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CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING

STATEMENTS

Information included in this Annual Report on Form 10-K (this “Report”) contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”).  Forward-looking statements are not statements of historical facts, but rather reflect our current expectations concerning future events and results.  We generally use the words “believes,” “expects,” “intends,” “plans,” “anticipates,” “likely,” “will” and similar expressions to identify forward-looking statements.  Such forward-looking statements, including those concerning our expectations, involve risks, uncertainties and other factors, some of which are beyond our control, which may cause our actual results, performance or achievements, or industry results, to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements.  These risks, uncertainties and factors include, but are not limited to, those factors set forth in this Report under “Item 1A. – Risk Factors” below.  Except as required by applicable law, including the securities laws of the United States, we undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.  You are cautioned not to unduly rely on such forward-looking statements when evaluating the information presented in this Report.

CERTAIN TERMS USED IN THIS REPORT

References in this Report to “we,” “us,” “our,” the “Company” or “Anixa” means Anixa Biosciences, Inc. unless otherwise indicated. 

PART I

Item 1.                        Business.  

Overview

Anixa Biosciences, Inc. is a biotechnology company focused on using the body’s immune system to diagnose, treat and prevent cancer.  We were incorporated on November 5, 1982 under the laws of the State of Delaware.  Effective October 1, 2018, the Company changed its name from ITUS Corporation to Anixa Biosciences, Inc.  From inception through October 2012, our primary operations involved the development of patented technologies in the areas of thin-film displays and encryption.  From October 2012 through June 2015, the primary operations of the Company involved the development, acquisition, licensing, and enforcement of patented technologies that were either owned or controlled by the Company. 

In June 2015, the Company announced the formation ofwe formed a subsidiary, Anixa Diagnostics Corporation (“Anixa Diagnostics”), to develop Cchek™ a platform for non-invasive blood tests for the early detection of cancer.  In July 2015, the Company announcedWe then began a collaborative research agreementcollaboration with The Wistar Institute (“Wistar”), the nation’s first independent biomedical research institute and a leading National Cancer Institute designated cancer research center, for the purpose of validating proprietary cancer detection methodologies and establishing protocols for identifying certain biomarkersbiomarker patterns in the blood which we identified and which are known to be associated with malignancies.

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We haveThrough our collaboration with Wistar, we demonstrated the efficacy of our Cchek™ early cancer detection platform with 20 different types of cancer, including:cancer:  breast, lung, colon, melanoma, ovarian, liver, thyroid, pancreatic, appendiceal, uterine, osteosarcoma, leiomyosarcoma, liposarcoma, vulvar, prostate, bladder, cervical, head and neck, gastric and testicular cancers.  Breast, lung, colon and prostate cancers represent the four largest categories of cancer worldwide.

Based on a number of factors, including key scientific, clinical, and commercial considerations, for the initialpast year the primary commercial focus for Cchek™ will behas been on developing a prostate cancer confirmatory test.  In February 2019, we formed a strategic alliance with ResearchDx, a CLIA certified, CAP Accredited laboratory, to prepare the Cchek™ Prostate Cancer Confirmation (“Cchek™ PCC”) test for launch as a laboratory developed test.  In December 2019, upon completion of independent validation by ResearchDx, we announced the commercial launch of Cchek™ PCC.  We are currently conducting a number of activities to support the marketing of Cchek™ PCC, including the development of marketing materials, education of key opinion leaders in urology and development of a reimbursement path for the test.  We expect Cchek™ PCC to be broadly available throughout the U.S. by April 2020.

In November 2017, the Company announced the formation ofwe formed a new subsidiary, Certainty Therapeutics, Inc. (“Certainty”), to develop immuno-therapy drugs against cancer.  Certainty entered into a license agreement with Wistar pursuant to which Certainty was granted an exclusive worldwide, royalty-bearing license to use certain intellectual property owned or controlled by Wistar relating to Wistar’s chimeric endocrine receptor targeted therapy technology (such technology being akin to chimeric antigen receptor T-cell (“CAR-T”) technology).  We have initially focused on the development of a treatment for ovarian cancer, but we also may pursue future applications of the technology for the development of treatments for additional solid tumors.  The license agreement requires Certainty to make certain cash and equity payments to Wistar.Wistar upon achievement of specific development milestones.  With respect to Certainty’s equity obligations to Wistar, Certainty issued to Wistar shares of its common stock equal to five percent (5%) of the common stock of Certainty.

Following the formation of Certainty and the license agreement with Wistar, Certainty entered into a collaboration agreement with the H. Lee Moffitt Cancer Center and Research Institute, Inc. (“Moffitt”) to advance toward human clinical testing the CAR-T technology licensed by Certainty from Wistar aimed initially at treating ovarian cancer.  Certainty is working with researchers at Moffitt to complete studies necessary to submit an Investigational New Drug (“IND”) application with the U.S. Food and Drug Administration (“FDA”).

In July 2019, we entered into a license agreement with The Cleveland Clinic Foundation (“Cleveland Clinic”) pursuant to which the Company was granted an exclusive worldwide, royalty-bearing license to use certain intellectual property owned or controlled by Cleveland Clinic relating to Cleveland Clinic’s breast cancer vaccine technology.  This technology pertains to the use of vaccines for the treatment or prevention of triple negative breast cancer (“TNBC”) and other breast cancers which express the α-lactalbumin protein.  This protein is only expressed during lactation in healthy women, but may also be expressed in individuals with certain breast cancers, most notably TNBC, the most lethal form of breast cancer.

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We have been working with researchers at Cleveland Clinic to advance the breast cancer vaccine technology toward human clinical testing and are completing the activities necessary to submit an IND application with the FDA.

Over the next several quarters, we expect Cchek™ and Certainty’s, our CAR-T ovarian cancer treatment and our breast cancer vaccine to be the primary focus of the Company.  As part of our legacy operations, the Company remains engaged in limited patent licensing activities in the area of encrypted audio/video conference calling.  We do not expect these activities to be a significant part of the Company’s ongoing operations nor do we expect these activities to require material financial resources or attention of senior management.

Over the past several quarters,years, our revenue was derived from technology licensing and the sale of patented technologies, including revenue from the settlement of litigation.  In addition to Anixa Diagnostics and Certainty, the Company may make investments in and form new companies to develop additional emerging technologies.

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Table of ContentsCchek™

Cchek™

Our Cchek™ cancer detection platform measures a patient's immune response to a malignancy by detecting the presence, absence, and quantity of certain immune cells that exist in and around a tumor and that can be found in the blood stream.  These types of cells and the tumor micro-environment have been the focus of recent ground breaking published and reported research in immuno-oncology, enabling the development of revolutionary immunotherapies used for treating certain cancer types.  We have developed proprietary techniques and protocols for measuring the subtle immunological changes that occur in the blood stream during tumor development.  Specifically, we seek to identify a subset of myeloid cells that we believe are diagnostic.  These cells, often referred to as Myeloid Derived Suppressor Cells (“MDSCs”), are identified by specific surface proteins enabling characterization.  We generally refer to MDSCs and other cells of the immune system which we believe can be diagnostic in nature as biomarkers.  Through our proprietary protocols, we have had early success and have demonstrated accuracy in detecting these biomarkers in the peripheral blood of biopsy verified cancer patients, and in distinguishing the blood of healthy patients from the blood of cancer patients.  We utilize Artificial Intelligence (“AI”), specifically a Neural Network (“NN”) to analyze our data and to determine the presence of a tumor.  We believe that a NN is better able to identify subtle changes in immune response than other analytical approaches.  The distinguishing feature of a NN is that it can be trained to answer the key biological questions of interest, in our case whether or not the patient is tumor-bearing, and as it is trained with more data, its ability to answer these questions may improve.  Our goal is to establish Cchek™ as a non-invasive, inexpensive, cancer diagnostic blood test that can reduce or eliminate the need for traditionally expensive, invasive, painful, and often inaccurate cancer diagnostic procedures which are currently in use.

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In each instance where the Company haswe have demonstrated the efficacy of itsour cancer detection platform, fresh (utilized within 48 hours) blood samples from biopsy verified cancer patients have been tested at Wistar using a variety of experimental methodologies and protocols.protocols, including the use of certain over the counter reagents and other supplies.  Such un-blinded, non-uniform testing is common during the initial development stage of new technologies and diagnostic tests.  Blood samples from patients with differing severities of cancers (with some cancers such as Breast Cancerbreast cancer stage I to stage IV) have been tested, including samples from both pre-treatment and post-treatment patients.  In addition, Wistar haswe have also tested blood from healthy donors.  A critical aspect of any cancer diagnostic is the ability to accurately distinguish patients with cancer from healthy patients.  Based upon our encouraging early results, our scientists arewe continue working with Wistar to refine protocols and methodologies for identifying and classifying the immunologic biomarkers that are the foundation for our Cchek™ early cancer detection platform.  Although our scientists, working in collaboration with Wistar, will continue to improve our processes and methodologies to achieve maximum performance, we expect our testing to become more uniform over time, and to eventually test patient samples in a double blinded manner.  

While studies comparing biopsy verified cancer patients have been compared to healthy donors we have only recently begun evaluatingare critical, it is also vital to evaluate the impact of benign conditions such as benign prostatic hyperplasia, non-malignant neoplasias, systemic inflammatory conditions, infections, and other potential conditions that impact or may impacton the immune system.  SuchWe have performed such testing comparing cancer patients to those with benign conditions in the development of Cchek™ PCC, as patients in need of a confirmatory test will not likely be necessary for regulatory approval.healthy, but instead will have either prostate cancer or a benign condition. 

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Based upon and following the results of more extensive clinical studies, as well as discussions with the FDA,As we will determine what further studiesdevelop our Cchek™ platform, there are necessary and whether and when to begin the process of seekingmultiple regulatory approval pathways available for a confirmatory diagnostic test based upon our Cchek™ technology.each test.  One manner of seeking regulatory approval is to have a lab certified to run our cancerdiagnotic tests pursuant to the Clinical Laboratory Improvement Act of 1967 and the Clinical Laboratory Improvement ActAmendments of 1988 (collectively, “CLIA”).  Among other things, CLIA requires clinical laboratories that perform diagnostic testing to be certified by the state in which the lab is located, as well as the Center for Medicare and Medicaid Services.  If we seek regulatory approval pursuant to CLIA, only those laboratories that are certified under CLIA to run our diagnostic test would be able to process test samples.  CLIA certification may or may not require additional studies.  We could seek to establish our own CLIA certified laboratory to run the diagnostic tests, or we could potentially contract with an existing CLIA certified lab and seek to have that laboratory certified to run our diagnostic test.

Another manner of obtaining regulatory approval would be to seek to have Cchek™our diagnostic test approved by the FDA pursuant to what are commonly referred to as either the 510(K) process, or the Premarket Application (“PMA”) process.  The appropriate pathway for FDA approval would depend upon a variety of factors, including the intended use of the test, and the risks associated with such use.  FDA approval can take several years and would entail additional clinical studies.

Our decision as to whether and when to seek CLIA certification or FDA approval of a diagnostic test or tests utilizing our Cchek™ technology will be dependent on a variety of factors, including the capital requirements of each approval process, the landscape for competitive diagnostic testing, and the time and resources required by each approval process.  It is possible that we may seek to have one or more diagnostic tests approved via CLIA certification, and other diagnostic test or tests approved by the FDA, or that we may seek simultaneous FDA approval and CLIA certification of a particular diagnostic test or tests.

Based on a number of factors, we have launched our Cchek™ PCC test as a laboratory developed test under CLIA guidelines, and our CLIA certified commercialization partner, ResearchDx, will run the test.  Under CLIA guidelines, the test must be run in ResearchDx’s southern California facility, while the blood samples can come from patients anywhere in the U.S.

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For other tests based on the Cchek™ platform, based upon and following the results of more extensive clinical studies, as well as potential discussions with the FDA, we will determine whether and when to begin the process of seeking regulatory approval.  

While we believe our Cchek™ platform could eventually form the basis of a pan-cancer (all cancer) test, for our first commercial focus we will seek to launch a confirmatory test for prostate cancer.  We feel such an approach will enable faster clinical and regulatory approval.  

Thethe decision to initially focus on a prostate cancer confirmation test incorporated a number of factors, including key scientific, clinical, and commercial considerations.  The current method of diagnosing prostate cancer is highly inaccurate, with approximately 75% of all prostate biopsies in the U.S. being negative for high risk cancer.  Our recentmost recently reported studies with Cchek™ PCC have demonstrated sensitivity of 92%, meaning 92% of all men with prostate cancer have demonstrated excellent sensitivitymay be correctly diagnosed with cancer, and specificity—over 90%specificity of 41%, meaning 41% of all men without cancer may be correctly diagnosed as not having cancer.  With approximately 1-1.5 million prostate biopsies performed annually, Cchek™ PCC has the potential to eliminate hundreds of thousands of unnecessary prostate biopsies annually in a blinded study.  The current standard screening method for prostate cancer, Prostate Specific Antigen (“PSA”) testing, results in large numbers of false results, resulting in high numbers of negative biopsies, and therefore presenting a tremendous opportunity for a confirmatory test with high accuracy.the U.S. alone. 

Historical Biomarker Studies

On December 7, 2016 we announced the preliminary results from our initial Cchek™ cancer patient efficacy study.  Using our most recent protocols and methods for measuring a patients’ immunological response to a malignancy, the Companywe achieved sensitivity of 92% and specificity of 92% for 88 patient samples, including 54 samples from patients with multiple types and severities of cancer, and 34 healthy patients.  During the initial phase of the study, which involved multiple experimental protocols and techniques for measuring immunological responses, the Companywe reviewed and analyzed data from a total of 315 patient samples, including 228 patients with varying stages of cancer, as well as blood samples from 87 healthy donors.

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Patient samples representing 14 different types of cancer including breast(breast cancer, lung cancer, colon cancer, melanoma, ovarian cancer, liver cancer, thyroid cancer, pancreatic cancer, appendiceal cancer, uterine cancer, osteosarcoma (cancer of the bone), leiomyosarcoma (cancer of the soft tissue), liposarcoma (cancer of the connective tissue), and vulvar cancercancer) were included in the study.  The study included samples from patients with early and late stage, biopsy-verified, drug-naïve (before therapy) tumors, as well as biopsy-verified, refractory (unresponsive to attempted chemotherapy) tumors.

Sensitivity and specificity are scientific measurements commonly used to determine the accuracy of a diagnostic test, where sensitivity measures how good a test is at identifying people with a particular disease, and specificity measures how good a test is at identifying people without the disease.  Although published results vary widely, established diagnostic tests such as Low Dose Computed Tomography (LDCT), which is used by other companies to screen for lung cancer, has sensitivity of approximately 93% and specificity of approximately 73%, the PSA test, which is used by other companies to screen for prostate cancer, has sensitivity of approximately 21% and specificity of approximately 91%, and Mammography,mammography, used by other companies to screen for breast cancer and considered to be the “gold standard” for breast cancer screening, has reported sensitivity as low as approximately 68% and specificity as low as approximately 75%.  As these results indicate, current diagnostic testing is hampered by low sensitivity, low specificity or both, meaning that the tests miss a substantial portion of the cancers they are supposed to detect, or miss-diagnose a large number of healthy patients as having cancer.  There is currently no inexpensive, non-invasive, diagnostic test that excels in both sensitivity and specificity.  

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Initial samples in our study were tested utilizing immunostaining and fluorescent microscopic imaging.  While results were promising, subjectivity in interpreting the imaging results together with labor intensive and time consuming sample processing hampered the commercial viability of this approach.  Subsequently, patient samples were analyzed using flow cytometry, enabling more efficient processing and analysis.  In addition, the Company implemented its proprietary NN software application for analysis, which currently relies on multiple quantitative parameters to analyze test results.  This approach, which is highly data intensive and requires substantial computer processing power to develop, results in a test which can be performed using a desktop computer.  An initial version of our NN, which was trained to distinguish between the immunological responses from cancer patients and healthy patients, was responsible for the sensitivity and specificity results reported above.  The Company expectsWe expect to continue to improve itsour protocols, continue to upgrade itsour NN software by increasing the number of patient samples used to train the software and expanding the range of markers, increasingincrease the data resolution, and enhancingenhance the architecture of the software, which may enable better results.

In a study released in January 2018, augmenting data from our preliminary study, we reported a sensitivity of 89% and a specificity of 95%.  All cancer patients were biopsy-verified with all clinical stages (I to IV) included.  The total number of patients in this study was 163, which included 81 cancer patients and 82 healthy donors.  The majority of patient samples collected for this study were from breast cancer and prostate cancer patients, but several other types were also included, bringing the total number of cancer types where we have successfully used Cchek™ to 20.

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In an additional study released in March 2018, we announced the results of a prostate cancer study with Serametrix Corporation (“Serametrix”) in which data from a previous collaboration between Serametrix and Memorial Sloan Kettering Cancer Center (“MSK”) was re-evaluated using our Cchek™ technology.technology.  Previously, Serametrix analyzed a number of metastatic prostate cancer and normal healthy blood samples using an MSK proprietary assay and algorithm for cancer detection.  Following this, a blinded re-analysis of the data was performed by Anixa Diagnostics, using Cchek™.  This study achieved 92% sensitivity and 92% specificity using 121 prostate cancer and 125 healthy donor samples.

In October 2018, at the 30th Anniversary AACR Special Conference – Convergence: Artificial Intelligence, we presented data demonstrating the ability of Cchek™ to distinguish, among patients scheduled for biopsy, those who had high risk prostate cancer and those who had benign conditions or low grade cancer, for whom surgery is not required and a biopsy is unnecessary.  The Cchek™ data showed the ability to distinguish healthy males from high risk prostate cancer patients with a sensitivity of 89% and a specificity of 100%.  This study further demonstrated the potential for Cchek™ to reduce the number of unnecessary prostate biopsies by up to 56%, while still retaining 89% sensitivity for detecting prostate cancers.

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In November 2018, we released the results of our first study demonstrating the ability of Cchek™ to identify the presence of early stage breast cancer.  Our Cchek™ technology demonstrated a sensitivity of 89% when detecting early stage breast cancer (Stage I or II) and a specificity of 95% when used to test blinded samples.  Furthermore, Cchek™ was also able to detect the early stages of breast cancer (Stage 0) in subjects with biopsy-confirmed ductal carcinoma in situ (DCIS), a type of pre-cancerous/non-invasive breast lesion that often leads to invasive breast cancer, with 72% sensitivity. 

Since that time, we have continued to process patient samples and refine our procedures and have presented data with consistent results at several conferences and meetings.

Related to our collaborative research agreement, the Company and/or Wistar currently have or have had collaborations with doctors from University of Pennsylvania Abramson Cancer Center, The Helen F. Graham Cancer Center and Research Institute at Christiana Hospital in Wilmington, Delaware, Virtua Healthcare System in southern New Jersey, New Jersey Urology, the largest urology practice in the country, and MD Anderson Cancer Center at Cooper Hospital in southern New Jersey.Jersey, Potomac Urology in northern Virginia, the University of Maryland School of Medicine, Urology San Antonio, Idaho Urologic Institute, Urology Centers of Alabama, Genesis Research, in the San Diego area, and several U.S. Department of Veterans Affairs VA Medical Centers.  In most cases, patients from participating doctors at these healthcare institutions who are beginning or in some cases, continuing cancer treatment are asked to consent to have an additional tube of blood drawn for the purpose of participating in the Cchek™ patient efficacy trials.  Because the number of cancer patients treated by these hospitals varies over time, and the decision whether to participate in the Cchek™ patient studies is ultimately at the discretion of the patient, it is difficult to predict the number of patient samples that we will receive in any given week, or during any given month.  Due to this unpredictability in sample flow, the Company is currently in discussions with additional doctors and healthcare providers about providing blood samples for our patient efficacy trials, and the Company has capacity available to process an additional quantity of samples.  

The Market

There are four primary markets for a cancer diagnostic test:  screening, confirmatory testing, treatment monitoring, and recurrence testing.

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Screening

Screening occurs when asymptomatic people are tested for indications of cancer. Examples of existing screening tests include the mammogram for breast cancer, PSA for prostate cancer, and colonoscopy for colon cancer.  All screening tests have their strengths and weaknesses, and for many cancers there are currently no recommended screening tests available.

Confirmatory Testing

Confirmatory testing is used to confirm the results of a screening test.  In certain instances, existing confirmatory testing can be invasive, painful, expensive, and have relatively high risks of complications.  For example, a positive mammogram is often followed up with additional imaging, which can lead to a biopsy during which a needle is inserted into the breast to sample suspicious tissue or lesions.  For lung cancer, existing confirmatory diagnostics include bronchoscopies, during which a flexible tube is inserted through the nose or mouth and into the lung, and needle biopsies, during which a long needle is inserted between the ribs and into the lung.  One potential side effect of a lung biopsy is a pneumothorax (commonly referred to as a “collapsed lung”), which has been reported to occur in approximately fifteen percent (15%) of needle biopsies of the lung.  A pneumothorax can lead to other complications and sometimes requires extended hospitalization.  In addition to the potential side effects, biopsies of any sort can be extremely painful for the patient.

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Treatment Monitoring

Treatment monitoring includes follow-on testing to monitor the effectiveness of a specific regimen of treatment.  For example, diagnostic monitoring testing may be used to monitor the effectiveness of a particular type of chemotherapy, to determine how the cancer is responding and whether such treatment should be continued.  Often, imaging techniques are not able to identify whether a treatment is working, so a biopsy is useful, however it is painful and impractical to perform multiple biopsies on a patient.  Therefore, a “liquid biopsy” enabling therapy monitoring via a blood test can be useful.

Recurrence Testing

Recurrence testing is used for cancer survivors to test for cancer recurrence.  According to the most recently published statistics published byfrom the American Cancer Society, in 2017, there are approximately fifteenwere more than 15.5 million Americans living with a history of cancer survivors in the U.S., sixty-seven (67%)as of which were diagnosed with cancer five or more years ago.January 1, 2016.  Most cancer survivors live in fear of recurrence, and limitations of existing diagnostics, including repeated exposure to radiation from imaging tests, and invasiveness and costs and pain from tests such as traditional biopsies, prevent cancer survivors from being tested as often as they would like.

The Company’s long term vision is to have one or more tests based upon the CchekÔCchek™ platform to serve each of the markets identified above.  We anticipatehave made the initial market focus of Cchek™ will be in the confirmatory, or pre-biopsy, testing.testing, and in particular, confirmatory testing of prostate cancer.  We estimate that there is a U.S. market of roughly 12 million biopsies annually and a high rate of negative biopsy results.  Accordingly, we believe that positioning Cchek™ as a pre-biopsy test will reduce the number of unnecessary biopsies, thus improving patient outcomes and reducing healthcare costs.

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Competition

Background

Continuing scientific advances and discoveries, the ability to more quickly process and analyze large amounts of scientific data, and decreases in the cost of sophisticated equipment and technologies, have resulted in the potential for significant advances in cancer treatment, and in particular, cancer diagnostics.  Cancer statistics gathered over the past several decades provide overwhelming evidence that the earlier that cancers are detected, the greater the survival rates.  Up until now, doctors have primarily relied upon technologies such as imaging (x-rays, mammograms, CT scans, MRIs, PET scans, ultrasounds) and biopsies and other invasive procedures for cancer detection and cancer diagnoses.  In many cases, these diagnostic procedures were performed after patients exhibited one or more symptoms of cancer, at which point the cancer may likely no longer be at an early stage.  Existing diagnostic technologies such as imaging have gotten better, and invasive diagnostic procedures such as colonoscopies have become more accurate and less risky, and we expect these types of traditional diagnostic tools to continue to predominate the cancer diagnostic market for the foreseeable future.

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We believe that with advancing medical knowledge, improvements in equipment and technologies, and reduction in costs of new technologies, new types of cancer diagnostics will be created and new types of cancer diagnostic testing that will outperform many of the traditional diagnostic tests, eliminate many of the negative consequences of existing diagnostic testing, and ultimately predominate the cancer diagnostic market.

We have identified a class and subclasses of biomarkers that we believe are measurable in the blood of patients with malignancies, and are perfecting a process and methodology for detecting those biomarkers.  The goal is to create a platform, Cchek™, that can be used to launch a series of simple and affordable blood tests that can be used to detect and monitor many of the most deadly forms of cancer, including lung cancer, breast cancer, ovarian cancer, colon cancer, pancreatic cancer, prostate cancer and others.  It is unlikely that the CompanyWe will not initially simultaneously launch tests for each of the cancers identified above, but expect to develop and thatlaunch over time, specific and individual cancer tests for each of the four markets identified above (screening, confirmatory testing, treatment monitoring, recurrence) will be launched over time..

Statistics from The American Cancer Society in 20172019 indicate that one out of every two males, and one out of every three femalespeople that are born in the U.S. today, will develop some form of cancer during their lifetimes.  With approximately 200 million adults in the United States alone, we believe that the market for new, non-invasive cancer diagnostic technologies and testing will be enormous, and that there will be sufficient demand to support many different technologies and tests.

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Cancer Diagnostic Technologies

If successful, we believe Cchek™ will have several advantages over existing diagnostic technologies.  For example, repeated exposure to radiation from x-ray technologies, such as mammograms, has become an increasing concern for the medical community, causing authorities to re-evaluate the recommended frequency of such x-ray based tests.  Traditional biopsies are often impossible for some tumor based cancers depending on the location of the tumor, and are invasive, expensive, and painful enough to warrant only limited use for other cancers even when the tumor can be accessed.  In addition, such biopsies are limited in their inability to detect the heterogeneity of many cancerous tumors, and the ongoing mutations that are often evident as the tumor progresses.  False positives in existing testing such as the PSA test, result in otherwise healthy patients being misdiagnosed, and subject to unnecessary follow-on treatments and medical procedures.  Patient inconvenience, risk of side effects from anesthesia, and risk of other complications result in low patient compliance with otherwise effective cancer screening tests such as the colonoscopy.  These are just a few examples of the challenges with traditional diagnostic tests that we seek to eliminate with Cchek™.  This will be the foundation for the competitive advantages that we expect to have over existing diagnostic testing.  We expect Cchek™ will be utilized as a component of multiple diagnostic technologies and patient background information to diagnose and manage the patient’s condition.

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Many public and private companies have announced plans and ongoing research efforts to launch non-invasive cancer diagnostic tests and tools that can be used for non-invasive cancer testing.  These companies include well established, and successful biotech companies, start-ups, and companies of all sizes.  Almost every bodily fluid, including blood, plasma, urine, saliva, and excrement, are being studied for biomarkers or indicators of one or more types of cancer.  The term that has been used to describe the category of this type of non-invasive cancer diagnostic testing is “liquid biopsy”.biopsy.”  In general, most of these companies are focused on identifying and analyzing one of three types of biomarkers:  circulating tumor cells (“CTC’s”CTCs”), circulating tumor DNA (“ctDNA”), and exosomes.  Each of these types of biomarkers has their advantages and disadvantages, and we expect that tests incorporating these and other biomarkers will make their way into the cancer diagnostic marketplace.

The Company believesWe believe that itsour Cchek™ diagnostic platform has the potential for at least three distinct advantages over the types of biomarker tests referred to above.  First, it appears that the biomarkers that we are using may be present in multiple types of and varying severities of cancers.  As a result, we anticipate that Cchek™ will become a platform from which multiple tests could be launched for multiple types of cancers.  Second, it appears that the biomarkers utilized by Cchek™ may be present in both advanced, and early stages of cancers.  Third, we expect Cchek™ to be significantly less expensive than the technologies commonly used for tests based on CTC’s, ctDNA, and exosomes.

Commercialization of Cchek™ PCC

In order to prepare Cchek™ PCC for commercialization, ResearchDx, our CLIA certified CAP accredited laboratory partner, performed an independent CLIA validation study.  For this study, ResearchDx processed blood samples from biopsy verified patients, then utilized our NN to distinguish between patients with high risk prostate cancer and those with benign conditions or low grade cancer, for whom a biopsy is unnecessary.  This CLIA validation study resulted in a sensitivity of 96% and a specificity of 45%, meaning that nearly all patients with high risk prostate cancer were correctly identified and nearly half of all unnecessary biopsies could be avoided.

While Cchek™ PCC was commercially launched in December 2019, there are a number of activities we are currently conducting to support marketing of the test, including the development of marketing materials, education of key opinion leaders in urology and development of a reimbursement path for the test.  We anticipate that once these activities are completed, we will have a team of key opinion leaders in urology using Cchek™ PCC in parallel with the standard methods of prostate cancer diagnosis.  We believe that we will demonstrate to such key opinion leaders that Cchek™ PCC provides significantly greater diagnostic accuracy than standard methods, as well as improved patient care.  We therefore believe that with favorable clinical experience amongst key opinion leaders in urology using Cchek™ PCC, we will be positioned to execute a strategic partnership with national or regional testing laboratories for the sales, marketing and operations of Cchek™ PCC.

CAR-T therapeutics

Certainty was formed to develop immuno-therapy drugs against cancer, and in November 2017, we entered into a license with Wistar whereby we obtained rights to certain intellectual property surrounding Wistar’s chimeric endocrine receptor targeted therapy technology.

CAR-T therapeutics have demonstrated positive results in B-cell cancers, but very little progress has been made on solid tumors.  Our CAR-T technology is initially focused on ovarian cancer and is based on engineering killer T-cells with the Follicle Stimulating Hormone (“FSH”) to target ovarian cells that express the FSH-Receptor.  Data on this technology, including the animal studies showing efficacy, was published in January 2017 in the journal, Clinical Cancer Research.  The FSH-Receptor has been shown to be a very exclusive protein found on a large percentage of ovarian cancer cells, but not on a significant number of non-ovarian healthy tissues in adult females.  

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We are working with researchers at Moffitt to complete studies necessary to submit an IND application with the FDA.  We then anticipate taking this therapy into human clinical testing for patients suffering from ovarian cancer.  Moffitt is one of the top cancer centers in the country with pre-clinical and clinical expertise with CAR-T technology.  Moffitt has conducted many of the highest profile CAR-T trials in the world.

We have performed numerous studies in preparation for an IND application.  In those studies, several groups of tumor free, female mice were intra-peritoneally infused with increasing concentrations of the murine CAR-T construct and their health status was monitored for up to five months.  The following summarizes the results of these studies:

·      No treated mice showed any signs of pain/stress, difficulty breathing or increased respiratory rate, reduced movement, reduced grooming or feeding, dehydration, anorexia or any other sign of distress.  Control mice also did not show any distress.

·      The treated mice did not show any weight loss.  Control mice also did not show any weight loss.

·      One cohort of treated mice also had blood drawn periodically for measurement of markers for liver function (AST-Aspartate transaminase/ALT-Alanine transaminase), kidney function (creatinine), and metabolic function (glucose).  No abnormal values were observed, as was the case for control mice.

·      Serum IL-6 (interleukin-6) increased in the treated mice, as well as mice treated with control T-cells.  This indicated that the T-cells were inducing the expected inflammatory response.

·      Histological analysis of the ovaries showed that 60% of the treated mice had significant reduction in ovarian mass, while the control mice exhibited no reduction.  This observation confirms that the CAR-T was successfully attacking the ovaries, as we hoped and expected. 

While these results are positive, there are many uncertainties in drug development, and most drugs fail to reach commercialization,commercialization.  In the future, we hope to achieve a profitable outcome by eventually licensing our technology to a large pharmaceutical company that has the resources and infrastructure in place to manufacture, market and sell our technology as a cancer treatment.

In October 2018, we attended a pre-IND meeting with the FDA to discuss numerous aspects of the planned clinical trial of our CAR-T therapy for ovarian cancer.  The FDA answered a number of questions, providing a good understanding of the design for the clinical trial in our IND application. 

We are in the process of completingoptimizing the final experiments neededviral vector necessary for genetically engineering patient T-cells, thereupon we believe we will have the clinical grade vector manufactured and tested and we will then be prepared to file our IND application.  We anticipate filing the IND by the end of 2020.  The IND application, after review and approval by the FDA, will enable us to begin testing our therapy in ovarian cancer patients.  Assuming the FDA approves our IND application, we anticipate beginning the human clinical trial as early as the summerthe second calendar quarter of 2019.2021. 

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The Market

The American Cancer Society estimates that 1.7 million people in the United States will be diagnosed with cancer in 2018.  The lifetime probability of being diagnosed with an invasive cancer is 39.7% for men and 37.6% for women. It is projected that 610,000 Americans will die from cancer in 2018 and that one in four deaths in the United States is due to cancer.

According to American Cancer Society statistics, ovarian cancer accounts for just 2.5% of all female cancer cases, but 5% of cancer deaths in women due to the disease’s low survival rate.  It is estimated that in 2018, 22,0002019, 23,000 new cases of ovarian cancer will be diagnosed and 16,00014,000 American women will die from this disease.  Despite continuous advances made in the field of cancer research every year, there remains a significant unmet medical need, as the overall five-year relative survival rate for ovarian cancer patients is 47%.  However, ovarian cancer survival varies substantially by age, with the overall five-year survival rate for women 65 and older of only 29%30%.  

Competition

The biopharmaceutical industry is characterized by intense and dynamic competition to develop new technologies and proprietary therapies.  Any product candidates that we successfully develop and commercialize will have to compete with existing therapies and new therapies that may become available in the future.  While we believe that our proprietary FSH-Receptor targeted immuno-therapy platform for treating solid tumors and scientific expertise in the field of cell therapy provide us with competitive advantages, we face potential competition from various sources, including larger and better-funded pharmaceutical and biotechnology companies, as well as from academic institutions, governmental agencies and public and private research institutions.

Many of our competitors, either alone or with their strategic partners, have substantially greater financial, technical and human resources than we do and significantly greater experience in the discovery and development of product candidates, obtaining FDA and other regulatory approvals of treatments and commercializing those treatments.  Accordingly, our competitors may be more successful than us in obtaining approval for treatments and achieving widespread market acceptance.  Our competitors’ treatments may be more effective, or more effectively marketed and sold, than any treatment we may commercialize and may render our treatments obsolete or non-competitive before we can recover the expenses of developing and commercializing any of our treatments.

Mergers and acquisitions in the biotechnology and pharmaceutical industries may result in even more resources being concentrated among a smaller number of our competitors.  These competitors also compete with us in recruiting and retaining qualified scientific and management personnel and establishing clinical study sites and subject registration for clinical studies, as well as in acquiring technologies complementary to, or necessary for, our program.  Smaller or early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large and established companies.

We anticipate that we will face intense and increasing competition as new drugs enter the market and advanced technologies become available.  We expect any treatments that we develop and commercialize to compete on the basis of, among other things, efficacy, safety, convenience of administration and delivery, price and the availability of reimbursement from government and other third-party payers. 

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Our commercial opportunity could be reduced or eliminated if our competitors develop and commercialize products that are safer, more effective, have fewer or less severe side effects, are more convenient or are less expensive than any products that we may develop.  Our competitors also may obtain FDA or other regulatory approval for their products more rapidly than we may obtain approval for ours, which could result in our competitors establishing a strong market position before we are able to enter the market. 

Breast Cancer vaccine

We licensed certain technology from Cleveland Clinic to develop vaccines for the treatment or prevention of TNBC and other breast cancers which express the α-lactalbumin protein.  This protein is only expressed during lactation in healthy women, but may also be expressed in individuals with certain breast cancers, most notably TNBC, the most lethal form of breast cancer.

Typically, vaccines harness the immune system to protect people from infectious diseases.  Broad-based vaccination programs have essentially eliminated some of the most deadly and debilitating diseases in history, small pox and polio among them.  However, there has been little success developing a preventative (prophylactic) vaccine against cancer.

Vaccines work by exposing a benign form of a disease agent to an individual’s immune system.  The immune system identifies the agent and learns to attack and destroy it, retaining a memory of the agent so the immune system knows to react quickly if an individual is exposed to the disease agent months or years later.

Most vaccines attack pathogens, such as viruses and bacteria.  The immune system is better able to assail these agents because they come from outside the body.  Cancer, however, is caused by aberrant cells that arise out of our resident cells, which can make it difficult for our immune system to find the diseased cells, especially as advancing age weakens our immune system.  Once these aberrant cells gain critical mass, they become cancer.

Despite the lack of success with cancer vaccines, recently gained knowledge about the human immune system has led to the development, approval and commercialization of revolutionary immuno-therapy drugs.  These drugs do not attack cancer directly, but rather modulate the immune system in ways that enable it to destroy or dramatically impair cancer cells.

The technology licensed from Cleveland Clinic has identified a protein called alpha-lactalbumin that is present in healthy breast tissue only when a woman is lactating and disappears when she stops nursing her child.  Alpha-lactalbumin is never present on any other cell in the body.  However, it does show up in many types of breast cancer, including TNBC, an aggressive and deadly form of the disease.  By developing a vaccine that targets alpha-lactalbumin, we feel the immune system can destroy these breast cancer cells as they arise and ultimately prevent breast tumors from forming.  

Cleveland Clinic researchers have demonstrated in animal studies that vaccination against alpha-lactalbumin completely prevented breast cancer in mice that were specifically bred to develop breast cancer.  Data on this technology, including the animal studies showing efficacy, was published in March 2016 in the journal, Cancers. 

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While the data thus far has been positive, there are many uncertainties in drug development, and most drugs fail to reach commercialization.  We hope to achieve a profitable outcome by eventually licensing our technology to a large pharmaceutical company that has the resources and infrastructure in place to manufacture, market and sell our technology as a therapeutic or prophylactic cancer vaccine.

We have been working with researchers at Cleveland Clinic to advance the breast cancer vaccine technology toward human clinical testing, and we are in the process of testing the clinical grade materials and upon completion we will then be prepared to file our IND application.  We anticipate filing the IND in 2020.  The IND application, after review and approval by the FDA, will enable us to begin testing our therapy in breast cancer patients.  Assuming the FDA approves our IND application, we anticipate beginning the human clinical trial as soon as practicable thereafter. 

The Market

According to American Cancer Society statistics, breast cancer accounts for 30% of all female cancer cases, and 15% of cancer deaths in women.  It is estimated that in 2019, 269,000 new cases of breast cancer will be diagnosed in the U.S. and 42,000 women will die from this disease.  Despite continuous advances made in the field of cancer research every year, there has been little change in breast cancer incidence rate over the last ten years. 

The market for prophylactic cancer vaccines is sizable—bigger in fact than the market for any type of cancer therapeutic.  After all, doctors administer cancer drugs only after a patient has been diagnosed, while a prophylactic vaccine may be administered to all people who have a possibility of developing the disease.

While in the U.S., 269,000 women are estimated to be diagnosed with breast cancer this year, there are approximately 75 million women over the age of 40—the time in life when women face an increased risk of developing breast cancer.  Worldwide, the number is dramatically larger.

Competition

The biopharmaceutical industry is characterized by intense and dynamic competition to develop new technologies and proprietary therapies.  Any product candidates that we successfully develop and commercialize will have to compete with existing therapies and new therapies that may become available in the future.  While we believe that our proprietary breast cancer vaccine technology and scientific expertise in the field of cell therapy provide us with competitive advantages, we face potential competition from various sources, including larger and better-funded pharmaceutical and biotechnology companies, as well as from academic institutions, governmental agencies and public and private research institutions.

Many of our competitors, either alone or with their strategic partners, have substantially greater financial, technical and human resources than we do and significantly greater experience in the discovery and development of product candidates, obtaining FDA and other regulatory approvals of vaccines and commercializing those vaccines.  Accordingly, our competitors may be more successful than us in obtaining approval for vaccines and achieving widespread market acceptance.  Our competitors’ vaccines may be more effective, or more effectively marketed and sold, than any vaccine we may commercialize and may render our vaccines obsolete or non-competitive before we can recover the expenses of developing and commercializing any of our vaccines.

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Mergers and acquisitions in the biotechnology and pharmaceutical industries may result in even more resources being concentrated among a smaller number of our competitors.  These competitors also compete with us in recruiting and retaining qualified scientific and management personnel and establishing clinical study sites and subject registration for clinical studies, as well as in acquiring technologies complementary to, or necessary for, our program.  Smaller or early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large and established companies.

We anticipate that we will face intense and increasing competition as new drugs enter the market and advanced technologies become available.  We expect any vaccines that we develop and commercialize to compete on the basis of, among other things, efficacy, safety, convenience of administration and delivery, price and the availability of reimbursement from government and other third-party payers. 

Our commercial opportunity could be reduced or eliminated if our competitors develop and commercialize products that are safer, more effective, have fewer or less severe side effects, are more convenient or are less expensive than any products that we may develop.  Our competitors also may obtain FDA or other regulatory approval for their products more rapidly than we may obtain approval for ours, which could result in our competitors establishing a strong market position before we are able to enter the market. 

Employees

As of October 31, 2018, on a consolidated basis,2019, we had eight employees, seven full-time and one part time.time, working for our Company and subsidiaries.

Other

Our principal executive offices are located at 3150 Almaden Expressway, San Jose, California 95118, our telephone number is (408) 708-9808 and our Internet website address is www.anixa.com.  We make available free of charge on or through our Internet website our annual report on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K, proxy statements on Schedule 14A, and amendments to those reports filed or furnished pursuant to Section 13(a) or 15(d) of the Exchange Act as soon as reasonably practicable after we electronically file such materials with, or furnish them to, the Securities and Exchange Commission (the “SEC”).  Alternatively, you may also access our reports at the SEC’s website at www.sec.gov.  You may also read and copy any document we file with the SEC at the SEC’s public reference room located at 100 F Street, NE, Washington, DC 20549, on official business days during the hours

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Table of 10:00 a.m. and 3:00 p.m. Please call the SEC at 1-800-SEC-0330 for further information on the operation of the public reference room.

Contents

Item 1A.         Risk Factors.Factors.

Our business involves a high degree of risk and uncertainty, including the following risks and uncertainties:

Risks Related to Our Financial Condition and Operations

We have a history of losses and may incur additional losses in the future.

On a cumulative basis we have sustained substantial losses and negative cash flows from operations since our inception.  As of October 31, 2018,2019, our accumulated deficit was approximately $170,170,000.$181,817,000.  As of October 31, 2018,2019, we had approximately $5,056,000$5,842,000 in cash, cash equivalents and short-term investments, and working capital of approximately $4,273,000.$4,612,000.  In fiscal year 2018,2019, we incurred losses of approximately $14,243,000$11,819,000 and we experienced negative cash flows from operations of approximately $4,273,000.$4,773,000.  We expect to incurcontinue incurring material research and development expenses and to continue incurring significant legal and general and administrative expenses in connection with our operations.  As a result, we anticipate that we will incur losses in the future.

We will need additional funding in the future which may not be available on acceptable terms, or at all, and, if available, may result in dilution to our stockholders.

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Based on currently available information as of January 11, 2019,9, 2020, we believe that our existing cash, cash equivalents, short-term investments and expected cash flows will be sufficient to fund our activities for the next 12 months.  However, our projections of future cash needs and cash flows may differ from actual results.  If current cash on hand, cash equivalents, short term investments and cash that may be generated from our business operations are insufficient to continue to operate our business, or if we elect to invest in or acquire a company or companies that are synergistic with or complimentary to our technologies, we may be required to obtain more working capital.  We may seek to obtain working capital through sales of our equity securities or through bank credit facilities or public or private debt from various financial institutions where possible.  We cannot be certain that additional funding will be available on acceptable terms, or at all.  If we do identify sources for additional funding, the sale of additional equity securities or convertible debt could result in dilution to our stockholders.  Additionally, the sale of equity securities or issuance of debt securities may be subject to certain security holder approvals or may result in the downward adjustment of the exercise or conversion price of our outstanding securities.  We can give no assurance that we will generate sufficient cash flows in the future to satisfy our liquidity requirements or sustain future operations, or that other sources of funding, such as sales of equity or debt, would be available or would be approved by our security holders, if needed, on favorable terms or at all.  If we fail to obtain additional working capital as and when needed, such failure could have a material adverse impact on our business, results of operations and financial condition.  Furthermore, such lack of funds may inhibit our ability to respond to competitive pressures or unanticipated capital needs, or may force us to reduce operating expenses, which would significantly harm the business and development of operations.

Failure to effectively manage our potential growth could place strains on our managerial, operational and financial resources and could adversely affect our business and operating results.

Our business strategy and potential growth may place a strain on managerial, operational and financial resources and systems.  Although we may not grow as we expect, if we fail to manage our growth effectively or to develop and expand our managerial, operational and financial resources and systems, our business and financial results will be materially harmed.

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We may use our financial and human resources to pursue a particular research program or product candidate and fail to capitalize on programs or product candidates that may be more profitable or for which there is a greater likelihood of success.

Because we have limited resources, we may forego or delay pursuit of opportunities with certain programs or product candidates or for indications that later prove to have greater commercial potential.  Our resource allocation decisions may cause us to fail to capitalize on viable commercial products or profitable market opportunities.  Our spending on current and future research and development programs for product candidates may not yield any commercially viable products.  If we do not accurately evaluate the commercial potential or target market for a particular product candidate, we may relinquish valuable rights to that product candidate through strategic collaboration, licensing or other royalty arrangements in cases in which it would have been more advantageous for us to retain sole development and commercialization rights to such product candidate, or we may allocate internal resources to a product candidate which it would have been more advantageous to enter into a partnering arrangement.

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We are currently subject to a putative shareholder derivative complaint which could distract our management and could result in substantial costs or large judgments against us.

On November 5, 2018, a putative shareholder derivative complaint was filed in the Court of Chancery of the State of Delaware, captioned Howland v. Kumar et al., C.A. No. 2018-0804-KSJM (the “Howland Matter”), that alleges claims for breach of fiduciary duty and unjust enrichment.  The complaint named as defendants certain of the Company’s current and former officers and directors, and the Company is named solely as a nominal defendant.  The complaint seeks, on behalf of the Company, a declaration that the defendant officers and directors breached their fiduciary duties, unspecified damages, certain changes to the Company’s internal procedures, and an award of the plaintiff’s attorneys’ fees and costs.  The defendants moved to dismiss the complaint on November 29, 2018 and the parties are currently engaged in briefing the motion.  If the Howland Matter is not dismissed at the pleading stage, we will be required to devote significant time to the adjudication of the matter which will distract our management and may have an adverse impact on our business, operating results and financial condition.  Further, if the Howland Matter is not dismissed, we could incur substantial costs related to the adjudication of the Howland Matter that may not be covered by insurance. In addition, we are obligated pursuant to Article 10 of our by-laws, as amended (the "By-Laws"), to indemnify any person who was or is a party or is threatened to be made a party to, or testifies in, any threatened, pending or completed action, suit or proceeding, whether civil, criminal, administrative or investigative in nature, by reason of the fact that such person is or was a director or officer of the Company against expenses (including attorneys' fees and disbursements), judgments, fines and amounts paid in settlement actually and reasonably incurred by such person in connection with such action, suit or proceeding to the full extent permitted by law. Accordingly, we may incur substantial costs related to the indemnification of our current and former officers and directors that were named as defendants in the Howland Matter. While we have director and officer insurance, there is no assurance that our policy will cover any or all of the costs associated with the indemnification of our current and former officers and directors that were named as defendants in the Howland Matter.

Our ability to use our net operating loss carryforwards and certain other tax attributes may be limited.

We have incurred net losses since our inception and we may never achieve or sustain profitability.  Generally, losses incurred will carry forward until such losses expire (for losses generated prior to January 1, 2018) or are used to offset future taxable income, if any.  Under Sections 382 and 383 of the Internal Revenue Code of 1986, as amended (the “Internal Revenue Code”), if a corporation undergoes an “ownership change,” generally defined as a greater than 50 percentage point change (by value) in its equity ownership by certain stockholders over a three-year period, the corporation’s ability to use its pre-change net operating loss, or NOL, carryforwards and other pre-change tax attributes (such as research tax credits) to offset its post-change income or taxes may be limited.  We have not completed a study to assess whether an ownership change for purposes of Section 382 or 383 has occurred, or whether there have been multiple ownership changes since our inception.  We may have experienced ownership changes in the past and may experience ownership changes in the future as a result of shifts in our stock ownership (some of which shifts are outside our control).  As a result, if we earn net taxable income, our ability to use our pre-change NOL carryforwards to offset such taxable income will be subject to limitations.  Similar provisions of state tax law may also apply to limit our use of accumulated state tax attributes.  As a result, even if we attain profitability, we may be unable to use a material portion of our NOL carryforwards and other tax attributes, which could adversely affect our future cash flows.

We have not yet determined the consequences to our business of the “Tax Cuts and Jobs Act” (see the risk factor entitled, “U.S. federal income tax reform could adversely affect us and holders of our common stock” below), which could increase our future U.S. tax expense.  For example, the new tax laws impose a reduction to the maximum deduction allowed for NOLs generated in tax years beginning after December 31, 2017, but allow such NOLs to be carried forward indefinitely.  These changes may adversely affect our future cash flows.

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Our employees, scientific advisors, principal investigators, consultants and commercial partners may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements, and insider trading.

We are exposed to the risk of fraud or other misconduct by our employees, scientific advisors, principal investigators, consultants and commercial partners.  Misconduct by these parties could include intentional failures to comply with the regulations of the FDA or other regulatory bodies, comply with healthcare fraud and abuse laws and regulations in the United States and abroad, report financial information or data accurately or disclose unauthorized activities to us.  In particular, sales, marketing, and business arrangements in the healthcare industry are subject to extensive laws and regulations intended to prevent fraud, misconduct, kickbacks, self-dealing and other abusive practices.  These laws and regulations may restrict or prohibit a wide range of pricing, discounting, marketing and promotion, sales commission, customer incentive programs and other business arrangements.  Such misconduct could also involve the improper use of information obtained in the course of clinical studies, which could result in regulatory sanctions and cause serious harm to our reputation.  We currently have a code of conduct applicable to all of our employees, but it is not always possible to identify and deter employee misconduct, and our code of conduct and the other precautions we take to detect and prevent this activity may not be effective in controlling unknown or unmanaged risks or losses, or in protecting us from governmental investigations or other actions or lawsuits stemming from a failure to comply with these laws or regulations.  If any such actions are instituted against us, and we are not successful in defending ourselves or asserting our rights, those actions could result in the imposition of significant civil, criminal and administrative penalties, including, without limitation, damages, monetary fines, individual imprisonment, disgorgement of profits, possible exclusion from participation in Medicare, Medicaid and other federal healthcare programs, contractual damages, reputational harm, diminished profits and future earnings, additional reporting or oversight obligations if we become subject to a corporate integrity agreement or other agreement to resolve allegations of non-compliance with the law and curtailment or restructuring of our operations, which could have a significant impact on our business.  Whether or not we are successful in defending against such actions or investigations, we could incur substantial costs, including legal fees and divert the attention of management in defending ourselves against any of these claims or investigations.

Risks Related to our Biotechnology Research & Development and Commercialization Activities

Our cancer diagnostic and cancer therapeutics businesses are pre-revenue, and subject to the risks of an early stage biotechnology company.

Since the Company’s primary focus for the foreseeable future will likely be our cancer diagnostics and therapeutics businesses, shareholders should understand that we are primarily an early stage biotechnology company with no history of revenue-generating operations, and our only assets consist of our proprietary and licensed technologies and the know-how of our officers.  Therefore we are subject to all the risks and uncertainties inherent in a new business, in particular new businesses engaged in the early detection of certain cancers, and CAR-T cancer therapeutics.therapeutics and cancer vaccines.  CchekÔ, and our CAR-T ovarian cancer therapeuticstherapeutic and our breast cancer vaccine are in their early stages of development, and we still must establish and implement many important functions necessary to commercialize the technologies.

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Accordingly, you should consider the Company’s prospects in light of the costs, uncertainties, delays and difficulties frequently encountered by companies in their pre-revenue generating stages, particularly those in the biotechnology field.  Shareholders should carefully consider the risks and uncertainties that a business with no operating history will face.  In particular, shareholders should consider that there is a significant risk that we will not be able to:

·         demonstrate the effectiveness and clinical utility of the Cchek™; platform;

·         develop a reimbursement pathway for our Cchek™ PCC test;

·         recruit key opinion leaders in urology to order Cchek™ PCC for their patients;

·         successfully complete studies necessary to submit an IND applicationapplications to the FDA for our CAR-T ovarian cancer therapeutic;therapeutic or breast cancer vaccine;

·         obtain FDA approvals to commence human clinical trials of our CAR-T ovarian cancer therapeutic or breast cancer vaccine;

·         successfully enroll sufficient numbers of qualified patients to participate in our clinical trials;

·         obtain sufficient quantity and quality of materials manufactured for use in our clinical trials;

·         successfully meet the primary endpoints in our clinical trials;

·         implement or execute our current business plan, or that our current business plan is sound;

·         raise sufficient funds in the capital markets or otherwise to fully effectuate our business plan;

·         maintain our management team, including the members of our scientific advisory board;

·         determine that the processes and technologies that we have developed or will develop are commercially viable; and/or

·         attract, enter into or maintain contracts with potential commercial partners such as licensors of technology and suppliers.suppliers or licensees of our technologies.

Any of the foregoing risks may adversely affect the Company and result in the failure of our business.  In addition, we expect to encounter unforeseen expenses, difficulties, complications, delays and other known and unknown factors.  Over the next several quarters, we will need to transition from a company with a research and development focus to a company capable of supporting clinical trials and commercial activities.  We may not be able to reach such achievements, which would have a material adverse effect on our Company.

Our current business model, as it relates to both Cchek™our diagnostic and our CAR-T cancer therapeutics businesses, relies on strategic collaborations with commercial partners to provide the resources and infrastructure to manufacture and ultimately market and/or sell our technologies.  We may have difficulty in timing the establishment of these partnerships to achieve the greatest economic benefit for the Company, or in establishing these partnerships at all.

We do not currently have the resources and infrastructure to manufacture, market or sell our products or technologies.  While our technologies have generated interest from multiple potential strategic partners, due to the early stage of development of our technologies, we can give no assurance that we will be able to successfully establish any strategic partnerships.  Further, even if we elect to engage with a potential strategic partner, development of these partnerships can take an extended period of time in which significant analysis is performed by the potential strategic partner on our technologies and our intellectual property, as well as on the market opportunities and how well our technologies may fit strategically with the partner’s existing business.  Accordingly, it will be difficult for us to time the establishment of a strategic partnership to achieve the greatest economic benefit for the Company. 

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We may have difficulty in raising capital for our cancer diagnostics and therapeutics businesses and may consume resources faster than expected.

We currently do not generate any revenue from CchekÔ, our CAR-T therapeutic or our ovarianbreast cancer therapeuticvaccine nor do we generate any other recurring revenues and as of October 31, 2018,2019, the Company only had approximately $5,056,000$5,842,000 in cash, cash equivalents and short-term investments.  Therefore, we have a limited source of cash to meet our future capital requirements, which may include the expensive process of obtaining FDA approvals for our CAR-T ovarian cancer therapeutic, our breast cancer vaccine and for CchekÔCchek™ for each type of cancer for which we desire to launch a diagnostic test.  We do not expect to generate significant revenues for the foreseeable future, and we may not be able to raise funds in the future, which would leave us without resources to continue our operations and force us to resort to the Company raising additional capital in the form of equity or debt financings, which may not be available to us.  We may have difficulty raising needed capital in the near or longer term as a result of, among other factors, the very early stage of our diagnostic businessand therapeutics businesses and our lack of revenues as well as the inherent business risks associated with an early stage, biotechnology company and present and future market conditions.  Also, we may consume available resources more rapidly than currently anticipated, resulting in the need for additional funding sooner than anticipated.  Our inability to raise funds could lead to decreases in the price of our common stock and the failure of our cancer diagnostic and therapeutictherapeutics businesses which would have a material adverse effect on the Company.

If product liability lawsuits are brought against us, we are unablemay incur substantial liabilities and may be required to obtain and maintain intellectual property protection,limit commercialization of our competitive position will be harmed.product candidates.

Our ability to competeWe will face an inherent risk of product liability as a result of the upcoming human clinical testing and to achieve sustained profitability will be impacted by our ability to protect our CchekÔ cancer diagnostic technologies, our CAR-T cancer therapeutics technologies and other proprietary discoveries and technologies.  We expect to rely on a combination of patent protection, copyrights, trademarks, trade secrets, know-how, and regulatory approvals to protect CchekÔ, our CAR-T cancer therapeutics and anycommercialization of our other technologies.  Our intellectual property strategy is intended to help develop and maintain our competitive position.  Whileproduct candidates.  For example, we have been granted two patents related to CchekÔ, there is no assurance that we will be able to obtain further patent protection for CchekÔ, our CAR-T cancer therapeutics and any other technologies, nor can we be certain that the steps we will have taken will prevent the misappropriation and unauthorized use of our technologies.  If we are not able to obtain and maintain patent protection our competitive position may be harmed.

Third parties may initiate legal proceedings alleging that wesued if our product candidates cause or are infringing their intellectual property rights, the outcome of which would be uncertain and could have a material adverse effect on the success of our business.

Our commercial success depends upon our abilityperceived to develop, manufacture, market and sell our CchekÔ cancer diagnostic technologies, our CAR-T therapeutics, and other proprietary discoveries and technologies without infringing, misappropriatingcause injury or otherwise violating the proprietary rights or intellectual property of third parties.  We may become party to, or be threatened with, future adversarial proceedings or litigation regarding intellectual property rights with respect to our CchekÔ cancer diagnostic technologies, our CAR-T therapeutics, and other proprietary discoveries and technologies.  Third parties may assert infringement claims against us based on existing patents or patents that may be granted in the future.  If we are found to infringebe otherwise unsuitable during clinical testing, manufacturing, marketing or sale.  Any such product liability claims may include allegations of defects in manufacturing, defects in design, a third-party's intellectual property rights,failure to warn of dangers inherent in the product, negligence, strict liability or a breach of warranties.  Claims could also be asserted under state consumer protection acts.  If we couldcannot successfully defend ourselves against product liability claims, we may incur substantial liabilities or be required to obtain a license from such third-party to continue developinglimit or cease commercialization of our CchekÔ cancer diagnostic technologies, our CAR-T therapeutics,product candidates.  Even successful defense would require significant financial and other proprietary discoveries and technologies.  However, wemanagement resources.  Regardless of the merits or eventual outcome, liability claims may not be able to obtain any required license on commercially reasonable terms or at all.  Even if we were able to obtain a license, it could be non-exclusive, thereby giving our competitors access to the same technologies licensed to us.  We could be forced, including by court order, to cease developing the infringing technology or product.  In addition, we could be found liable for monetary damages.  Claims that we have misappropriated the confidential information or trade secrets of third parties can have a similar negative impact on our business.result in:

18·         decreased demand for our product candidates;

·         injury to our reputation;

·         withdrawal of clinical trial participants;

·         initiation of investigations by regulators;

·         costs to defend the related litigation;

·         a diversion of management’s time and our resources;

·         substantial monetary awards to clinical trial participants or patients;

·         product recalls, withdrawals or labeling, marketing or promotional restrictions;

·         loss of revenue;

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·         exhaustion of any available insurance and our capital resources;

·         the inability to commercialize any product candidate; and

·         a decline in our share price.

We do not currently carry product liability insurance, but intend to obtain such coverage prior to commencement of our therapeutic clinical trials and broad commercialization of our diagnostic tests.  Our inability to obtain sufficient product liability insurance at an acceptable cost to protect against potential product liability claims could prevent or inhibit the commercialization of any products we develop, alone or with corporate collaborators.  

If we cannot license rights to use technologies on reasonable terms, we may not be able to commercialize new products in the future.

In the future, we may identify third-party technology we need, including to develop or commercialize new products or services.  In return for the use of a third party’s technology, we may agree to pay the licensor royalties based on sales of our products or services.  Royalties are a component of cost of products or services and affect the margins on our products or services.  We may also need to negotiate licenses to patents or patent applications before or after introducing a commercial product.  We may not be able to obtain necessary licenses to patents or patent applications, and our business may suffer if we are unable to enter into the necessary licenses on acceptable terms or at all, if any necessary licenses are subsequently terminated, if the licensors fail to abide by the terms of the licenses or fail to prevent infringement by third parties, or if the licensed patents or other rights are found to be invalid or unenforceable.

Risks Related to CchekÔ™

While our CchekÔ  diagnostic technology has shown favorable results from initial testing, we cannot guarantee that these results will be replicated in future testing nor can we guarantee the success of the technology at all.

We have initially used CchekÔCchek™ to test the blood of small groups of individuals consisting of cancer patients, patients with benign conditions and healthy patients and have in some studies reported sensitivity and specificity of over 90%.  While these preliminary results far exceed existing diagnostic testing, and we have launched Cchek™ PCC based on these results, there is no guarantee that these results will be replicable when we test a larger group of patients, as we seek to commercialize CchekÔ PCC, or at all.  If we are unable to consistently attain results that are necessary to realize economic benefit for CchekÔ PCC or for commercialization of CchekÔ,additional Cchek™ tests, our diagnostic technology will not have any monetary value and we will be unable to generate any revenue from this technology.

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Even if we are able to attain results necessary for the commercialization of any test based on the CchekÔtechnology, our ability to commercialize the technology in the future will depend on our ability to provide evidence of clinical utility.

Our ability to successfully commercialize CchekÔCchek™ will depend on numerous factors, including whether health care providers believe that CchekÔCchek™ provides sufficient incremental clinical utility; whether the medical community accepts that CchekÔCchek™ has sufficient sensitivity (there are no or very few false positives), specificity (detects the cancer the test is supposed to detect) and predictive value to be meaningful in patient care and treatment decisions; whether the cost of the test is reasonably priced and commercially viable; and whether health insurers, government health programs and other third-party payers will cover and pay for CchekÔCchek™ and the amount that they will reimburse for such tests.  These factors may present obstacles to commercial acceptance of CchekÔCchek™.  To the extent these obstacles arise, we will need to devote substantial time and resources to overcome these obstacles, and we might not be successful.  Failure to achieve market acceptance of CchekÔCchek™ would materially harm our business, financial condition and results of operations.

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We are unable to give any assurance that we will be successful in providing sufficient evidence of clinical utility or any assurance that we will have adequate managerial, technical or financial resources to support the studies necessary to provide sufficient evidence of clinical utility of CchekÔCchek™ or to adequately differentiate our test from other diagnostic products in the manner, timeframe or cost parameters we anticipate, if at all.  If we are unable to provide evidence of clinical utility and differentiate CchekÔCchek™, we will not be able to generate the revenues and market growth that we seek.  Our failure to generate revenue from the sale of our products would materially adversely impact our business, financial condition, results of operations and prospects.

To run diagnostic tests on blood samples on our CchekÔ  platform, we rely on certain over the counter reagents and other specialty raw materials which may not be available to us in a timely manner or at all.

When performing diagnostic tests on blood samples on our Cchek™ platform, we use certain over the counter reagents and other supplies.  Generally, all of the reagents and other supplies that we use for our diagnostic tests are off the shelf, are available from multiple suppliers and are able to be obtained without significant lead time.  However, there is no assurance that this will be true in the future.  For example, if a supplier has quality control issues, the delivery of these materials may be slower than expected.  Further, if we need to find a new supplier for any of these materials, there is a risk that the new materials will not perform precisely as the old materials performed.  While we seek to mitigate these risks by keeping extra supplies of the necessary materials on hand, if we are unable to obtain the necessary materials to run our diagnostic tests, if the materials we are able to obtain do not perform precisely as expected, or if the materials are only available on terms that are unacceptable to us, it would have a material impact on our Cchek™ platform and operations.

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Even though CchekÔ PCC has been commercially launched, we may not realize any revenues or any other economic benefit from the test.

While we have commercially launched CchekÔ PCC, the first test based on the CchekÔ technology platform, there can be no assurance that the test will find any commercial success.  There are a number of factors that may limit our ability to generate an economic benefit from the CchekÔ PCC test, including the inability to:

·         develop a reimbursement pathway for the test;

·         maintain third party relationships with one or more CLIA certified labs to perform the test;

·         negotiate and maintain a beneficial cost structure with third parties for performing the test;

·         recruit key opinion leaders in urology to order the test for their patients;

·         develop a strategic relationship with one or more national or regional CLIA certified laboratories to broadly market, sell and perform the test; and

·         obtain patient test results consistent with results found during product development.

Any of the foregoing factors, or others, could significantly limit our ability to achieve economic success with our CchekÔ PCC test, and could result in the failure of the CchekÔ PCC test as well as the CchekÔ technology platform as a whole.

Diagnostic test development involves a lengthy and complex process, and we may be unable to commercialize additional tests based on the CchekÔ technology on a timely basis, or at all.

We have devoted considerable resources to research and development for CchekÔCchek™, however there can be no assurance that CchekÔCchek™ will be capable of reliably predicting the occurrence or recurrence of any cancers with the sensitivity and specificity necessary to be clinically and commercially useful, or, even if such technology is clinically and commercially useful, that it will result in commercially successful products.  In addition, before we can fully develop CchekÔCchek™ and commercialize any newadditional products, we will need to:

·         conduct substantial research and development;

·         conduct validation studies;

·         expend significant funds;

·         enter into agreements and maintain relationships with third party vendors to provide third party blood samples;

·         obtain regulatory approval (either CLIA, FDA or both); and

·         depending on which regulatory pathway we select, establish or contract with the owner of a CLIA certified laboratory to process test samples.

Accordingly, our product development process involves a high degree of risk and may take several years, especially if the Company seekswe seek FDA approval for eachany of itsour diagnostic tests.  If CchekÔadditional Cchek™ tests should fail at the research or development stage, not produce sufficient clinical validation data to support the effectiveness of the product or not gain regulatory approval or if we should run out of cash to devote towards the commercialization of the technology or fail to establish agreements with necessary third party vendors, we will not be able to commercialize CchekÔany additional Cchek™ tests and we will not generate any revenue from the technology.

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If we fail to obtain, or if there are delays in obtaining, required regulatory approvals, we will not be able to further commercialize our CchekÔ technology beyond CchekÔ PCC, and our ability to generate revenue and the viability of our Company will be materially impaired.

Commercialization of CchekÔadditional Cchek™ tests will require that we obtain either CLIA certification, FDA approval or both.  If we are unable to timely obtain regulatory approval for CchekÔ,additional Cchek™ tests, we will be unable to commercialize and generate revenue from the technology which would have a material adverse effect on our business, financial condition and results of operations.

UntilUnless we obtain FDA approval for CchekÔ, and unless PCC or any other CchekÔ tests or we establish a CLIA certified laboratory, we will be dependent on laboratory contractors for testing of patient samples that are essential toperforming the development and validation of CchekÔ.PCC test and any other CchekÔ tests we may develop in the future for commercial purposes.

To pursuefulfill physician orders and perform the development and validation of CchekÔ,Cchek™ PCC test or any other Cchek™ tests we may develop in the future, we will require accessa CLIA certified laboratory to test results obtained from patient blood samples.perform the test.  We have currently contracted with WistarResearchDx to provide these services.services with respect to the Cchek™ PCC test.  Unless and until CchekÔCchek™ PCC (or any other Cchek™ tests we may develop in the future) receives FDA approval, or we establish our own CLIA certified laboratory, we will continue to be dependent on contractors or collaborators such as WistarResearchDx for testing of patient blood samples to develop and validate CchekÔ.samples.

We will be dependent on third parties for the patient samples that are essential to the development and validation of additional CchekÔ.tests.

To pursue our development and validation of CchekÔ,Cchek™ tests beyond Cchek™ PCC, we will need access, over time, to patient blood samples and such patients will need to consent to the use of their blood.  As a result, we have made arrangements with hospitals and medical practices to give us access to patient samples for the development and validation of CchekÔCchek™.  In the event that we are unable to obtain patient samples, or access to patient samples becomes more limited due to changes in privacy laws governing the use and disclosure of medical information or due to changes in the laws restricting our ability to obtain patient samples and associated information, our ability to pursue the development of CchekÔCchek™ may be slowed or halted, which could have a material adverse effect on our business, financial condition and results of operations.

Our business could be harmed from the loss or suspension of a license or imposition of a fine or penalties under, or future changes in, or changing interpretations of, the law or regulations of the Clinical Laboratory Improvement Act of 1967, the Clinical Laboratory Improvement Amendments of 1988, or the FDA or other federal, state or local agencies.

We will need to seek regulatory approval in order to market CchekÔCchek™.  The clinical laboratory testing industry is subject to extensive federal and state regulation, and many of these statutes and regulations have not been interpreted by the courts.  The Clinical Laboratory Improvement Act of 1967 and the Clinical Laboratory Improvement Amendments of 1988 are federal regulatory standards that apply to virtually all clinical laboratories (regardless of the location, size or type of laboratory), including those operated by physicians in their offices, by requiring that they be certified under federal law.  CLIA does not pre-empt state law, which in some cases may be more stringent than federal law and require additional personnel qualifications, quality control, record maintenance and proficiency testing.  The sanction for failure to comply with CLIA and state requirements may be suspension, revocation or limitation of a laboratory’s CLIA certificate, which is necessary to conduct business, as well as significant fines and/or criminal penalties.  Several states have similar laws and we may be subject to similar penalties.  The FDA regulates diagnostic products and periodically inspects and reviews their manufacturing processes and product performance.  We may choose to seek FDA approval for one or more CchekÔCchek™ tests, as opposed to seeking CLIA certification.  We cannot assure that applicable statutes and regulations will not be interpreted or applied by a prosecutorial, regulatory or judicial authority in a manner that would adversely affect our business.  Potential sanctions for violation of these statutes and regulations include significant fines and the suspension or loss of various licenses, certificates and authorizations, which could have a material adverse effect on our business.  In addition, compliance with future legislation could impose additional requirements on us, which may be costly, including FDA regulation of laboratory developed tests.

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Health insurers and other third-party payers may decide not to reimburse our CchekÔ™ diagnostic testing or may provide inadequate reimbursement, which could jeopardize our commercial prospects and require customers to pay for the tests out of pocket.

In the United States, the regulatory process that allows diagnostic tests to be marketed is independent of any coverage determinations made by third-party payers.  For new diagnostic tests, private and government payers decide whether to cover the test, the reimbursement amount for a covered test and the specific conditions for reimbursement.  Physicians may order diagnostic tests that are not reimbursed by third-party payers, but coverage determinations and reimbursement levels and conditions are critical to the commercial success of a diagnostic product.  Each third-party payer makes its own decision about which tests it will cover and how much it will pay, although many payers will follow the lead of Medicare.  As a result, the coverage determination process will be a time-consuming and costly process that requires us to provide scientific, clinical and economic support for the use of CchekÔCchek™ diagnostic testing to each payer separately, with no assurance that approval will be obtained.  If third-party payers decide not to cover CchekÔCchek™ or if they offer inadequate payment amounts, our ability to generate revenue from CchekÔCchek™ could be limited since patients who want to take the diagnostic tests would have to pay for it out of pocket.  Even if one or more third-party payers decide to reimburse for CchekÔCchek™ diagnostic testing, a third-party payer may stop or lower payment at any time, which could reduce revenue.  We cannot predict whether third-party payers will cover CchekÔCchek™ diagnostic testing or offer adequate reimbursement.  We also cannot predict the timing of such decisions.  In addition, physicians or patients may decide not to order CchekÔCchek™ tests if third-party payments are inadequate, especially if ordering the test could result in financial liability for the patient.

Whether or not health insurers and other third-party payers decide to reimburse CchekÔ™, the technology may cost patients more than we anticipate.

We believe that our CchekÔCchek™ diagnostic testing will significantly reduce the cost to patients of screening and confirmatory testing for certain types of cancer.  If, however, the cost to utilize CchekÔCchek™ is more expensive than we anticipate, many patients and third-party payers may elect not to utilize the technology which would significantly impact our ability to generate revenue on the technology.

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We operate in a competitive market and expect to face intense competition, often from companies with greater resources and experience than us.

The clinical diagnostics industry is highly competitive and subject to rapid change.  We are aware of many different types of diagnostic tests available to detect cancer that are currently in use or being developed and many more types of diagnostic tests may be developed in the future.  If we are able to successfully commercialize CchekÔCchek™, all of these tests will compete with our product.products.  If CchekÔCchek™ is more expensive than and/or does not have sufficient specificity, sensitivity or predictive value to compete with tests that are currently on the market, or if any other diagnostic tests that are under development, once successfully developed and commercialized, have greater specificity, sensitivity or predictive value and/or are cheaper than our technology, we may be unable to compete successfully with such products which would have a material adverse effect on our business, financial condition and results of operations.

Furthermore, as the industry continues to expand and evolve, an increasing number of competitors and potential competitors may enter the market.  Many of these competitors and potential competitors have substantially greater financial, technological, managerial and research and development resources and experience than we do.  Some of these competitors and potential competitors have more experience than we do in the development of diagnostic products, including validation procedures and regulatory matters.  In addition, CchekÔCchek™ will compete with product offerings from large and well established companies that have greater marketing and sales experience and capabilities than we do.  If we are unable to compete successfully, we may be unable to sustain and grow our revenue.

We are dependent upon a few key personnel and the loss of their services could adversely affect us.

Our future success of developing CchekÔCchek™ will depend on the efforts of the inventor of the technology, our President and Chief Executive Officer Dr. Amit Kumar.  We do not have an employment agreement with Dr. Kumar which means that Dr. Kumar does not have a set term of employment and may renegotiate his employment arrangement with the Company at any time.  Further, we do not maintain “key person” life insurance on Dr. Kumar.  The loss of the services of Dr. Kumar could have a material adverse effect on our business and operating results.

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Risks Related to our CAR-T therapeuticsTherapeutics Business

Biopharmaceutical product development is a highly speculative undertaking and involves a substantial degree of uncertainty.  We have never generated any revenue from biopharmaceutical product sales and our biopharmaceutical products may never be profitable.

We are in the pre-clinical stage of developing our CAR-T therapeutics technology.therapeutic and breast cancer vaccine technologies.  Our ability to generate revenue depends in large part on our ability, alone or with partners, to successfully complete the development of, obtain the necessary regulatory approvals for, and commercialize, product candidates.  We do not anticipate generating revenues from sales of such products for the foreseeable future.  Our ability to generate future revenues from product sales of our CAR-T therapeutics technologytherapeutic and breast cancer vaccine technologies depends heavily on our success in:

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·         progressing our pre-clinical programs into human clinical trials;

·         completing requisite clinical trials through all phases of clinical development of our ovarian cancer therapy and other potential CAR-T product candidates;candidates and our breast cancer vaccine;

·         seeking and obtaining marketing approvals for our ovarian cancer therapy and other potential CAR-T product candidates and out breast cancer vaccine that successfully complete clinical trials, if any;

·         launching and commercializing our ovarian cancer therapy and other potential CAR-T product candidates and our breast cancer vaccine for which we obtain marketing approval, if any, with a partner or, if launched independently, successfully establishing a manufacturing, sales force, marketing and distribution infrastructure;

·         identifying and developing new CAR-T product candidates;

·         establishing and maintaining supply and manufacturing relationships with third parties;

·         maintaining, protecting, expanding and enforcing our intellectual property; and

·         attracting, hiring and retaining qualified personnel.

Because of the numerous risks and uncertainties associated with biologic product development, we are unable to predict the likelihood or timing for when we may receive regulatory approval of our ovarian cancer therapy and any other potential CAR-T product candidates and our breast cancer vaccine or when we will be able to achieve or maintain profitability, if ever.  If we are unable to establish a development and or commercialization partnership, or do not receive regulatory approvals, our business, prospects, financial condition and results of operations will be adversely affected.  Even if we or a partner obtain the regulatory approvals to market and sell one or more of our product candidates, we may never generate significant revenues from any commercial sales for several reasons, including because the market for our products may be smaller than we anticipate, or products may not be adopted by physicians and payors or because our products may not be as efficacious or safe as other treatment options.  If we fail to successfully commercialize one or more products, by ourselves or through a partner, we may be unable to generate sufficient revenues to sustain and grow our business and our business, prospects, financial condition and results of operations will be adversely affected.  

Cancer vaccines are novel and present significant challenges.

The development of preventive and therapeutic cancer vaccines is difficult, with very few cancer vaccines successfully reaching the market.  The only vaccines shown to be effective in preventing cancer have been vaccines against cancer causing agents, not the cancer itself.  Vaccines work by exposing a benign form of a disease agent to an individual’s immune system.  The immune system identifies the agent and learns to attack and destroy it, retaining a memory of the agent so the immune system knows to react quickly if an individual is exposed to the disease agent months or years later.  Most vaccines attack pathogens, such as viruses and bacteria.  The immune system is better able to assail these agents because they come from outside the body.  Cancer, however, is caused by aberrant cells that arise out of our resident cells, which can make it difficult for our immune system to find the diseased cells, especially as advancing age weakens our immune system.  Once these aberrant cells gain critical mass, they become cancer.

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CAR-T cell therapies are novel and present significant challenges.

CAR-T product candidates represent a relatively new field of cellular immunotherapy.  Advancing this novel and personalized therapy creates significant challenges for us, or a partner, including:

·         obtaining regulatory approval, as the FDA and other regulatory authorities have limited experience with commercial development of T-cell therapies for cancer;

·         sourcing clinical and, if approved, commercial supplies for the materials used to manufacture and process our product candidates;

·         developing a consistent and reliable process, while limiting contamination risks, for engineering and manufacturing T cells ex vivo and infusing the engineered T cells into the patient;

·         educating medical personnel regarding the potential safety benefits, as well as the challenges, of incorporating our product candidates into their treatment regimens;

·         establishing sales and marketing capabilities upon obtaining any regulatory approval to gain market acceptance of a novel therapy; and

·         the availability of coverage and adequate reimbursement from third-party payors for our novel and personalized therapy.

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Our inability to successfully develop CAR-T cell therapies or develop processes related to the manufacture, sales and marketing of these therapies would adversely affect our business, results of operations and prospects.

While CAR-T technology has shown positive results in B-cell cancers by others, its safety and efficacy has not been seen in solid tumors and we cannot guarantee our CAR-T technology will be safe or effective in ovarian cancer.or other cancers.

CAR-T therapies function through the binding of a genetically engineered killer T-cell to a cancer cell.  However, these engineered T-cells destroy the cell they are bound to whether it is a cancer cell or a healthy cell.  Therefore, the engineered T-cells must be designed to only bind to either cancer cells or other target cells to minimize toxicity.  Our CAR-T technology relies on the natural affinity of FSH to FSH-Receptor.  Research by others has shown that in women the FSH-Receptor protein is found on ovary cells and generally in no other healthy tissue, and therefore, we engineer our T-cells with FSH.  However, as the research in this field is still new, we cannot guarantee that there is no FSH-Receptor on any other healthy tissue in the human body.

While both our CAR-T technology hasand our breast cancer vaccine have shown favorable results from in-vitro and in-vivo testing, including in large numbers of animals under the Good Laboratory Practice (“GLP”) conditions necessary for inclusion in an IND application, we cannot guarantee that these results will be sufficient for the FDA to allow us to commence human clinical trials.

While studies on each of our CAR-T ovarian cancer therapeutic and breast cancer vaccine have generated promising results in large numbers of mice under GLP conditions, and toxicity studies have been performed and have had favorable results, there can be no assurance that the FDA will find these results sufficient to allow us to commence testing of either of our ovarian cancer therapy or breast cancer vaccine in human patients.  If we are unable to commence human clinical trials for either or both of our product candidates, or if commencement of such trials is significantly delayed, we may be required to expend significant additional resources, which may not be available to us, and our business, prospects, financial condition and results of operations may be adversely affected.

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While pre-clinical testing of our ovarian cancer CAR-T therapy hasproduct candidates have been positive, we may experience unfavorable results once we commence human clinical trials.

We have not initiated clinical trials for our ovarian cancer therapy or our breast cancer vaccine and we may not be able to commence clinical trials on the time frames we expect.  As thisthese product candidate hascandidates have only been tested in animals, we face significant uncertainty regarding how effective and safe itthey will be in human patients and the results from preclinical studies may not be indicative of the results of clinical trials.  Preclinical and clinical data are often susceptible to varying interpretations and analyses, and many companies that have believed their product candidates performed satisfactorily in preclinical studies and clinical trials have nonetheless failed to obtain marketing approval for their products.

Even if clinical trials are successfully completed, the FDA or foreign regulatory authorities may not interpret the results as we do, and more clinical trials could be required before we submit our product candidates for approval.  To the extent that the results of our clinical trials are not satisfactory to the FDA or foreign regulatory authorities for support of a marketing application, approval of our product candidates may be significantly delayed, or we may be required to expend significant additional resources, which may not be available to us, to conduct additional clinical trials in support of potential approval of our product candidates.

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We are dependent on third parties to conduct our pre-clinical and clinical trials.

We depend and will continue to depend upon independent investigators and collaborators, such as universities, medical institutions, and strategic partners such as Moffitt is performingfor our CAR-T therapy and Cleveland Clinic for our breast cancer vaccine to conduct our preclinical and clinical trials under agreements with us.  Negotiations of budgets and contracts with study sites may result in delays to our development timelines and increased costs.  We will rely heavily on these third parties over the necessary pre-clinical studies to file an IND application to begin human clinical testingcourse of our ovarian cancer therapeuticclinical trials, and we control only certain aspects of their activities.  Nevertheless, we are responsible for ensuring that each of our studies is conducted in accordance with applicable protocol, legal, regulatory and scientific standards, and our reliance on third parties does not relieve us of our regulatory responsibilities.  We and these third parties are required to comply with current good clinical practices, or cGCPs, which are regulations and guidelines enforced by the FDA and comparable foreign regulatory authorities for product candidates in clinical development.  Regulatory authorities enforce these cGCPs through periodic inspections of clinical trial sponsors, principal investigators and clinical trial sites.  If we or any of these third parties fail to comply with applicable cGCP regulations, the clinical data generated in our clinical trials may be deemed unreliable and the FDA or comparable foreign regulatory authorities could require us to perform additional clinical trials before approving our marketing applications.  It is possible that, upon inspection, such regulatory authorities could determine that any of our clinical trials fail to comply with the cGCP regulations.  In addition, our clinical trials must be conducted with biologic product produced under current good manufacturing practices, or cGMPs, and will performrequire a large number of test patients.  Our failure or any failure by these third parties to comply with these regulations or to recruit a sufficient number of patients may require us to repeat clinical trials, which would delay the regulatory approval process.  Moreover, our business may be implicated if any of these third parties violates federal or state fraud and abuse or false claims laws and regulations or healthcare privacy and security laws.

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Any third parties conducting our clinical trials are not and will not be our employees and, except for remedies available to us under our agreements with these third parties, we cannot control whether they devote sufficient time and resources to our ongoing preclinical, clinical and nonclinical programs.  These third parties may also have relationships with other commercial entities, including our competitors, for whom they may also be conducting clinical trials or other drug development activities, which could affect their performance on our behalf.  If these third parties do not successfully carry out their contractual duties or obligations or meet expected deadlines, if they need to be replaced or if the quality or accuracy of the clinical trials.  Unlessdata they obtain is compromised due to the failure to adhere to our clinical protocols or untilregulatory requirements or for other reasons, our clinical trials may be extended, delayed or terminated and we have an in-house scientific teammay not be able to performcomplete development of, obtain regulatory approval of or successfully commercialize our product candidates.  As a result, our financial results and manage these studies, we will remain reliant on Moffittthe commercial prospects for our product candidates would be harmed, our costs could increase and our ability to generate revenue could be delayed.

Switching or otheradding third parties for these services.to conduct our clinical trials involves substantial cost and requires extensive management time and focus.  In addition, there is a natural transition period when a new third party commences work.  As a result, delays occur, which can materially impact our ability to meet our desired clinical development timelines.

If we encounter difficulties enrolling patients in our clinical trial,trials, our clinical development activities could be delayed or otherwise adversely affected.

Even if we are permitted to conduct clinical trials for our product candidate,candidates, we may experience difficulties in patient enrollment in our clinical trialtrials for a variety of reasons.  The timely completion of clinical trials in accordance with their protocols depends, among other things, on our ability to enroll a sufficient number of patients who remain in the study until its conclusion.  The enrollment of patients depends on many factors, including:

·         the patient eligibility criteria defined in the clinical trial protocol;

·         the size of the patient population required for analysis of the trial’s primary endpoints;

·         the proximity of patients to the study site;

·         the design of the clinical trial;

·         our ability to retain clinical trial investigators with the appropriate competencies and experience;

·         our ability to obtain and maintain patient consents;

·         the risk that patients enrolled in clinical trials will drop out of the clinical trials before completion; and

·         competing clinical trials and approved therapies available for patients.

In particular, our CAR-T ovarian cancer clinical trial will look to enroll patients with late stage ovarian cancer who have failed conventional treatment.  treatment, and are willing and able to be treated at Moffitt.  Our first breast cancer vaccine clinical trial will look to enroll patients who have undergone standard of care treatment for TNBC.  Our second breast cancer vaccine clinical trial will look to enroll healthy women who, as a result of testing positive for the BRCA1 gene mutation which is a leading predictor of future incidence of breast cancer, have elected to have prophylactic mastectomies.  These potential trial participants have to be willing and able to undergo treatment at the Cleveland Clinic.

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Our clinical trialtrials will compete with other companies' clinical trials for product candidates that are in the same therapeutic areaareas as our product candidate,candidates, and this competition will reduce the number and types of patients available to us, because some patients who might have opted to enroll in our clinical trialtrials may instead opt to enroll in a trial being conducted by one of our competitors.  We expect to conduct our clinical trialtrials at the same clinical trial sitesites that some of our competitors may use, which will reduce the number of patients who are available for our clinical trial in thisthese clinical trial site.sites.  Moreover, because our product candidate representscandidates represent a departure from more commonly used methods for cancer treatment, potential patients and their doctors may be inclined to use experimental therapies that use conventional technologies, such as chemotherapy and antibody therapy, rather than enroll patients in our future clinical trial.trials.  Patients may also be unwilling to participate in our clinical trialtrials because of negative publicity from adverse events in the biotechnology or gene therapy industries.

Additionally, due to the design of our breast cancer vaccine trials it is unlikely that any of the trial participants will experience a positive therapeutic effect which may further reduce the number of patients who may enroll in our trials.

Delays in patient enrollment may result in increased costs or may affect the timing or outcome of our planned clinical trial,trials, which could prevent completion of the clinical trialtrials and adversely affect our ability to advance the development of our ovarian cancer CAR-T therapy.

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Any adverse developments that occur during any clinical trials conducted by academic investigators, our collaborators or other entities conducting clinical trials under independent INDs may negatively affect the conduct of our clinical trialtrials or our ability to obtain regulatory approvalapprovals or commercialize our product candidate.candidates.

CAR-T, vaccines and other immuno-therapy technologies are being used by third parties in clinical trials for which we are collaborating or in clinical trials which are completely independent of our development programs.  We have little to no control over the conduct of those clinical trials.  If serious adverse events occur during these or any other clinical trials using technologies similar to ours, the FDA and other regulatory authorities may delay our clinical trial, or could delay, limit or deny approval of our product candidatecandidates or require us to conduct additional clinical trials as a condition to marketing approval, which would increase our costs.  If we receive regulatory approval for any product candidate and a new and serious safety issue is identified in connection with clinical trials conducted by third parties, the applicable regulatory authorities may withdraw their approval of the productour products or otherwise restrict our ability to market and sell our product.products. In addition, treating physicians may be less willing to administer our productproducts due to concerns over such adverse events, which would limit our ability to commercialize our product.products.

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Adverse side effects or other safety risks associated with our ovarian cancer therapyproduct candidates could cause us to suspend or discontinue clinical trials or delay or preclude approval.

In third party clinical trials involving CAR-T cell therapies, the most prominent acute toxicities included symptoms thought to be associated with the release of cytokines, such as fever, low blood pressure and kidney dysfunction.  Some patients also experienced toxicity of the central nervous system, such as confusion, cranial nerve dysfunction and speech impairment.  Adverse side effects attributed to CAR-T therapies were severe and life-threatening in some patients.  The life-threatening events were related to kidney dysfunction and toxicities of the central nervous system.system or other organ failure.  Severe and life-threatening toxicities occurred primarily in the first two weeks after cell infusion and generally resolved within three weeks.  In the past, several patients have also died in clinical trials by others involving CAR-T cells.

Side effects of our breast cancer vaccine may include mild effects such as injection site pain or irritation, or more severe side effects such as fever, inflammation, organ failure or other adverse effects. 

Undesirable side effects observed in our clinical trial,trials, whether or not they are caused by our product candidate,candidates, could result in the delay, suspension or termination of clinical trials, by the FDA or other regulatory authorities or us for a number of reasons.  In addition, because the patients who will be enrolled in our clinical trial aretrials may be suffering from a life-threatening disease and willmay often be suffering from multiple complicating conditions it may be difficult to accurately assess the relationship between our product candidate and adverse events experienced by very ill patients.  If we elect or are required to delay, suspend or terminate a clinical trialany of our ovarian cancer therapy,clinical trials, the commercial prospects of such therapy will be harmed and our ability to generate product revenues from such therapy will be delayed or eliminated.  In addition, serious adverse events observed in clinical trials could hinder or prevent market acceptance of the product candidate at issue.  Any of these occurrences may harm our business, prospects, financial condition and results of operations significantly.

Clinical trials are expensive, time-consuming and difficult to design and implement.

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Human clinical trials are expensive and difficult to design and implement, in part because they are subject to rigorous regulatory requirements.  Because our CAR-T ovarian cancer therapy is based on relatively new technology and engineered on a patient-by-patient basis, we expect that it will require extensive research and development and have substantial manufacturing and processing costs.  In addition, costs to treat patients with relapsed/refractory cancer and to treat potential side effects that may result from therapies such as our current and future product candidates can be significant.  Accordingly, our clinical trial costs are likely to be significantly higher than for more conventional therapeutic technologies or drug products.  In addition, our proposed personalized product candidates involve several complex and costly manufacturing and processing steps, the costs of which will be borne by us.  

In one of our planned breast cancer vaccine clinical trials, we will treat healthy women who, as a result of testing positive for the BRCA1 gene mutation, have elected to have prophylactic mastectomies.  Delivering an experimental treatment to a healthy individual is more complex and subject to more rigorous regulatory requirements and is more difficult to design and implement.  In addition, in future clinical trials we will need to determine efficacy of the breast cancer vaccine as a cancer prevention which will be a considerably more complex clinical trial and will have significantly greater costs.

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The costs of our clinical trials may increase if the FDA does not agree with our clinical development plans or requires us to conduct additional clinical trials to demonstrate the safety and efficacy of our product candidates.

We face significant competition from other biotechnology and pharmaceutical companies, and our operating results will suffer if we fail to compete effectively.

The biopharmaceutical industry is characterized by intense competition and rapid innovation.  Our competitors may be able to develop other compounds or drugs that are able to achieve similar or better results.  Our potential competitors include major multinational pharmaceutical companies, established biotechnology companies, specialty pharmaceutical companies and universities and other research institutions.  Many of our competitors have substantially greater financial, technical and other resources, such as larger research and development staff and experienced marketing and manufacturing organizations and well-established sales forces.  Smaller or early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large, established companies.  Mergers and acquisitions in the biotechnology and pharmaceutical industries may result in even more resources being concentrated in our competitors.  Competition may increase further as a result of advances in the commercial applicability of technologies and greater availability of capital for investment in these industries.  Our competitors, either alone or with collaborative partners, may succeed in developing, acquiring or licensing on an exclusive basis drug or biologic products that are more effective, safer, more easily commercialized or less costly than our product candidates or may develop proprietary technologies or secure patent protection that we may need for the development of our technologies and products.  

Cell-based therapies rely on the availability of specialty raw materials, which may not be available to us on acceptable terms or at all.

Gene-modified cell therapy manufacture requires many specialty raw materials, some of which are manufactured by small companies with limited resources and experience to support a commercial product.  Some suppliers typically support biomedical researchers or blood-based hospital businesses and may not have the capacity to support commercial products manufactured under cGMP by biopharmaceutical firms. The suppliers may be ill-equipped to support our needs, especially in non-routine circumstances like a FDA inspection or medical crisis, such as widespread contamination.  We also do not have commercial supply arrangements with many of these suppliers, and may not be able to contract with them on acceptable terms or at all.  Accordingly, we may experience delays in receiving key raw materials to support clinical or commercial manufacturing.

In addition, some raw materials are currently available from a single supplier, or a small number of suppliers.  We cannot be sure that these suppliers will remain in business, or that they will not be purchased by one of our competitors or another company that is not interested in continuing to produce these materials for our intended purpose.

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We may form or seek strategic alliances or enter into additional licensing arrangements in the future, and we may not realize the benefits of such alliances or licensing arrangements.

We may form or seek strategic alliances, create joint ventures or collaborations and enter into additional licensing arrangements with third parties that we believe will complement or augment our development and commercialization efforts with respect to our product candidates and any future product candidates that we may develop.  Any of these relationships may require us to incur non-recurring and other charges, increase our near and long-term expenditures, issue securities that dilute our existing stockholders or disrupt our management and business.  In addition, we face significant competition in seeking appropriate strategic partners and the negotiation process is time-consuming and complex.  Moreover, we may not be successful in our efforts to establish a strategic partnership or other alternative arrangements for our product candidates because they may be deemed to be at too early of a stage of development for collaborative effort and third parties may not view our product candidates as having the requisite potential to demonstrate safety and efficacy.  If we license products or businesses, we may not be able to realize the benefit of such transactions if we are unable to successfully integrate them with our existing operations and company culture.  It is possible that, following a strategic transaction or license, we may not achieve the revenue or specific net income that justifies such transaction.  Any delays in entering into new strategic partnership agreements related to our product candidates could delay the development and commercialization of our product candidates in certain geographies for certain indications, which would harm our business prospects, financial condition and results of operations.

The FDA regulatory approval process is lengthy and time-consuming, and we may experience significant delays in the clinical development and regulatory approval of our product candidates.

We have not previously submitted a Biologics License Application (“BLA”) to the FDA, or similar approval filings to other foreign authorities.  A BLA must include extensive preclinical and clinical data and supporting information to establish the product candidate’s safety, purity and potency for each desired indication.  It must also include significant information regarding the chemistry, manufacturing and controls for the product.  We expect the novel nature of our product candidates to create further challenges in obtaining regulatory approval.  For example, the FDA has limited experience with commercial development of T-cell therapies and vaccines for cancer.  The regulatory approval pathway for our product candidates may be uncertain, complex, expensive and lengthy, and approval may not be obtained.

We may also experience delays in completing planned clinical trials for a variety of reasons, including delays related to:

·         the availability of financial resources to commence and complete our planned clinical trials;

·         reaching agreement on acceptable terms with prospective clinical trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different clinical trial sites;

·         recruiting suitable patients to participate in a clinical trial;

·         having patients complete a clinical trial or return for post-treatment follow-up;

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·         clinical trial sites deviating from clinical trial protocol, failing to follow GCPs, or dropping out of a clinical trial;

·         adding new clinical trial sites; or

·         manufacturing sufficient quantities of qualified materials under cGMPs and applying them on a subject by subject basis for use in clinical trials.

Also, before a clinical trial can begin at an NIH-funded institution, that institution’s independent institutional review board, or IRB, and its Institutional Biosafety Committee must review the proposed clinical trial to assess the safety of the trial.  In addition, adverse developments in clinical trials of gene therapy products conducted by others may cause the FDA or other regulatory bodies to change the requirements for approval of any of our product candidates.

We could also encounter delays if physicians encounter unresolved ethical issues associated with enrolling patients in clinical trials of our product candidates in lieu of prescribing existing treatments that have established safety and efficacy profiles.  Further, a clinical trial may be suspended or terminated by us, the IRBs for the institutions in which such clinical trials are being conducted, the Data Monitoring Committee for such clinical trial, or by the FDA or other regulatory authorities due to a number of factors, including failure to conduct the clinical trial in accordance with regulatory requirements or our clinical protocols, inspection of the clinical trial operations or clinical trial site by the FDA or other regulatory authorities resulting in the imposition of a clinical hold, unforeseen safety issues or adverse side effects, failure to demonstrate a benefit from using a product candidate, changes in governmental regulations or administrative actions or lack of adequate funding to continue the clinical trial.  If we experience termination of, or delays in the completion of, any clinical trial of our product candidates, the commercial prospects for our product candidates will be harmed, and our ability to generate product revenue will be delayed.  In addition, any delays in completing our clinical trials will increase our costs, slow down our product development and approval process and jeopardize our ability to commence product sales and generate revenue.

Many of the factors that cause, or lead to, a delay in the commencement or completion of clinical trials may ultimately lead to the denial of regulatory approval of our product candidates.

Even if we obtain regulatory approval of our product candidates, the products may not gain market acceptance among physicians, patients, hospitals, cancer treatment centers, third-party payors and others in the medical community.

The use of engineered T-cells as a potential cancer treatment and the use of therapeutic and prophylactic cancer vaccines are recently developed technologies and may not become broadly accepted by physicians, patients, hospitals, cancer treatment centers, third-party payors and others in the medical community.  Many factors will influence whether our product candidates are accepted in the market, including:

·         the clinical indications for which our product candidates are approved;

·         physicians, hospitals, cancer treatment centers and patients considering our product candidates as a safe and effective treatment;

·         the potential and perceived advantages of our product candidates over alternative treatments;

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·         the prevalence and severity of any side effects;

·         product labeling or product insert requirements of the FDA or other regulatory authorities;

·         limitations or warnings contained in the labeling approved by the FDA or other regulatory authorities;

·         the extent and quality of the clinical evidence supporting the efficacy and safety of our product candidates;

·         the timing of market introduction of our product candidates as well as competitive products;

·         the cost of treatment in relation to alternative treatments;

·         the availability of adequate reimbursement and pricing by third-party payors and government authorities;

·         the willingness and ability of patients to pay out-of-pocket in the absence of coverage by third-party payors, including government authorities;

·         relative convenience and ease of administration, including as compared to alternative treatments and competitive therapies; and

·         the effectiveness of our or any of our strategic partners’ sales and marketing efforts.

If our product candidates are approved but fail to achieve market acceptance among physicians, patients, hospitals, cancer treatment centers or others in the medical community, we will not be able to generate significant revenue.   Even if our products achieve market acceptance, we may not be able to maintain that market acceptance over time if new products or technologies are introduced that are more favorably received than our products, are more cost effective or render our products obsolete.

Risks Related to Our Intellectual Property

If we are unable to obtain and maintain intellectual property protection, our competitive position will be harmed.

Our ability to compete and to achieve sustained profitability will be impacted by our ability to protect our Cchek™ cancer diagnostic technologies, our CAR-T cancer therapeutics technologies, our breast cancer vaccine technologies and other proprietary discoveries and technologies.  We expect to rely on a combination of patent protection, copyrights, trademarks, trade secrets, know-how, and regulatory approvals to protect our technologies.  Our intellectual property strategy is intended to help develop and maintain our competitive position.  While we have been granted multiple patents related to our technologies, there is no assurance that we will be able to obtain further patent protection for our technologies or any other technologies, nor can we be certain that the steps we will have taken will prevent the misappropriation and unauthorized use of our technologies.  If we are not able to obtain and maintain patent protection our competitive position may be harmed.

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Third parties may initiate legal proceedings alleging that we are infringing their intellectual property rights, the outcome of which would be uncertain and could have a material adverse effect on the success of our business.

Our commercial success depends upon our ability to develop, manufacture, market and sell our Cchek™ cancer diagnostic technologies, our CAR-T therapeutics, our breast cancer vaccine and other proprietary discoveries and technologies without infringing, misappropriating or otherwise violating the proprietary rights or intellectual property of third parties.  We may become party to, or be threatened with, future adversarial proceedings or litigation regarding intellectual property rights with respect to our Cchek™ cancer diagnostic technologies, our CAR-T therapeutics, our breast cancer vaccine and other proprietary discoveries and technologies.  Third parties may assert infringement claims against us based on existing patents or patents that may be granted in the future.  If we are found to infringe a third-party's intellectual property rights, we could be required to obtain a license from such third-party to continue developing our Cchek™ cancer diagnostic technologies, our CAR-T therapeutics, our breast cancer vaccine and other proprietary discoveries and technologies.  However, we may not be able to obtain any required license on commercially reasonable terms or at all.  Even if we were able to obtain a license, it could be non-exclusive, thereby giving our competitors access to the same technologies licensed to us.  We could be forced, including by court order, to cease developing the infringing technology or product.  In addition, we could be found liable for monetary damages.  Claims that we have misappropriated the confidential information or trade secrets of third parties can have a similar negative impact on our business.

We rely on a licenselicenses from Wistar for our CAR-T technology and Cleveland Clinic for our breast cancer vaccine technology, and if we lose this licenseeither of these licenses we may be subjected to future litigation.

We are party to a royalty-bearing license agreementagreements that grantsgrant us rights to use certain intellectual property, including patents and patent applications.  We may need to obtain additional licenses from others to advance our research, development and commercialization activities.  Our license agreement imposes, and we expect that future license agreements if necessary will impose, various development, diligence, commercialization and other obligations on us.

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In spite of our efforts, our licensors might conclude that we have materially breached our obligations under such license agreements and might therefore terminate the license agreements, thereby removing or limiting our ability to develop and commercialize products and technology covered by these license agreements.  If these in-licenses are terminated, or if the underlying patents fail to provide the intended exclusivity, competitors or other third parties might have the freedom to seek regulatory approval of, and to market, products identical to ours and we may be required to cease our development and commercialization activities.  Any of the foregoing could have a material adverse effect on our competitive position, business, financial conditions, results of operations and prospects.

Moreover, disputes may arise with respect to any one of our licensing agreements, including:

·         the scope of rights granted under the license agreement and other interpretation-related issues;

·         the extent to which our product candidates, technology and processes infringe on intellectual property of the licensor that is not subject to the licensing agreement;

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·         the sublicensing of patent and other rights under the licensing agreement and our collaborative development relationships;

·         our diligence obligations under the license agreement and what activities satisfy those diligence obligations;

·         the inventorship and ownership of inventions and know-how resulting from the joint creation or use of intellectual property by our licensors and us and our partners; and

·         the priority of invention of patented technology.

If we do not prevail in such disputes, we may lose any of such license agreements.

In addition, the agreements under which we currently license intellectual property or technology from third parties are complex, and certain provisions in such agreements may be susceptible to multiple interpretations.  The resolution of any contract interpretation disagreement that may arise could narrow what we believe to be the scope of our rights to the relevant intellectual property or technology, or increase what we believe to be our financial or other obligations under the relevant agreement, either of which could have a material adverse effect on our business, financial condition, results of operations and prospects.  Moreover, if disputes over intellectual property that we have licensed prevent or impair our ability to maintain our current licensing arrangements on commercially acceptable terms, we may be unable to successfully develop and commercialize the affected product candidates, which could have a material adverse effect on our business, financial conditions, results of operations and prospects.

Our failure to maintain such licenses could have a material adverse effect on our business, financial condition and results of operations.  Any of these licenses could be terminated, such as if either party fails to abide by the terms of the license, or if the licensor fails to prevent infringement by third parties or if the licensed patents or other rights are found to be invalid or unenforceable.  Absent the license agreements, we may infringe patents subject to those agreements, and if the license agreements are terminated, we may be subject to litigation by the licensor.  Litigation could result in substantial costs and be a distraction to management.  If we do not prevail, we may be required to pay damages, including treble damages, attorneys’ fees, costs and expenses, royalties or, be enjoined from selling our products, which could adversely affect our ability to offer products, our ability to continue operations and our financial condition.

29If our efforts to protect the proprietary nature of our technologies are not adequate, we may not be able to compete effectively in our market.

Any disclosure to or misappropriation by third parties of our confidential proprietary information could enable competitors to quickly duplicate or surpass our technological achievements, thus eroding our competitive position in our markets.  Certain intellectual property which is covered by our in-license agreements has been developed at academic institutions which have retained non-commercial rights to such intellectual property.

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Risks Related to Legacy Patent Licensing ActivitiesThere are several pending U.S. and foreign patent applications in our portfolio, and we anticipate additional patent applications will be filed both in the U.S. and in other countries, as appropriate.  However, we cannot predict:

In connection·         if and when patents will issue;

·         the degree and range of protection any issued patents will afford us against competitors including whether third parties will find ways to invalidate or otherwise circumvent our patents;

·         whether or not others will obtain patents claiming aspects similar to those covered by our patents and patent applications; or

·         whether we will need to initiate litigation or administrative proceedings which may be costly whether we win or lose.

Composition of matter patents for biological and pharmaceutical products are generally considered to be the strongest form of intellectual property.  We cannot be certain that the claims in our pending patent applications directed to compositions of matter for our product candidates will be considered patentable by the U.S. Patent and Trademark Office (the “USPTO”) or by patent offices in foreign countries, or that the claims in any of our issued patents will be considered valid by courts in the U.S. or foreign countries.  Method of use patents have claims directed to the use of a product for the specified method.  This type of patent does not prevent a competitor from making and marketing a product that is identical to our product for an indication that is outside the scope of the patented method.  Moreover, even if competitors do not actively promote their product for our targeted indications, physicians may prescribe these products “off-label.”  Although off-label prescriptions may infringe or contribute to the infringement of method of use patents, the practice is common and such infringement is difficult to prevent or prosecute.

The strength of patents in the biotechnology and pharmaceutical field involves complex legal and scientific questions and can be uncertain.  The patent applications that we own or in-license may fail to result in issued patents with claims that cover our legacyproduct candidates or uses thereof in the U.S. or in other foreign countries.  Even if the patents do successfully issue, third parties may challenge the validity, enforceability or scope thereof, which may result in such patents being narrowed, invalidated or held unenforceable.  Furthermore, even if they are unchallenged, patents in our portfolio may not adequately exclude third parties from practicing relevant technology or prevent others from designing around our claims.  If the breadth or strength of our intellectual property position with respect to our product candidates is threatened, it could dissuade companies from collaborating with us to develop, and threaten our ability to commercialize, our product candidates.  Further, if we encounter delays in our clinical trials, the period of time during which we could market our product candidates under patent licensing activities, weprotection would be reduced.  Since patent applications in the U.S. and most other countries are confidential for a period of time after filing, it is possible that patent applications in our portfolio may not be ablethe first filed patent applications related to licenseour product candidates.  Furthermore, for U.S. applications in which all claims are entitled to a priority date before March 16, 2013, an interference proceeding can be provoked by a third-party or instituted by the USPTO, to determine who was the first to invent any of the subject matter covered by the patent claims of our applications.  For U.S. applications containing a claim not entitled to priority before March 16, 2013, there is a greater level of uncertainty in the patent law with the passage of the America Invents Act (2012) which brings into effect significant changes to the U.S. patent laws that are yet untried and untested, and which introduces new procedures for challenging pending patent applications and issued patents.  A primary change under this reform is the creation of a “first to file” system in the U.S.  This will require us to be cognizant going forward of the time from invention to filing of a patent application.

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Obtaining and maintaining our patents depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent portfolios which may have an adverse impact on our future operations.position could be reduced or eliminated for non-compliance with these requirements.

We may generate revenuesPeriodic maintenance fees on any issued patent are due to be paid to the USPTO and related cash flows fromforeign patent agencies in several stages over the licensinglifetime of the patent.  The USPTO and enforcementvarious foreign governmental patent agencies require compliance with a number of procedural, documentary, fee payment and other similar provisions during the patent application process.  While an inadvertent lapse can in many cases be cured by payment of a late fee or by other means in accordance with the applicable rules, there are situations in which noncompliance can result in abandonment or lapse of the patent or patent application, resulting in partial or complete loss of patent rights in the relevant jurisdiction.  Noncompliance events that could result in abandonment or lapse of a patent or patent application include, but are not limited to, failure to respond to official actions within prescribed time limits, non-payment of fees and failure to properly legalize and submit formal documents.  Such noncompliance events are outside of our direct control for (1) non-U.S. patents that we currently own and from the rightspatent applications owned by us, and (2) patents and patent applications licensed to license and enforce additional patents we have obtained from third parties.  However, we can give no assurances that we willus by another entity.  In such an event, our competitors might be able to identify opportunities to exploit such patents or that such opportunities, even if identified, will generate sufficient revenues to sustain future operations.

We, in certain circumstances, rely on representations, warranties and opinions made by third parties that, if determined to be false or inaccurate, may expose us to certain material liabilities.

From time to time, we may rely uponenter the opinions of purported experts.  In certain instances, we may not have the opportunity to independently investigate and verify the facts uponmarket, which such opinions are made.  By relying on these opinions, we may be exposed to liabilities in connection with the licensing and enforcement of certain patents and patent rights which couldwould have a material adverse effect on our operating results and financial condition.business.

In connection with patent licensing activities conducted by certain ofIssued patents covering our subsidiaries, aproduct candidates could be found invalid or unenforceable if challenged in court that has ruled unfavorably against us may also impose sanctions or award attorney’s fees, exposing us and our operating subsidiaries to certain material liabilities.the USPTO.

If we or one of our licensing partners initiate legal proceedings against a third party to enforce a patent covering one of our product candidates, the defendant could counterclaim that the patent covering our product candidate, as applicable, is invalid and/or unenforceable.  In connectionpatent litigation in the U.S., defendant counterclaims alleging invalidity and/or unenforceability are commonplace, and there are numerous grounds upon which a third party can assert invalidity or unenforceability of a patent.  Third parties may also raise similar claims before administrative bodies in the U.S. or abroad, even outside the context of litigation.  Such mechanisms include re-examination, post grant review, and equivalent proceedings in foreign jurisdictions, for example, opposition proceedings.  Any such proceedings could result in revocation or amendment to our patents in such a way that they no longer cover our product candidates.  The outcome following legal assertions of invalidity and unenforceability is unpredictable.  With respect to the validity question, for example, we cannot be certain that there is no invalidating prior art and that prior art that was cited during prosecution, but not relied on by the patent examiner, will not be revisited.  If a defendant were to prevail on a legal assertion of invalidity and/or unenforceability, we would lose at least part, and perhaps all, of the patents directed to our product candidates.  A loss of patent rights could have a material adverse impact on our business.

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Changes in U.S. patent law could diminish the value of patents in general, thereby impairing our ability to protect our products.

As is the case with other biopharmaceutical companies, our success is heavily dependent on intellectual property, particularly patents.  Obtaining and enforcing patents in the biopharmaceutical industry involve both technological and legal complexity, and is therefore costly, time-consuming and inherently uncertain.  In addition, the U.S. has recently enacted and is currently implementing wide-ranging patent reform legislation.  Recent U.S. Supreme Court rulings have narrowed the scope of patent protection available in certain circumstances and weakened the rights of patent owners in certain situations.  In addition to increasing uncertainty with regard to our ability to obtain patents in the future, this combination of events has created uncertainty with respect to the value of patents, once obtained.  Depending on decisions by the U.S. Congress, the federal courts, and the USPTO, the laws and regulations governing patents could change in unpredictable ways that would weaken our ability to obtain new patents or to enforce our existing patents and patents that we might obtain in the future.  For example, in the recent case, Assoc. for Molecular Pathology v. Myriad Genetics, Inc., the U.S. Supreme Court held that certain claims to DNA molecules are not patentable.  While we do not believe that any of the patents owned or licensed by us will be found invalid based on this decision, we cannot predict how future decisions by the courts, the U.S. Congress or the USPTO may impact the value of our patents.

We have limited foreign intellectual property rights and may not be able to protect our intellectual property rights throughout the world.

We have limited intellectual property rights outside the U.S.  Filing, prosecuting and defending patents on product candidates in all countries throughout the world would be prohibitively expensive, and our intellectual property rights in some countries outside the U.S. can be less extensive than those in the U.S.  In addition, the laws of some foreign countries do not protect intellectual property to the same extent as federal and state laws in the U.S.  Consequently, we may not be able to prevent third parties from practicing our inventions in all countries outside the U.S., or from selling or importing products made using our inventions in and into the U.S. or other jurisdictions.  Competitors may use our technologies in jurisdictions where we have not obtained patents to develop their own products and further, may export otherwise infringing products to territories where we have patents, but enforcement is not as strong as that in the U.S.  These products may compete with our products and our patents or other intellectual property rights may not be effective or sufficient to prevent them from competing.

Many companies have encountered significant problems in protecting and defending intellectual property in foreign jurisdictions.  The legal systems of certain countries, particularly China and certain other developing countries, do not favor the enforcement of patents, trade secrets and other intellectual property, particularly those relating to biopharmaceutical products, which could make it difficult for us to stop the infringement of our patents or marketing of competing products in violation of our proprietary rights generally.  To date, we have not sought to enforce any issued patents in these foreign jurisdictions.  Proceedings to enforce our patent licensing activities, it is possiblerights in foreign jurisdictions could result in substantial costs and divert our efforts and attention from other aspects of our business, could put our patents at risk of being invalidated or interpreted narrowly and our patent applications at risk of not issuing and could provoke third parties to assert claims against us.  We may not prevail in any lawsuits that a court that has ruled against uswe initiate, and the damages or other remedies awarded, if any, may also impose sanctionsnot be commercially meaningful.  The requirements for patentability may differ in certain countries, particularly developing countries.  Furthermore, generic drug manufacturers or award attorney’s fees to defendants, exposingother competitors may challenge the scope, validity or enforceability of our or our licensors’ patents, requiring us or our operating subsidiarieslicensors to material liabilities,engage in complex, lengthy and costly litigation or other proceedings.  Certain countries in Europe and developing countries, including China and India, have compulsory licensing laws under which a patent owner may be compelled to grant licenses to third parties.  In those countries, we and our licensors may have limited remedies if patents are infringed or if we or our licensors are compelled to grant a license to a third party, which could materially harmdiminish the value of those patents.  This could limit our operating resultspotential revenue opportunities.  Accordingly, our efforts to enforce our intellectual property rights around the world may be inadequate to obtain a significant commercial advantage from the intellectual property that we develop or license.

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We may be subject to claims that our employees, consultants or independent contractors have wrongfully used or disclosed confidential information of third parties.

We have received confidential and proprietary information from third parties.  In addition, we employ individuals who were previously employed at other biotechnology or pharmaceutical companies.  We may be subject to claims that we or our financial condition.employees, consultants or independent contractors have inadvertently or otherwise used or disclosed confidential information of these third parties or our employees’ former employers.  Litigation may be necessary to defend against these claims.  Even if we are successful in defending against these claims, litigation could result in substantial cost and be a distraction to our management and employees.

Risks Related to Our Common Stock

The issuance or sale of shares in the future to raise money or for strategic purposes could reduce the market price of our common stock.

In the future, we may issue securities to raise cash for operations, to pay down then existing indebtedness, as consideration for the acquisition of assets, as consideration for receipt of goods or services, to pay for the development of our CchekÔCchek™ platform, to pay for the development of our CAR-T cancer therapeutics, to pay for the development of our breast cancer vaccine and for acquisitions of companies.  We have an at-the-market equity offering under which we may issue up to $50 million of common stock, which is currently effective and under which we commenced selling shares in November 2019, and which may remain available to us in the future.  We have and in the future may issue securities convertible into our common stock.  Any of these events may dilute stockholders' ownership interests in our company and have an adverse impact on the price of our common stock.

In addition, sales of a substantial amount of our common stock in the public market, or the perception that these sales may occur, could reduce the market price of our common stock.  This could also impair our ability to raise additional capital through the sale of our securities.

Any actual or anticipated sales of shares by our stockholders may cause the trading price of our common stock to decline.  The sale of a substantial number of shares of our common stock by our stockholders, or anticipation of such sales, could make it more difficult for us to sell equity or equity-related securities in the future at a time and at a price that we might otherwise wish to effect sales.

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Delaware law and our charter documents contain provisions that could discourage or prevent a potential takeover of our company that might otherwise result in our stockholders receiving a premium over the market price of their shares.

Provisions of Delaware General Corporation Law (“DGCL”) and our certificate of incorporation, as amended (the “Certificate of Incorporation”), and By-Laws could make the acquisition of our company by means of a tender offer, proxy contest or otherwise, and the removal of incumbent officers and directors, more difficult.  These provisions include:

·         Section 203 of the DGCL, which prohibits a merger with a 15%-or-greater stockholder, such as a party that has completed a successful tender offer, until three years after that party became a 15%-or-greater stockholder;

·         the authorization in our Certificate of Incorporation of undesignated preferred stock, which could be issued without stockholder approval in a manner designed to prevent or discourage a takeover;

·         provisions in our By-Laws establishing advance notice requirements for nominations for election to the board of directors or for proposing matters that can be acted on by stockholders at stockholder meetings; and

·         provisions in our By-Laws regarding stockholders' rights to call a special meeting of stockholders limit such rights to stockholders of record holding together at least 66 2/3% of shares of the Company entitled to vote at the meeting, which could make it more difficult for stockholders to wage a proxy contest for control of our Board of Directors or to vote to repeal any of the anti-takeover provisions contained in our Certificate of Incorporation and By-Laws.

Together, these provisions may make the removal of management more difficult and may discourage transactions that could otherwise involve payment of a premium over prevailing market prices for our common stock.

We may fail to meet market expectations because of fluctuations in quarterly operating results, which could cause the price of our common stock to decline.

Our reported revenues and operating results have fluctuated in the past and may continue to fluctuate significantly from quarter to quarter in the future, specifically as we continue to devote more of our resources towards our CchekÔCchek™ diagnostic technology, and our CAR-T cancer therapeutics.therapeutics and our breast cancer vaccine.  It is possible that in future periods, we will have no revenue or, in any event, revenues could fall below the expectations of securities analysts or investors, which could cause the market price of our common stock to decline.  The following are among the factors that could cause our operating results to fluctuate significantly from period to period:

·         clinical trial results relating to our diagnostic technology;

·         pre-clinical testing results relatingadoption and reimbursement rates of our Cchek™ PCC test;

·         patient enrollment rates for our clinical trials;

·         delays with respect to our CAR-T cancer therapeutics;clinical trials;

·         clinical trial results relating to our CAR-T cancer therapeutics;

·         clinical trial results relating to our breast cancer vaccine;

·         progress with regulatory authorities towards the certification/approval of our diagnostic technology, or our CAR-T cancer therapeutics;therapeutics or our breast cancer vaccine;

·         costs related to acquisitions, alliances and licenses.

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Biotechnology company stock prices are especially volatile, and this volatility may depress the price of our common stock.

The stock market has experienced significant price and volume fluctuations, and the market prices of biotechnology companies have been highly volatile.  We believe that various factors may cause the market price of our common stock to fluctuate, perhaps substantially, including, among others, the following:

·         announcements of developments in the cancer diagnostic testing industry or in the fieldfields of CAR-T therapeutics;therapeutics or cancer vaccines;

·         developments in relationships with third party vendors and laboratories;

·        announcements of developments in our remaining patent enforcement actions;

·         developments or disputes concerning our patents and other intellectual property;

·         our or our competitors' technological innovations;

·         variations in our quarterly operating results;

·         our failure to meet or exceed securities analysts' expectations of our financial results;

·         a change in financial estimates or securities analysts' recommendations;

·         changes in management's or securities analysts' estimates of our financial performance;

·         announcements by us or our competitors of significant contracts, acquisitions, strategic partnerships, joint ventures, capital commitments, new technologies, or patents; and

·         the timing of or our failure to complete significant transactions.

In addition, we believe that fluctuations in our stock price during applicable periods can also be impacted by changes in governmental regulations in the diagnostic testing and drug development industries and/or court rulings and/or other developments in our remaining patent licensing and enforcement actions.  For example, if government regulators no longer allow for the use of diagnostic technology that has not been granted FDA approval (e.g. denying products that have only received CLIA certification), the time and cost to bring our technology to market will increase which will likely have an adverse impact on our stock price.

In the past, companies that have experienced volatility in the market price of their stock have been the objects of securities class action litigation.  If our common stock was the object of securities class action litigation due to volatility in the market price of our stock, it could result in substantial costs and a diversion of management's attention and resources, which could materially harm our business and financial results.

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Our common stock is currently listed on NASDAQ Capital Market, however if our common stock is delisted for any reason, it will become subject to the SEC’s penny stock rules which may make our shares more difficult to sell.

If our common stock is delisted from NASDAQ Capital Market, our common stock will then fit the definition of a penny stock and therefore would be subject to the rules adopted by the SEC regulating broker-dealer practices in connection with transactions in penny stocks.  The SEC rules may have the effect of reducing trading activity in our common stock making it more difficult for investors to sell their shares.  The SEC’s rules require a broker or dealer proposing to effect a transaction in a penny stock to deliver the customer a risk disclosure document that provides certain information prescribed by the SEC, including, but not limited to, the nature and level of risks in the penny stock market.  The broker or dealer must also disclose the aggregate amount of any compensation received or receivable by him in connection with such transaction prior to consummating the transaction.  In addition, the SEC’s rules also require a broker or dealer to make a special written determination that the penny stock is a suitable investment for the purchaser and receive the purchaser’s written agreement to the transaction before completion of the transaction.  The existence of the SEC’s rules may result in a lower trading volume of our common stock and lower trading prices.

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We have issued a significant number of securities pursuant to our incentive plans and may continue to do so in the future.  The vesting and, if applicable, exercise of these securities and the sale of the shares of common stock issuable thereunder may dilute your percentage ownership interest and may also result in downward pressure on the price of our common stock.

As of the date of this report, we have issued and outstanding options to purchase 7,405,8688,431,668 shares of our common stock with a weighted average exercise price of $2.75$3.30 and 1,500,000 restricted stock awards (including options to purchase 1,500,000 shares of our common stock and a restricted stock award of 1,500,000 shares of our common stock that vest based upon achievement of certain stock price based milestones issued to Dr. Kumar in May 2018).  Further, as of the date of this report, our Board of Directors and Compensation Committee have the authority to issue awards totaling an additional 2,800,000 shares of our common stock (not including any additional shares of common stock that will be available for issuance pursuant to the evergreen provisions in our 2010 Share Incentive Plan and our 2018 Share Incentive Plan on the first business day of the 2020 calendar year as described in more detail herein).stock.  Additionally, we have registered for resale all of the shares of common stock issuable under our incentive plans.  Because the market for our common stock is thinly traded, the sales and/or the perception that those sales may occur, could adversely affect the market price of our common stock.  Furthermore, the mere existence of a significant number of shares of common stock issuable upon vesting and, if applicable, exercise of these securities may be perceived by the market as having a potential dilutive effect, which could lead to a decrease in the price of our common stock.

U.S. federal income tax reform could adversely affect us and holders of our common stock.

On December 22, 2017, President Trump signed into law H.R. 1, originally known as the “Tax Cuts and Jobs Act,” which significantly reformed the Internal Revenue Code.  The new legislation, among other things, changes the U.S. federal tax rates, imposes significant additional limitations on the deductibility of interest, allows the expensing of capital expenditures, and puts into effect the migration from a “worldwide” system of taxation to a territorial system.  Additionally, the legislation imposes a reduction to the maximum deduction allowed for NOLs generated in tax years beginning after December 31, 2017, but allows such NOLs to be carried forward indefinitely.  We continue to examine the impact this tax reform legislation may have on us.  The impact of this tax reform, or of any future administrative guidance interpreting provisions thereof, on holders of our shares is uncertain and could be adverse.  This annual report does not discuss any such tax legislation or the manner in which it might affect holders of our shares.  We urge holders of our shares to consult with their legal and tax advisors with respect to any such legislation and the potential tax consequences of their ownership of our shares.

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We are a smaller reporting company and the reduced reporting requirements applicable to smaller reporting companies may make our common stock less attractive to investors.

We are a smaller reporting company (“SRC”) and a non-accelerated filer, which allows us to take advantage of exemptions from various reporting requirements that are applicable to other public companies that are not SRCs or non-accelerated filers, including not being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act of 2002, as amended, reduced disclosure obligations regarding executive compensation in our Annual Report and our periodic reports and proxy statements and providing only two years of audited financial statements in our Annual Report and our periodic reports.  We will remain an SRC until (a) the aggregate market value of our outstanding common stock held by non-affiliates as of the last business day our most recently completed second fiscal quarter exceeds $250 million or (b) (1) we have over $100 million in annual revenues and (2) the aggregate market value of our outstanding common stock held by non-affiliates as of the last business day our most recently completed second fiscal quarter exceeds $700 million.  We cannot predict whether investors will find our common stock less attractive if we rely on certain or all of these exemptions.  If some investors find our common stock less attractive as a result, there may be a less active trading market for our common stock and our stock price may be more volatile and may decline.

Changes in accounting rules, assumptions and/or judgments could materially and adversely affect us.

Accounting rules and interpretations for certain aspects of our operations are highly complex and involve significant assumptions and judgment.  These complexities could lead to a delay in the preparation and dissemination of our financial statements.  Furthermore, changes in accounting rules and interpretations or in our accounting assumptions and/or judgments, such as asset impairments, could significantly impact our financial statements.  In some cases, we could be required to apply a new or revised standard retroactively, resulting in restating prior period financial statements.  Any of these circumstances could have a material adverse effect on our business, prospects, liquidity, financial condition and results of operations.

We do not anticipate declaring any cash dividends on our common stock which may adversely impact the market price of our stock.

We have never declared or paid cash dividends on our common stock and do not plan to pay any cash dividends in the near future.  Our current policy is to retain all funds and any earnings for use in the operation and expansion of our business.  If we do not pay dividends, our stock may be less valuable to you because a return on your investment will only occur if our stock price appreciates.

If securities or industry analysts do not publish research or publish inaccurate or unfavorable research about our business, our stock price and trading volume could decline.

The trading market for our common stock depends in part on the research and reports that securities or industry analysts publish about us or our business.  In the event securities or industry analysts that cover us downgrade our stock or publish inaccurate or unfavorable research about our business, our stock price may decline.  If one or more of these analysts ceases coverage of us or fails to publish reports on us regularly, demand for our stock could decrease, which might cause our stock price and trading volume to decline.

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Item 1B.          Unresolved Staff Comments.

None.

Item 2.            Properties.

We lease approximately 2,000 square feet of office space at 3150 Almaden Expressway, San Jose, California (our principal executive offices) from an unrelated party pursuant to a lease that expires September 30, 2019.2021.  Our base rent is approximately $4,000$5,000 per month and the lease provides for annual increases of approximately 3% and an escalation clause for increases in certain operating costs. We also lease approximately 3,000 square feet of office space at 12100 Wilshire Boulevard, Los Angeles, California (our former executive offices) from an unrelated party pursuant to a lease that expires May 31, 2019.  We vacated this space during the fourth quarter of fiscal year 2017 and are currently subleasing the space to an unrelated party.  Our base rent is approximately $11,000 per month and the lease provides for annual increases of approximately 3% and an escalation clause for increases in certain operating costs.  Our sublease pays rent of approximately $4,000 per month and terminates at the expiration of our lease of the premises.

Item 3.Legal ProceedingsProceedings..

Other than as described below and lawsuits we bring to enforce our patent rights we are not a party to any material pending legal proceedings other than that which arise in the ordinary course of business.  We believe that any liability that may ultimately result from the resolution of these matters will not, individually or in the aggregate, have a material adverse effect on our financial position or results of operations.

On November 5, 2018, a putative shareholder derivative complaint was filed in the Court of Chancery of the State of Delaware, captioned Howland v. Kumar et al., C.A. No. 2018-0804-KSJM, that alleges claims for breach of fiduciary duty and unjust enrichment.  The complaint named as defendants certain of the Company’s current and former officers and directors, and the Company is named solely as a nominal defendant.  The complaint seeks, on behalf of the Company, a declaration that the defendant officers and directors breached their fiduciary duties, unspecified damages, certain changes to the Company’s internal procedures, and an award of the plaintiff’s attorneys’ fees and costs.  The defendants moved to dismiss the complaint on November 29, 2018 and the parties are currently engaged in briefing the motion. Due to the early nature of the complaint and that the complaint does not specify a dollar amount of damages, we cannot make a reasonable estimate of potential losses at this time.

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Item 4.            Mine Safety Disclosures.Disclosures.

Not applicable.

PART II

Item 5.            Market for the Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities.

Market Information

Our common stock trades on the NASDAQ Capital Market under the symbol “ANIX”. The high and low sales prices as reported by the NASDAQ Capital Market for each quarterly fiscal period during our fiscal years ended October 31, 2018 and 2017 is as follows: 

Holders

As of January 9, 2019,8, 2020, the approximate number of record holders of our common stock was 325337 and the closing price of our common stock was $3.90$3.00 per share.

Securities Authorized for Issuance Under Equity Compensation Plans

See “Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters.”

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Dividend Policy

No cash dividends have been paid on our common stock since our inception.  We have no present intention to pay any cash dividends in the foreseeable future.

Recent Sales of Unregistered Securities

The Company did not issue any unregistered securities during the three months ended October 31, 2018.2019.

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Item 6.            Selected Financial Data.Data.

            Not required for a smaller reporting company.

Item 7.            Management’s Discussion and Analysis of Financial Condition and Results of Operations.Operations.

General

In reviewing Management’s Discussion and Analysis of Financial Condition and Results of Operations, you should refer to our Consolidated Financial Statements and the notes related thereto.

Results of Operations

Fiscal Year ended October 31, 20182019 compared with Fiscal Year ended October 31, 20172018

Revenue

In fiscal year 2019, we recorded revenue of $250,000 from one license agreement.  In fiscal year 2018, we recorded revenue of approximately $1,113,000 from two license agreements.  In fiscal year 2017, we recorded revenue of approximately $363,000 from one license agreement.  TheThese license agreements each provided for a one-time, non-recurring, lump sum payment in exchange for non-exclusive retroactive and future licenses, and/or covenants not to sue.  Pursuant to the terms of these agreements, we have no further obligations with respect to the granted intellectual property rights, including no obligation to maintain or upgrade the technology, or provide future support or services.  Accordingly, the earnings processperformance obligations from these licenses was completewere satisfied and 100% of the revenue was recognized upon execution of the license agreement.  As discussed in Note 1 to our consolidated financial statements,Consolidated Financial Statements, as part of our legacy operations, the Company remains engaged in limited patent licensing activities which we do not expect to be a significant part of our ongoing operations or revenue.

Inventor Royalties, Contingent Legal Fees, Litigation and Licensing Expenses Related to Patent Assertion

Inventor royalties, contingent legal fees, litigation and licensing expenses related to patent assertion activities increaseddecreased by approximately $663,000$602,000 in fiscal year 2019, to approximately $166,000, from approximately $768,000 in fiscal year 2018 to approximately $768,000, from approximately $105,000 in fiscal year 2017..  The increasedecrease was primarily due to the increasedecrease in related revenues.  Inventor royalties and contingent legal fees are expensed in the period that the related revenues are recognized.  Litigation and licensing expenses related to patent assertion, other than contingent legal fees, are expensed in the period incurred.

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Amortization of Patents

Amortization of patents wasincreased by approximately $94,000 in fiscal year 2019, to approximately $419,000, from approximately $325,000 in fiscal years 2018 and 2017.year 2018.  We capitalize patent and patent rights acquisition costs and amortize the cost over the estimated economic useful life. The increase in amortization of patents was due to a reduction in the estimated economic useful life of capitalized patents.  During fiscal year 2018,2019, we did not capitalize any patents or patent rights.

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Research and Development Expenses

Research and development expenses are related to the development of our early cancer detectiondiagnostics and cancer immuno-therapy drug platformstherapeutics programs and increaseddecreased by approximately $5,215,000$1,340,000 to approximately $5,473,000 in fiscal year 2019, from approximately $6,813,000 in fiscal year 2018, from approximately $1,598,000 in fiscal year 2017.2018.  The increasedecrease in research and development expenses was primarily due to a decrease of approximately $1,410,000 in employee stock option compensation expense, a decrease in employee stock award compensation expense of approximately $351,000 and a decrease in license fees of approximately $190,000, offset by an increase in Certainty’s outside research and development expense, excluding license expense, primarily related to its collaboration agreement with Moffitt of approximately $344,000, an increase in Anixa Diagnostics’ outside research and development expense, excluding license expense, primarily related to its agreement with our development partner, ResearchDx, of approximately $193,000 and an increase in depreciation expense of approximately $30,000.  License fees in the fiscal year 2019 are related to our license agreement with Cleveland Clinic.  License fees in fiscal year 2018 are related to our license agreement with Wistar.

General and Administrative Expenses

General and administrative expenses decreased by approximately $1,249,000 to approximately $5,663,000 in fiscal year 2019, from approximately $6,912,000 in fiscal year 2018. The decrease in general and administrative expenses was principally due to a decrease in employee stock option compensation expense of approximately $2,593,000, the granting of an$747,000, a decrease in employee stock awardsaward compensation expense of approximately $1,602,000, the costs associated with the commencement of our collaboration with Moffitt for the development of our CAR-T ovarian cancer treatment$555,000, a decrease in consultant stock option expense of approximately $403,000,$137,000, a decrease in outside services of approximately $63,000, a decrease in investor and public relations expense of approximately $59,000 and a decrease in rent expense of approximately $54,000, offset by patent expense reimbursement to Cleveland Clinic of approximately $164,000, an increase in corporate insurance expense of approximately $140,000 primarily due to an increase in our directors and officers insurance premium and an increase in employee compensation and related costs, other than equity-based compensation, of approximately $381,000, the costs associated with our license from Wistar for our CAR-T technology of approximately $290,000 that we entered into during the fiscal year 2018 and an increase in stock option compensation expense for options granted to consultants, primarily members of our scientific advisory board, of approximately $114,000.$46,000.

General and Administrative Expenses50

General and administrative expenses increased by approximately $2,501,000 to approximately $6,912,000 in fiscal year 2018, from approximately $4,411,000 in fiscal year 2017.  The increase in general and administrative expenses was principally due to an increase in employee stock option compensation expenseTable of approximately $1,902,000, the granting of an employee stock award of approximately $1,258,000, an increase in legal and accounting fees of approximately $180,000 due primarily to our at-the-market equity programs, the defense of the Howland Matter, potential acquisitions and collaborative arrangements and the filing of registration statements, an increase in stock option compensation expense for options granted to consultants, primarily associated with strategic alliances, of approximately $147,000, offset by a decrease in board compensation expense of approximately $454,000 resulting from the fiscal year 2017 grant of shares of Company common stock to the independent directors, a decrease in employee compensation and related costs, other than equity-based compensation, of approximately $261,000 resulting primarily from the fiscal year 2017 severance arrangement with our former chief executive officer and a decrease in rent expense of approximately $115,000 resulting from the fiscal year 2017 relocation of our principal executive offices.

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Impairment in Carrying Amount of Patent Assets

The impairment in carrying amount of patent assets related to our legacy patent licensing activities of approximately $419,000 in the fiscal year ended 2019 resulted from the write down of the value of our patent assets to the estimated undiscounted future cash flows we anticipated receiving from the patent assets as of January 31, 2019 of approximately $168,000.The impairment in carrying amount of patent assets related to our legacy patent licensing activities of approximately $583,000 in the fiscal year 2018 resulted from the write down of the value of our patent assets to the estimated undiscounted future cash flows we anticipateanticipated receiving from the patent assets as of October 31, 2018.

Gain on Extinguishment of Patent Acquisition Obligation

The gain on extinguishment of patent acquisition obligation2018 of approximately $1,548,000 in fiscal year 2017 resulted from the difference in the carrying value$838,000.  Our estimates of future cash flows were based on our most recent assessment of the patent acquisition obligation andmarket for potential licensees, as well as the fair valuestatus of the shares of common stock issued to satisfy the obligation on the date of extinguishment.

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Interest Expense

Interest expense of approximately $500,000 in fiscal year 2017 resulted from a patent acquisition obligation which was extinguished in fiscal year 2017.  Accordingly, there was no interest expense recorded in fiscal year 2018.ongoing negotiations with potential licensees.

Interest Income

Interest income increased to approximately $71,000 in fiscal year 2019 compared to approximately $46,000 in fiscal year 2018, compared to approximately $19,000 in fiscal year 2017, due to an increase in funds available for short-term investments.

Net Loss Attributable to Noncontrolling Interest

The net loss attributable to noncontrolling interest, of approximately $247,000 in fiscal year 2018 representsrepresenting Wistar’s 5% ownership interest in Certainty’s net loss, for thedecreased by approximately $75,000 to approximately $172,000 in fiscal year.  Wistar’s interest in Certainty commencedyear 2019, from approximately $247,000 in fiscal year 2018, and accordingly, there was noas Certainty’s net loss attributabledecreased.  The decrease in Certainty’s net loss was primarily due to noncontrolling interestdecreases in fiscal year 2017.

Deemed Dividend to Preferred Stockholder

The deemed dividend to preferred stockholder of approximately $2,009,000 in fiscal year 2017 resulted from the redemption of our Series A preferred stock.  The difference between the fair value of the consideration given to the holder of our Series A preferredemployee stock option compensation expense and the carrying value of the Series A preferredemployee stock represented a return to the preferred stockholder and was treated in a similar manner as that of dividends paid on preferred stock.award compensation expense.

Liquidity and Capital Resources

Our primary sources of liquidity are cash, cash equivalents and short termshort-term investments.

Based on currently available information as of January 11, 2019,9, 2020, we believe that our existing cash, cash equivalents, short-term investments and expected cash flows will be sufficient to fund our activities for the next twelve months.  We have implemented a business model that conserves funds by collaborating with third parties to develop our technologies.  However, our projections of future cash needs and cash flows may differ from actual results.  If current cash on hand, cash equivalents, short term investments and cash that may be generated from our business operations are insufficient to continue to operate our business, (including for the defense of the Howland Matter), or if we elect to invest in or acquire a company or companies or new technology or technologies that are synergistic with or complimentarycomplementary to our technologies, we may be required to obtain more working capital.  During fiscal year 2018,2019, we raised approximately $2,470,000$5,527,000 through an at-the-market equity offering of 1,363,872 shares of common stock (as of October 31, 2019 an additional 112,238 shares were available for sale under our at-the-market equity program, which shares were sold in November 2019).  Further, we have an additional at-the-market equity offering under which we may issue up to $50 million of common stock, which is currently effective and under which we commenced selling shares in November 2019, and which may remain available forto us to use in the future.  We may seek to obtain working capital during our fiscal year 20192020 or thereafter through sales of our equity securities or through bank credit facilities or public or private debt from various financial institutions where possible.  We cannot be certain that additional funding will be available on acceptable terms, or at all.  If we do identify sources for additional funding, the sale of additional equity securities or convertible debt could result in dilution to our stockholders.  Additionally, the sale of equity securities or issuance of debt securities may be subject to certain security holder approvals or may result in the downward adjustment of the exercise or conversion price of our outstanding securities.  We can give no assurance that we will generate sufficient cash flows in the future to satisfy our liquidity requirements or sustain future operations, or that other sources of funding, such as sales of equity or debt, would be available or would be approved by our security holders, if needed, on favorable terms or at all.  If we fail to obtain additional working capital as and when needed, such failure could have a material adverse impact on our business, results of operations and financial condition.  Furthermore, such lack of funds may inhibit our ability to respond to competitive pressures or unanticipated capital needs, or may force us to reduce operating expenses, which would significantly harm the business and development of operations.operations.

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During the year ended October 31, 2018,2019, cash used in operating activities was approximately $4,273,000.$4,773,000.  Cash provided byused in investing activities was approximately $1,462,000,$525,000, resulting from the purchases of certificates of deposit totaling $3,850,000 and the purchase of property and equipment of approximately $175,000, which was offset by the proceeds on maturities of certificates of deposit totaling $5,750,000 which was offset by the purchases of certificates of deposit totaling $4,250,000 and the purchase of property and equipment of approximately $38,000.$3,500,000.  Cash provided by financing activities was approximately $2,528,000,$5,734,000, resulting from the sale of 1,363,872 shares of common stock in an at-the-market equity offering of approximately $2,470,000 and$5,527,000, the proceeds from exercise of stock options of approximately $58,000.$122,000, the proceeds from settlement of a shareholder derivative complaint of approximately $45,000 and the proceeds from the sale of common stock pursuant to employee stock purchase plan of approximately $39,000.  As a result, our cash, cash equivalents, and short-term investments at October 31, 2018 decreased2019 increased approximately $1,783,000$786,000 to approximately $5,056,000$5,842,000 from approximately $6,839,000$5,056,000 at the end of fiscal year 2017.2018.

Off-Balance Sheet Arrangements

We have no variable interest entities or other significant off-balance sheet obligation arrangements.

Critical Accounting Policies

The Company’s consolidated financial statements are prepared in conformity with accounting principles generally accepted in the United States of America.  In preparing these financial statements, we make assumptions, judgments and estimates that can have a significant impact on amounts reported in our consolidated financial statements.  We base our assumptions, judgments and estimates on historical experience and various other factors that we believe to be reasonable under the circumstances.  Actual results could differ materially from these estimates under different assumptions or conditions.  On a regular basis, we evaluate our assumptions, judgments and estimates and make changes accordingly.

We believe that, of the significant accounting policies discussed in Note 2 to our consolidated financial statements,Consolidated Financial Statements, the following accounting policies require our most difficult, subjective or complex judgments:

·        

• Revenue Recognition; and

• Stock-Based Compensation

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Revenue Recognition

Our revenue has been derived solely from technology licensing and the sale of patented technologies.  Revenue is recognized when (i) persuasive evidenceupon transfer of control of intellectual property rights and satisfaction of other contractual performance obligations to licensees in an arrangement exists, (ii) all obligations have been substantially performed pursuantamount that reflects the consideration we expect to the terms of the arrangement, (iii) amounts are fixed or determinable, and (iv) the collectability of amounts is reasonably assured.receive. 

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TableOn November 1, 2018 we adopted Accounting Standards Update 2014-09 (“ASU 2014-09”), Revenue from Contracts with Customers.  Upon adoption of ContentsASU 2014-09 we are required to make certain judgments and estimates in connection with the accounting for revenue.  Such areas may include determining the existence of a contract and identifying each party’s rights and obligations to transfer goods and services, identifying the performance obligations in the contract, determining the transaction price and allocating the transaction price to separate performance obligations, estimating the timing of satisfaction of performance obligations, determining whether a promise to grant a license is distinct from other promised goods or services and evaluating whether a license transfers to a customer at a point in time or over time.

Patent Licensing

In certain instances, our pastOur revenue arrangements have providedprovide for the payment of contractually determined, one-time, paid-up license fees in settlement of litigation and in consideration for the grant of certain intellectual property rights for patented technologies owned or controlled by the Company.  These arrangements typically include some combination of the following: (i) the grant of a non-exclusive, retroactive and future license to manufacture and/or sell products covered by patented technologies owned or controlled by the Company, (ii) a covenant-not-to-sue, (iii) the release of the licensee from certain claims, and (iv) the dismissal of any pending litigation.  In such instances, the intellectual property rights granted have been perpetual in nature, extending until the expiration of the related patents.  Pursuant to the terms of these agreements, management believes we have no further obligations.obligations with respect to the granted intellectual property rights, including no obligation to maintain or upgrade the technology, or provide future support or services.  Licensees obtained control of the intellectual property rights they have acquired upon execution of the agreement.  As such, the earnings process was determined to be completeperformance obligation is satisfied and revenue has beenis recognized upon the execution of the agreement, when collectability was reasonably assured, and when all other revenue recognition criteria were met.agreement.

Stock-Based Compensation

We accountThe compensation cost for service-based stock options and stock awards granted to employees and directors using the accounting guidance in ASC 718 and recognize compensation expense over the requisite or implied service period of is measured at the grant date, based on the grant date fair value.  For service-based stock options we usevalue of the award using the Black-Scholes pricing model, to estimate grant date fair value and foris expensed on a straight-line basis over the requisite service period (the vesting period of the stock awards that vest on date of grant we use grant date market value as fair value.option).  For stockemployee options and stock awards that vest based on market conditions, such asvesting if the trading price of the Company’s common stock exceedingexceeds certain price targets, we use a Monte Carlo Simulation in estimating the fair value.value at grant date and recognize compensation cost over the implied service period. 

During the years ended October 31, 2018 and 2017, we recorded stock-based compensation expense related to stock options granted to employees and directors of approximately $5,718,000 and $1,219,000, respectively, and stock based compensation expense related toFor stock awards granted to employees and directors of approximately $2,860,000 and $454,000, respectively.  As of October 31, 2018, we had unrecognized compensation costs of approximately $6,920,000 related to service-based stock options, approximately $375,000 related to market condition stock options and approximately $1,954,000 related to market condition stock awards granted to employees and directors, which will be recognized in future periods based on the service period of the grant.

We account for stock options and stock awards granted to consultants using the accounting guidance under ASC 505-50 and recognize compensation expense over the requisite or implied service period of the grant.  For service-based and performance-based stock options we use the Black-Scholes pricing model to estimate fair value at each reporting period and for stock awards that vest onat date of grant we userecognize expense based on the grant date market value as fair value.  Duringprice of the years ended October 31, 2018 and 2017 we recorded consulting expense related to stock options granted to consultants of approximately $261,000 and $3,000, respectively, and consulting expense related tounderlying common stock.  For restricted stock awards granted to consultantsvesting upon achievement of approximately $15,000a price target of our common stock we use a Monte Carlo Simulation in estimating the fair value at grant date and $32,000, respectively.  As of October 31, 2018, we had unrecognized consulting expense of approximately $249,000 related to service-based stock options granted to consultants, which will be recognized in future periods based onrecognize compensation cost over the implied service period of the grant.(median time to vest). 

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Determining the appropriate fair value model and calculatingOn November 1, 2018 we adopted Accounting Standards Update 2018-07 (“ASU 2018-027”) for stock-based compensation to non-employees.  Upon adoption of ASU 2018-07 we estimated the fair value of stock-basedunvested awards at the date of adoption, using the Black-Scholes pricing model.  Future grants to consultants will be measured at the grant date, based on the fair value of the award using the Black-Scholes pricing model, consistent with our policy for grants to employees and directors. 

The Black-Scholes pricing model and the Monte Carlo Simulation we use to estimate fair values requires judgment, including estimating stock pricevaluation assumptions of expected term, expected volatility, forfeiturerisk-free interest rates and expected dividend yield.  The expected term of stock options represents the weighted average period the stock options are expected to remain outstanding.  For employees we use the simplified method, which is a weighted average of the vesting term and contractual term, to determine expected term.  The simplified method was adopted since we do not believe that historical experience is representative of future performance because of the impact of the changes in our operations and the change in terms from historical options.  For consultants we use the contract term for expected term.  We estimate the expected volatility of our shares of common stock based upon the historical volatility of our share price over a period of time equal to the expected term of the grants.  We estimate the risk-free interest rate based on the implied yield available on the applicable grant date of a U.S. Treasury note with a term equal to the expected term of the underlying grants.  We made the dividend yield assumption based on our history of not paying dividends and our expectation not to pay dividends in the future. 

We will reconsider use of the Black-Scholes pricing model and Monte Carlo Simulation if additional information becomes available in the future that indicates other models would be more appropriate.  If factors change and we employ different assumptions in the application of ASC 718 and ASC 505-50 in future periods, the compensation expense that we record may differ significantly from what we have recorded in the current period.  See Note 2 to the consolidated financial statementsConsolidated Financial Statements for additional information.

Effect of Recent Accounting Pronouncements

We discuss the effect of recently issued pronouncements in Note 2 to the consolidated financial statements.Consolidated Financial Statements.

Item 7A.         Quantitative and Qualitative Disclosures About Market Risk.Risk.

Not required for a smaller reporting company.

Item 8.            Financial Statements and Supplementary Data.Data.

See accompanying “Index to Consolidated Financial Statements.”

Item 9.            Changes in and Disagreements With Accountants on Accounting and Financial Disclosure.Disclosure.

None.

Item 9A.         Controls and Procedures.Procedures.

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Disclosure Controls and Procedures

We maintain disclosure controls and procedures, as such term is defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act.  Under the supervision and with the participation of our management, including our President and Chief Executive Officer and our Chief Operating Officer and Chief Financial Officer, we evaluated the effectiveness of the design and operation of our disclosure controls and procedures pursuant to Rule 13a-15 and 15d-15 of the Exchange Act.  Based upon that evaluation, our President and Chief Executive Officer and our Chief Operating Officer and Chief Financial Officer concluded that our disclosure controls and procedures were effective as of the end of fiscal year 2018.2019.

Management’s Report on Internal Control Over Financial Reporting

Our management is responsible for establishing and maintaining adequate internal control over financial reporting as such term is defined in Rules 13a-15(f) and 15d-15(f) of the Exchange Act.  Our management, including the principal executive officer and principal financial officer, does not expect that our internal controls over financial reporting will prevent all errors and all fraud.  A control system, no matter how well designed and operated, cannot provide full assurance that the objectives of the control system are met, and no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, within a company have been detected.  Our internal control over financial reporting is designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of consolidated financial statements for external purposes in accordance with generally accepted accounting principles.

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Under the supervision and with the participation of our management, including the principal executive officer and principal financial officer, we conducted an evaluation as to the effectiveness of our internal control over financial reporting as of October 31, 2018.2019.  In making this assessment, our management used the criteria for effective internal control set forth by the Committee of Sponsoring Organizations of the Treadway Commission in the 2013 Internal Control – Integrated Framework.  Based on this assessment, our management concluded that our internal control over financial reporting was effective as of October 31, 2018.2019.

This Annual Report on Form 10-K does not include an attestation report of our independent registered public accounting firm regarding internal control over financial reporting.  Management’s report was not subject to attestation by the Company’s independent registered public accounting firm pursuant to a permanent exemption of the Commission that permits the Company to provide only management’s report in this Annual Report on Form 10-K.  Accordingly, our management’s assessment of the effectiveness of our internal control over financial reporting as of October 31, 20182019 has not been audited by our auditors, Haskell & White LLP.

Changes in Internal Control Over Financial Reporting

There were no changes in our internal control over financial reporting during the fourth quarter of fiscal year 20182019 that has materially affected, or is reasonably likely to materially affect, the Company’s internal control over financial reporting.

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Item 9B.          Other Information.Information.

None.At the Annual Meeting of Shareholders of the Company held on October 23, 2019, the Company’s shareholders voted on, among other matters, an advisory vote regarding the frequency of future advisory votes on named executive officer compensation.  The Company’s shareholders voted for an advisory vote on named executive officer compensation to be held every year, consistent with the recommendation of the Company’s Board of Directors.  In response to the voting results and other factors, the Company’s Board of Directors determined at a meeting held on December 12, 2019, that the Company will hold an advisory vote on named executive officer compensation every year.  The Company will continue to hold advisory votes on named executive officer compensation every year until the Company’s Board of Directors decides to hold the next shareholder advisory vote on the frequency of advisory votes, which shall be no later than the Company’s Annual Meeting of Shareholders in 2025.

On January 6, 2020, the Board of Directors of the Company confirmed its intention to hold the Company's 2020 Annual Meeting of Shareholders (the “2020 Annual Meeting”) on Wednesday, July 15, 2020.  The time and location of the 2020 Annual Meeting, and the matters to be considered, will be as set forth in the Company's definitive proxy statement for the 2020 Annual Meeting to be filed in due course with the SEC.

Since the date of the 2020 Annual Meeting has been changed by more than 30 days from the anniversary date of the Company’s last annual meeting of shareholders, the Company is informing shareholders of this change and the updated deadline for shareholders to submit nominations for director or proposals for consideration at the 2020 Annual Meeting in accordance with the rules and regulations of the SEC and the Company’s By-laws (as amended on January 6, 2020).  Accordingly, shareholders wishing to nominate a candidate for director or to propose other business at the 2020 Annual Meeting must ensure proper notice is received by the Company at its offices no later than May 11, 2020.  The notice must include all of the information required by the Company’s By-laws.  

On January 6, 2020, the Board of Directors of the Company approved an amendment to the Company’s By-laws to provide that if during the prior year the Company did not hold an annual meeting or if the date of the annual meeting was changed more than thirty (30) days from the anniversary of the prior year’s meeting, notice of a proposal to be included at an annual meeting must be delivered to or mailed and received at the principal executive offices of the Company a reasonable time before the Company begins to print and send its proxy materials to be timely. No other changes were made to the Company’s By-laws.