UNITEDSTATES

SECURITIESAND EXCHANGE COMMISSION

WASHINGTON,D.C. 20549

FORM10-K

or

Commissionfile number: 001-37492

ANIXABIOSCIENCES, INC.

(ExactName of Registrant as Specified in its Charter)

3150Almaden Expressway, Suite 250

SanJose, CA 95118

(408)708-9808

(Address,Including Zip Code, and Telephone Number, Including Area Code, of Registrant’s Principal Executive Offices)

Securitiesregistered pursuant to Section 12(b) of the Act:

Securitiesregistered pursuant to Section 12(g) of the Act:

None

Indicateby check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☐ No ☒

Indicateby check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes ☐ No ☒

Indicateby check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities ExchangeAct of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2)has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐

Indicateby check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrantwas required to submit such files). Yes ☒ No ☐

Indicateby check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reportingcompany or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,”“smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

Ifan emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complyingwith any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Indicateby check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectivenessof its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registeredpublic accounting firm that prepared or issued its audit report. ☐

Indicateby check mark whether the financial statements of the registrant included in the filing reflect the correction of an error to previouslyissued financial statements. ☐

Indicateby check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensationreceived by any of the registrant’s executive officers during the relevant recovery period pursuant to §240.10D-1(b). ☐

Indicateby check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act). Yes ☐ No ☒

Aggregatemarket value of the voting stock (which consists solely of shares of common stock) held by non-affiliates of the registrant as of April30, 2025 (the last business day of the registrant’s most recently completed second fiscal quarter), computed by reference to theclosing sale price of the registrant’s common stock on the NASDAQ on such date ($2.79): $85,116,394.

OnJanuary 12, 2026, the registrant had outstanding 33,376,690 shares of common stock, par value $0.01 per share, which is the registrant’sonly class of common stock.

DOCUMENTSINCORPORATED BY REFERENCE:

NONE

TABLEOF CONTENTS

CAUTIONARYSTATEMENT REGARDING FORWARD-LOOKING STATEMENTS

Informationincluded in this Annual Report on Form 10-K (this “Report”) contains forward-looking statements within the meaning of Section27A 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 ourcurrent expectations concerning future events and results. We generally use the words “believes,” “expects,”“intends,” “plans,” “anticipates,” “likely,” “will” and similar expressionsto 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-lookingstatements. These risks, uncertainties and factors include, but are not limited to, those factors set forth in this Report under “Item1A. – Risk Factors” below. Except as required by applicable law, including the securities laws of the United States, we undertakeno 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.

CERTAINTERMS USED IN THIS REPORT

Referencesin this Report to “we,” “us,” “our,” the “Company” or “Anixa” means AnixaBiosciences, Inc. unless otherwise indicated.

PARTI

Item1. Business

Overview

AnixaBiosciences, Inc. is a biotechnology company developing therapies and vaccines that are focused on critical unmet needs in oncology.Our therapeutics program consists of the development of liraltagene autoleucel (“lira-cel”), a chimeric endocrine receptor-Tcell therapy, which is a novel form of chimeric antigen receptor-T cell (“CAR-T”) technology, initially focused on treatingovarian cancer, that is being developed at our subsidiary, Certainty Therapeutics, Inc. (“Certainty”). Our vaccine programsinclude (i) the development of a vaccine against breast cancer, (ii) the development of a vaccine against ovarian cancer, and (iii) avaccine discovery program utilizing the same mechanism as our breast and ovarian cancer vaccines to develop additional cancer vaccinesto address many intractable cancers, including high incidence malignancies in lung, colon and prostate.

Oursubsidiary, Certainty, is developing immuno-therapy drugs against cancer. Certainty holds an exclusive worldwide, royalty-bearing licenseto use certain intellectual property owned or controlled by The Wistar Institute (“Wistar”), the nation’s first independentbiomedical research institute and a leading National Cancer Institute (“NCI”) designated cancer research center, relatingto Wistar’s chimeric endocrine receptor targeted therapy technology. We have initially focused on the development of a treatmentfor ovarian cancer, but we also may pursue 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 upon achievement of specific developmentmilestones. With respect to Certainty’s equity obligations to Wistar, Certainty issued to Wistar shares of its common stock equalto five percent (5%) of the common stock of Certainty, such equity stake is subject to dilution by further funding of Certainty’sactivities by the Company. Due to such Company funding, Wistar’s equity stake in Certainty was 4.1% as of October 31, 2025.

Certainty,in collaboration with the H. Lee Moffitt Cancer Center and Research Institute, Inc. (“Moffitt”), has begun human clinicaltesting of lira-cel, the CAR-T technology licensed by Certainty from Wistar aimed initially at treating ovarian cancer. After receivingauthorization from the U.S. Food and Drug Administration (“FDA”), we commenced enrollment of patients in a Phase 1 clinicaltrial and treated the first patient in August 2022. Further, in May 2023 and August 2023, we treated the second and third patients inthe trial, respectively, at the same dose level as the first patient, and the treatment was well-tolerated by the patients. Between Februaryand June 2024, we treated the three patients of the second dose cohort, where the patients were administered a three-times higher doseof cells than the patients in the first cohort. The treatment at this dose level was also well-tolerated by the patients. From November2024 to February 2025, we treated three patients in the third dose cohort, where they were administered a ten-times higher dose of cellsthan the patients in the first dose cohort. Consistent with the lower dose cohorts, the treatment was well-tolerated by the patients.Subsequently, we treated the patients in the fourth dose cohort, administering a 30-times higher dose of cells than the patients in thefirst dose cohort, and again the treatment appears to have been well-tolerated.

Whilethe dose levels in the first three cohorts were expected to be sub-therapeutic, multiple patients have exhibited anecdotal signs of efficacy,including possible signs of T cell infiltration and tumor necrosis. For example, many patients have survived beyond expectations, includingone patient that survived over two years past initial treatment and three other patients that survived over one year past treatment.In the case of the patient that survived over two years past initial treatment, due to the encouraging results with her initial treatment,we sought single patient Investigational New Drug (“IND”) application permission from the FDA to re-dose her. This re-dosingwas approved by the FDA, and we administered her second treatment in October 2024. This second treatment was well-tolerated by the patient.

Thisstudy is a dose-escalation trial with two arms based on route of delivery—intraperitoneal or intravenous—to determine themaximum tolerated dose in patients with recurrent epithelial ovarian cancer and to assess persistence, expansion and efficacy of themodified T cells. The study is being conducted at Moffitt and will consist of up to 24 to 48 patients who have received at least twoprior lines of chemotherapy. The study is estimated to be completed in two to three years depending on multiple factors including whenthe maximum tolerated dose is reached, the rate of patient enrollment, the significance of efficacy data and how long we maintain thetwo different delivery methods.

Wehold an exclusive worldwide, royalty-bearing license to use certain intellectual property owned or controlled by The Cleveland ClinicFoundation (“Cleveland Clinic”) relating to certain breast cancer vaccine technology developed at Cleveland Clinic. The licenseagreement requires us to make certain cash payments to Cleveland Clinic upon achievement of specific development milestones. Utilizingthis technology, we are working in collaboration with Cleveland Clinic to develop a method to vaccinate women against breast cancer,focused initially on triple-negative breast cancer (“TNBC”), the most lethal form of the disease. The focus of this vaccineis a specific protein, α-lactalbumin, that is only expressed during lactation in a healthy woman’s mammary tissue. This proteindisappears when the woman is no longer lactating, but reappears in many forms of breast cancer, especially TNBC. Studies have shown thatvaccinating against this protein prevents breast cancer in mice.

InOctober 2021, following the FDA’s authorization to proceed, we commenced dosing patients in a Phase 1 clinical trial of our breastcancer vaccine. This study, which has been fully funded by a U.S. Department of Defense grant to Cleveland Clinic, is a multiple-ascendingdose Phase 1 trial to determine the maximum tolerated dose (“MTD”) of the vaccine in patients with early-stage, triple-negativebreast cancer as well as monitor immune response. The study has been conducted at Cleveland Clinic. During the course of the Phase 1study, participants received three vaccinations, each two weeks apart, and have been closely monitored for side effects and immune response.The first patient cohort in the study, Cohort Ia, consisted of patients who had completed treatment for early-stage, triple-negativebreast cancer within the past three years and were currently tumor-free but at high risk for recurrence. Studies show that 42% of TNBCpatients will have a recurrence of their cancer, with most of the recurrences occurring in the first two to three years after standardof care treatment. In January 2023, the number of participants in each dose cohort was expanded, and as of August 2023, we had completedvaccinating all patients in these expanded cohorts. Subsequently, we began vaccinating participants in additional dose cohorts at varyingdose levels of the different key components of the vaccine. Further, in November 2023, we commenced vaccination of participants in thesecond patient cohort in the trial, Cohort Ib, that included participants who have never had cancer, but carry certain mutations in genessuch as BRCA1, BRCA2 or PALB2, that indicate a greater risk of developing TNBC in the future, and had elected to have a prophylacticmastectomy. Finally, in January 2024, we commenced vaccination of participants in the third patient cohort in the trial, Cohort Ic, thatincludes post-operative TNBC patients that have residual disease following treatment and are currently undergoing treatment with pembrolizumab(Keytruda®). In June 2025, we completed enrollment in the Phase 1 trial and in October 2025, we completed all patient clinical visits.

OnDecember 11, 2025, we presented the final data from the Phase 1 clinical trial of our investigational breast cancer vaccine at the SanAntonio Breast Cancer Symposium. The key results presented were that i) all primary study endpoints were met, ii) protocol defined immuneresponses were observed in 74% of the study subjects, iii) the vaccine was safe and well-tolerated by study participants at the MTD,with adverse events primarily injection-site irritation and iv) preliminary immunohistochemistry (IHC) of the subjects’ primarytumors for alpha-lactalbumin protein revealed a range of expression from absent to strong—analysis and correlation to immune responseand clinical outcomes is ongoing. Consenting participants will be followed for five years after completing the study. Combination ofKeytruda and the vaccine also generated antigen-specific T cell responses and showed no major additional side effect. The data from thePhase 1 trial will inform planned Phase 2 study design, including a potential Phase 2 combination study with Keytruda in the neoadjuvantsetting among newly diagnosed breast cancer patients.

ThePhase 1 study evaluated safety and monitored immune response to an investigational vaccine targeting α-lactalbumin. The trial enrolled35 participants across three cohorts: Cohort Ia (n=26), women who completed standard-of-care treatment, including surgery, for early-stageTNBC within three years and were tumor-free but at elevated risk of recurrence; Cohort Ib (n=4), cancer-free women with BRCA1, BRCA2,or PALB2 mutations who elected preventive mastectomy and were vaccinated prior to surgery; and Cohort Ic (n=5), women with TNBC receivingpembrolizumab (Keytruda) in the adjuvant (post-surgery) setting, with evaluation of safety of combination administration and immune responses.In Cohort Ia, at the MTD, the vaccine was reported as safe, with no flu-like symptoms (fever and myalgias), no abnormal clinical laboratorytests, and no other observed adverse side effects in this cohort; the primary notable adverse event was injection-site irritation. Participantsdemonstrated α-lactalbumin-specific T cell responses, including production of interferon gamma and interleukin-17. In Cohort Ib,safety and tolerability were similar to Cohort Ia. Immunohistochemistry analyses of resected breast tissue are ongoing and will be presentedin a future scientific presentation. In Cohort Ic, a key objective was to assess whether administration of the investigational vaccinein combination with pembrolizumab could create intolerable side effects. No major adverse side effects were reported; as in other cohorts,the primary adverse event was injection-site irritation. Two participants in Cohort Ic experienced Grade 3 adverse events consistingof greater irritation at an injection site.

Wehold an exclusive worldwide, royalty-bearing license to use certain intellectual property owned or controlled by Cleveland Clinic relatingto certain ovarian cancer vaccine technology. The license agreement requires us to make certain cash payments to Cleveland Clinic uponachievement of specific development milestones. This technology pertains to, among other things, the use of vaccines for the treatmentor prevention of ovarian cancers which express the anti-Mullerian hormone receptor 2 protein containing an extracellular domain (“AMHR2-ED”).In healthy tissue, this protein regulates growth and development of egg-containing follicles in the ovary. While expression of AMHR2-EDnaturally and markedly declines during menopause, this protein is expressed at high levels in the ovaries of postmenopausal women withovarian cancer. Researchers at Cleveland Clinic believe that a vaccine targeting AMHR2-ED could prevent the occurrence of ovarian cancer.

InMay 2021, Cleveland Clinic was granted acceptance for our ovarian cancer vaccine technology into the NCI’s PREVENT program. TheNCI is a part of the National Institutes of Health (“NIH”). The PREVENT program is a peer-reviewed agent development programdesigned to support pre-clinical development of innovative interventions and biomarkers for cancer prevention and interception towardsclinical trials. The scientific and financial resources of the PREVENT program are being used for our ovarian cancer vaccine technologyto perform virtually all pre-clinical research and development, manufacturing and IND enabling studies. This work is being performedat NCI facilities, by NCI scientific staff and with NCI financial resources and will require no material financial expenditures by theCompany, nor the payment of any future consideration by the Company to NCI.

InMay 2024, based on the positive clinical results to date in the development of our breast cancer vaccine, we entered into a Joint Developmentand Option Agreement with Cleveland Clinic to collaborate in efforts to develop additional vaccines for the prevention or treatment ofcancers. Working with Cleveland Clinic researchers, we are focusing on the same novel scientific mechanism as in our breast and ovariancancer vaccines, and working to discover additional retired proteins that may be associated with other forms of cancer, specificallyhigh incidence malignancies in the lung, colon and prostate.

Overthe next several quarters, we expect the development of our therapeutics and vaccines to be the primary focus of the Company. As partof our legacy operations, the Company remains engaged in limited patent licensing activities of its various patent portfolios. We donot expect these activities to be a significant part of the Company’s ongoing operations nor do we expect these activities to requirematerial financial resources or attention of senior management.

Overthe past several years, our revenue was derived from technology licensing and the sale of patented technologies, including revenue fromthe settlement of litigation. We have not generated any revenue to date from our therapeutics or vaccine programs. In addition, whilewe pursue our therapeutics and vaccine programs, we may also make investments in and form new companies to develop additional emergingtechnologies. We do not expect to begin generating revenue with respect to any of our current therapeutics or vaccine programs in thenear term. We hope to achieve a profitable outcome by eventually licensing our technologies to large pharmaceutical companies that havethe resources and infrastructure in place to manufacture, market and sell our technologies as therapeutics or vaccines. The eventuallicensing of any of our technologies may take several years, if it is to occur at all, and may depend on positive results from humanclinical trials.

CAR-Ttherapeutics

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

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

Studieshave shown that the FSH-Receptor is also expressed in endothelial cells of the vasculature of neoplasias. We anticipate performing furtherstudies to evaluate the ability of lira-cel to disrupt the vasculature of other cancers, after we have analyzed data from clinical trialsof this technology against ovarian cancer.

Wehave been working with researchers at Moffitt to develop lira-cel. Moffitt is one of the top cancer centers in the country with pre-clinicaland clinical expertise with CAR-T technology. Moffitt has conducted many of the highest profile CAR-T trials in the world.

InAugust 2022, Moffitt began treating patients in a Phase 1 clinical trial of lira-cel. While the results to date have been positive, thereare many uncertainties in drug development, and most drugs fail to reach commercialization. In the future, we hope to achieve a profitableoutcome by eventually licensing lira-cel to a large pharmaceutical company that has the resources and infrastructure in place to manufacture,market and sell lira-cel as a cancer treatment.

TheMarket

Webelieve that lira-cel may be used as an effective treatment against multiple solid tumor types, however, we have initially focused onovarian cancer. According to American Cancer Society statistics, in the U.S., ovarian cancer accounts for just 2% of all female cancercases, but over 4% of cancer deaths in women due to the disease’s low survival rate. It has been estimated that in 2025, approximately21,000 new cases of ovarian cancer would be diagnosed in the U.S. and approximately 13,000 women would die from this disease. Despitecontinuous advances made in the field of cancer research every year, there remains a significant unmet medical need, as the overall five-yearrelative survival rate for ovarian cancer patients is 51%, but ranges from 43% among Black women to 61% among Asian American/PacificIslander women, and ranges from 92% to 31% based on whether it is first diagnosed at a local stage or a distant stage, respectively.

Cancervaccines

Welicensed certain technology from Cleveland Clinic to develop vaccines for the treatment or prevention of TNBC and other breast cancerswhich express the α-lactalbumin protein. This protein is only expressed during lactation in healthy women, but may also be expressedin individuals with certain breast cancers, most notably TNBC, the most lethal form of breast cancer. Further, we have licensed certaintechnology from Cleveland Clinic to develop vaccines for the treatment or prevention of ovarian cancers which express AMHR2-ED. Thisprotein regulates growth and development of egg-containing follicles in the ovary and its expression naturally and markedly declinesafter menopause. However, AMHR2-ED is expressed at high levels in the ovaries of postmenopausal women with ovarian cancer. In addition,we have entered into a Joint Development and Option Agreement with Cleveland Clinic to collaborate in efforts to develop additional vaccinesfor the prevention or treatment of cancers. Working with Cleveland Clinic researchers, we are focusing on the same novel scientific mechanismas in our breast and ovarian cancer vaccines, and working to discover additional retired proteins that may be associated with other formsof cancer, specifically high incidence malignancies in the lung, colon and prostate.

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

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

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

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

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

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

Theovarian cancer vaccine technology licensed from Cleveland Clinic has identified the AMHR2-ED protein, the expression of which is involvedin egg production in the ovaries and is no longer expressed after menopause. AMHR2-ED is not meaningfully present on any other cell inthe body. However, it does appear in many cases of epithelial ovarian cancers, the most common type of ovarian cancer. By developinga vaccine that targets AMHR2-ED, we feel the immune system can destroy these ovarian cancer cells as they arise and ultimately preventtumors from forming. Data on this technology, including animal studies showing efficacy, was published in November 2017 in the journal,Cancer Prevention Research.

InDecember 2025, the final data from the recently completed Phase 1 clinical trial of our breast cancer vaccine was presented at the SanAntonio Breast Cancer Symposium. While the reported results have been positive, there are many uncertainties in drug development, andmost drugs fail to reach commercialization. In addition, we and our partners at Cleveland Clinic continue working with the NCI who areor will be performing pre-clinical research and development, manufacturing and IND-enabling studies to advance our ovarian cancer vaccinetechnology toward human clinical testing. Further, the vaccine discovery program focused on discovering vaccine targets for lung, colonand prostate cancer is in its early stages, and there can be no assurance that appropriate vaccine targets may be identified or developed.

TheBreast Cancer Market

Accordingto American Cancer Society statistics, in the U.S., breast cancer accounts for over 30% of all female cancer cases, and nearly 15% ofcancer deaths in women. It has been estimated that in 2025, approximately 317,000 new cases of breast cancer would be diagnosed in theU.S. and approximately 42,000 women would die from this disease. Despite continuous advances made in the field of cancer research everyyear, invasive female breast cancer incidence rates have been increasing by 1% per year since the mid-2000s.

Themarket for prophylactic cancer vaccines is sizable—bigger in fact than the market for any type of cancer therapeutic. Cancer therapiesare only administered after a patient has been diagnosed, while a prophylactic vaccine may be administered to all people who have a possibilityof developing the disease.

Whilein the U.S., approximately 317,000 women were estimated to be diagnosed with breast cancer in 2025, there are approximately 84 millionwomen age 40 and over—the time in life when women face an increased risk of developing breast cancer. Worldwide, the number isdramatically larger.

TheOvarian Cancer Market

Accordingto American Cancer Society statistics, in the U.S., ovarian cancer accounts for just 2% of all female cancer cases, but over 4% of cancerdeaths in women due to the disease’s low survival rate. It has been estimated that in 2025, approximately 21,000 new cases of ovariancancer would be diagnosed in the U.S. and approximately 13,000 women would die from this disease. Despite continuous advances made inthe field of cancer research every year, there remains a significant unmet medical need, as the overall five-year relative survival ratefor ovarian cancer patients is 51%, but ranges from 43% among Black women to 61% among Asian American/Pacific Islander women, and rangesfrom 92% to 31% based on whether it is first diagnosed at a local stage or a distant stage, respectively.

Themarket for prophylactic cancer vaccines is sizable—bigger in fact than the market for any type of cancer therapeutic. While inthe U.S., approximately 21,000 women were estimated to be diagnosed with ovarian cancer in 2024, there are approximately 42 million womenage 60 and over—the time in life when women face an increased risk of developing ovarian cancer. Worldwide, the number is dramaticallylarger.

TheLung Cancer Market

Accordingto American Cancer Society statistics, lung cancer accounts for 11% of all cancer cases, and 20% of cancer deaths. It is the third mostcommon form of cancer, after breast and prostate cancers, but it accounts for more deaths than any other form of cancer. It has beenestimated that in 2025, approximately 227,000 new cases of lung cancer would be diagnosed in the U.S. and approximately 125,000 peoplewould die from this disease. Despite declining incidence and mortality rates, largely due to reductions in smoking, the 5-year relativesurvival rate for lung cancer is only 27%.

TheColon Cancer Market

Accordingto American Cancer Society statistics, colon cancer, including rectal cancer, accounts for 8% of all cancer cases, and 9% of cancer deaths.It is the fourth most common form of cancer, after breast, prostate and lung cancers, but it is second only to lung cancer in terms ofdeaths. It has been estimated that in 2025, approximately 154,000 new cases of colon cancer would be diagnosed in the U.S. and approximately53,000 people would die from this disease. While incidence rates have been declining, primarily due to improved screening, these reducedincidence rates have been confined to individuals 65 and older. Incidence rates have been increasing in individuals younger than 50,and have been stable for those between 50 and 64. Similar trends have been seen in mortality rates.

TheProstate Cancer Market

Accordingto American Cancer Society statistics, prostate cancer accounts for nearly 30% of all male cancer cases, and 11% of cancer deaths inmen. It has been estimated that in 2025, approximately 314,000 new cases of prostate cancer would be diagnosed in the U.S. and approximately36,000 men would die from this disease. While overall incidence rates have been increasing by 3% per year over the last 10 years, mortalityrates are relatively unchanged. The 5-year relative survival rate is nearly 100% for men diagnosed with localized- or regional-stageprostate cancer, but drops to 37% for those diagnosed with distant-stage disease.

Competition

Thebiopharmaceutical 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 therapiesthat may become available in the future. While we believe that our proprietary FSH-Receptor targeted immuno-therapy platform for treatingsolid tumors, our proprietary cancer vaccine technologies and our scientific expertise in the field of cell therapy provide us with competitiveadvantages, 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.

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

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

Weanticipate that we will face intense and increasing competition as new drugs and vaccines enter the market and advanced technologiesbecome available. We expect any therapies and 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-partypayers.

Ourcommercial opportunities 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 competitorsalso may obtain FDA or other regulatory approvals for their products more rapidly than we may obtain approvals for ours, which couldresult in our competitors establishing a strong market position before we are able to enter the market.

Employees

Asof October 31, 2025, we had four full-time employees working for our Company and subsidiaries. In addition, we work with research teamsat Moffitt and Cleveland Clinic, as well as their and our subcontractors, to develop each of our projects.

SummaryRisk Factors

Therisk factors described below are a summary of the principal risk factors associated with an investment in us. These are not the onlyrisks we face. You should carefully consider these risk factors, together with the risk factors set forth in Item 1A. of this Reportand the other reports and documents filed by us with the SEC.

RisksRelating to Our Financial Condition and Operations

RisksRelated to our Research & Development, Clinical and Commercialization Activities

RisksRelated to our Intellectual Property

RisksRelated to our Common Stock

Other

Wewere incorporated on November 5, 1982 under the laws of the State of Delaware. Our principal executive offices are located at 3150 AlmadenExpressway, 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, currentreports on Form 8-K, proxy statements on Schedule 14A, and amendments to those reports filed or furnished pursuant to Section 13(a) or15(d) of the Exchange Act as soon as reasonably practicable after we electronically file such materials with, or furnish them to, theSecurities and Exchange Commission (the “SEC”). Alternatively, you may also access our reports at the SEC’s websiteat www.sec.gov.

Item1A. Risk Factors

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

RisksRelated to Our Financial Condition and Operations

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

Ona cumulative basis, we have sustained substantial losses and negative cash flows from operations since our inception. As of October 31,2025, our accumulated deficit was approximately $251,677,000, and we had approximately $15,174,000 in cash, cash equivalents and short-terminvestments, and working capital of approximately $13,920,000. In fiscal year 2025, we incurred losses of approximately $11,028,000 andwe experienced negative cash flows from operations of approximately $7,173,000. We expect to continue incurring material research anddevelopment and general and administrative expenses in connection with our operations. As a result, we anticipate that we will incurlosses in the future.

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

Basedon currently available information as of January 12, 2026, we believe that our existing cash, cash equivalents and short-term investmentswill be sufficient to fund our activities for at least the next twelve months. We have implemented a business model that conserves fundsby collaborating with third parties to develop our technologies. However, our projections of future cash needs and cash flows may differfrom actual results. If current cash on hand, cash equivalents, short-term investments and cash that may be generated from our businessoperations are insufficient to continue to operate our business, or if we elect to invest in or acquire a company or companies or newtechnology or technologies that are synergistic with or complementary to our technologies, we may be required to obtain more workingcapital. During the year ended October 31, 2025, we raised approximately $2,378,000, net of expenses, through an at-the-market equityoffering of 772,001 shares of common stock. Under our at-the-market equity program, which is currently effective and may remain availablefor us to use in the future, as of October 31, 2025, we may sell up to an additional $100 million of common stock. We may seek to obtainworking capital during our fiscal year 2026 or thereafter through sales of our equity securities or through bank credit facilities orpublic or private debt from various financial institutions where possible. We cannot be certain that additional funding will be availableon acceptable terms, or at all. If we do identify sources for additional funding, the sale of additional equity securities or convertibledebt will result in dilution to our stockholders. We can give no assurance that we will generate sufficient cash flows in the futureto 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 additionalworking capital as and when needed, such failure could have a material adverse impact on our business, results of operations and financialcondition. 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 could significantly harm the business and development of operations.

Wemay have difficulty in raising capital and may consume resources faster than expected.

Wecurrently do not generate any revenue from our therapeutics or vaccines nor do we generate any other recurring revenues and as of October31, 2025, the Company had approximately $15,174,000 in cash, cash equivalents and short-term investments. Therefore, we have a limitedsource of cash to meet our future capital requirements, which may include the expensive process of obtaining FDA approvals for lira-celand our cancer vaccines. We do not expect to generate significant revenues for the foreseeable future, which would leave us without resourcesto continue our operations and force us to resort to raising additional capital in the form of equity or debt financings, which may notbe available to us. We may have difficulty raising needed capital in the near or longer term as a result of, among other factors, thevery early stage of our therapeutics and vaccine businesses and our lack of revenues as well as the inherent business risks associatedwith an early stage, biotechnology company and present and future market conditions. Also, we may consume available resources more rapidlythan currently anticipated, resulting in the need for additional funding sooner than anticipated. Our inability to raise funds couldlead to decreases in the price of our common stock and the failure of our therapeutics and vaccine businesses which would have a materialadverse effect on the Company.

Failureto effectively manage our potential growth could place strains on our managerial, operational and financial resources and could adverselyaffect our business and operating results.

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

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

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

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

Wehave incurred net losses since our inception and we may never achieve or sustain profitability. Generally, losses incurred will carryforward 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 corporationundergoes an “ownership change,” generally defined as a greater than 50 percentage point change (by value) in its equityownership 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 maybe limited. We have not completed a study to assess whether an ownership change for purposes of Section 382 or 383 has occurred, or whetherthere have been multiple ownership changes since our inception. We may have experienced ownership changes in the past and may experienceownership 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 may 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 attainprofitability, we may be unable to use a material portion of our NOL carryforwards and other tax attributes, which could adversely affectour future cash flows.

RisksRelated to our Research & Development, Clinical and Commercialization Activities

Ourtherapeutic and vaccine programs are pre-revenue, and subject to the risks of an early-stage biotechnology company.

Sincethe Company’s primary focus for the foreseeable future will likely be our therapeutics and vaccine businesses, shareholders shouldunderstand that we are primarily an early-stage biotechnology company with no history of revenue-generating operations, and our onlyassets consist of our proprietary and licensed technologies and the know-how of our officers and employees. Therefore, we are subjectto all the risks and uncertainties inherent in a new business, in particular new businesses engaged in CAR-T cancer therapeutics andcancer vaccines, as well as whether our current business plan is sound. Our CAR-T ovarian cancer therapeutic and our cancer vaccinesare in their early stages of development, and we still must establish and implement many important functions necessary to commercializethe technologies.

Accordingly,you should consider the Company’s prospects in light of the costs, uncertainties, delays and difficulties frequently encounteredby companies in their pre-revenue generating stages, particularly those in the biotechnology field. Shareholders should carefully considerthe risks and uncertainties that a business with limited operating history will face. In particular, shareholders should consider thatthere is a significant risk that we will not be able to:

Anyof the foregoing risks may adversely affect the Company and result in the failure of our business. In addition, we expect to encounterunforeseen expenses, difficulties, complications, delays and other known and unknown factors. Over the next several quarters, we willneed to continue broadening our focus from a research and development company to a company capable of supporting clinical trials andcommercial activities, or enter into collaborations with partners that may provide those capabilities. We may not be able to reach suchachievements, which would have a material adverse effect on our Company.

Ourcurrent business model relies on strategic collaborations with commercial partners to provide the resources and infrastructure to manufactureand ultimately market and/or sell our technologies. We may have difficulty in timing the establishment of these partnerships to achievethe greatest economic benefit for the Company, or in establishing these partnerships at all.

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

Ifproduct liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit commercializationof our product candidates.

Wewill face an inherent risk of product liability as a result of the ongoing and upcoming human clinical testing and commercializationof our product candidates. For example, we may be sued if our product candidates cause or are perceived to cause injury or are foundto be otherwise unsuitable during clinical testing, manufacturing, marketing or sale. Any such product liability claims may include allegationsof defects in manufacturing, defects in design, a failure to warn of dangers inherent in the product, negligence, strict liability ora breach of warranties. Claims could also be asserted under state consumer protection acts. If we cannot successfully defend ourselvesagainst product liability claims, we may incur substantial liabilities or be required to limit or cease commercialization of our productcandidates. Even successful defense would require significant financial and management resources. Regardless of the merits or eventualoutcome, liability claims may result in:

Whilewe carry product liability insurance, claims could be asserted that could result in damages in excess of such insurance coverage. Ifwe do not maintain sufficient product liability insurance at an acceptable cost to protect against potential product liability claims,the lack of sufficient coverage could prevent or inhibit the development and commercialization of any products we develop, alone or withcorporate collaborators.

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

Inthe future, we may identify third-party technology we need, including to develop or commercialize new products or services. In returnfor 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 negotiatelicenses to patents or patent applications before or after introducing a commercial product. We may not be able to obtain necessary licensesto patents or patent applications, and our business may suffer if we are unable to enter into the necessary licenses on acceptable termsor at all, if any necessary licenses are subsequently terminated, if the licensors fail to abide by the terms of the licenses or failto prevent infringement by third parties, or if the licensed patents or other rights are found to be invalid or unenforceable.

Biotechnologyand pharmaceutical product development is a highly speculative undertaking and involves a substantial degree of uncertainty. We havenever generated any revenue from biotechnology and pharmaceutical product sales and our biotechnology and pharmaceutical products maynever be profitable.

Weare in the early discovery stage of developing vaccines against high-incidence malignancies such as lung, colon and prostate cancers,in the pre-clinical stage of developing our ovarian cancer vaccine technology and in the clinical stage with our CAR-T therapeutic technologyand with our breast cancer vaccine technology. 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. Wedo not anticipate generating revenues from sales of such products for the foreseeable future. Our ability to generate future revenuesfrom product sales of our technologies depends heavily on our success in:

Becauseof the numerous risks and uncertainties associated with biologic and pharmaceutical product development, we are unable to predict thelikelihood or timing for when we may receive regulatory approval of our product candidates or when we will be able to achieve or maintainprofitability, if ever. If we are unable to establish a development and or commercialization partnership, or do not receive regulatoryapprovals, our business, prospects, financial condition and results of operations will be adversely affected. Even if we or a partnerobtain the regulatory approvals to market and sell one or more of our product candidates, we may never generate significant revenuesfrom any commercial sales for several reasons, including because the market for our products may be smaller than we anticipate, or productsmay not be adopted by physicians and payors or because our products may not be as efficacious or safe as other treatment options. Ifwe fail to successfully commercialize one or more products, by ourselves or through a partner, we may be unable to generate sufficientrevenues to sustain and grow our business and our business, prospects, financial condition and results of operations will be adverselyaffected.

Cancervaccines are novel and present significant challenges.

Thedevelopment 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 agentand learns to attack and destroy it, retaining a memory of the agent so the immune system knows to react quickly if an individual isexposed to the disease agent months or years later. Most vaccines attack pathogens, such as viruses and bacteria. The immune system isbetter able to assail these agents because they come from outside the body. Cancer, however, is caused by aberrant cells that arise outof our resident cells, which can make it difficult for our immune system to find the diseased cells, especially as advancing age weakensour immune system. Once these aberrant cells gain critical mass, they become cancer.

CAR-Tcell therapies are novel and present significant challenges.

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

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

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

CAR-Ttherapies function through the binding of a genetically engineered killer T cell to a cancer cell. However, these engineered T cellsdestroy the cell they are bound to whether it is a cancer cell or a healthy cell. Therefore, the engineered T cells must be designedto only bind to either cancer cells or other target cells to minimize toxicity. Our CAR-T technology relies on the natural affinity ofFSH to FSH-Receptor. Research by others has shown that in women the FSH-Receptor protein is found on ovary cells and generally in noother healthy tissue, and therefore, we engineer our T cells with FSH. However, as the research in this field is still new, we cannotguarantee that there is no FSH-Receptor on any other healthy tissue in the human body.

Whilepre-clinical testing and the limited human clinical testing of our product candidates has been positive, we may experience unfavorableresults once we collect statistically significant data from human clinical trials.

Wehave limited human clinical data from our CAR-T ovarian cancer therapeutic and our breast cancer vaccine, and we have not initiated clinicaltrials for our ovarian cancer vaccine and we may not be able to commence clinical trials on the time frames we expect. Further, our vaccineresearch programs in high-incidence cancers of the lung, colon and prostate are in the early discovery stage, and have generated no datato date. As our pre-clinical stage product candidate has only been tested in animals and our clinical stage candidates currently havelimited human data, we face significant uncertainty regarding how effective and safe they will be in human patients and the results frompre-clinical studies may not be indicative of the results of clinical trials. Pre-clinical and clinical data are often susceptible tovarying interpretations and analyses, and many companies that have believed their product candidates performed satisfactorily in pre-clinicalstudies and clinical trials have nonetheless failed to obtain marketing approval for their products.

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

Weare dependent on third parties to conduct our pre-clinical studies and clinical trials.

Wedepend and will continue to depend upon independent investigators and collaborators, such as universities, medical institutions, andstrategic partners such as Moffitt for lira-cel and Cleveland Clinic for our cancer vaccines to conduct our pre-clinical studies andclinical trials under agreements with us. Negotiations of budgets and contracts with study sites may result in delays to our developmenttimelines and increased costs. We will rely heavily on these third parties over the course of our clinical trials, and we control onlycertain aspects of their activities. Nevertheless, we are responsible for ensuring that each of our studies is conducted in accordancewith applicable protocol, legal, regulatory and scientific standards, and our reliance on third parties does not relieve us of our regulatoryresponsibilities. We and these third parties are required to comply with current good clinical practices, or cGCPs, which are regulationsand guidelines enforced by the FDA and comparable foreign regulatory authorities for product candidates in clinical development. Regulatoryauthorities 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 trialsmay be deemed unreliable and the FDA or comparable foreign regulatory authorities could require us to perform additional clinical trialsbefore approving our marketing applications. It is possible that, upon inspection, such regulatory authorities could determine that anyof our clinical trials fail to comply with the cGCP regulations. In addition, our clinical trials must be conducted with biologic productproduced under current good manufacturing practices, or cGMPs, and will require a large number of test patients. Our failure or any failureby these third parties to comply with these regulations or to recruit a sufficient number of patients may require us to repeat clinicaltrials, which would delay the regulatory approval process. Moreover, our business may be implicated if any of these third parties violatesfederal or state fraud and abuse or false claims laws and regulations or healthcare privacy and security laws.

Anythird parties conducting our clinical trials are not and will not be our employees and, except for remedies available to us under ouragreements with these third parties, we cannot control whether they devote sufficient time and resources to our ongoing pre-clinical,clinical and non-clinical 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 ourbehalf. If these third parties do not successfully carry out their contractual duties or obligations or meet expected deadlines, if theyneed to be replaced or if the quality or accuracy of the clinical data they obtain is compromised due to the failure to adhere to ourclinical protocols or regulatory requirements or for other reasons, our clinical trials may be extended, delayed or terminated and wemay not be able to complete development of, obtain regulatory approval of or successfully commercialize our product candidates. As aresult, our financial results and the commercial prospects for our product candidates would be harmed, our costs could increase and ourability to generate revenue could be delayed.

Switchingor adding third parties to conduct our clinical trials involves substantial cost and requires extensive management time and focus. Inaddition, there is a natural transition period when a new third party commences work. As a result, delays occur, which can materiallyimpact our ability to meet our desired clinical development timelines.

Ifwe encounter difficulties enrolling patients in our clinical trials, our clinical development activities could be delayed or otherwiseadversely affected.

Wemay experience difficulties in patient enrollment in our clinical trials for a variety of reasons. The timely completion of clinicaltrials in accordance with their protocols depends, among other things, on our ability to enroll a sufficient number of patients who remainin the study until its conclusion. The enrollment of patients depends on many factors, including:

Inparticular, our Phase 1 clinical trial of lira-cel is enrolling patients with late-stage ovarian cancer who have failed conventionaltreatment, and are willing and able to undergo treatment at Moffitt.

Ourclinical trials will compete with other companies’ clinical trials for product candidates that are in the same therapeutic areasas our product candidates, and this competition will reduce the number and types of patients available to us, because some patients whomight have opted to enroll in our clinical trials may instead opt to enroll in a trial being conducted by one of our competitors. Weexpect to conduct our clinical trials at the same clinical trial sites that some of our competitors may use, which will reduce the numberof patients who are available for our clinical trial in these clinical trial sites. Moreover, because our product candidates representa departure from more commonly used methods for cancer treatment, potential patients and their doctors may be inclined to use experimentaltherapies that use conventional technologies, such as chemotherapy and antibody therapy, rather than enroll patients in our clinicaltrials. Patients may also be unwilling to participate in our clinical trials because of negative publicity from adverse events in thebiotechnology or gene therapy industries.

Delaysin patient enrollment may result in increased costs or may affect the timing or outcome of our planned clinical trials, which could preventcompletion of the clinical trials and adversely affect our ability to advance the development of lira-cel and our breast cancer vaccine.

Anyadverse developments that occur during any clinical trials conducted by academic investigators, our collaborators or other entities conductingclinical trials under independent IND applications may negatively affect the conduct of our clinical trials or our ability to obtainregulatory approvals or commercialize our product candidates.

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

Adverseside effects or other safety risks associated with our product candidates could cause us to suspend or discontinue clinical trials ordelay or preclude approval.

Inthird party clinical trials involving CAR-T cell therapies, the most prominent acute toxicities included symptoms thought to be associatedwith the release of cytokines, such as fever, low blood pressure and kidney dysfunction. Some patients also experienced toxicity of thecentral nervous system, such as confusion, cranial nerve dysfunction and speech impairment. Adverse side effects attributed to CAR-Ttherapies were severe and life-threatening in some patients. The life-threatening events were related to kidney dysfunction and toxicitiesof the central nervous system or other organ failure. Severe and life-threatening toxicities occurred primarily in the first two weeksafter cell infusion and generally resolved within three weeks. In the past, several patients have also died in clinical trials by othersinvolving CAR-T cell therapies. While we have not observed any adverse side effects in our clinical trial of lira-cel to date, as wecontinue dose escalation, future trial participants may experience adverse side effects.

Sideeffects of our breast cancer vaccine may include mild effects such as injection site pain or irritation, or more severe side effectssuch as fever, inflammation, organ failure or other adverse effects. In the Phase 1 clinical trial of our breast cancer vaccine, theside effects observed were limited to injection site reactions.

Undesirableside effects observed in our clinical trials, whether or not they are caused by our product candidates, could result in the delay, suspensionor termination of clinical trials, by the FDA or other regulatory authorities or us for a number of reasons. In addition, because thepatients who will be enrolled in our clinical trials may be suffering from a life-threatening disease and may often be suffering frommultiple complicating conditions it may be difficult to accurately assess the relationship between our product candidate and adverseevents experienced by very ill patients. If we elect or are required to delay, suspend or terminate any of our clinical trials, the commercialprospects 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 atissue. Any of these occurrences may harm our business, prospects, financial condition and results of operations significantly.

Vaccinehesitancy, misinformation about vaccine safety, and evolving positions of public health authorities on vaccines could adversely affectthe development and commercial success of our cancer vaccine product candidates.

Ourcancer vaccines depend on the willingness of patients, caregivers, physicians, payors and regulators to accept vaccination as a safeand effective approach to preventing or treating cancer. Public confidence in vaccines has been challenged in recent years by highlypublicized debates about vaccine safety, the spread of misinformation and disinformation on traditional and social media, and increasingskepticism toward public health institutions. These trends, often described collectively as “vaccine hesitancy,” could materiallyand adversely impact our ability to successfully develop, obtain regulatory approval for, and commercialize our cancer vaccines.

U.S.public health authorities, including the Department of Health and Human Services (“HHS”), the FDA, and the Centers for DiseaseControl and Prevention (“CDC”), have consistently stated that vaccines that meet regulatory standards are safe and effective,that vaccination is one of the most important tools to prevent serious disease, and that for licensed vaccines the benefits are expectedto outweigh the risks. At the same time, these authorities acknowledge that vaccines, like all medical products, can have side effects,that rare but serious adverse events may occur, and that vaccine safety is continuously monitored before and after licensure. Regulatoryagencies may update product labeling, add warnings or contraindications, restrict indications or age groups, or modify recommended dosingschedules as new data emerge. Any such actions with respect to vaccines generally, or to products that use similar technologies or deliveryplatforms to ours, even if not directly related to our product candidates, could negatively affect public perception of vaccine safetyand reduce willingness to receive our cancer vaccines.

Negativepublicity about vaccine safety, whether accurate or inaccurate, could also reduce enrollment and retention in our clinical trials, particularlyif patients or investigators are reluctant to participate in studies labeled as “vaccine” trials, or if competing cancertherapies are perceived as safer or more familiar. Even if our cancer vaccines demonstrate an acceptable safety profile in clinical trialsand receive regulatory approval, vaccine hesitancy could limit physician prescribing, patient acceptance, and payor coverage. This riskmay be heightened if our products are used in earlier-stage disease, in adjuvant or prophylactic settings, or in combination with othertherapies, where both patients and clinicians may have lower tolerance for perceived safety concerns relative to expected benefit.

Furthermore,evolving recommendations, public statements, or guidance from HHS, FDA, CDC, or other health authorities regarding vaccine safety, benefit-riskassessment, or target populations may lead to changes in standard-of-care vaccination practices, reimbursement policies, or clinicaltrial design expectations that are difficult to anticipate. If public health authorities adopt more conservative positions toward vaccinesor certain vaccine technologies, impose more stringent evidentiary requirements, or prioritize alternative modalities for cancer preventionor treatment, our development strategy could become less attractive or more costly to pursue. Any of the foregoing could materially andadversely affect our ability to obtain and maintain regulatory approvals for our cancer vaccine candidates, the size of the addressablemarket for our products, and, ultimately, our business, financial condition, and results of operations.

Clinicaltrials are expensive, time consuming and difficult to design and implement.

Humanclinical trials are expensive and difficult to design and implement, in part because they are subject to rigorous regulatory requirements.Because lira-cel is based on relatively new technology and engineered on a patient-by-patient basis, we expect that it will have substantialmanufacturing and processing costs. In addition, costs to treat patients with relapsed/refractory cancer and to treat potential sideeffects that may result from therapies such as our current and future product candidates can be significant. Accordingly, our clinicaltrial 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 whichwill be borne by us.

Infuture clinical trials of our breast cancer vaccine we will need to determine efficacy of the breast cancer vaccine as a cancer preventionwhich will be a considerably more complex clinical trial and will have significantly greater costs than a trial designed to assess therapeuticeffect.

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

Weface significant competition from other biotechnology and pharmaceutical companies, and our operating results will suffer if we failto compete effectively.

Thebiopharmaceutical industry is characterized by intense competition and rapid innovation. Our competitors may be able to develop othercompounds or drugs that are able to achieve similar or better results. Our potential competitors include major multinational pharmaceuticalcompanies, 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 developmentstaff and experienced marketing and manufacturing organizations and well-established sales forces. Smaller or early-stage companies mayalso prove to be significant competitors, particularly through collaborative arrangements with large, established companies. Mergersand 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 ofcapital 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 orless costly than our product candidates or may develop proprietary technologies or secure patent protection that we may need for thedevelopment of our technologies and products.

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

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

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

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

Wemay form or seek strategic alliances, create joint ventures or collaborations and enter into additional licensing arrangements with thirdparties that we believe will complement or augment our development and commercialization efforts with respect to our product candidatesand 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-consumingand complex. Moreover, we may not be successful in our efforts to establish a strategic partnership or other alternative arrangementsfor our product candidates because they may be deemed to be at too early of a stage of development for collaborative effort and thirdparties may not view our product candidates as having the requisite potential to demonstrate safety and efficacy. If we license productsor businesses, we may not be able to realize the benefit of such transactions if we are unable to successfully integrate them with ourexisting operations and company culture. It is possible that, following a strategic transaction or license, we may not achieve the revenueor specific net income that justifies such transaction. Any delays in entering into new strategic partnership agreements related to ourproduct 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.

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

Wehave not previously submitted a Biologics License Application (“BLA”) or a New Drug Application (“NDA”) to theFDA, or similar approval filings to other foreign authorities. A BLA or NDA must include extensive pre-clinical and clinical data andsupporting information to establish the product candidate’s safety, purity and potency for each desired indication. It must alsoinclude significant information regarding the chemistry, manufacturing and controls for the product. We expect the novel nature of ourproduct candidates to create further challenges in obtaining regulatory approval. For example, the FDA has limited experience with commercialdevelopment 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.

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

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, adversedevelopments in clinical trials of gene therapy products conducted by others may cause the FDA or other regulatory bodies to change therequirements for approval of any of our product candidates.

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

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

Evenif 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.

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

Ifour product candidates are approved but fail to achieve market acceptance among physicians, patients, hospitals, cancer treatment centersor 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 favorablyreceived than our products, are more cost effective or render our products obsolete.

RisksRelated to Our Intellectual Property

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

Ourability to compete and to achieve sustained profitability will be impacted by our ability to protect our CAR-T cancer therapeutics technologies,our breast cancer vaccine technologies, our ovarian cancer vaccine technologies and other proprietary discoveries and technologies. Weexpect to rely on a combination of patent protection, copyrights, trademarks, trade secrets, know-how, and regulatory approvals to protectour technologies. Our intellectual property strategy is intended to help develop and maintain our competitive position. While we havebeen granted multiple patents related to our technologies, there is no assurance that we will be able to obtain further patent protectionfor our technologies or any other technologies, nor can we be certain that the steps we will have taken will prevent the misappropriationand unauthorized use of our technologies. If we are not able to obtain and maintain patent protection our competitive position may beharmed, including our ability to license any product if we choose to have other parties commercialize them.

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

Ourcommercial success depends upon our ability to develop, manufacture, market and sell our CAR-T therapeutics, our breast cancer vaccine,our ovarian cancer vaccine and other proprietary discoveries and technologies without infringing, misappropriating or otherwise violatingthe proprietary rights or intellectual property of third parties. We may become party to, or be threatened with, future adversarial proceedingsor litigation regarding intellectual property rights with respect to our CAR-T therapeutics, our breast cancer vaccine, our ovarian cancervaccine and other proprietary discoveries and technologies. Third parties may assert infringement claims against us based on existingpatents 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 CAR-T therapeutics, our breast cancer vaccine,our ovarian cancer vaccine and other proprietary discoveries and technologies. However, we may not be able to obtain any required licenseon commercially reasonable terms or at all. Even if we were able to obtain a license, it could be non-exclusive, thereby giving our competitorsaccess to the same technologies licensed to us. We could be forced, including by court order, to cease developing the infringing technologyor product. In addition, we could be found liable for monetary damages. Claims that we have misappropriated the confidential informationor trade secrets of third parties can have a similar negative impact on our business.

Werely on licenses from Wistar for our CAR-T technology and Cleveland Clinic for our cancer vaccine technologies, and if we lose any ofthese licenses we may be subjected to future litigation.

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

Inspite of our efforts, our licensors might conclude that we have materially breached our obligations under such license agreements andmight therefore terminate the license agreements, thereby removing or limiting our ability to develop and commercialize products andtechnology covered by these license agreements. If these in-licenses are terminated, or if the underlying patents fail to provide theintended exclusivity, competitors or other third parties might have the freedom to seek regulatory approval of, and to market, productsidentical to ours and we may be required to cease our development and commercialization activities. Any of the foregoing could have amaterial 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:

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

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

Ourfailure 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 failsto prevent infringement by third parties or if the licensed patents or other rights are found to be invalid or unenforceable. Absentthe license agreements, we may infringe patents subject to those agreements, and if the license agreements are terminated, we may besubject to litigation by the licensor. Litigation could result in substantial costs and be a distraction to management. If we do notprevail, we may be required to pay damages, including treble damages, attorneys’ fees, costs and expenses, royalties or, be enjoinedfrom selling our products, which could adversely affect our ability to offer products, our ability to continue operations and our financialcondition.

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

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

Thereare several pending U.S. and foreign patent applications in our portfolio, and we anticipate additional patent applications will be filedboth in the U.S. and in other countries, as appropriate. However, we cannot predict:

Compositionof 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 candidateswill 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 patentshave claims directed to the use of a product for the specified method. This type of patent does not prevent a competitor from makingand 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 andsuch infringement is difficult to prevent or prosecute.

Thestrength 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 product candidatesor uses thereof in the U.S. or in other foreign countries. Even if the patents do successfully issue, third parties may challenge thevalidity, 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 technologyor prevent others from designing around our claims. If the breadth or strength of our intellectual property position with respect toour product candidates is threatened, it could dissuade companies from collaborating with us to develop, and threaten our ability tocommercialize, our product candidates. Further, if we encounter delays in our clinical trials, the period of time during which we couldmarket our product candidates under patent protection would be reduced. Since patent applications in the U.S. and most other countriesare confidential for a period of time after filing, it is possible that patent applications in our portfolio may not be the first filedpatent applications related to our product candidates. Furthermore, for U.S. applications in which all claims are entitled to a prioritydate before March 16, 2013, an interference proceeding can be provoked by a third-party or instituted by the USPTO, to determine whowas the first to invent any of the subject matter covered by the patent claims of our applications. For U.S. applications containinga claim not entitled to priority before March 16, 2013, there is a greater level of uncertainty in the patent law with the passage ofthe 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 reformis the creation of a “first to file” system in the U.S. This will require us to be cognizant going forward of the time frominvention to filing of a patent application.

Obtainingand maintaining our patents depends on compliance with various procedural, document submission, fee payment and other requirements imposedby governmental patent agencies, and our patent position could be reduced or eliminated for non-compliance with these requirements.

Periodicmaintenance fees on any issued patent are due to be paid to the USPTO and foreign patent agencies in several stages over the lifetimeof the patent. The USPTO and various 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 curedby payment of a late fee or by other means in accordance with the applicable rules, there are situations in which noncompliance can resultin 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, failureto respond to official actions within prescribed time limits, non-payment of fees and failure to properly legalize and submit formaldocuments. Such noncompliance events are outside of our direct control for i) non-U.S. patents and patent applications owned by us, andii) patents and patent applications licensed to us by another entity. In such an event, our competitors might be able to enter the market,which would have a material adverse effect on our business.

Issuedpatents covering our product candidates could be found invalid or unenforceable if challenged in court or the USPTO.

Ifwe or one of our licensing partners initiate legal proceedings against a third party to enforce a patent covering one of our productcandidates, the defendant could counterclaim that the patent covering our product candidate, as applicable, is invalid and/or unenforceable.In patent litigation in the U.S., defendant counterclaims alleging invalidity and/or unenforceability are commonplace, and there arenumerous grounds upon which a third party can assert invalidity or unenforceability of a patent. Third parties may also raise similarclaims 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 couldresult in revocation or amendment to our patents in such a way that they no longer cover our product candidates. The outcome followinglegal assertions of invalidity and unenforceability is unpredictable. With respect to the validity question, for example, we cannot becertain that there is no invalidating prior art and that prior art that was cited during prosecution, but not relied on by the patentexaminer, will not be revisited. If a defendant were to prevail on a legal assertion of invalidity and/or unenforceability, we wouldlose at least part, and perhaps all, of the patents directed to our product candidates. A loss of patent rights could have a materialadverse impact on our business.

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

Wehave limited intellectual property rights outside the U.S. Filing, prosecuting and defending patents on product candidates in all countriesthroughout the world would be prohibitively expensive, and our intellectual property rights in some countries outside the U.S. can beless extensive than those in the U.S. In addition, the laws of some foreign countries do not protect intellectual property to the sameextent as federal and state laws in the U.S. Consequently, we may not be able to prevent third parties from practicing our inventionsin 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, mayexport otherwise infringing products to territories where we have patents, but enforcement is not as strong as that in the U.S. Theseproducts may compete with our products and our patents or other intellectual property rights may not be effective or sufficient to preventthem from competing.

Manycompanies have encountered significant problems in protecting and defending intellectual property in foreign jurisdictions. The legalsystems of certain countries, particularly China and certain developing countries, do not favor the enforcement of patents, trade secretsand other intellectual property, particularly those relating to biopharmaceutical products, which could make it difficult for us to stopthe infringement of our patents or marketing of competing products in violation of our proprietary rights generally. To date, we havenot sought to enforce any issued patents in these foreign jurisdictions. Proceedings to enforce our patent rights in foreign jurisdictionscould result in substantial costs and divert our efforts and attention from other aspects of our business, could put our patents at riskof being invalidated or interpreted narrowly and our patent applications at risk of not issuing and could provoke third parties to assertclaims against us. We may not prevail in any lawsuits that we initiate, and the damages or other remedies awarded, if any, may not becommercially meaningful. The requirements for patentability may differ in certain countries, particularly developing countries. Furthermore,generic drug manufacturers or other competitors may challenge the scope, validity or enforceability of our or our licensors’ patents,requiring us or our licensors to engage in complex, lengthy and costly litigation or other proceedings. Certain countries in Europe anddeveloping countries, including China and India, have compulsory licensing laws under which a patent owner may be compelled to grantlicenses to third parties. In those countries, we and our licensors may have limited remedies if patents are infringed or if we or ourlicensors are compelled to grant a license to a third party, which could materially diminish the value of those patents. This could limitour potential revenue opportunities. Accordingly, our efforts to enforce our intellectual property rights around the world may be inadequateto obtain a significant commercial advantage from the intellectual property that we develop or license.

RisksRelated to Our Common Stock

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

Inthe future, we may issue securities to raise cash for operations, to pay down then existing indebtedness, as consideration for the acquisitionof assets, as consideration for receipt of goods or services, to pay for the development of lira-cel, to pay for the development of ourcancer vaccines and for acquisitions of companies. We have an at-the-market equity offering under which, as of January 12, 2026 we mayissue up to approximately $98.6 million of common stock, which is currently effective, and which may remain available to us in the future.We also 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.

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

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

Wemay fail to meet market expectations because of fluctuations in quarterly operating results, which could cause the price of our commonstock to decline.

Ourreported revenues and operating results have fluctuated in the past and may continue to fluctuate significantly from quarter to quarterin the future, specifically as we continue to devote our resources towards our CAR-T cancer therapeutics and our cancer vaccines. Itis possible that in future periods, we will have no revenue or, in any event, revenues could fall below or expenses could rise abovethe expectations of securities analysts or investors, which could cause the market price of our common stock to decline. The followingare among the factors that could cause our operating results to fluctuate significantly from period to period:

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

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

Inaddition, we believe that fluctuations in our stock price during applicable periods can also be impacted by changes in governmental regulationsin the drug development industry and/or court rulings and/or other developments in our remaining patent licensing and enforcement actions.

Inthe past, companies that have experienced volatility in the market price of their stock have been the objects of securities class actionlitigation. 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 businessand financial results.

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

Ifour common stock is delisted from NASDAQ Capital Market, our common stock will then fit the definition of a penny stock and thereforewould 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 theirshares. The SEC’s rules require a broker or dealer proposing to effect a transaction in a penny stock to deliver the customer arisk disclosure document that provides certain information prescribed by the SEC, including, but not limited to, the nature and levelof risks in the penny stock market. The broker or dealer must also disclose the aggregate amount of any compensation received or receivableby him in connection with such transaction prior to consummating the transaction. In addition, the SEC’s rules also require a brokeror dealer to make a special written determination that the penny stock is a suitable investment for the purchaser and receive the purchaser’swritten agreement to the transaction before completion of the transaction. The existence of the SEC’s rules may result in a lowertrading volume of our common stock and lower trading prices.

Wehave 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 stockholders’percentage ownership interest and may also result in downward pressure on the price of our common stock.

Asof the date of this Report, we have issued and outstanding options to purchase 13,897,094 shares of our common stock with a weighted averageexercise price of $3.53. Further, as of the date of this Report, our Board of Directors and Compensation Committee have the authorityto issue awards totaling an additional 1,295,000 shares of our common stock which is replenished on a yearly basis in accordance with the provisionsof our plan. Additionally, we have registered for resale all of the shares of common stock issuable under our incentive plans. Becausethe market for our common stock is thinly traded, the sales and/or the perception that those sales may occur, could adversely affectthe market price of our common stock. Furthermore, the mere existence of a significant number of shares of common stock issuable uponvesting and, if applicable, exercise of these securities may be perceived by the market as having a potential dilutive effect, whichcould lead to a decrease in the price of our common stock.

Weare a smaller reporting company and the reduced reporting requirements applicable to smaller reporting companies may make our commonstock less attractive to investors.

Weare a smaller reporting company (“SRC”) and a non-accelerated filer, which allows us to take advantage of exemptions fromvarious reporting requirements that are applicable to other public companies that are not SRCs or non-accelerated filers, including notbeing required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act of 2002, as amended, reduceddisclosure obligations regarding executive compensation in our Annual Report and our periodic reports and proxy statements and providingonly two years of audited financial statements in our Annual Report and our periodic reports. We will remain an SRC until (a) the aggregatemarket value of our outstanding common stock held by non-affiliates as of the last business day our most recently completed second fiscalquarter exceeds $250 million or (b) (1) we have over $100 million in annual revenues and (2) the aggregate market value of our outstandingcommon 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 someinvestors find our common stock less attractive as a result, there may be a less active trading market for our common stock and our stockprice may be more volatile and may decline.

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

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

Item1B. Unresolved Staff Comments

None.

Item1C. Cybersecurity

Overview

Governance

Item2. Properties

Welease approximately 2,000 square feet of office space at 3150 Almaden Expressway, San Jose, California 95118 (our principal executiveoffices) from an unrelated party pursuant to a lease that expires September 30, 2027, with an option to extend the lease an additionaltwo years. Our base rent is approximately $5,000 per month and the lease provides for annual increases of approximately 3% and an escalationclause for increases in certain operating costs.

Item3. Legal Proceedings

Otherthan lawsuits we bring to enforce our patent rights, we are not a party to any material pending legal proceedings, nor are we aware ofany pending litigation or legal proceeding against us that would have a material adverse effect on our financial position or resultsof operations.

Item4. Mine Safety Disclosures

Notapplicable.

PARTII

Item5. Market for the Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities

MarketInformation

Ourcommon stock trades under the symbol “ANIX” on the NASDAQ Capital Market.

Holders

Asof January 9, 2026, the approximate number of record holders of our common stock was 280 and the closing price of our common stockwas $3.38 per share.

SecuritiesAuthorized for Issuance Under Equity Compensation Plans

Thefollowing is information as of October 31, 2025 about shares of our common stock that may be issued upon the exercise of options, warrantsand rights under all equity compensation plans in effect as of that date, including our 2010 Share Incentive Plan and our 2018 ShareIncentive Plan. See Note 4 to our Consolidated Financial Statements for more information on these plans.

DividendPolicy

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

RecentSales of Unregistered Securities

TheCompany did not issue any unregistered securities during the three months ended October 31, 2025.

Item6. [Reserved]

Item7. Management’s Discussion and Analysis of Financial Condition and Results of Operations

General

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

Resultsof Operations

FiscalYear ended October 31, 2025 compared with Fiscal Year ended October 31, 2024

Revenue

Wedid not have any revenue in fiscal years 2025 and 2024. Over the past several years, our revenue, if any, was derived from technologylicensing and the sale of patented technologies, including revenue from the settlement of litigation. 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 notexpect these activities to be a significant part of the Company’s ongoing operations, nor do we expect these activities to requirematerial financial resources or attention of senior management.

Wehave not generated any revenue to date from our therapeutics or vaccine programs. In addition, while we pursue our therapeutics and vaccineprograms, we may also make investments in and form new companies to develop additional emerging technologies. We do not expect to begingenerating revenue with respect to any of our current therapy or vaccine programs in the near term. Our plan is to achieve a profitable outcomeby eventually licensing our technologies to large pharmaceutical companies that have the resources and infrastructure in place to manufacture,market and sell our technologies as therapeutics or vaccines. The eventual licensing of any of our technologies may take several years,if it is to occur at all, and may depend on positive results from human clinical trials.

Researchand Development Expenses

Ourresearch and development expenses are related to the development of our cancer vaccines and CAR-T therapeutics programs and in fiscal year 2025,the expenses incurred consisted of approximately $3,121,000 and $1,950,000 for cancer vaccines and CAR-T therapeutics, respectively.In fiscal year 2024, research and development expenses for our cancer vaccines and CAR-T therapeutics were approximately $3,748,000 and$2,648,000, respectively.

Researchand development expenses decreased by approximately $1,325,000 to approximately $5,071,000 in fiscal year 2025, from approximately$6,396,000 in fiscal year 2024. The decrease in research and development expenses was primarily due to a decrease in research anddevelopment expenses related to our breast cancer vaccine development program as a result of fluctuations in the timing of certainmaterials manufacturing activities of approximately $674,000, a decrease in research and development expenses related to our CAR-Tdevelopment program as a result of fluctuations in the timing of certain materials manufacturing activities of approximately$406,000, a decrease in employee stock option expense as a result of decreases in the calculated fair market value of stock optionsgranted during the year and allocations of headcount to research and development activities of approximately $274,000, and adecrease in employee compensation expense other than stock-based compensation as a result of changes in allocations of headcount toresearch and development activities of approximately $61,000, offset by an increase in research and development expenses related toour new vaccine discovery program due to a full year of activity compared to the prior year of approximately $113,000.

Generaland Administrative Expenses

Generaland administrative expenses decreased by approximately $805,000 to approximately $6,630,000 in fiscal year 2025, from approximately$7,435,000 in fiscal year 2024. The decrease in general and administrative expenses was principally due to a decrease in investorand public relations firm expenses as a result of changes in firms used during the year of approximately $454,000, a decrease indirector stock option compensation expense as a result of decreases in the calculated fair market value of stock options grantedduring the year of approximately $359,000, a decrease in stock compensation for investor and public relations firms as a result ofchanges in firms used during the year of approximately $219,000, a decrease in employee stock option compensation expense as aresult of decreases in the calculated fair market value of stock options granted during the year of approximately $106,000, and adecrease in employee compensation expense other than stock-based compensation as a result of changes in allocations of headcount between research and development and general and administrativeactivities as well as changes in employee compensation of approximately $54,000, offset by an increase in expenses related to a change in clinical materials manufacturing vendors of approximately $244,000, an increase inshareholder relations expenses of approximately $74,000, and an increase in patent prosecution expenses of approximately$73,000.

InterestIncome

Interestincome decreased to approximately $673,000 in fiscal year 2025 compared to approximately $1,133,000 in fiscal year 2024, due to a decreasein the amount of short-term investments held and a decrease in interest rates.

NetLoss Attributable to Noncontrolling Interest

Thenet loss attributable to noncontrolling interest, representing Wistar’s ownership interest in Certainty’s net loss, decreasedby approximately $43,000 to approximately $101,000 in fiscal year 2025, from approximately $144,000 in fiscal year 2024, as Certainty’snet loss decreased.

Liquidityand Capital Resources

Ourprimary sources of liquidity are cash, cash equivalents and short-term investments.

Basedon currently available information as of January 12, 2026, we believe that our existing cash, cash equivalents, short-term investmentsand expected cash flows will be sufficient to fund our activities for at least the next twelve months. We have implemented a businessmodel that conserves funds by collaborating with third parties to develop our technologies. However, our projections of future cash needsand cash flows may differ from actual results. If current cash on hand, cash equivalents, short-term investments and cash that may begenerated from our business operations are insufficient to continue to operate our business, or if we elect to invest in or acquire acompany or companies or new technology or technologies that are synergistic with or complementary to our technologies, we may be requiredto obtain more working capital. During the year ended October 31, 2025, we raised approximately $2,378,000, net of expenses, throughan at-the-market equity offering of 772,001 shares of common stock. Under our at-the-market equity program, which is currently effectiveand may remain available for us to use in the future, as of October 31, 2025, we may sell up to $100 million of common stock. We mayseek to obtain working capital during our fiscal year 2026 or thereafter through sales of our equity securities or through bank creditfacilities or public or private debt from various financial institutions where possible. We cannot be certain that additional fundingwill be available on acceptable terms, or at all. If we do identify sources for additional funding, the sale of additional equity securitiesor convertible debt will result in dilution to our stockholders. We can give no assurance that we will generate sufficient cash flowsin the future to satisfy our liquidity requirements or sustain future operations, or that other sources of funding, such as sales ofequity or debt, would be available or would be approved by our security holders, if needed, on favorable terms or at all. If we failto obtain additional working capital as and when needed, such failure could have a material adverse impact on our business, results ofoperations and financial condition. Furthermore, such lack of funds may inhibit our ability to respond to competitive pressures or unanticipatedcapital needs, or may force us to reduce operating expenses, which could significantly harm the business and development of operations.

Duringthe fiscal year ended October 31, 2025, cash used in operating activities was approximately $7,173,000. Cash provided by investing activitieswas approximately $4,866,000, resulting from the proceeds on maturities of short-term investments of approximately $49,226,000, whichwas offset by the purchase of short-term investments of approximately $44,360,000. Cash provided by financing activities was approximately$2,280,000, resulting from the sale of 772,001 shares of common stock in an at-the-market equity offering of approximately $2,378,000net of expenses and proceeds from the sale of common stock pursuant to an employee stock purchase plan of approximately $7,000, offsetby net costs from the exercise of stock options of approximately $105,000. As a result, our cash, cash equivalents, and short-term investmentsat October 31, 2025 decreased approximately $4,750,000 to approximately $15,174,000 from approximately $19,924,000 at the end of fiscalyear 2024.

Wehave expected future cash obligations related to the lease of our offices through 2029, inclusive of extension periods, estimated atapproximately $256,000.

Off-BalanceSheet Arrangements

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

CriticalAccounting Policies

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

Webelieve that, of the significant accounting policies discussed in Note 2 to our Consolidated Financial Statements, the following accountingpolicies require our most difficult, subjective, or complex judgments:

RevenueRecognition

Ourrevenue has been derived solely from technology licensing and the sale of patented technologies. Revenue is recognized upon transferof control of intellectual property rights and satisfaction of other contractual performance obligations to licensees in an amount thatreflects the consideration we expect to receive.

Ourrevenue recognition policy requires us to make certain judgments and estimates in connection with the accounting for revenue. Such areasmay 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 separateperformance obligations, estimating the timing of satisfaction of performance obligations, determining whether a promise to grant a licenseis distinct from other promised goods or services and evaluating whether a license transfers to a customer at a point in time or overtime.

Ourrevenue arrangements provide for the payment, within 30 days of execution of the agreement, of contractually determined, one-time, paid-uplicense fees in settlement of litigation and in consideration for the grant of certain intellectual property rights for patented technologiesowned 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 relatedpatents. Pursuant to the terms of these agreements, we have no further obligations with respect to the granted intellectual propertyrights, including no obligation to maintain or upgrade the technology, or provide future support or services. Licensees obtained controlof the intellectual property rights they have acquired upon execution of the agreement. Accordingly, the performance obligations fromthese agreements were satisfied and 100% of the revenue was recognized upon the execution of the agreements.

Stock-BasedCompensation

Thecompensation cost for service-based stock options granted to employees, directors and consultants is measured at the grant date, basedon the fair value of the award using the Black-Scholes pricing model, and is recognized as an expense on a straight-line basis over therequisite service period (the vesting period of the stock option) which is one to four years. For employee options vesting if the tradingprice of the Company’s common stock exceeds certain price targets, we use a Monte Carlo Simulation in estimating the fair valueat grant date and recognize compensation cost over the implied service period. For stock-based awards that vest upon the achievementof a performance metric, the Company recognizes the estimated fair value of the award when achievement becomes probable.

Forrestricted stock awards granted to employees and directors that vest at date of grant, we recognize expense based on the grant datemarket price of the underlying common stock. For restricted stock awards vesting upon achievement of a price target of our commonstock, we use a Monte Carlo Simulation in estimating the fair value at grant date and recognize compensation cost over the impliedservice period (median time to vest).

TheBlack-Scholes pricing model and the Monte Carlo Simulation we use to estimate fair value requires valuation assumptions of expected term,expected volatility, risk-free interest rates and expected dividend yield. The expected term of stock options represents the weightedaverage period the stock options are expected to remain outstanding. For employees, we use the simplified method, which is a weightedaverage of the vesting term and contractual term, to determine expected term. The simplified method was adopted since we do not believethat we have sufficient historical exercise data on which to base our own estimate. For consultants, we use the contract term for expected term. Under the Black-Scholes pricing model,we estimated the expected volatility of our shares of common stock based upon the historical volatility of our share price over a periodof time equal to the expected term of the grants. We estimated the risk-free interest rate based on the implied yield available on theapplicable grant date of a U.S. Treasury note with a term equal to the expected term of the underlying grants. We made the dividend yieldassumption based on our history of not paying dividends and our expectation not to pay dividends in the future.

Wewill reconsider use of the Black-Scholes pricing model and the Monte Carlo Simulation if additional information becomes available inthe future that indicates another model would be more appropriate. If factors change and we employ different assumptions in future periods,the compensation expense that we record may differ significantly from what we have recorded in the current period.

Researchand Development Expense

Werecognize research and development expenses as incurred. Advance payments for future research and development activities are deferredand expensed as the services are performed. We recognize our preclinical studies and clinical trial expenses based on the services performedpursuant to contracts with research institutions, clinical research organizations (“CROs”), clinical manufacturing organizations(“CMOs”), and other parties that conduct and manage various stages of research and development activities on our behalf.Fees for such services are recognized based on management’s estimates after considering the activities and tasks completed by eachservice provider in a given period, the time period over which services are expected to be performed, and the level of effort expendedin each reporting period.

Ateach balance sheet date, management estimates prepaid and accrued research and development costs by discussing progress or stage of completionof activities with internal personnel and external service providers, and comparing this information to payments made, invoices received,and the agreed-upon contractual fee to be paid for such services in the applicable contract or statements of work.

Inaddition, we allocate certain internal compensation costs to research and development expenses based on management’s estimatesof each employee’s time and effort expended.

Effectof Recent Accounting Pronouncements

Wediscuss the potential expected impacts of recently issued pronouncements in Note 2 to the Consolidated Financial Statements.

Item7A. Quantitative and Qualitative Disclosures About Market Risk

Notrequired for a smaller reporting company.

Item8. Financial Statements and Supplementary Data

Seeaccompanying “Index to Consolidated Financial Statements.”

Item9. Changes in and Disagreements With Accountants on Accounting and Financial Disclosure

None.

Item9A. Controls and Procedures

DisclosureControls and Procedures

Wemaintain disclosure controls and procedures, as such term is defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act. Under thesupervision and with the participation of our management, including our Chief Executive Officer and our Chief Financial Officer, we evaluatedthe effectiveness of the design and operation of our disclosure controls and procedures pursuant to Rule 13a-15 and 15d-15 of the ExchangeAct. Based upon that evaluation, our Chief Executive Officer and our Chief Financial Officer concluded that our disclosure controls andprocedures were effective as of October 31, 2025.

Management’sReport on Internal Control Over Financial Reporting

Ourmanagement is responsible for establishing and maintaining adequate internal control over financial reporting as such term is definedin Rules 13a-15(f) and 15d-15(f) of the Exchange Act. Our management, including the principal executive officer and principal financialofficer, 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 evaluationof 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 reportingand the preparation of consolidated financial statements for external purposes in accordance with generally accepted accounting principles.

Underthe 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, 2025. In makingthis assessment, our management used the criteria for effective internal control set forth by the Committee of Sponsoring Organizationsof the Treadway Commission in the 2013 Internal Control – Integrated Framework. Based on this assessment, our managementconcluded that our internal control over financial reporting was effective as of October 31, 2025.

ThisAnnual Report on Form 10-K does not include an attestation report of our independent registered public accounting firm regarding internalcontrol over financial reporting. Management’s report was not subject to attestation by the Company’s independent registeredpublic accounting firm pursuant to an exemption of the Commission that permits smaller reporting companies and non-accelerated filers,such as the Company, to provide only management’s report in this Annual Report on Form 10-K. Accordingly, our management’sassessment of the effectiveness of our internal control over financial reporting as of October 31, 2025 has not been audited by our independent registered public accounting firm,Haskell & White LLP.

Changesin Internal Control Over Financial Reporting

Therewere no changes in our internal control over financial reporting during the fourth quarter of fiscal year 2025 that has materially affected,or is reasonably likely to materially affect, the Company’s internal control over financial reporting.

Item9B. Other Information

None.

PARTIII

Item10. Directors, Executive Officers and Corporate Governance

Theinformation required by this Item will be set forth in our Proxy Statement for the 2026 Annual Meeting of Stockholders scheduled forMarch 10, 2026 which such Proxy Statement will be filed with the SEC within 120 days of October 31, 2025, and will be incorporated intothis Annual Report on Form 10-K by reference.

Item11. Executive Compensation

Theinformation required by this Item will be set forth in our Proxy Statement for the 2026 Annual Meeting of Stockholders scheduled forMarch 10, 2026 which such Proxy Statement will be filed with the SEC within 120 days of October 31, 2025, and will be incorporated intothis Annual Report on Form 10-K by reference.

Item12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters

Theinformation required by this Item will be set forth in our Proxy Statement for the 2026 Annual Meeting of Stockholders scheduled forMarch 10, 2026 which such Proxy Statement will be filed with the SEC within 120 days of October 31, 2025, and will be incorporated intothis Annual Report on Form 10-K by reference.

Item13. Certain Relationships and Related Transactions, and Director Independence

Theinformation required by this Item will be set forth in our Proxy Statement for the 2026 Annual Meeting of Stockholders scheduled forMarch 10, 2026 which such Proxy Statement will be filed with the SEC within 120 days of October 31, 2025, and will be incorporated intothis Annual Report on Form 10-K by reference.

Item14. Principal Accountant Fees and Services

Theinformation required by this Item will be set forth in our Proxy Statement for the 2026 Annual Meeting of Stockholders scheduled forMarch 10, 2026 which such Proxy Statement will be filed with the SEC within 120 days of October 31, 2025, and will be incorporated intothis Annual Report on Form 10-K by reference.

PARTIV

Item15. Exhibits and Financial Statement Schedules

(a)(1)(2)Financial Statement Schedules

Seeaccompanying “Index to Consolidated Financial Statements.”

Item16. Form 10-K Summary

TheCompany has elected not to include a summary pursuant to this Item 16.

SIGNATURES

Pursuantto the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signedon its behalf by the undersigned, thereunto duly authorized.

Pursuantto the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of theregistrant and in the capacities and on the date indicated.

ANIXABIOSCIENCES, INC. AND SUBSIDIARIES

INDEXTO CONSOLIDATED FINANCIAL STATEMENTS

OCTOBER31, 2025

Additionalinformation required by schedules called for under Regulation S-X is either not applicable or is included in the consolidated financialstatements or notes thereto.

REPORTOF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

Tothe Board of Directors and Shareholders

AnixaBiosciences, Inc.

Opinionon the Consolidated Financial Statements

Wehave audited the accompanying consolidated balance sheets of Anixa Biosciences, Inc. (the “Company”) as of October 31, 2025and 2024, and the related consolidated statements of operations, equity, and cash flows for each of the two years in the period endedOctober 31, 2025, and the related notes (collectively, the “consolidated financial statements”). In our opinion, the consolidatedfinancial statements present fairly, in all material respects, the consolidated financial position of the Company as of October 31, 2025and 2024, and the consolidated results of its operations and its cash flows for each of the years in the two year period ended October31, 2025, in conformity with accounting principles generally accepted in the United States of America.

Basisfor Opinion

Theseconsolidated financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinionon the Company’s consolidated financial statements based on our audits. We are a public accounting firm registered with the PublicCompany Accounting Oversight Board (United States) (“PCAOB”) and are required to be independent with respect to the Companyin accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commissionand the PCAOB.

Weconducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audits to obtainreasonable assurance about whether the consolidated financial statements are free of material misstatement, whether due to error or fraud.The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As partof our audits, we are required to obtain an understanding of internal control over financial reporting, but not for the purpose of expressingan opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.

Ouraudits included performing procedures to assess the risks of material misstatement of the consolidated financial statements, whetherdue to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidencesupporting the amounts and disclosures in the consolidated financial statements. Our audits also included evaluating the accounting principlesused and significant estimates made by management, as well as evaluating the overall presentation of the consolidated financial statements.We believe that our audits provide a reasonable basis for our opinion.

CriticalAudit Matters

Critical audit matters are matters arising from thecurrent period audit of the financial statements that were communicated or required to be communicated to the audit committee and that:(1) relate to accounts or disclosures that are material to the financial statements and (2) involved our especially challenging, subjective,or complex judgments. We determined that there are no critical audit matters.

Wehave served as the Company’s auditor since 2013.

Irvine,California

January12, 2026

ANIXABIOSCIENCES, INC. AND SUBSIDIARIES

CONSOLIDATEDBALANCE SHEETS

(inthousands, except share and per share data)

Theaccompanying notes are an integral part of these statements.

ANIXABIOSCIENCES, INC. AND SUBSIDIARIES

CONSOLIDATEDSTATEMENTS OF OPERATIONS

(inthousands, except per share data)

Theaccompanying notes are an integral part of these statements.

 \

ANIXABIOSCIENCES, INC. AND SUBSIDIARIES

CONSOLIDATEDSTATEMENTS OF EQUITY

FORTHE YEARS ENDED OCTOBER 31, 2025 AND 2024

(inthousands, except share data)

Theaccompanying notes are an integral part of these statements.

ANIXABIOSCIENCES, INC. AND SUBSIDIARIES

CONSOLIDATEDSTATEMENTS OF CASH FLOWS

(inthousands)

Theaccompanying notes are an integral part of these statements.

ANIXABIOSCIENCES, INC. AND SUBSIDIARIES

NOTESTO CONSOLIDATED FINANCIAL STATEMENTS