discussed in a poster presentation at AACR entitled “Neoantigens that fail to beelicit measurable T cell responses following peptide immunization can control tumor growth when delivered using a significant advancementListeria-based immunotherapy platform,” showed that ADXS-NEO generates T cell responses against neoantigen peptides that control tumor growth, even when they were identified as “non-immunogenic” using a conventional peptide-adjuvant immunization.

In the second study, discussed in a poster presentation at AACR entitled “Targeting frameshift mutations with aListeria monocytogenesimmunotherapy as they integrate multiple functions into a single immunotherapy as they accessdrives neoantigen-specific antitumor immunity in MC38 and direct antigen presentingCT26 mouse tumor models,” Advaxis’Lm platform was shown to target frameshift mutations and generate T cells to stimulate anti-tumor T-cell immunity, stimulatemultiple neoantigens per frameshift in these models. This data highlighted the physical capacity of the AdvaxisLm platform and activateits ability to target frameshift mutations of greater than 90 amino acids, and to generate T cells to multiple neoantigens per frameshift in tumor mouse models.

The initial tumor types for the immune system with the equivalent of multiple adjuvants,open-label, dose-escalation, multicenter Phase 1 trial are microsatellite stable colorectal cancer, head and simultaneously reduce tumor protectionneck cancer, and NSCLC. The first patient, being treated for NSCLC, was dosed in June 2018. Additionally, in June 2018, we announced plans to increase our internal investment in the tumor microenvironment to enable the T-cells to eliminate tumors.ADXS-NEO program.

ADXS-PSA

Advaxis is conducting a trial in collaboration with Merck & Co. (“Merck”) evaluating the safety and efficacy of ADXS-PSA as monotherapy and in combination with KEYTRUDA^® (“pembrolizumab”), Merck’s anti PD-1 antibody, in a Phase 1/2, open-label, multicenter, dose determination and expansion trial in patients with previously treated metastatic, castration-resistant prostate cancer (Keynote-046). The Company presented data at the 2018 American Society of Clinical Oncology (“ASCO”) annual meeting. ADXS-PSA was tested alone or in combination with KEYTRUDA in an advanced and heavily pretreated patient population who had progressed on androgen deprivation therapy. A total of 13 and 37 patients were evaluated on monotherapy and combination therapy, respectively. Overall, the safety profile was consistent with findings from prior clinical studies using theLm platform. Treatment-related adverse events (TRAEs) were mostly mild or moderate constitutional symptoms such as fever, chills, rigors, hypotension, nausea and fatigue, consistent with immune activation and manageable with standard care. There were no new toxicities observed with the combination therapy. In all treated patients, those who received the combination therapy experienced the longest overall survival (OS) at data cut-off. Additional efficacy related data include:

These data, while early, have proven worthy of further evaluation and the company will continue to investfollow patients’ survival for the next six to nine months in its core clinical franchises and will also remain opportunistic based on Investigator Sponsored Trials (“ISTs”) as well as licensing opportunities. Our proprietaryLm Technology platform is protected by a range of patents, covering both product and process, some of which we believe can be maintained into 2037.order to determine the path forward.

HPV Related Cancers

We have developed a strong franchiseseveral programs in HPV-related cancers including bothbased on axalimogene filolisbac, and ADXS-DUAL. Axalimogene filolisbac is anLm–based antigen delivery product directed against HPV and designed to target cells expressing the HPV. ADXS-DUAL, our second immunotherapy targeting HPV-associated cancers,Axalimogene filolisbac is anLm–based immunotherapy that secretes a fusion protein containing E7 protein antigens from both alpha 7 (HPV18) and alpha 9 (HPV 16) families, and has the potential to promote more potent T-cell responses for patients with metastatic cancer and a greater disease burden. We developed ADXS-DUAL by building on our learnings from the clinical development of axalimogene filolisbac and have incorporated an additional HPV target antigen into ourLm bacterial vector. Our HPV-related products are currently under investigation in three HPV-associated cancers: cervical cancer, head and neck cancer, and anal cancer, either as a monotherapy or in combination.combination with other therapies, and has shown encouraging safety and efficacy in numerous clinical studies to date.

Cervical Cancer

There are approximately 527,000 new cases of cervical cancer caused by HPV worldwide every year, and 12,000 new cases in the U.S. alone, according to the WHO Human Papillomavirus and Related Cancers in the World Summary Report 2017 (“WHO”). Current preventative vaccines cannot protect all women who are infected with this very common virus. Challenges with acceptance, accessibility, and compliance have resulted in approximately 30% of young women and 7% of young men being vaccinated in the United States with even lower vaccination rates in other countries around the world.

We completed a randomized Phase 2 clinical study (Lm-LLO-E7-15), conducted exclusively in India, in 110 women with recurrent/refractory cervical cancer. The final results showed that 34.9% (38/109) of patients were alive at 12 months, 24.8% (27/109) of patients were Long-term Survivors (“LTS”) alive greater than 18 months. Of the 15 patients consenting to further follow-up beyond 18 months, 12 (11%) achieved 24-month OS status (range 24 – 34+ months) at the time of study closure. LTS included not only patients with tumor shrinkage but also patients who had experienced stable disease or increased tumor burden. Investigator assessment of best Overall Response (“OR”) was assessed in the efficacy population. These data demonstrated a best objective response rate (ORR; CR + PR) of 17.1% (N= 6). The mean duration of OR was 7.2 months. The disease control rate (CR + PR + SD) was 62.9% (N= 22) and the mean duration of stable disease was 5.2 months. The addition of cisplatin chemotherapy to axalimogene filolisbac (N=54) in this study did not significantly improve overall survival or objective tumor response (p=0.9981).

In this study, 109 patients received 254 doses of axalimogene filolisbac. Axalimogene filolisbac was found to be well tolerated with the majority of the AEs were mild to moderate in severity (566 of 704 reported AEs, 80.4%) and were not related to study drug (539 of 704 reported AEs, 76.6%). Four patients experienced a Grade 3 treatment-associated Serious Adverse Events (“SAE”). All observed treatment-related adverse eventsThese data were infusion related and either self-resolved or responded readily to symptomatic treatment.published in the May 2018 edition of the peer-reviewedInternational Journal of Gynecological Cancer.

We have reached an agreement with the FDA, under the Special Protocol Assessment (“SPA”) process, to conduct aOur ongoing Phase 3 trial is evaluating axalimogene filolisbac in patients with high-risk, locally advanced cervical (“AIM2CERV” or “AdvaxisImmunotherapy2 PreventCervical Recurrence”). Pursuant to the SPA, theThe study is being conducted under a Special Protocol Assessment (“SPA”), and has been determined by the FDA to be adequate, well-designed, and suitable for registration if successful. This study will beis being conducted in collaboration with the GOG/NRG Oncology, an independent international non-profit organization with the purpose of promoting excellence in the quality and integrity of clinical and basic scientific research in the field of gynecologic malignancies, and we have initiated the AIM2CERV study to support a Biologics License Application (“BLA”) submission in the U.S. and regulatory registration in other territories around the world.

AIM2CERV is a double-blind, randomized, placebo-controlled, Phase 3 study of adjuvant axalimogene filolisbac, following primary chemoradiation treatment of women with high-risk locally advanced cervical cancer (“HRLACC”). The primary objective of AIM2CERV is to compare the disease freedisease-free survival of axalimogene filolisbac to placebo administered in the adjuvant setting following standard concurrent chemotherapy and radiotherapy (“CCRT”) administered with curative intent to patients with HRLACC. Secondary endpoints include examining overall survival and safety. Our goal is to develop a treatment to prevent or reduce the risk of cervical cancer recurrence after primary, standard of care treatment in women who are at high risk of recurrence. The study is active in eightfourteen countries and is currently enrolling.with 129 sites open to date.

Biocon LimitedIn February 2018, the Company submitted a conditional MAA to the European Medicines Agency’s (“Biocon”EMA”), our co-development Committee for the Company’s leadLm Technology product candidate, axalimogene filolisbac, for the treatment of adult women who progress beyond first-line therapy of persistent/recurrent metastatic cervical cancer (“PRmCC”). The MAA submission was primarily based on data from the GOG-0265 study, as well as supportive data from other clinical trials evaluating axalimogene filolisbac and was validated by the EMA in March 2018. In July 2018, the Company rescinded its application based on EMA feedback following its initial review indicating the application would likely need additional data to support a conditional approval.

The Company is seeking a U.S. and/or European partner to fund the development and commercialization partner forof axalimogene filolisbac in India and key emerging markets, filedcervical cancer including the completion of the AIM2CERV study. If the Company is unable to secure a Marketing Authorization Application (“MAA”) for licensurepartner within a limited period of this immunotherapytime, we will wind down the ongoing AIM2CERV trial in India. The companieshigh-risk locally advanced cervical cancer. In the short term, patients participating in the AIM2CERV trial are currently evaluating next steps.continuing treatment.

We have a clinical trial collaboration agreement with MedImmune, the global biologics research and development arm of AstraZeneca, and are conducting a Phase 1/2, open-label, multicenter, two-part study to evaluate the safety and efficacy of axalimogene filolisbac in combination with MedImmune’s investigational anti-PD-L1 immune checkpoint inhibitor, durvalumab, as a combination treatment for patients with metastatic squamous or non-squamous carcinoma of the cervix and metastatic HPV-associated Squamous Cell Carcinoma of the Head and Neck (“SCCHN”).SCCHN. For the axalimogene filolisbac and durvalumab dose escalation portion of the study, the dose-escalation phase has been completed. As reported at the Society for Immunotherapy of Cancer (“SITC”) 2016 annual meeting, preliminary results from the dose escalation portion of the study showed that there were no dose limiting toxicities observed, and the safety profile was consistent with previous findings for both axalimogene filolisbac and durvalumab. The recommended phase 2 dose was established as 1x10⁹Colony Forming Units (“CFU”) for axalimogene filolisbac and 10 mg/kg for durvalumab. As previously reported in preliminary data reported from this ongoing trial, one patient with cervical cancer achieved a complete response and one patient, also with cervical cancer, achieved a partial response with subsequent disease progression. In addition, two patients with SCCHN achieved stable disease. Treatment related adverse events (“TRAE”) were reported in 91% of patients; the majority were either grade 1 or grade 2 events such as chills, fever, nausea and hypotension. Grade 3 TRAEs occurred in three patients, and one patient experienced a grade 4 event. We have commenced enrollment in the Part A (20 patients with SCCHN) and B (90 patients with cervical cancer) expansion phases. Accrual is ongoing.

The GOG Foundation, Inc. (nowphases; however, this trial was placed on clinical hold by FDA on March 9, 2018 following its review of a member of NRG Oncology), under the sponsorship of the Cancer Therapy Evaluation Program (“CTEP”) of the National Cancer Institute (“NCI”), conducted GOG-0265, an open-label, single arm Phase 2 studysafety report regarding a Grade 5 Serious Adverse Event occurring on February 27, 2018 and involving respiratory failure which followed a sixth combination cycle (11th dose of axalimogene filolisbac, 21st dose of durvalumab) in persistent or recurrent cervical cancer (patients mustthe trial. As of the end of 2017, over 430 patients have received at least 1 prior chemotherapy regimenaxalimogene filolisbac, and approximately 1,260 doses have been delivered across multiple trials in HPV-associated cancers, to date, and this is the first time we have seen this type of event. On July 13, 2018, the Company announced that it received notification from the FDA that the clinical hold has been lifted. New guidelines for the early detection and treatment of their recurrent/metastatic disease, not including that administered as a component of primary treatment) at numerous clinical sites in the U.S. The study was a Simon 2-stage design. The primary efficacy endpoint was the 12-month survival rate,such rare events were agreed to with the objective ofFDA and have been implemented for this combination study and will be implemented across the secondary efficacy endpoints to evaluate progression-free survival, overall survivalportfolio as needed. Enrollment and objective tumor response. The primary safety endpoints were to evaluate the number of patients with dose-limiting toxicities and the frequency and severity of adverse effects.

In order to evaluate the study’s primary endpoint of the 12-month overall survival rate, the GOG’s protocol featured a prospectively-defined logistic model-based calculation of the expected 12-month survival rate using key predictive factors significantly related to survival and derived from 17 serially conducted GOG/NRG 2-stage studies of inactive agentsdosing in PRmCC involving approximately 500 patients. This accumulated data by GOG used a consistent protocol design and a similar data collection methodology resulting in a robust and homogeneous patient dataset for the per protocol analysis of the primary endpoint. Per the study protocol, this logistic model-based calculation was then used as a comparator for evaluating the 12-month survival rate of axalimogene filolisbac actually observed.

The first stage of enrollment in GOG-0265 was successfully completed with 26 patients treated and met the predetermined safety and efficacy criteria required 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 conditional power needed in order to progress to Stage 2 was ≥20%), and, among patients who had received the full treatment regimen of 3 doses of axalimogene filolisbac, the 12-month survival rate was 55.6% (10/18). The adverse events observed in the first stage of the study were consistent with those reported inall other clinical studies with axalimogene filolisbac.

Stage 2 of the study began enrollment in February 2015 which included a protocol amendment to allow patients to continue to receive repeat cycles of therapy until disease progression. Stage 2 enrollment was temporarily suspended with a clinical hold in October 2015 that resolved in mid-December 2015. Prior to re-initiating enrollment of a new cohort of Stage 2 patients, Advaxis and durvalumab clinical programs were not affected by the GOG Foundation/NRG Oncology examined the 12-month survival rate and safety data obtained from the 24 patients who had previously enrolled in Stage 2. The Stage 2 population demonstrated that treatment with axalimogene 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 stages of 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-based calculation of the expected 12-month milestone survival rate was calculated to be 24.5% using the key predictors from the patients enrolled in the study. The 12 month survival rate of 38% for patients receiving axalimogene filolisbac in the study represented a 52% improvement over the expected 12-month milestone 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 patients experienced a Grade 4 AE, including a Klebsiella lung infection in one patient, and hypotension/cytokine related symptoms in another patient, which were considered possibly related to treatment.

In October 2016, upon review of these findings, we announced early closure of GOG-0265. Results from the GOG-0265 study were presented as an oral late-breaker presentation at the Society of Gynecologic Oncology (“SGO”) annual meeting on March 14, 2017. Based on these data, we plan on pursuing regulatory opportunities for this unmet medical need in Europe in 2017.hold.

We have entered into a clinical development collaboration agreement with BMS to evaluate their PD-1 immune checkpoint inhibitor, OPDIVO^® (nivolumab), in combination with ADXS-DUALaxalimogene filolisbac as a potential treatment option for women with metastatic cervical cancer. We planThe ADVANCE trial was planned to file our IND application for ADXS-DUAL in 2017. Pending FDA feedback, we plan to initiate a global, randomized, registrational quality trial in 1H 2018 and will evaluate this combination regimen in women with persistent, recurrent or metastatic (squamous or non-squamous cell) carcinoma of the cervix who have failed at least one prior line of systemic chemotherapy. Under the terms of the agreement, each party willwould bear its own internal costs and provide its immunotherapy agents. Advaxis will sponsorThis trial has not yet been initiated as the Company is seeking a U.S. and/or European partner to fund the cervical cancer program. If a partner is not found, the study and pay third-party costs. Subject to the positive outcome of this study, we plan to file a BLA for approval of ADXS-DUAL for metastatic cervical cancer in combination treatment.will not be initiated.

Axalimogene filolisbac has received FDA orphan drug designation for invasive FIGO Stage II-IV cervical cancer, and has received Fast Track designation from the FDA for high-risk locally advanced cervical cancer patients. Axalimogene filolisbac has also been classified as an advanced-therapy medicinal product (“ATMP”) for the treatment of cervical cancer by the European Medicines Agency’s Committee for Advanced Therapies (“CAT”). The CAT is the EMA’s committee responsible for assessing the quality, safety and efficacy of ATMPs. The Company has completed the CAT certification procedure and the CAT has certified the preclinical and quality information have met the scientific and technical standards for a MAA.

Head and Neck Cancer

SCCHN is the most frequently occurring malignant tumor of the head and neck and is a major cause of morbidity and mortality worldwide. More than 90% of SCCHNs originate from the mucosal linings of the oral cavity, pharynx, or larynx and 70% of these cancers are caused by HPV, with the incidence increasing every year. According to the American Cancer Society, head and neck cancer accounts for about 3% of all cancers in the United States. According to the 2017 American Cancer Society data report, approximately 30,000 new cases will be diagnosed in the United States in 2017.

The safety and immunogenicity of axalimogene filolisbac is being evaluated in a Phase 2 study under an investigator-sponsored IND at Mount Sinai and Baylor College of Medicine in a pre-surgery “window of opportunity” trial in patients with HPV-positive head and neck cancer. This clinical trial is the first study to evaluate the immunologic and pathologic effects of axalimogene filolisbac in patients when they are initially diagnosed with HPV-associated head and neck cancer. The study is designed to show that axalimogene filolisbac is highly immunogenic and worth further investigation if the overall rate of vaccine-induced T-cell responses is 75% or more. 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 study met the target for the overall rate 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 five of the study patients. Increased infiltration of both CD4+ and CD8+ T cells were observed in the Tumor Immune Microenvironment (“TME”) of four patients, with a reduction of FOXP3+ regulatory T cells within the tumors of 3/6 patients. Increased T cell responses to HPV E6 supports enhanced immune activity against additional tumor targets. Changes to the TME included cytotoxic T cell infiltration into the post-resection tumor, increased immune activation, a reduction of regulatory T cells, infiltration of cytotoxic T cells, and increased expression of inflammatory activation markers. In addition, fluctuations of circulating serum cytokine were observed suggesting consumption by activated T cells and migration of T cells to the TME. This study met its Stage 1 primary objective and is now advancing into the second stage of the clinical study. Stage 2 of the clinical study is currently accruing patients. We anticipate the expansion phase will be sponsored by Baylor College of Medicine.

We will continue to be opportunistic as it relates to IST development in HPV-positive head and neck cancer patients.

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 studytrial to evaluate safety and efficacy of axalimogene filolisbac, in combination with durvalumab (MEDI4736), for patients with metastatic HPV-associated SCCHN.

Axalimogene filolisbac has received FDA orphan drug designation for HPV-associated head and neck cancer.

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 cervical cancer. According to the 2017 American Cancer Society data report, approximately 8,200 new cases will be diagnosed in the United States in 2017.

The safety and efficacy of axalimogene filolisbac was evaluated in a Phase 2 study under an investigator-sponsored IND by Brown University in patients with high-risk locally advanced anal cancer. As of December 2016, 11 patients were enrolled and all patients who have completed radiation treatment and received treatment experienced a six-month complete response (n=9), with no evidence of recurrence. Eight of 9 patients (89%) are disease-free at a median follow-up of 34 months. No further enrollment in this study is planned. These data were accepted and published in the on-line journal at American Society of Clinical Oncology (“ASCO”) 2017.

We are conducting a Phase 2 multi-center, open-label, Simon two-stage study (“FAWCETT” or “FightingAnal-CancerwithCTLEnhancingTumorTherapy”), testing axalimogene filolisbac in patients with persistent or recurrent metastatic anal cancer. FAWCETT is designed to evaluate the efficacy and safety of axalimogene filolisbac as a monotherapy in patients with HPV-associated metastatic anal cancer who have received at least one prior treatment regimen for the advanced disease. Patients will receive IV axalimogene filolisbac monotherapy (1x10⁹ CFU) every 3 weeks for ≤ 2 years or until a discontinuation criterion is met. Stage 1 of the trial targeted enrollment of 36 patients with anal cancer whose disease recurred after receiving treatment, with an interim analysis planned on enrollment of 31 evaluable pts (≥ 1 post-baseline scan) and met the predetermined safety and efficacy criteria required to proceed 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 estimate is 22%, indicating the study can proceed to Stage 2 of enrollment. Common (≥ 30%) TRAEs were grade 1-2 chills/rigors, fever, hypotension and vomiting. 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 is evaluating the potential for collaborative external opportunities to further develop our HPV program in anal cancer.

Axalimogene filolisbac has received FDA and EMA orphan drug designation for anal cancer.

ADXS-PSA Franchise

Prostate Cancer

According to the American Cancer Society, prostate cancer is the second most common type of cancer found in American men. Prostate cancer is the second leading cause of cancer death in men, behind only lung cancer. One man in seven will get prostate cancer during his lifetime, and one man in 36 will die of this disease. According to the 2017 American Cancer Society data report, approximately 161,000 new cases will be diagnosed in the United States in 2017.

ADXS-PSA is anLm–based antigen delivery product designed to target the PSA antigen commonly overexpressed in prostate cancer.

We have entered into a clinical trial collaboration and supply agreement with Merck & Co. (“Merck”) to evaluate the safety and efficacy of ADXS-PSA as monotherapy and in combination with KEYTRUDA^® (pembrolizumab), Merck’s anti PD-1 antibody, in a Phase 1/2, open-label, multicenter, dose escalation and expansion study in patients with previously treated metastatic, castration-resistant prostate cancer. For the ADXS-PSA monotherapy dose escalation portion of the study, cohorts were successfully escalated to higher dose levels of 5x10⁹ CFU and 1x10¹⁰ CFU without achieving a maximum tolerated dose. Side effects noted at these higher dose levels were generally consistent with those observed at the lower dose level, other than a higher occurrence rate of predominantly Grade 2/3 hypotension. The ADXS-PSA monotherapy dose-determination phases of the trial have been completed. The Recommendation Phase 2 Dose (“RP2D”) is 1 x 10⁹ ADXS-PSA and 200 mg KEYTRUDA^® (pembrolizumab). Enrollment in the expansion cohort phase using the RP2D combination is underway.

Preliminary data identifying potential pharmacodynamics biomarkers of clinical response and preliminary immune correlative data in mCRPC patients treated with ADXS-PSA monotherapy, as well as preclinical data regarding molecular biomarkers associated with tumor regression in a murine HPV+ tumor model were presented at the third annual CRI-CIMT-EATI-AACR International Cancer Immunotherapy Conference in September 2017.

ADXS-NEO Franchise

In August 2016, we entered into a global agreement (the “Agreement”) with Amgen Inc. (“Amgen”) for the development and commercialization of ADXS-NEO, a novel, investigational cancer immunotherapy treatment, using our proprietaryLm Technology^™attenuated bacterial vector which activates a patient’s immune system to respond against multiple potential unique mutations, or neoepitopes, contained in and identified from an individual patient’s tumor through DNA sequencing.

ADXS-NEO is an individualizedLm-based antigen delivery product combined with a fusion protein based on information captured by whole-genome sequencing of a patient’s tumor and comparing the patient’s DNA from normal tissue with that from the patient’s tumor. It will target multiple patient-specific neoantigens resulting from those mutations that are not present in normal cells. Each ADXS-NEO construct is designed to target the non-synonymous mutations found in the tumor, which is unique to each patient’s cancer. ADXS-NEO works by presenting a large payload of neoantigens directly into dendritic cells within the patient’s immune system and stimulating a T-cell response against cancerous cells. The FDA has cleared the IND application of our new precision immunotherapy (ADXS-NEO) for the treatment of cancers and we plan to initiate a Phase 1 study in first half of 2018. The initial tumor types for the Phase 1 are metastatic colon, head and neck, and non-small cell lung cancers.

Clinical studies using ADXS-NEO are in active development in collaboration with our partner, Amgen. Further, we have entered into various research collaborations, including the Parker Institute for Cancer Immunotherapy, to advance the study of neoepitope-based, personalized cancer therapy as part of theTumor neoantigEnSeLectionAlliance (“TESLA”) initiative.

ADXS-HOT Franchise (preclinical)

We are developing multipleLm-based products that could target common (public or shared) or “hot-spot” mutations in tumor driver genes. ADXS-HOT products may target acquired public mutations in tumor driver genes that are shared by multiple patients, and could have greater immunogenicity than the natural sequence peptides in normal cells. DNA sequencing is not required, and the ADXS-HOT products are expected to be “off the shelf” and ready to administer for multiple patients. The Company plans to file INDs in 2018.

ADXS-HER2 Franchise

HER2 Expressing Solid Tumors

HER2 is overexpressed in a percentage of solid tumors including osteosarcoma. According to the SEER database and recent published literature, approximately 60-70% of osteosarcoma are HER2 positive, which is associated with poor outcomes for patients.

ADXS-HER2 is anLm–based antigen delivery product designed to target HER2 expressing solid tumors including human and canine osteosarcoma. The dose finding phase of the trial is complete. The Company has evaluated the data and decided not to proceed to the expansion phase of the trial. In addition, based on the Company’s priorities, the ADXS-HER2 development program, which includes Pediatric Osteosarcoma, will be discontinued but remains open to investigator-initiated research or licensing proposals.

Canine Osteosarcoma

On March 19, 2014, we entered into a definitive Exclusive License 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 technology that enables Aratana to develop and commercialize animal health products that will be targeted for treatment of osteosarcoma and other cancer indications in animals. A product license request has been filed by Aratana for ADXS-HER2 (also known as AT-014 by Aratana) for the treatment of canine osteosarcoma with the USDA. Aratana received communication from the USDA in March 2015 stating that the previously submitted efficacy data for product licensure for AT-014 (ADXS-HER2), the cancer immunotherapy for canine osteosarcoma, was accepted and that it provides a reasonable expectation of efficacy that supports conditional licensure. While additional steps need to be completed and data, when available, needs to be analyzed, including in the areas of manufacturing and safety, we understand that Aratana anticipates that AT-014 could receive conditional licensure from the USDA in 2017. The Company does not anticipate significant revenue from this collaboration in 2017. Aratana has been granted exclusive worldwide rights by us to develop and commercialize ADXS-HER2 in animals. Aratana is further responsible for the conduct of clinical research with ADXS-Survivin in canine/feline lymphoma, as well as pending investigations of two additional Advaxis constructs in animals.

Strategic Clinical Collaborations, focused on combination therapies

Axalimogene filolisbac and Durvalumab

As further described above, we have entered into a clinical trial collaboration agreement with MedImmune to conduct a Phase 1/2, open-label, multicenter, two part study to evaluate safety and efficacy of axalimogene filolisbac, in combination with MedImmune’s investigational anti-PD-L1 immune checkpoint inhibitor, durvalumab (MEDI4736), as a combination treatment for patients with metastatic squamous or non-squamous carcinoma of the cervix and metastatic HPV-associated SCCHN. ForPart 1 of this trial is complete, and the axalimogene filolisbac and durvalumab dose escalation portion of the study, the dose-escalation cohortCompany has been completed. We have commenced enrollment in the Part A (20 patients with SCCHN) and B (90 patients with cervical cancer) expansion phases. Accrual

The Company is ongoing.evaluating opportunities to conduct cost effective studies evaluating axalimogene filolisbac in head and neck cancer and are in discussion with third parties about a potential study.

ADXS-DUAL and OPDIVO^® (nivolumab)

As further described above, we have entered into a clinical development collaboration agreement with BMS to evaluate their PD-1 immune checkpoint inhibitor, OPDIVO^® (nivolumab), in combination with ADXS-DUAL as a potential treatment optionResults of Operations for women with metastatic cervical cancer. Pending FDA feedback, we plan to initiate a global, randomized, registrational quality trial in 1Hthe Three Months Ended July 31, 2018 and will evaluate this combination regimen in women with persistent, recurrent or metastatic (squamous or non-squamous cell) carcinoma of the cervix who have failed at least one prior line of systemic chemotherapy.

ADXS-PSA and KEYTRUDA^® (pembrolizumab)

As further described above, we have entered into a clinical trial collaboration agreement with Merck to evaluate the safety and efficacy of ADXS-PSA as monotherapy and in combination with KEYTRUDA^® (pembrolizumab), Merck’s anti PD-1 antibody, in a Phase 1/2, open-label, multicenter, dose escalation and expansion study in patients with previously treated metastatic, castration-resistant prostate cancer. For the ADXS-PSA monotherapy dose escalation portion of the study, cohorts were successfully escalated to higher dose levels of 5x10⁹ CFU and 1x10¹⁰ CFU without achieving a maximum tolerated dose. Side effects noted at these higher dose levels were generally consistent with those observed at the lower dose level, other than a higher occurrence rate of predominantly Grade 2/3 hypotension. The ADXS-PSA monotherapy portion of this clinical trial has been completed and accrual and patient treatment has begun in the cohort combining ADXS-PSA and KEYTRUDA^® (pembrolizumab).

RESULTS OF OPERATIONS FOR THE THREE MONTHS ENDED JULY 31, 2017 AND 2016

Revenue

During the quarter ended July 31, 2017, the Company recorded revenue of $3,051,620. The Company recognized revenue from the collaboration agreement with Amgen relatedRevenue decreased $2.0 million to amortization of the upfront fees received.

We did not record any revenueapproximately $1.1 million for the three months ended July 31, 2018 compared to $3.1 million the three months ended July 31, 2017. The decrease was due to a change in the estimated performance period associated with upfront fees received from Amgen in conjunction with the collaboration agreement signed in August 2016.

Research and Development Expenses

We make significant investmentsinvest in research and development in support ofto advance our Lm technology through our pre-clinical and clinical development programs both clinically and pre-clinically. Research and 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.programs. Research and development expenses for the three months ended July 31, 20172018 and 20162017 were categorized as follows:follows (in thousands):

Research and Development (in thousands)

HPV-associated cancers

Axalimogene Filolisbac Franchise

Axalimogene filolisbac expenses were $5,686,197HPV-associated research and development costs include clinical trial and other related costs associated with our cervical and head and neck programs. HPV-associated costs for the three months ended July 31, 20172018 decreased approximately $1.7 million, or 29%, compared to $2,698,005the same period in 2017. The decrease resulted primarily from lower enrollment activities associated with the Phase 3 AIM2CERV trial as well as the winding down of the GOG-0265 study.

Neoantigen-based therapies

Research and development costs associated with neoantigen-based therapies for the three months ended July 31, 2016, an increase of $2,988,192.2018 increased approximately $0.1 million, or 15%, compared to the same period in 2017. The increase resulted from startup activities foris attributable to additional countriesmanufacturing and certain study management costs in conjunction with the Phase 3 AIM2CERV study.

ADXS-PSA Franchise

PSA expenses were $1,366,225 for the three months ended July 31, 2017 as compared to $564,831 for the three months ended July 31, 2016, an increase of $801,394. The increase resulted from higher costs incurred due1 ADXS-NEO study in addition to the active enrollment of an expansion cohort on the Phase 1/2 studycosts associated with filing our first IND in combination with Merck’s KEYTRUDA^®(pembrolizumab).

ADXS-HER2 Franchise

HER2 expenses were $519,790 for the three months ended July 31, 2017 compared to $476,644 for the three months ended July 31, 2016, an increase of $43,146. HER2 expenses during the three months ended July 31, 2017 were consistentADXS-HOT with the comparable prior period.

ADXS-NEO Franchise

NEO expenses were $553,289 for the three months ended July 31, 2017 compared to $373,006 for the three months ended July 31, 2016, an increase of $180,283. The increase was attributable to Phase 1 start-up costs incurred during the three months ended July 31, 2017.

Personnel Expenses

Personnel expenses were $6,455,302 for the three months ended July 31, 2017 compared to $3,301,179 for the three months ended July 31, 2016, an increase of $3,154,123. The increase was attributable to an increase in headcount.

Professional Fees

Professional fees were $5,751,377 for the three months ended July 31, 2017 compared to $1,520,417 for the three months ended July 31, 2016, and increase of $4,230,960. The increase was attributable to an increase in drug manufacturing process validation costs and drug stability studies.

Laboratory Costs

Laboratory costs were $2,560,697 for the three months ended July 31, 2017 compared to $994,686 for the three months ended July 31, 2016, an increase of $1,566,011. An increase in technical operation support as well as the expansion of laboratory space accounted for the increase.FDA.

Other Expenses

Other expenses were $905,262include salary and benefit costs, stock-based compensation expense, professional fees, laboratory costs and other internal and external costs associated with our research & development activities. Other expenses for the three months ended July 31, 20172018 decreased approximately $9.9 million, or 58%, compared to $213,464 for the three months ended July 31, 2016, an increase of $691,798.same period in 2017. The increasedecrease was primarily attributable to a decrease in laboratory costs, drug manufacturing process validation and drug stability studies supporting the MAA, which was filed in February 2018. In addition, there was a decrease in salary-related expenses, including stock compensation, and travel expenses resulting from a reduction in headcount due to additional infrastructure costs incurred to support the increased headcount and laboratory expansion.reduction in force that the Company initiated in June 2018.

Partner Reimbursementsreimbursements

Partner reimbursements for the three months ended July 31, 2017 were $6,000,000. For2018 decreased approximately $4.6 million, or 76%, compared to the same period in 2017. The decrease is attributable to reimbursements from Amgen supporting ADXS-NEO covering three months during the three months ended July 31, 2017, the Company received clinical development payments2018 as compared to reimbursements from Amgen for ADXS-NEO totaling $4,500,000 and recorded an additional expected payment of $1,500,000, which was receivedcovering one year during the same period in August 2017.

General and Administrative Expenses

General and administrative expenses primarily include salary and benefit costs and stock-based compensation expense for employees included in our finance, legal and administrative organizations, outside legal and professional services, and facilities costs. General and administrative expenses were approximately $18.1 million for the three months ended July 31, 2018 and 2017 compared with approximately $6.4 millionwere as follows (in thousands):

General and administrative expenses for the three months ended July 31, 2016, an increase of2018 decreased approximately $11.7 million.$13.5 million, or 75%, compared to the same period in 2017. The increasedecrease is primarily attributable to stocka decrease in stock-based compensation of approximately $11.4 million related to the resignation of the Company’s Chief Financial Officer and cashChief Executive Officer in April 2018 and July 2017, respectively, two Board members who did not seek re-election in March 2018, a reduction in headcount and the elimination of stock-based compensation expense for past employees, of which approximately $9.5 million was a non-cash expense.paid to consultants. In addition, there was an increasea decrease to legal costs on general corporate matters.

Interest Income

Interest income was $184,479Results of Operations for the three months endedNine Months Ended July 31, 2017, compared with $73,872 for the three months ended July 31, 2016. The increase in interest income earned was attributable to an increase in interest rates as well as cash resulting from sales of the Company’s common share2018 and an up-front payment received in conjunction with the collaboration agreement with Amgen. The cash was invested in held-to-maturity investments and a savings account.

Changes in Fair Values

For the three months ended July 31, 2017 the Company recorded $0 non-cash income as the fair value of the warrant liability remained $0. Most of the liability warrants have expired and the remaining liability warrants expire in August 2017.