UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 10-K

☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended October 31, ~~2024~~2025

☐	TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ___________ to ___________

Commission file number: 001-37492

ANIXA BIOSCIENCES, INC.

(Exact Name of Registrant as Specified in its Charter)

Delaware

11-2622630

(State or Other Jurisdiction

of Incorporation or Organization)

(I.R.S. Employer

Identification No.)

3150 Almaden Expressway, Suite 250

San Jose, CA 95118

(408) 708-9808

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

Securities registered pursuant to Section 12(b) of the Act:

Title of Each Class:		Trading Symbol		Name of Each Exchange on Which Registered:
Common Stock, $0.01 par value		ANIX		The NASDAQ Stock Market LLC

Securities registered pursuant to Section 12(g) of the Act:

None

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

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

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

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐

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

	Large accelerated filer ☐	Accelerated filer ☐
	Non-accelerated filer ☒	Smaller reporting company ☒
	Emerging growth company ☐

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

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

Indicate by check mark whether the financial statements of the registrant included in the filing reflect the correction of an error to previously issued financial statements. ☐

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

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

Aggregate market value of the voting stock (which consists solely of shares of common stock) held by non-affiliates of the registrant as of April 30, ~~2024~~2025 (the last business day of the registrant’s most recently completed second fiscal quarter), computed by reference to the closing sale price of the registrant’s common stock on the NASDAQ on such date ($2.9779): $9085,~~560~~116,~~860~~394.

On January 1012, ~~2025~~2026, the registrant had outstanding 32 33,~~196~~376,~~862~~690 shares of common stock, par value $0.01 per share, which is the registrant’s only class of common stock.

DOCUMENTS INCORPORATED BY REFERENCE:

NONE

TABLE OF CONTENTS

		Page
	PART I
Item 1.	Business	2
Item 1A.	Risk Factors	9
Item 1B.	Unresolved Staff Comments	26
Item 1C.	Cybersecurity	26
Item 2.	Properties	27
Item 3.	Legal Proceedings	27
Item 4.	Mine Safety Disclosures	27
	PART II
Item 5.	Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities	28
Item 6.	[Reserved]	2928
Item 7.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	2928
Item 7A.	Quantitative and Qualitative Disclosures about Market Risk	3332
Item 8.	Financial Statements and Supplementary Data	3332
Item 9.	Changes in and Disagreements With Accountants on Accounting and Financial Disclosure	3332
Item 9A.	Controls and Procedures	3332
Item 9B.	Other Information	3433
	PART III
Item 10.	Directors, Executive Officers and Corporate Governance	3433
Item 11.	Executive Compensation	3433
Item 12.	Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters.	34
Item 13.	Certain Relationships and Related Transactions, and Director Independence	34
Item 14.	Principal ~~Accounting~~Accountant Fees and Services	34
	PART IV
Item 15.	Exhibits, and Financial Statement Schedules	3534
Item 16.	Form 10-K Summary	3635

CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS

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

CERTAIN TERMS USED IN THIS REPORT

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

PART I

Item 1. Business

Overview

Anixa Biosciences, Inc. is a biotechnology company developing therapies and vaccines that are focused on critical unmet needs in oncology. Our therapeutics ~~programs~~program ~~include~~consists ~~(i)~~ of the development of liraltagene autoleucel (“lira-cel”), a chimeric endocrine receptor-T cell therapy, which is a novel form of chimeric antigen receptor-T cell (“CAR-T”) technology, initially focused on treating ovarian cancer, ~~which~~that is being developed at our subsidiary, Certainty Therapeutics, Inc. (“Certainty”)~~, and (ii) until March 2023, the development of anti-viral drug candidates for the treatment of COVID-19~~. Our vaccine programs include (i) the development of a vaccine against breast cancer, ~~initially focused on triple negative breast cancer~~ (~~“TNBC”), the most lethal form of breast cancer, (~~ii) the development of a vaccine against ovarian cancer, and (iii) a vaccine discovery program utilizing the same mechanism as our breast and ovarian cancer vaccines, to develop additional cancer vaccines to address many intractable cancers, including high incidence malignancies in lung, colon and prostate.

Our subsidiary, Certainty, is developing immuno-therapy drugs against cancer. Certainty holds an exclusive worldwide, royalty-bearing license to use certain intellectual property owned or controlled by The Wistar Institute (“Wistar”), the nation’s first independent biomedical research institute and a leading National Cancer Institute (“NCI”) designated cancer research center, relating to Wistar’s chimeric endocrine receptor targeted therapy technology. We have initially focused on the development of a treatment for 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 development milestones. With respect to Certainty’s equity obligations to Wistar, Certainty issued to Wistar shares of its common stock equal to five percent (5%) of the common stock of Certainty, such equity stake is subject to dilution by further funding of Certainty’s activities by the Company. Due to such Company funding, Wistar’s equity stake in Certainty was 4.41% as of October 31, ~~2024~~2025.

Certainty, in collaboration with the H. Lee Moffitt Cancer Center and Research Institute, Inc. (“Moffitt”), has begun human clinical testing of lira-cel, the CAR-T technology licensed by Certainty from Wistar aimed initially at treating ovarian cancer. After receiving authorization from the U.S. Food and Drug Administration (“FDA”), we commenced enrollment of patients in a Phase 1 clinical trial and treated the first patient in August 2022. Further, in May 2023 and August 2023, we treated the second and third patients in the trial, respectively, at the same dose level as the first patient, and the treatment was well-tolerated by the patients. InBetween February ~~2024, May 2024~~ and June 2024, we treated the three patients, ~~respectively,~~ of the second dose cohort, where the patients were administered a three-times higher dose of cells than the patients in the first cohort. The treatment at this dose level ~~has~~was also ~~been~~ well-tolerated by the patients. ~~While~~From ~~the~~November 2024 ~~dose levels in the first two cohorts were expected~~ to beFebruary ~~sub-therapeutic~~2025, ~~two~~ ofwe ~~the~~treated ~~six~~three patients ~~exhibited~~in ~~some~~the ~~anecdotal~~third ~~signs~~dose ~~of efficacy. Both have shown possible signs of tumor necrosis~~cohort, ~~and~~where ~~one~~they iswere 20administered ~~months past~~a ~~initial~~ten-times ~~treatment.~~higher Indose ~~the case~~ of ~~this~~cells than ~~patient, due to~~ the ~~encouraging~~patients ~~results~~in ~~with her initial treatment, we sought single patient Investigational New Drug (“IND”) application permission from~~ the ~~FDA~~first ~~to re-~~dose ~~her~~cohort. ~~This~~Consistent ~~re-dosing~~with ~~was~~the ~~approved~~lower bydose ~~the FDA~~cohorts, ~~and~~ wethe ~~administered her second~~ treatment inwas ~~October 2024. This second treatment appears to have been~~ well-tolerated by the ~~patient~~patients. In ~~November 2024~~Subsequently, we treated the ~~first~~patients ~~patient~~ in the ~~third~~fourth dose cohort, ~~where~~administering ~~patients are administered~~ a ~~ten~~30-times higher dose of cells than the patients in the first dose cohort~~. As of January 10~~, ~~2025, we have treated two patients in this dose cohort~~ and again the treatment at ~~this dose level~~ appears to behave been well-tolerated ~~by the patients~~. We anticipate completing treatment of patients in the third dose cohort in February 2025, and commencing treatment of the fourth dose cohort—at a three-times higher dose than the third dose cohort—shortly thereafter.

~~This~~While the ~~study~~dose islevels ain ~~dose-escalation trial~~the ~~with~~first ~~two~~three ~~arms~~cohorts ~~based~~were onexpected ~~route~~to ofbe ~~delivery—intraperitoneal~~sub-therapeutic, ormultiple ~~intravenous—to~~patients ~~determine~~have ~~the~~exhibited ~~maximum~~anecdotal ~~tolerated~~signs ~~dose~~of ~~in patients~~efficacy, ~~with~~including ~~recurrent~~possible ~~epithelial~~signs ~~ovarian~~of ~~cancer~~T cell infiltration and totumor ~~assess~~necrosis. ~~persistence~~For example, ~~expansion~~many ~~and~~patients ~~efficacy~~have ofsurvived ~~the~~beyond ~~modified~~expectations, Tincluding one ~~cells.~~patient ~~The~~that ~~study~~survived isover ~~being conducted~~two atyears ~~Moffitt~~past initial treatment and ~~will~~three ~~consist~~other ofpatients upthat tosurvived 24over toone 48year ~~patients~~past ~~who~~treatment. In ~~have~~the ~~received~~case atof ~~least~~the ~~two~~patient ~~prior~~that ~~lines~~survived ofover ~~chemotherapy.~~two ~~The~~years ~~study is~~past ~~estimated~~initial treatment, due to bethe ~~completed~~encouraging inresults ~~two~~with toher ~~three~~initial ~~years~~treatment, we ~~depending~~sought onsingle ~~multiple~~patient ~~factors~~Investigational ~~including~~New ~~when~~Drug (“IND”) application permission from the ~~maximum~~FDA ~~tolerated~~to re-dose isher. ~~reached,~~This re-dosing ~~the~~was ~~rate~~approved ofby ~~patient~~the ~~enrollment~~FDA, ~~the~~and ~~significance~~we ofadministered ~~efficacy~~her ~~data~~second ~~and~~treatment ~~how~~in ~~long~~October we2024. ~~maintain~~This ~~the~~second ~~two~~treatment ~~different~~was ~~delivery~~well-tolerated ~~methods~~by the patient.

2This study is a dose-escalation trial with two arms based on route of delivery—intraperitoneal or intravenous—to determine the maximum tolerated dose in patients with recurrent epithelial ovarian cancer and to assess persistence, expansion and efficacy of the modified T cells. The study is being conducted at Moffitt and will consist of up to 24 to 48 patients who have received at least two prior lines of chemotherapy. The study is estimated to be completed in two to three years depending on multiple factors including when the maximum tolerated dose is reached, the rate of patient enrollment, the significance of efficacy data and how long we maintain the two different delivery methods.

We hold an exclusive worldwide, royalty-bearing license to use certain intellectual property owned or controlled by The Cleveland Clinic Foundation (“Cleveland Clinic”) relating to certain breast cancer vaccine technology developed at Cleveland Clinic. The license agreement requires us to make certain cash payments to Cleveland Clinic upon achievement of specific development milestones. Utilizing this 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 vaccine is a specific protein, α-lactalbumin, that is only expressed during lactation in a healthy woman’s mammary tissue. This protein disappears when the woman is no longer lactating, but reappears in many forms of breast cancer, especially TNBC. Studies have shown that vaccinating against this protein prevents breast cancer in mice.

In October 2021, following the U.S. Food and Drug Administration’s (“FDA”) authorization to proceed, we commenced dosing patients in a Phase 1 clinical trial of our breast cancer vaccine. This study, which is being fully funded by a U.S. Department of Defense grant to Cleveland Clinic, is a multiple-ascending dose Phase 1 trial to determine the maximum tolerated dose (“MTD”) of the vaccine in patients with early-stage, triple-negative breast cancer as well as monitor immune response. The study is being conducted at Cleveland Clinic. During the course of the Phase 1 study, participants will receive three vaccinations, each two weeks apart, and will be closely monitored for side effects and immune response. The first segment of the study, Phase 1a, will consist of approximately 24 patients who have completed treatment for early-stage, triple-negative breast cancer within the past three years and are currently tumor-free but at high risk for recurrence. Studies show that 42% of TNBC patients will have a recurrence of their cancer, with most of the recurrences occurring in the first two to three years after standard of care treatment. In January 2023, the number of participants in each dose cohort was expanded, and as of August 2023, we had completed vaccinating all patients in these expanded cohorts. In December 2023, we presented the immunological data collected to date at the San Antonio Breast Cancer Symposium. The data presented show that in the vaccinated women who had been tested to date, various levels of antigen-specific T cell responses were observed at all dose levels. Subsequently, we began vaccinating participants in additional dose cohorts at varying dose levels of the different key components of the vaccine. Further, in November 2023, we commenced vaccination of participants in the second segment of the trial, Phase 1b, that includes participants who have never had cancer, but carry certain mutations in genes such as BRCA1, BRCA2 or PALB2, that indicate a greater risk of developing TNBC in the future, and have elected to have a prophylactic mastectomy. Finally, in January 2024, we commenced vaccination of participants in the third segment of the trial, Phase 1c, that includes post-operative TNBC patients that have residual disease following treatment and are currently undergoing treatment with pembrolizumab (Keytruda®). In November 2024, we presented the most recent data from each of the three arms of the trial at the Society for Immunotherapy of Cancer (SITC) Annual Meeting. Key findings presented include i) patients exhibited antigen-specific immune responses at all dose levels and in all three patient groups (Phase 1a, 1b and 1c), ii) patients receiving our vaccine in combination with Keytruda are not showing any additional or more severe adverse side effects, and iii) no adverse side effects were seen other than varying degrees of injection site irritation. These findings are promising, and as we continue the Phase 1 trial, we are preparing to initiate a Phase 2 ~~clinical trial in the neo-adjuvant setting (pre-surgery) to determine possible therapeutic effect of the vaccine. We anticipate commencing the Phase 2 trial in 2025.~~

WeIn October ~~hold~~2021, anfollowing ~~exclusive~~the ~~worldwide, royalty-bearing~~FDA’s ~~license~~authorization to ~~use~~proceed, ~~certain~~we ~~intellectual~~commenced ~~property~~dosing ~~owned~~patients orin ~~controlled~~a Phase 1 clinical trial of our breast cancer vaccine. This study, which has been fully funded by a U.S. Department of Defense grant to Cleveland Clinic, ~~relating~~is a multiple-ascending dose Phase 1 trial to ~~certain~~determine ~~ovarian~~the ~~cancer~~ maximum tolerated dose (“MTD”) of the vaccine ~~technology.~~in ~~The~~patients ~~license~~with ~~agreement~~early-stage, ~~requires~~triple-negative breast uscancer toas ~~make~~well ~~certain~~as ~~cash~~monitor ~~payments~~immune toresponse. The study has been conducted at Cleveland Clinic. ~~upon~~During ~~achievement~~the course of ~~specific~~the ~~development~~Phase 1 ~~milestones.~~study, ~~This~~participants ~~technology~~received ~~pertains~~three tovaccinations, ~~among~~each ~~other~~two ~~things~~weeks apart, ~~the~~and ~~use~~have ofbeen ~~vaccines~~closely monitored for side effects and immune response. The first patient cohort in the ~~treatment~~study, orCohort ~~prevention~~Ia, consisted of ~~ovarian~~patients ~~cancers~~who ~~which express~~had ~~the~~completed ~~anti~~treatment for early-~~Mullerian~~stage, ~~hormone~~triple-negative breast ~~receptor~~cancer 2within ~~protein~~the ~~containing~~past anthree ~~extracellular~~years ~~domain~~and ~~(“AMHR2~~were currently tumor-~~ED”)~~free but at high risk for recurrence. InStudies ~~healthy~~show ~~tissue,~~that 42% of TNBC ~~this~~patients ~~protein~~will ~~regulates~~have ~~growth~~a ~~and~~recurrence ~~development~~of their cancer, with most of ~~egg-containing~~the ~~follicles~~recurrences occurring in the ~~ovary~~first two to three years after standard of care treatment. ~~While~~In ~~expression~~January 2023, the number of ~~AMHR2-ED~~participants ~~naturally~~in each dose cohort was expanded, and ~~markedly~~as of August 2023, we had completed ~~declines~~vaccinating ~~during~~all ~~menopause~~patients in these expanded cohorts. Subsequently, ~~this~~we ~~protein~~began isvaccinating ~~expressed~~participants in additional dose cohorts at ~~high~~varying dose levels inof the ~~ovaries~~different key components of ~~postmenopausal~~the ~~women~~vaccine. ~~with~~Further, ~~ovarian~~in November 2023, we commenced vaccination of participants in the second patient cohort in the trial, Cohort Ib, that included participants who have never had cancer., ~~Researchers~~but carry certain mutations in genes atsuch ~~Cleveland~~as ~~Clinic~~BRCA1, ~~believe~~BRCA2 or PALB2, that indicate a ~~vaccine~~greater ~~targeting~~risk ~~AMHR2-ED~~of ~~could~~developing ~~prevent~~TNBC in the ~~occurrence~~future, and had elected to have a prophylactic mastectomy. Finally, in January 2024, we commenced vaccination of ~~ovarian~~participants ~~cancer~~in the third patient cohort in the trial, Cohort Ic, that includes 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.

3On December 11, 2025, we presented the final data from the Phase 1 clinical trial of our investigational breast cancer vaccine at the San Antonio Breast Cancer Symposium. The key results presented were that i) all primary study endpoints were met, ii) protocol defined immune responses 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’ primary tumors for alpha-lactalbumin protein revealed a range of expression from absent to strong—analysis and correlation to immune response and clinical outcomes is ongoing. Consenting participants will be followed for five years after completing the study. Combination of Keytruda and the vaccine also generated antigen-specific T cell responses and showed no major additional side effect. The data from the Phase 1 trial will inform planned Phase 2 study design, including a potential Phase 2 combination study with Keytruda in the neoadjuvant setting among newly diagnosed breast cancer patients.

InThe Phase ~~May~~1 ~~2021,~~study ~~Cleveland~~evaluated ~~Clinic was~~safety ~~granted~~and ~~acceptance~~monitored ~~for~~immune ~~our~~response ~~ovarian~~to ~~cancer~~an investigational vaccine ~~technology~~targeting ~~into~~α-lactalbumin. ~~the~~The ~~National~~trial ~~Cancer~~enrolled 35 ~~Institute’s~~participants across three cohorts: Cohort Ia (~~“NCI”~~n=26), ~~PREVENT~~women who completed standard-of-care treatment, including surgery, for early-stage ~~program.~~TNBC ~~The~~within ~~NCI~~three isyears aand ~~part~~were oftumor-free ~~the~~but ~~National~~at ~~Institutes~~elevated risk of ~~Health~~recurrence; Cohort Ib (~~“NIH”~~n=4)., ~~The~~cancer-free ~~PREVENT~~women ~~program~~with isBRCA1, aBRCA2, or ~~peer-reviewed~~PALB2 ~~agent~~mutations ~~development program~~who ~~designed~~elected topreventive ~~support~~mastectomy ~~pre-clinical~~and ~~development~~were ofvaccinated ~~innovative~~prior ~~interventions~~to surgery; and ~~biomarkers~~Cohort ~~for~~Ic ~~cancer~~(n=5), ~~prevention~~women ~~and~~with ~~interception~~TNBC receiving ~~towards~~pembrolizumab ~~clinical~~(Keytruda) ~~trials.~~in ~~The~~the ~~scientific~~adjuvant ~~and~~(post-surgery) ~~financial~~setting, ~~resources~~with evaluation of ~~the~~safety ~~PREVENT~~of ~~program~~combination ~~are~~administration ~~being~~and ~~used~~immune ~~for~~responses. In ~~our~~Cohort ~~ovarian~~Ia, ~~cancer~~at the MTD, the vaccine ~~technology to~~was ~~perform~~reported ~~virtually~~as ~~all~~safe, ~~pre~~with no flu-~~clinical~~like ~~research~~symptoms (fever and ~~development~~myalgias), ~~manufacturing~~no abnormal clinical laboratory tests, and ~~IND~~no ~~enabling~~other ~~studies.~~observed ~~This~~adverse ~~work~~side iseffects ~~being~~in ~~performed~~this atcohort; the primary notable adverse event was injection-site irritation. Participants ~~NCI~~demonstrated ~~facilities~~α-lactalbumin-specific T cell responses, byincluding ~~NCI~~production ~~scientific~~of ~~staff~~interferon gamma and ~~with~~interleukin-17. ~~NCI~~In ~~financial~~Cohort ~~resources~~Ib, safety and tolerability were similar to Cohort Ia. Immunohistochemistry analyses of resected breast tissue are ongoing and will ~~require~~be nopresented in ~~material~~a ~~financial~~future ~~expenditures~~scientific bypresentation. ~~the~~In ~~Company~~Cohort Ic, ~~nor~~ ~~the~~a ~~payment~~key objective was to assess whether administration of ~~any~~the ~~future~~investigational ~~consideration~~vaccine in bycombination with pembrolizumab could create intolerable side effects. No major adverse side effects were reported; as in other cohorts, the ~~Company~~primary toadverse ~~NCI~~event was injection-site irritation. Two participants in Cohort Ic experienced Grade 3 adverse events consisting of greater irritation at an injection site.

InWe hold ~~May~~an ~~2024~~exclusive worldwide, ~~based~~royalty-bearing onlicense ~~the~~to ~~positive clinical~~use ~~results~~certain tointellectual ~~date~~property inowned ~~the~~or ~~development~~controlled ofby ~~our~~Cleveland ~~breast~~Clinic relating to certain ovarian cancer vaccine, wetechnology. ~~entered~~The ~~into~~license aagreement ~~Joint~~requires ~~Development~~us ~~and~~to ~~Option~~make ~~Agreement~~certain ~~with~~ cash payments to Cleveland Clinic toupon achievement ~~collaborate~~of inspecific ~~efforts~~development milestones. This technology pertains to, ~~develop~~among ~~additional~~other things, the use of vaccines for the ~~prevention~~ treatment or ~~treatment~~prevention of ovarian cancers. ~~Working~~which ~~with~~express ~~Cleveland~~the anti-Mullerian hormone receptor 2 protein containing an extracellular domain (“AMHR2-ED”). ~~Clinic~~In ~~researchers~~healthy tissue, wethis ~~are~~protein ~~focusing~~regulates ongrowth ~~the~~and ~~same~~development ~~novel~~of ~~scientific~~egg-containing ~~mechanism~~follicles as in ~~our~~the ~~breast~~ovary. ~~and~~While ~~ovarian~~expression ~~cancer~~of ~~vaccines,~~AMHR2-ED naturally and ~~working~~markedly ~~to discover~~declines ~~additional~~during ~~retired~~menopause, ~~proteins~~this ~~that~~protein ~~may~~is beexpressed ~~associated~~at ~~with~~high ~~other~~levels ~~forms~~in the ovaries of postmenopausal women with ovarian cancer,. ~~specifically~~Researchers ~~high~~at ~~incidence~~Cleveland ~~malignancies~~Clinic inbelieve that a vaccine targeting AMHR2-ED could prevent the ~~lung,~~ ~~colon~~occurrence ~~and~~of ~~prostate~~ovarian cancer.

~~Over~~In May 2021, Cleveland Clinic was granted acceptance for our ovarian cancer vaccine technology into the ~~next~~NCI’s ~~several~~PREVENT ~~quarters,~~program. The weNCI ~~expect~~is a part of the National Institutes of Health (“NIH”). The PREVENT program is a peer-reviewed agent development program designed to support pre-clinical development of ~~our~~innovative ~~therapeutics~~interventions and ~~vaccines~~biomarkers tofor becancer ~~the~~prevention ~~primary~~and ~~focus~~interception towards clinical trials. The scientific and financial resources of the ~~Company.~~PREVENT Asprogram ~~part~~are ofbeing used for our ~~legacy~~ovarian ~~operations,~~cancer ~~the~~vaccine technology ~~Company~~to ~~remains~~perform ~~engaged~~virtually inall ~~limited~~pre-clinical ~~patent~~research ~~licensing~~and ~~activities~~development, ofmanufacturing ~~its~~and ~~various~~IND ~~patent~~enabling ~~portfolios~~studies. WeThis dowork ~~not~~is ~~expect~~being ~~these activities to~~performed beat aNCI ~~significant~~facilities, ~~part~~by ofNCI ~~the~~scientific ~~Company’s~~staff ~~ongoing~~and ~~operations~~with ~~nor~~NCI dofinancial weresources ~~expect~~and ~~these~~will ~~activities to~~ require no material financial ~~resources~~expenditures by the orCompany, ~~attention~~nor the payment of ~~senior~~any ~~management~~future consideration by the Company to NCI.

~~Over~~In May ~~the past several years~~2024, ~~our revenue~~based ~~was~~on ~~derived from technology licensing and~~ the ~~sale~~positive ofclinical ~~patented~~results ~~technologies,~~to ~~including~~date ~~revenue~~in ~~from~~ the ~~settlement~~development of ~~litigation. We have not generated any revenue to date from~~ our ~~vaccine~~breast orcancer ~~therapeutics programs. In addition~~vaccine, ~~while~~ we ~~pursue~~entered ~~our~~into ~~vaccine~~a ~~and~~Joint ~~therapeutics~~Development ~~programs,~~and weOption ~~may~~Agreement ~~also~~with ~~make~~Cleveland ~~investments~~Clinic into ~~and~~collaborate ~~form~~in ~~new~~efforts ~~companies~~ to develop additional ~~emerging~~vaccines ~~technologies.~~for Wethe doprevention ~~not~~or ~~expect~~treatment ~~to begin~~of ~~generating~~cancers. ~~revenue~~Working with ~~respect~~Cleveland toClinic ~~any~~researchers, ofwe ~~our~~are ~~current~~focusing ~~vaccine~~on ~~or therapy programs in~~ the ~~near~~same ~~term.~~novel Wescientific ~~hope~~mechanism toas ~~achieve~~in ~~a profitable outcome by eventually licensing~~ our ~~technologies~~breast toand ~~large~~ovarian cancer ~~pharmaceutical~~vaccines, ~~companies that have the resources~~ and ~~infrastructure~~working ~~in place~~ to ~~manufacture, market~~discover ~~and~~additional ~~sell~~retired ~~our~~proteins ~~technologies~~that asmay ~~vaccines~~be orassociated ~~therapeutics.~~with ~~The~~other ~~eventual~~forms ~~licensing~~ of ~~any of our technologies may take several years~~cancer, specifically ifhigh itincidence ismalignancies toin ~~occur~~the ~~at all~~lung, colon and ~~may depend on positive results from human clinical trials~~prostate.

~~CAR-T~~Over the next several quarters, we expect the development of our therapeutics and vaccines to be the primary focus of the Company. As part of our legacy operations, the Company remains engaged in limited patent licensing activities of its various patent portfolios. We do not expect these activities to be a significant part of the Company’s ongoing operations nor do we expect these activities to require material financial resources or attention of senior management.

Certainty was formed to develop immuno-therapy drugs against cancer, and in November 2017, we entered into a license with Wistar whereby we obtained rights to certain intellectual property surrounding Wistar’s chimeric endocrine receptor targeted therapy technology.3

~~CAR-T~~Over the ~~therapeutics~~past ~~have~~several ~~demonstrated positive~~years, ~~results~~our inrevenue Bwas ~~cell~~derived ~~cancers,~~from ~~but~~technology ~~very~~licensing ~~little~~and ~~progress~~the ~~has~~sale ~~been~~of ~~made~~patented ontechnologies, ~~solid~~including ~~tumors~~revenue from the settlement of litigation. ~~Our~~We ~~CAR-T~~have ~~technology~~not isgenerated ~~initially~~any ~~focused~~revenue to date from our therapeutics or vaccine programs. In addition, while onwe ~~ovarian~~pursue ~~cancer~~our therapeutics and isvaccine ~~based~~programs, onwe ~~engineering~~may ~~killer~~also Tmake ~~cells~~investments ~~with~~in ~~the~~and ~~Follicle~~form ~~Stimulating~~new ~~Hormone~~companies ~~(“FSH”)~~ to ~~target~~develop ~~ovarian~~additional emerging ~~cells~~technologies. ~~that~~We ~~express~~do ~~the~~not ~~FSH-Receptor.~~expect ~~Data~~to onbegin ~~this~~generating ~~technology,~~revenue ~~including~~with ~~the~~respect ~~animal~~to ~~studies~~any ~~showing~~of ~~efficacy,~~our ~~was~~current ~~published~~therapeutics inor ~~January 2017~~vaccine programs in the near ~~journal,~~term. ~~Clinical~~We ~~Cancer~~hope ~~Research.~~to ~~The~~achieve ~~FSH-Receptor~~a ~~has~~profitable ~~been~~outcome ~~shown~~by eventually licensing our technologies to belarge apharmaceutical ~~very~~companies ~~exclusive~~that ~~protein~~have the ~~found~~resources onand ainfrastructure ~~large~~in ~~percentage~~place to manufacture, market and sell our technologies as therapeutics or vaccines. The eventual licensing of ~~ovarian~~any ~~cancer~~of ~~cells~~our technologies may take several years, ~~but~~if ~~not~~it onis ato ~~significant~~occur ~~number~~at ofall, ~~non-ovarian~~and ~~healthy~~may ~~tissues~~depend inon ~~adult~~positive ~~females~~results from human clinical trials.

4CAR-T therapeutics

~~Studies~~Certainty was ~~have~~formed ~~shown~~to ~~that~~develop ~~the FSH~~immuno-~~Receptor is~~therapy ~~also~~drugs ~~expressed~~against incancer, ~~endothelial~~and ~~cells~~in ofNovember ~~the~~2017, ~~vasculature~~we ofentered ~~neoplasias.~~into Wea ~~anticipate~~license ~~performing~~with ~~further~~Wistar ~~studies~~whereby towe ~~evaluate the ability~~obtained ofrights ~~our CAR-T~~ to ~~disrupt~~certain ~~the~~intellectual ~~vasculature~~property ofsurrounding ~~other~~Wistar’s ~~cancers,~~chimeric ~~after~~endocrine wereceptor ~~have~~targeted ~~analyzed~~therapy ~~data from clinical trials of this~~ technology ~~against ovarian cancer~~.

WeCAR-T therapeutics have ~~been~~demonstrated ~~working~~positive ~~with~~results ~~researchers at~~in ~~Moffitt~~B tocell ~~develop~~cancers, ~~our~~but very little progress has been made on solid tumors. Our CAR-T technology, ~~therapy.~~lira-cel, ~~Moffitt~~ is ~~one~~initially offocused ~~the~~on ~~top~~ovarian cancer ~~centers~~and inis ~~the~~based ~~country~~on ~~with~~engineering ~~pre-clinical~~killer ~~and~~T ~~clinical~~cells ~~expertise~~ with ~~CAR~~the Follicle Stimulating Hormone (“FSH”) to target cells that express the FSH-TReceptor. Data on this technology, including the animal studies showing efficacy, was published in January 2017 in the journal, Clinical Cancer Research. ~~Moffitt~~The FSH-Receptor has ~~conducted~~been ~~many~~shown to be a very exclusive protein found on a large percentage of ~~the~~ovarian ~~highest~~cancer ~~profile~~cells, ~~CAR~~but not on a significant number of non-Tovarian ~~trials~~healthy tissues in ~~the world~~adult females.

InStudies have ~~August~~shown ~~2022,~~that ~~Moffitt~~the ~~began treating~~FSH-Receptor ~~patients~~is inalso aexpressed ~~Phase~~in 1endothelial ~~clinical~~cells ~~trial~~ of ~~our CAR-T therapy. While~~ the ~~results~~vasculature toof ~~date~~neoplasias. ~~have~~We ~~been~~anticipate ~~positive,~~performing ~~there are many uncertainties~~further instudies ~~drug development, and most drugs fail~~ to ~~reach~~evaluate ~~commercialization. In~~ the ~~future,~~ability weof ~~hope~~lira-cel to ~~achieve~~disrupt athe ~~profitable~~vasculature ~~outcome~~of byother ~~eventually licensing~~cancers, ~~our~~after ~~technology~~we tohave aanalyzed ~~large~~data ~~pharmaceutical~~from ~~company~~clinical ~~that has the resources and infrastructure in place to manufacture, market and~~trials ~~sell~~of ~~our~~this technology asagainst aovarian cancer ~~treatment~~.

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

~~We believe that our CAR-T technology~~In ~~may~~August ~~be used as an effective treatment against multiple solid tumor types~~2022, ~~however,~~Moffitt webegan ~~have~~treating ~~initially~~patients ~~focused on ovarian cancer. According to American Cancer Society statistics,~~ in ~~the~~a ~~U.S.,~~Phase ~~ovarian~~1 ~~cancer~~clinical ~~accounts~~trial ~~for just 2%~~ of ~~all~~lira-cel. ~~female~~While ~~cancer~~the ~~cases,~~results ~~but nearly 5% of cancer deaths in women due~~ to ~~the~~date ~~disease’s~~have ~~low survival rate. It has~~ been ~~estimated that in 2024~~positive, ~~approximately 20,000 new cases of ovarian~~there ~~cancer~~are ~~would~~many beuncertainties ~~diagnosed~~ in ~~the~~drug ~~U.S.~~development, and ~~approximately~~most ~~13,000~~drugs ~~women~~fail ~~would~~to ~~die~~reach ~~from this disease~~commercialization. ~~Despite~~In ~~continuous advances made in~~ the ~~field~~future, ofwe ~~cancer~~hope ~~research~~to ~~every~~achieve ~~year, there remains~~ a ~~significant~~profitable outcome ~~unmet~~by ~~medical~~eventually ~~need,~~licensing ~~as the overall five~~lira-~~year~~cel ~~relative~~to ~~survival~~a ~~rate for~~large ~~ovarian~~pharmaceutical ~~cancer~~company ~~patients~~that ishas ~~51%,~~the ~~but~~resources ~~ranges~~and ~~from~~infrastructure ~~42%~~in ~~among~~place ~~Black~~to ~~women~~manufacture, market toand ~~61%~~sell ~~among~~lira-cel ~~Asian~~as ~~American/Pacific~~a ~~Islander~~cancer ~~women~~treatment.

~~Cancer vaccines~~The Market

We ~~licensed certain technology~~ ~~from~~believe ~~Cleveland~~that ~~Clinic~~lira-cel tomay ~~develop~~be ~~vaccines~~used ~~for~~as ~~the~~an effective treatment oragainst ~~prevention~~multiple ofsolid ~~TNBC~~tumor ~~and~~types, ~~other~~however, ~~breast~~we ~~cancers~~have ~~which~~initially ~~express~~focused ~~the α-lactalbumin~~on ~~protein~~ovarian cancer. ~~This~~According ~~protein~~to isAmerican ~~only~~Cancer ~~expressed~~Society ~~during~~statistics, ~~lactation~~ in ~~healthy~~the ~~women~~U.S., ~~but~~ovarian ~~may~~cancer ~~also~~accounts befor ~~expressed~~just in2% ~~individuals~~of ~~with~~all ~~certain~~female ~~breast~~cancer ~~cancers~~cases, ~~most~~but ~~notably~~over ~~TNBC,~~4% ~~the most lethal form~~ of ~~breast~~ cancer. ~~Further,~~deaths wein ~~have~~women ~~licensed~~due ~~certain technology from Cleveland Clinic~~ to ~~develop~~the ~~vaccines~~disease’s ~~for~~low ~~the~~survival ~~treatment~~rate. orIt ~~prevention~~has ofbeen ~~ovarian~~estimated ~~cancers~~that ~~which~~in ~~express~~2025, ~~AMHR2-ED.~~approximately 21,000 ~~This~~new ~~protein~~cases ~~regulates~~of ~~growth~~ovarian ~~and~~cancer ~~development of~~would ~~egg-containing~~be ~~follicles~~diagnosed in the ~~ovary~~U.S. and ~~its~~approximately ~~expression~~13,000 ~~naturally~~women ~~and~~would ~~markedly~~die ~~declines~~from ~~after~~this ~~menopause~~disease. ~~However, AMHR2-ED is expressed~~Despite atcontinuous ~~high~~advances ~~levels~~made in the ~~ovaries~~field of ~~postmenopausal women with ovarian~~ cancer. Inresearch ~~addition~~every year, wethere ~~have~~remains ~~entered into~~ a ~~Joint~~significant ~~Development~~unmet ~~and~~medical ~~Option Agreement~~need, ~~with~~as ~~Cleveland~~the ~~Clinic~~overall tofive-year relative ~~collaborate~~survival inrate ~~efforts to develop additional vaccines~~ for ~~the~~ovarian ~~prevention~~cancer orpatients ~~treatment~~is ~~of cancers. Working with Cleveland Clinic researchers~~51%, webut ~~are~~ranges ~~focusing~~from on43% ~~the~~among ~~same~~Black ~~novel~~women ~~scientific~~to ~~mechanism~~61% asamong inAsian ~~our~~American/Pacific Islander ~~breast~~women, and ~~ovarian~~ranges ~~cancer~~from ~~vaccines, and~~92% ~~working~~ to ~~discover~~31% ~~additional~~based ~~retired~~on ~~proteins~~whether ~~that~~it ~~may~~is befirst ~~associated~~diagnosed ~~with~~at ~~other~~a ~~forms~~local ofstage ~~cancer,~~or ~~specifically~~a ~~high~~distant ~~incidence malignancies in the lung~~stage, ~~colon and prostate~~respectively.

Typically, vaccines harness the immune system to protect people from infectious diseases. Broad-based vaccination programs have essentially eliminated some of the most deadly and debilitating diseases in history, small pox and polio among them. However, there has been little success developing a preventative (prophylactic) vaccine against cancer.4

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

~~Most~~We licensed certain technology from Cleveland Clinic to develop vaccines ~~attack~~for ~~pathogens~~the treatment or prevention of TNBC and other breast cancers which express the α-lactalbumin protein. This protein is only expressed during lactation in healthy women, but may also be expressed ~~such~~in asindividuals ~~viruses~~with ~~and~~certain ~~bacteria~~breast cancers, most notably TNBC, the most lethal form of breast cancer. ~~The~~Further, ~~immune~~we ~~system~~have islicensed ~~better~~certain technology ~~able~~from Cleveland Clinic to ~~assail~~develop ~~these~~vaccines ~~agents~~for ~~because~~the ~~they~~treatment ~~come~~or ~~from~~prevention ~~outside~~of ovarian cancers which express AMHR2-ED. This protein regulates growth and development of egg-containing follicles in the ~~body~~ovary and its expression naturally and markedly declines after menopause. ~~Cancer~~However, ~~however,~~ AMHR2-ED is ~~caused~~expressed byat ~~aberrant~~high ~~cells~~levels ~~that~~in ~~arise~~the ~~out~~ovaries of ~~our~~postmenopausal ~~resident~~women ~~cells~~with ovarian cancer. In addition, we ~~which~~have ~~can~~entered ~~make~~into ita ~~difficult~~Joint ~~for~~Development ~~our~~and ~~immune~~Option ~~system~~Agreement with Cleveland Clinic to ~~find~~collaborate ~~the~~in efforts to develop additional vaccines ~~diseased~~for ~~cells~~the prevention or treatment of cancers. Working with Cleveland Clinic researchers, ~~especially~~we asare ~~advancing~~focusing ~~age~~on ~~weakens~~the ~~our~~same ~~immune~~novel ~~system.~~scientific ~~Once~~mechanism as ~~these~~in ~~aberrant~~our ~~cells~~breast ~~gain~~and ~~critical~~ovarian ~~mass~~cancer vaccines, ~~they~~and ~~become~~working to discover additional retired proteins that may be associated with other forms of cancer, specifically high incidence malignancies in the lung, colon and prostate.

5Typically, vaccines harness the immune system to protect people from infectious diseases. Broad-based vaccination programs have essentially eliminated some of the most deadly and debilitating diseases in history, small pox and polio among them. However, there has been little success developing a preventative (prophylactic) vaccine against cancer.

~~Despite~~Vaccines work ~~the~~by ~~lack~~exposing ofa ~~success~~benign ~~with cancer~~form ~~vaccines,~~of ~~recently~~a ~~gained~~disease ~~knowledge~~agent ~~about~~to ~~the~~an ~~human~~individual’s immune system. ~~has~~The ~~led~~immune tosystem identifies the ~~development,~~agent ~~approval~~ and ~~commercialization of~~ ~~revolutionary~~learns ~~immuno-therapy~~to ~~drugs.~~attack ~~These~~and ~~drugs~~destroy doit, ~~not~~retaining ~~attack~~a ~~cancer~~memory ~~directly,~~of ~~but~~the ~~rather~~agent ~~modulate~~so the immune system inknows ~~ways~~to ~~that~~react ~~enable it~~quickly if an individual is exposed to ~~destroy~~the ordisease ~~dramatically~~agent ~~impair~~months ~~cancer~~or ~~cells~~years later.

~~The breast cancer vaccine technology~~Most ~~licensed~~vaccines ~~from~~attack ~~Cleveland Clinic has identified a protein~~pathogens, ~~alpha-lactalbumin,~~such ~~that~~as isviruses ~~present~~and inbacteria. ~~healthy~~The ~~breast~~immune ~~tissue~~system ~~only when a woman~~ is ~~lactating~~better ~~and~~able ~~disappears~~to ~~when~~assail ~~she~~these ~~stops~~agents ~~nursing~~because ~~her~~they ~~child.~~come ~~Alpha-lactalbumin~~from outside ~~is never present on any other cell in~~ the body. ~~However~~Cancer, it ~~does~~however, ~~show~~is upcaused inby ~~many~~aberrant ~~types~~cells that arise out of ~~breast~~our ~~cancer~~resident cells, ~~including~~which ~~TNBC,~~can anmake ~~aggressive~~it ~~and~~difficult ~~deadly~~for our ~~form~~immune ofsystem ~~the~~to ~~disease.~~find Bythe ~~developing~~diseased acells, ~~vaccine that~~especially ~~targets~~as ~~alpha-lactalbumin,~~advancing weage ~~feel~~weakens ~~the~~our immune system. ~~can~~Once ~~destroy~~ these ~~breast~~aberrant ~~cancer~~ cells asgain ~~they arise and ultimately prevent breast~~critical ~~tumors~~mass, ~~from~~they ~~forming~~become cancer.

~~Cleveland~~Despite the ~~Clinic~~lack ~~researchers~~of ~~have demonstrated~~success inwith ~~animal~~cancer ~~studies~~vaccines, ~~that~~recently ~~vaccination~~gained ~~against~~knowledge ~~alpha-lactalbumin~~about ~~completely~~the ~~prevented~~human ~~breast~~immune ~~cancer~~system inhas ~~mice~~led ~~that~~to ~~were~~the ~~specifically~~development, approval ~~bred~~and tocommercialization ~~develop~~of ~~breast~~revolutionary ~~cancer~~immuno-therapy drugs. ~~Data~~These ondrugs ~~this~~do ~~technology~~not attack cancer directly, ~~including~~but rather modulate the ~~animal~~immune system ~~studies~~in ~~showing~~ways ~~efficacy,~~that ~~was~~enable ~~published~~it into ~~March~~destroy ~~2016~~or ~~in the~~dramatically ~~journal,~~impair ~~Cancers~~cancer cells.

The breast ~~ovarian~~ cancer vaccine technology licensed from Cleveland Clinic has identified ~~the~~a ~~AMHR2-ED~~ protein, ~~the~~alpha-lactalbumin, ~~expression~~that ~~of which~~ is ~~involved~~present in ~~egg~~healthy breast ~~production~~tissue inonly ~~the~~when ~~ovaries and~~a woman is nolactating ~~longer~~and ~~expressed~~disappears ~~after~~when ~~menopause~~she stops nursing her child. ~~AMHR2~~Alpha-EDlactalbumin is ~~not~~never ~~meaningfully~~ present on any other cell in the body. However, it does ~~appear~~ show up in many ~~cases~~types of ~~epithelial~~breast ~~ovarian~~cancer, ~~cancers~~including TNBC, ~~the~~an ~~most~~aggressive ~~common~~and ~~type~~deadly form of ~~ovarian cancer~~the disease. By developing a vaccine that targets ~~AMHR2~~alpha-EDlactalbumin, we feel the immune system can destroy these ~~ovarian~~breast cancer cells as they arise and ultimately prevent breast tumors from forming. ~~Data on this technology, including animal studies showing efficacy, was published in November 2017 in the journal, Cancer Prevention Research.~~

~~In October 2021,~~ Cleveland ~~Clinic~~ ~~began~~Clinic ~~treating~~researchers ~~patients~~have demonstrated in aanimal ~~Phase~~studies 1that ~~clinical~~vaccination ~~trial~~against ofalpha-lactalbumin ~~our~~completely prevented breast cancer ~~vaccine. While the results to date have been positive, there~~ ~~are many uncertainties~~ in ~~drug~~mice ~~development,~~that ~~and~~were ~~most~~specifically ~~drugs~~bred ~~fail~~ to ~~reach~~develop ~~commercialization~~breast cancer. InData ~~addition,~~on wethis ~~and~~technology, ~~our~~including ~~partners at Cleveland Clinic continue working with~~ the ~~NCI~~animal ~~who are or will be performing pre-clinical research and development, manufacturing and IND-enabling~~ studies toshowing ~~advance our ovarian cancer vaccine technology toward human clinical testing. Further~~efficacy, ~~the vaccine discovery program focused~~ onwas ~~discovering~~published ~~vaccine~~in ~~targets~~July ~~for~~2016 ~~lung, colon and prostate cancer is~~ in ~~its~~the ~~early stages~~journal, ~~and~~Nature ~~there can be no assurance that appropriate vaccine targets may be identified or developed~~Medicine.

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

~~According~~In December to2025, ~~American~~the ~~Cancer~~final ~~Society statistics,~~data infrom the ~~U.S.,~~recently ~~breast~~completed ~~cancer~~Phase ~~accounts~~1 ~~for~~clinical ~~over~~trial ~~30%~~ of ~~all~~our ~~female~~breast cancer ~~cases,~~vaccine ~~and~~was ~~15%~~presented ofat ~~cancer~~the ~~deaths~~San Antonio inBreast ~~women~~Cancer Symposium. ItWhile ~~has~~the reported results have been ~~estimated~~ ~~that~~positive, there are many uncertainties in ~~2024~~drug development, ~~approximately~~and most ~~314~~drugs fail to reach commercialization. In addition,~~000~~ ~~new~~we ~~cases~~and ofour ~~breast~~partners ~~cancer~~at ~~would~~Cleveland beClinic ~~diagnosed~~continue inworking with the ~~U.S.~~NCI ~~and~~who ~~approximately~~are or 42will be performing pre-clinical research and development,~~000~~ ~~women~~manufacturing and IND-enabling studies to advance our ovarian cancer vaccine ~~would~~technology ~~die~~toward ~~from~~human ~~this~~clinical ~~disease~~testing. ~~Despite~~Further, ~~continuous~~the ~~advances~~vaccine ~~made~~discovery inprogram ~~the~~focused ~~field~~on ofdiscovering ~~cancer~~vaccine ~~research~~targets ~~every~~for ~~year~~lung, ~~invasive~~colon and ~~female~~prostate ~~breast~~ cancer ~~incidence~~ ~~rates~~is ~~have~~in ~~been~~its ~~increasing~~early bystages, ~~approximately~~and ~~0.6%~~there ~~per~~can ~~year~~be ~~over~~no ~~the~~assurance ~~past~~that 20appropriate ~~years~~vaccine targets may be identified or developed.

The market for prophylactic cancer vaccines is sizable—bigger in fact than the market for any type of cancer therapeutic. Cancer therapies are only administered after a patient has been diagnosed, while a prophylactic vaccine may be administered to all people who have a possibility of developing the disease.5

~~While in the U.S., approximately~~The ~~314,000~~Breast ~~women~~Cancer were estimated to be diagnosed with breast cancer in 2024, there are approximately 84 million women age 40 and over—the time in life when women face an increased risk of developing breast cancer. Worldwide, the number is dramatically larger.Market

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

~~According to American Cancer Society~~The ~~statistics,~~market infor ~~the~~prophylactic ~~U.S., ovarian~~ cancer ~~accounts~~vaccines ~~for~~is ~~just~~sizable—bigger 2%in offact ~~all~~than ~~female~~the ~~cancer~~market ~~cases,~~for ~~but~~any ~~nearly~~type 5% of cancer ~~deaths~~therapeutic. inCancer ~~women due to~~therapies ~~the~~are ~~disease’s~~only ~~low~~administered ~~survival~~after ~~rate.~~a Itpatient has been ~~estimated that in 2024~~diagnosed, ~~approximately~~while ~~20,000~~a ~~new~~prophylactic ~~cases~~vaccine ofmay ~~ovarian cancer would~~ be ~~diagnosed in~~administered ~~the~~to ~~U.S.~~all ~~and~~people ~~approximately~~who ~~13,000~~have ~~women~~a ~~would die from this disease. Despite continuous advances made in the field~~ possibility of ~~cancer~~developing ~~research every year, there remains a significant unmet medical need, as~~ the ~~overall five-year relative survival rate for ovarian cancer patients is 51%, but ranges from 42% among Black women to 61% among Asian American/Pacific Islander women~~disease.

6While in the U.S., approximately 317,000 women were estimated to be diagnosed with breast cancer in 2025, there are approximately 84 million women age 40 and over—the time in life when women face an increased risk of developing breast cancer. Worldwide, the number is dramatically larger.

The ~~market for prophylactic cancer~~ ~~vaccines~~Ovarian isCancer sizable—bigger in fact than the market for any type of cancer therapeutic. While in the U.S., approximately 20,000 women were estimated to be diagnosed with ovarian cancer in 2024, there are approximately 42 million women age 60 and over—the time in life when women face an increased risk of developing ovarian cancer. Worldwide, the number is dramatically larger.Market

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

~~According to American Cancer Society~~The ~~statistics,~~market ~~lung cancer accounts~~ for ~~12%~~prophylactic ~~of all~~ cancer ~~cases,~~vaccines ~~and~~is ~~over~~sizable—bigger ~~20%~~in offact ~~cancer~~than ~~deaths. It is~~ the ~~third~~market ~~most common form of cancer, after breast and prostate cancers, but it accounts~~ for ~~more deaths than~~ any ~~other~~type ~~form~~ of cancer therapeutic. ItWhile ~~has been estimated that~~ in the ~~2024~~U.S., approximately ~~235~~21,000 ~~new~~women ~~cases~~were ofestimated ~~lung~~to ~~cancer would~~ be diagnosed inwith ~~the~~ovarian ~~U.S.~~cancer ~~and~~in ~~approximately 125~~2024,~~000~~ ~~people~~there ~~would~~are ~~die~~approximately ~~from~~42 ~~this~~million ~~disease.~~women ~~Despite~~age ~~declining~~60 ~~incidence~~ and ~~mortality~~over—the ~~rates,~~time ~~largely~~in ~~due~~life towhen ~~reductions~~women inface ~~smoking,~~an ~~the~~increased ~~5-year~~risk ~~relative~~of ~~survival~~developing ~~rate~~ovarian ~~for~~cancer. ~~lung~~Worldwide, ~~cancer is~~the ~~only~~number ~~25%~~is dramatically larger.

The Lung ~~Colon~~ Cancer Market

According to American Cancer Society statistics, ~~colon~~lung cancer, ~~including rectal cancer,~~ accounts for 811% of all cancer cases, and 920% of cancer deaths. It is the ~~fourth~~third most common form of cancer, after breast, ~~prostate~~ and ~~lung~~prostate cancers, but it isaccounts ~~second~~for ~~only~~more todeaths ~~lung~~than ~~cancer~~any inother ~~terms~~form of ~~deaths~~cancer. It has been ~~estimated~~ estimated that in ~~2024~~2025, approximately ~~153~~227,000 new cases of ~~colon~~lung cancer would be diagnosed in the U.S. and approximately 53125,000 people would die from this disease. ~~While~~Despite ~~incidence rates have been~~ declining, ~~primarily due to improved screening, these reduced~~ incidence ~~rates have been confined to individuals 65~~ and ~~older.~~mortality ~~Incidence~~ rates, ~~have~~largely ~~been~~due ~~increasing~~to reductions in ~~individuals younger than 55~~smoking, ~~and~~the ~~have~~5-year ~~been~~relative survival ~~stable~~rate for ~~those~~ ~~between~~lung 55cancer ~~and~~is ~~65.~~only ~~Similar trends have been seen in mortality rates~~27%.

The Colon ~~Prostate~~ Cancer Market

According to American Cancer Society statistics, ~~prostate~~colon cancer, including rectal cancer, accounts for ~~nearly 30~~8% of all ~~male~~ cancer cases, and 119% 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 ~~men~~terms of deaths. It has been estimated that in ~~2024~~2025, approximately ~~299~~154,000 new cases of ~~prostate~~colon cancer would be diagnosed in the U.S. and approximately 35 53,000 ~~men~~people would die from this disease. While ~~overall~~ incidence rates have been ~~increasing~~declining, byprimarily 3%due ~~per~~to ~~year~~improved ~~over~~screening, ~~the~~these ~~last~~reduced incidence 10rates ~~years,~~have ~~mortality~~been ~~rates~~confined ~~are~~to ~~relatively unchanged~~individuals 65 and older. ~~The~~Incidence ~~5-year~~rates ~~relative~~have ~~survival~~been ~~rate~~increasing isin ~~nearly~~individuals ~~100%~~younger ~~for~~than ~~men~~50, and ~~diagnosed~~have ~~with~~been ~~localized-~~stable orfor ~~regional-stage~~those ~~prostate~~between ~~cancer,~~50 ~~but~~and ~~drops to~~64. ~~34%~~Similar ~~for~~trends ~~those~~have ~~diagnosed~~been ~~with~~seen ~~distant-stage~~in ~~disease~~mortality rates.

~~Competition~~6

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

~~Many~~According to ofAmerican ~~our~~Cancer ~~competitors~~Society statistics, ~~either alone~~prostate orcancer ~~with~~accounts ~~their~~for ~~strategic~~nearly ~~partners,~~30% ~~have~~of ~~substantially~~all ~~greater~~male ~~financial~~cancer cases, ~~technical~~ and ~~human~~11% ~~resources~~of ~~than~~cancer wedeaths ~~do and significantly~~in ~~greater~~men. ~~experience~~It inhas ~~the~~been ~~discovery~~estimated ~~and~~that ~~development~~in of2025, ~~product~~approximately ~~candidates~~314,000 ~~obtaining~~new ~~FDA~~cases ~~and other regulatory approvals~~ of ~~therapies~~prostate ~~and vaccines~~cancer ~~and~~would ~~commercializing~~be ~~those~~diagnosed ~~therapies~~in ~~and~~the ~~vaccines~~U.S. ~~Accordingly~~and approximately 36,000 ~~our~~men ~~competitors~~would ~~may~~die befrom ~~more~~this ~~successful~~disease. ~~than~~While usoverall inincidence ~~obtaining~~rates ~~approval for~~have ~~therapies~~been ~~and~~increasing ~~vaccines~~by ~~and~~3% ~~achieving~~per ~~widespread~~year ~~market~~over ~~acceptance.~~the ~~Our~~last ~~competitors’~~10 ~~therapies and vaccines may be more effective~~years, mortality orrates ~~more~~are ~~effectively~~relatively ~~marketed~~unchanged. ~~and~~The ~~sold,~~5-year ~~than~~relative ~~any~~survival ~~therapy~~rate oris ~~vaccine~~nearly we100% ~~may~~for ~~commercialize~~men ~~and~~diagnosed ~~may~~with ~~render~~localized- ~~our therapies and vaccines obsolete~~ or ~~non~~regional-~~competitive~~stage prostate ~~before~~cancer, webut ~~can~~drops ~~recover~~to ~~the~~37% ~~expenses~~for ofthose ~~developing~~diagnosed ~~and~~with ~~commercializing~~distant-stage ~~any of our therapies and vaccines~~disease.

7Competition

~~Mergers~~The biopharmaceutical ~~and~~industry ~~acquisitions~~is incharacterized ~~the biotechnology~~by intense and ~~pharmaceutical~~dynamic ~~industries~~competition ~~may~~to ~~result~~develop innew ~~even~~technologies ~~more~~and ~~resources~~proprietary ~~being~~therapies. Any ~~concentrated~~product ~~among~~candidates athat ~~smaller~~we ~~number~~successfully ofdevelop ~~our~~and ~~competitors. These~~commercialize ~~competitors~~will ~~also~~have to compete with usexisting intherapies ~~recruiting~~ and ~~retaining~~new ~~qualified~~therapies that ~~scientific~~may ~~and~~become ~~management~~available ~~personnel~~in ~~and~~the ~~establishing~~future. ~~clinical study~~While ~~sites~~we ~~and~~believe ~~subject~~that ~~registration~~our proprietary FSH-Receptor targeted immuno-therapy platform for ~~clinical~~treating solid ~~studies~~tumors, asour ~~well~~proprietary ascancer vaccine technologies and our scientific expertise in ~~acquiring~~the ~~technologies~~field ~~complementary~~of tocell therapy provide us with competitive advantages, orwe ~~necessary~~face ~~for~~potential competition from various sources, ~~our programs.~~including ~~Smaller~~larger orand ~~early~~better-~~stage~~funded ~~companies~~pharmaceutical ~~may~~and ~~also~~biotechnology ~~prove~~companies, as towell beas ~~significant~~from ~~competitors~~academic institutions, ~~particularly~~governmental ~~through~~agencies ~~collaborative~~and ~~arrangements with~~public ~~large~~ and ~~established~~private ~~companies~~research institutions.

WeMany of ~~anticipate~~our ~~that~~competitors, weeither ~~will~~alone ~~face~~or with their strategic partners, have substantially greater financial, technical and human resources ~~intense~~than we do and ~~increasing~~significantly ~~competition~~greater asexperience ~~new~~in ~~drugs~~the discovery and ~~vaccines~~development ~~enter~~of ~~the~~product ~~market~~candidates, obtaining FDA and ~~advanced~~other ~~technologies~~regulatory approvals ~~become~~of ~~available~~therapies and vaccines and commercializing those therapies and vaccines. WeAccordingly, ~~expect~~our ~~any~~competitors may be more successful than us in obtaining approval for therapies and vaccines ~~that~~and weachieving ~~develop~~widespread ~~and~~market ~~commercialize~~acceptance. toOur ~~compete~~competitors’ ontherapies and ~~the~~vaccines ~~basis~~may ofbe more effective, ~~among~~or ~~other~~more ~~things,~~effectively ~~efficacy,~~marketed ~~safety~~and sold, ~~convenience of~~than ~~administration~~any therapy or vaccine we may commercialize and ~~delivery,~~may ~~price~~render our therapies and vaccines obsolete or non-competitive before we can recover the ~~availability~~expenses of ~~reimbursement~~developing ~~from~~and ~~government~~commercializing ~~and~~any ~~other~~of ~~third-party~~our therapies ~~payers~~and vaccines.

~~Our commercial opportunities could~~Mergers beand ~~reduced~~acquisitions orin ~~eliminated~~the ifbiotechnology ~~our competitors develop~~ and ~~commercialize~~pharmaceutical ~~products~~industries ~~that~~may ~~are~~result ~~safer,~~in even more ~~effective,~~resources ~~have~~being ~~fewer~~concentrated oramong ~~less~~a ~~severe~~smaller ~~side~~number ~~effects,~~of ~~are~~our ~~more~~competitors. ~~convenient~~These orcompetitors ~~are~~also ~~less~~compete ~~expensive~~with ~~than~~us ~~any~~in ~~products~~recruiting ~~that~~and weretaining ~~may~~qualified ~~develop.~~scientific ~~Our~~and ~~competitors~~management ~~also~~personnel and ~~may~~establishing ~~obtain~~clinical ~~FDA~~study ~~or other~~sites ~~regulatory~~and ~~approvals~~subject registration for ~~their~~clinical ~~products~~studies, ~~more~~as ~~rapidly~~well ~~than~~as wein ~~may~~acquiring ~~obtain~~technologies ~~approvals~~complementary to, ~~for~~or ~~ours~~necessary for, ~~which~~our ~~could~~programs. ~~result~~Smaller inor ~~our~~early-stage ~~competitors establishing~~companies amay ~~strong~~also ~~market~~prove ~~position~~to ~~before~~be wesignificant ~~are~~competitors, ~~able~~particularly tothrough collaborative ~~enter~~arrangements ~~the~~with ~~market~~large and established companies.

~~Employees~~We anticipate that we will face intense and increasing competition as new drugs and vaccines enter the market and advanced technologies become 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-party payers.

AsOur commercial ofopportunities ~~October~~could ~~31,~~be ~~2024~~reduced or eliminated if our competitors develop and commercialize products that are safer, wemore ~~had~~effective, ~~five~~have ~~full-time~~fewer ~~employees~~or ~~working~~less ~~for~~severe ~~our~~side ~~Company~~effects, ~~and~~are ~~subsidiaries.~~more Inconvenient ~~addition,~~or weare ~~work~~less ~~with~~expensive ~~research~~than ~~teams~~any atproducts ~~Moffitt~~that ~~and~~we ~~Cleveland~~may ~~Clinic,~~develop. Our competitors asalso ~~well~~may asobtain FDA or other regulatory approvals for their ~~and~~products ~~our~~more ~~subcontractors,~~rapidly tothan ~~develop~~we ~~each~~may ofobtain approvals for ours, which could result in our ~~projects~~competitors establishing a strong market position before we are able to enter the market.

~~Summary Risk Factors~~Employees

~~The risk factors described below~~As ~~are a summary~~ of ~~the~~October ~~principal~~31, ~~risk~~2025, ~~factors~~we ~~associated~~had ~~with~~four anfull-time ~~investment~~employees inworking ~~us.~~for ~~These~~our ~~are~~Company ~~not~~and ~~the~~subsidiaries. ~~only~~In ~~risks~~addition, we ~~face.~~work ~~You~~with ~~should~~research ~~carefully~~teams ~~consider~~at ~~these~~Moffitt ~~risk~~and ~~factors~~Cleveland Clinic, ~~together~~as ~~with~~well ~~the~~as ~~risk~~their ~~factors~~and ~~set~~our ~~forth~~subcontractors, into ~~Item~~develop ~~1A.~~each of ~~this~~our ~~Report and the other reports and documents filed by us with the SEC~~projects.

~~Risks~~Summary Risk ~~Relating to Our Financial Condition and Operations~~Factors

●The risk Wefactors ~~have~~described below are a ~~history~~summary of ~~losses and may incur additional losses in~~ the ~~future.~~principal ●risk Wefactors ~~will~~associated ~~need~~with ~~additional~~an ~~funding~~investment in ~~the~~us. ~~future~~These ~~which~~are ~~may~~ not bethe ~~available~~only risks onwe ~~acceptable~~face. ~~terms,~~You orshould atcarefully ~~all,~~consider ~~and,~~these ifrisk ~~available~~factors, ~~may~~together ~~result~~with inthe ~~dilution~~risk tofactors ~~our~~set ~~stockholders.~~forth ●in WeItem ~~may~~1A. ~~have~~of ~~difficulty~~this inReport and ~~raising~~the ~~capital~~other reports and ~~may~~documents ~~consume~~filed ~~resources~~by ~~faster~~us ~~than~~with ~~expected~~the SEC.

~~Risks Related to our Research & Development, Clinical and Commercialization Activities~~7

●Risks Relating ~~Our therapeutic and vaccine programs are pre-revenue, and subject~~ to ~~the risks of an early-stage biotechnology company. ●~~ Our ~~current~~Financial ~~business~~Condition ~~model relies on strategic collaborations with commercial partners to provide the resources~~ and infrastructure to manufacture and ultimately market and/or sell our technologies. We may have difficulty in timing the establishment of these partnerships to achieve the greatest economic benefit for the Company, or in establishing these partnerships at all. ● If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit commercialization of our product candidates. ● We have never generated any revenue from biotechnology and pharmaceutical product sales and our biotechnology and pharmaceutical products may never be profitable. ● The therapeutics and vaccines that we are developing are novel and present significant challenges to successfully reaching market.Operations

8● We have a history of losses and may incur additional losses in the future. ● We will need additional funding in the future which may not be available on acceptable terms, or at all, and, if available, may result in dilution to our stockholders. ● We may have difficulty in raising capital and may consume resources faster than expected.

●Risks Related While pre-clinical testing and the limited human clinical testing of our product candidates has been positive, we may experience unfavorable results once we collect statistically significant data from human clinical trials. ● We are dependent on third parties to ~~conduct~~ our ~~pre-clinical~~Research ~~and~~& ~~clinical trials. ● If we encounter difficulties enrolling patients in our clinical trials~~Development, ~~our~~Clinical ~~clinical development activities could be delayed or otherwise adversely affected. ● We face significant competition from other biotechnology~~ and ~~pharmaceutical~~Commercialization ~~companies, and our operating results will suffer if we fail to compete effectively.~~Activities

~~Risks~~● ~~Related~~Our therapeutic and vaccine programs are pre-revenue, and subject to the risks of an early-stage biotechnology company. ● Our current business model relies on strategic collaborations with commercial partners to provide the resources and infrastructure to manufacture and ultimately market and/or sell our ~~Intellectual~~technologies. ~~Property~~We may have difficulty in timing the establishment of these partnerships to achieve the greatest economic benefit for the Company, or in establishing these partnerships at all. ● If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit commercialization of our product candidates. ● We have never generated any revenue from biotechnology and pharmaceutical product sales and our biotechnology and pharmaceutical products may never be profitable. ● The therapeutics and vaccines that we are developing are novel and present significant challenges to successfully reaching market. ● While pre-clinical testing and the limited human clinical testing of our product candidates has been positive, we may experience unfavorable results once we collect statistically significant data from human clinical trials. ● We are dependent on third parties to conduct our pre-clinical and clinical trials. ● If we encounter difficulties enrolling patients in our clinical trials, our clinical development activities could be delayed or otherwise adversely affected. ● We face significant competition from other biotechnology and pharmaceutical companies, and our operating results will suffer if we fail to compete effectively.

●Risks Related Weto ~~rely on licenses from Wistar for~~ our ~~CAR-T~~Intellectual technology and Cleveland Clinic for our breast and ovarian cancer vaccine technologies, and if we lose any of these licenses it may remove or limit our ability to develop and commercialize products and technology covered by these license agreements and we may be subjected to future litigation.Property

~~Risks~~● ~~Related~~We torely on licenses from Wistar for our ~~Common~~CAR-T ~~Stock~~technology and Cleveland Clinic for our breast and ovarian cancer vaccine technologies, and if we lose any of these licenses it may remove or limit our ability to develop and commercialize products and technology covered by these license agreements and we may be subjected to future litigation.

●Risks Related ~~The issuance or sale of shares in the future, including in connection with our current at-the-market offering program,~~ to ~~raise money or for strategic purposes could reduce the market price of~~ our ~~common~~Common stock. ● We have issued a significant number of securities pursuant to our incentive plans and may continue to do so in the future. The vesting and, if applicable, exercise of these securities and the sale of the shares of common stock issuable thereunder may dilute stockholders’ percentage ownership interest and may also result in downward pressure on the price of our common stock.Stock

~~Other~~● The issuance or sale of shares in the future, including in connection with our current at-the-market offering program, to raise money or for strategic purposes could reduce the market price of our common stock. ● We have issued a significant number of securities pursuant to our incentive plans and may continue to do so in the future. The vesting and, if applicable, exercise of these securities and the sale of the shares of common stock issuable thereunder may dilute stockholders’ percentage ownership interest and may also result in downward pressure on the price of our common stock.

We were incorporated on November 5, 1982 under the laws of the State of Delaware. Our principal executive offices are located at 3150 Almaden Expressway, San Jose, California 95118, our telephone number is (408) 708-9808 and our Internet website address is www.anixa.com. We make available free of charge on or through our Internet website our annual report on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K, proxy statements on Schedule 14A, and amendments to those reports filed or furnished pursuant to Section 13(a) or 15(d) of the Exchange Act as soon as reasonably practicable after we electronically file such materials with, or furnish them to, the Securities and Exchange Commission (the “SEC”). Alternatively, you may also access our reports at the SEC’s website at www.sec.gov.Other

~~Item~~We were 1Aincorporated on November 5, 1982 under the laws of the State of Delaware. ~~Risk~~Our ~~Factors~~principal executive offices are located at 3150 Almaden Expressway, San Jose, California 95118, our telephone number is (408) 708-9808 and our Internet website address is www.anixa.com. We make available free of charge on or through our Internet website our annual report on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K, proxy statements on Schedule 14A, and amendments to those reports filed or furnished pursuant to Section 13(a) or 15(d) of the Exchange Act as soon as reasonably practicable after we electronically file such materials with, or furnish them to, the Securities and Exchange Commission (the “SEC”). Alternatively, you may also access our reports at the SEC’s website at www.sec.gov.

~~Our business involves a high degree of risk and uncertainty, including the following risks and uncertainties:~~8

~~Risks~~Item 1A. ~~Related~~Risk ~~to Our Financial Condition and Operations~~Factors

WeOur business ~~have~~involves a ~~history~~high degree of ~~losses~~ risk and ~~may~~uncertainty, ~~incur~~including ~~additional~~the ~~losses~~following inrisks ~~the~~and ~~future.~~uncertainties:

~~On a cumulative basis, we have~~Risks ~~sustained~~Related substantial losses and negative cash flows from operations since our inception. As of October 31, 2024, our accumulated deficit was approximately $240,750,000, and we had approximately $19,924,000 in cash, cash equivalents and short-term investments, and working capital of approximately $18,862,000. In fiscal year 2024, we incurred losses of approximately $12,698,000 and we experienced negative cash flows from operations of approximately $7,335,000. We expect to ~~continue~~Our ~~incurring~~Financial ~~material~~Condition ~~research~~ and ~~development and general and administrative expenses in connection with our operations. As a result, we anticipate that we will incur losses in the future.~~Operations

9We have a history of losses and may incur additional losses in the future.

WeOn a ~~will~~cumulative ~~need~~basis, ~~additional~~we have sustained substantial losses and negative cash flows from operations since our inception. As of October 31, ~~funding~~2025, inour ~~the~~accumulated ~~future~~deficit ~~which~~was ~~may~~approximately ~~not~~$251,677,000, beand ~~available~~we onhad ~~acceptable~~approximately ~~terms~~$15,174,000 orin atcash, ~~all~~cash equivalents and short-term investments, and working capital of approximately $13,920,000. ifIn ~~available~~fiscal year 2025, ~~may~~we ~~result~~incurred inlosses ~~dilution~~of approximately $11,028,000 and we experienced negative cash flows from operations of approximately $7,173,000. We expect to continue incurring material research and development and general and administrative expenses in connection with our ~~stockholders~~operations. As a result, we anticipate that we will incur losses in the future.

~~Based on currently available information~~We ~~as of January 10, 2025, we believe that our existing cash, cash equivalents and short-term investments~~ will beneed ~~sufficient~~additional tofunding ~~fund~~in ~~our activities for at least~~ the ~~next twelve months. We have implemented a business model that conserves funds by collaborating with third parties to develop our technologies. However, our projections of~~ future cash needs and cash flows may differ from actual results. If current cash on hand, cash equivalents, short-term investments and cash that may be generated from our business operations are insufficient to continue to operate our business, or if we elect to invest in or acquire a company or companies or new technology or technologies that are synergistic with or complementary to our technologies, we may be required to obtain more working capital. During the year ended October 31, 2024, we raised approximately $2,955,000, net of expenses, through an at-the-market equity offering of 785,290 shares of common stock. Under our at-the-market equity program, which ~~is currently effective and~~ may ~~remain~~not available for us to use in the future, as of October 31, 2024, we may sell up to $97 million of common stock. We may seek to obtain working capital during our fiscal year 2025 or thereafter through sales of our equity securities or through bank credit facilities or public or private debt from various financial institutions where possible. We cannot be ~~certain that additional funding will be~~ available on acceptable terms, or at all., Ifand, weif ~~do identify sources for additional funding~~available, ~~the~~may ~~sale of additional equity securities or convertible debt will~~ result in dilution to our stockholders. We can give no assurance that we will generate sufficient cash flows in the future to satisfy our liquidity requirements or sustain future operations, or that other sources of funding, such as sales of equity or debt, would be available or would be approved by our security holders, if needed, on favorable terms or at all. If we fail to obtain additional working capital as and when needed, such failure could have a material adverse impact on our business, results of operations and financial condition. Furthermore, such lack of funds may inhibit our ability to respond to competitive pressures or unanticipated capital needs, or may force us to reduce operating expenses, which could significantly harm the business and development of operations.

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

We ~~currently do not generate any~~ revenue from our therapeutics or vaccines nor do we generate any other recurring revenues and as of October 31, 2024, the Company had approximately $19,924,000 in cash, cash equivalents and short-term investments. Therefore, we have a limited source of cash to meet our future capital requirements, which may include the expensive process of obtaining FDA approvals for our CAR-T ovarian cancer therapeutic and our breast and ovarian cancer vaccines. We do not expect to generate significant revenues for the foreseeable future, which would leave us without resources to continue our operations and force us to resort to raising additional capital in the form of equity or debt financings, which may not be available to us. We may have difficulty in raising ~~needed~~ capital ~~in the near or longer term as a result of, among other factors, the very early stage of our therapeutics~~ and ~~vaccine businesses and our lack of revenues as well as the inherent business risks associated with an early stage, biotechnology company and present and future market conditions. Also, we~~ may consume ~~available~~ resources ~~more~~faster ~~rapidly~~ than ~~currently anticipated, resulting in the need for additional funding sooner than anticipated~~expected. Our inability to raise funds could lead to decreases in the price of our common stock and the failure of our therapeutics and vaccine businesses which would have a material adverse effect on the Company.

~~Failure~~We currently todo ~~effectively~~not ~~manage~~ generate any revenue from our ~~potential~~therapeutics ~~growth~~or ~~could~~vaccines ~~place~~nor ~~strains~~do onwe generate any other recurring revenues and as of October 31, 2025, the Company had approximately $15,174,000 in cash, cash equivalents and short-term investments. Therefore, we have a limited source of cash to meet our ~~managerial~~future capital requirements, ~~operational~~which may include the expensive process of obtaining FDA approvals for lira-cel and ~~financial~~our cancer vaccines. We do not expect to generate significant revenues for the foreseeable future, which would leave us without resources to continue our operations and ~~could~~force ~~adversely~~us ~~affect~~to resort to raising additional capital in the form of equity or debt financings, which may not be available to us. We may have difficulty raising needed capital in the near or longer term as a result of, among other factors, the very early stage of our therapeutics and vaccine businesses and our lack of revenues as well as the inherent business risks associated with an early stage, biotechnology company and ~~operating~~present ~~results~~and future market conditions. Also, we may consume available resources more rapidly than currently anticipated, resulting in the need for additional funding sooner than anticipated. Our inability to raise funds could lead to decreases in the price of our common stock and the failure of our therapeutics and vaccine businesses which would have a material adverse effect on the Company.

Our business strategy and potential growth may place a strain on managerial, operational and financial resources and systems. Although we may not grow as we expect, if we fail to manage our growth effectively or to develop and expand our managerial, operational and financial resources and systems, our business and financial results will be materially harmed.9

WeFailure to ~~may~~effectively ~~use~~manage our ~~financial and~~potential ~~human~~growth ~~resources~~could toplace ~~pursue~~strains aon ~~particular~~our ~~research~~managerial, ~~program~~operational orand ~~product~~financial ~~candidate~~resources and ~~fail~~could ~~to capitalize on programs or product candidates~~adversely ~~that~~affect ~~may~~our bebusiness ~~more~~and ~~profitable~~operating ~~or for which there is a greater likelihood of success~~results.

~~Because we have limited resources,~~Our webusiness ~~may~~strategy ~~forego~~and ~~or delay pursuit of opportunities with certain programs or product candidates or for indications that later prove to have greater commercial~~ potential. ~~Our~~growth ~~resource allocation decisions~~ may ~~cause~~place usa tostrain ~~fail to capitalize~~ on ~~viable~~managerial, ~~commercial~~operational ~~products or profitable market opportunities. Our spending on current~~ and ~~future~~financial ~~research~~resources and ~~development~~systems. ~~programs~~Although ~~for product candidates~~ we may not ~~yield~~grow ~~any~~as ~~commercially viable products. If~~ we ~~do not accurately evaluate the commercial potential or target market for a particular product candidate~~expect, if we ~~may relinquish~~fail ~~valuable rights~~ to ~~that~~manage ~~product~~our ~~candidate~~growth ~~through~~effectively ~~strategic collaboration, licensing~~ or ~~other royalty arrangements in cases in which it would have been more advantageous for us~~ to ~~retain~~develop ~~sole development~~ and ~~commercialization~~expand ~~rights~~our ~~to such product candidate~~managerial, or weoperational ~~may~~and ~~allocate internal~~ financial resources toand asystems, ~~product~~our ~~candidate~~business ~~which~~and itfinancial ~~would~~results ~~have~~will ~~been~~be ~~more~~materially ~~advantageous to enter into a partnering arrangement~~harmed.

10We may use our financial and human resources to pursue a particular research program or product candidate and fail to capitalize on programs or product candidates that may be more profitable or for which there is a greater likelihood of success.

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

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

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

~~Our therapeutic and vaccine~~Risks ~~programs~~Related ~~are pre-revenue, and subject~~ to ~~the~~our ~~risks~~Research of& anDevelopment, ~~early-stage~~Clinical ~~biotechnology~~and ~~company.~~Commercialization Activities

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

~~Accordingly, you should consider~~Since the Company’s ~~prospects~~primary infocus ~~light~~for of the ~~costs,~~foreseeable ~~uncertainties,~~future ~~delays~~will ~~and~~likely ~~difficulties~~be ~~frequently~~our ~~encountered~~therapeutics byand ~~companies~~vaccine inbusinesses, ~~their~~shareholders should ~~pre~~understand that we are primarily an early-~~revenue~~stage biotechnology company with no history of revenue-generating ~~stages~~operations, ~~particularly~~and ~~those~~our inonly assets consist of our proprietary and licensed technologies and the ~~biotechnology~~know-how ~~field~~of our officers and employees. ~~Shareholders~~Therefore, ~~should~~we ~~carefully~~are ~~consider~~subject to all the risks and uncertainties ~~that~~ inherent in a new business, ~~with~~in ~~limited~~particular ~~operating~~new ~~history~~businesses ~~will~~engaged ~~face.~~in InCAR-T ~~particular~~cancer therapeutics and cancer vaccines, ~~shareholders~~as ~~should~~well ~~consider~~as ~~that~~whether ~~there~~our current business plan is asound. ~~significant~~Our ~~risk~~CAR-T ovarian cancer therapeutic and our cancer vaccines ~~that~~are in their early stages of development, and we ~~will~~still ~~not~~must beestablish ~~able~~and implement many important functions necessary to: commercialize the technologies.

● successfully enroll sufficient numbers of qualified patients to participate in our clinical trials; ● obtain sufficient quantity and quality of materials manufactured for use in our clinical trials; ● successfully meet the primary endpoints in our clinical trials; ● implement or execute our current business plan; ● raise sufficient funds in the capital markets or otherwise to fully effectuate our business plan; ● maintain our management team; ● determine that the processes and technologies that we have developed or will develop are commercially viable; and/or ● attract, enter into or maintain contracts with potential commercial partners such as licensors of technology and suppliers or licensees of our technologies.10

~~Any of the foregoing risks may~~Accordingly, ~~adversely~~you ~~affect~~should consider the Company’s ~~and~~prospects ~~result~~ in ~~the~~light ~~failure~~ of ~~our~~the ~~business. In addition~~costs, ~~we expect to encounter unforeseen expenses~~uncertainties, ~~difficulties, complications,~~ delays and ~~other~~difficulties ~~known~~frequently ~~and~~encountered by ~~unknown~~companies ~~factors.~~in ~~Over~~their ~~the~~pre-revenue ~~next~~generating ~~several quarters~~stages, weparticularly ~~will~~those ~~need~~in tothe ~~continue~~biotechnology ~~broadening~~field. ~~our~~Shareholders ~~focus from~~should acarefully ~~research~~consider the risks and ~~development~~uncertainties ~~company~~that to a ~~company~~business ~~capable~~with oflimited ~~supporting~~operating ~~clinical~~history ~~trials~~will ~~and~~face. ~~commercial~~In ~~activities~~particular, orshareholders ~~enter~~should ~~into~~consider ~~collaborations~~that ~~with~~there ~~partners~~is ~~that~~a ~~may~~significant ~~provide~~risk ~~those~~that ~~capabilities.~~we Wewill ~~may~~ not be able to ~~reach such achievements, which would have a material adverse effect on our Company.~~:

11● successfully enroll sufficient numbers of qualified patients to participate in our clinical trials; ● obtain sufficient quantity and quality of materials manufactured for use in our clinical trials; ● successfully meet the primary endpoints in our clinical trials; ● implement or execute our current business plan; ● raise sufficient funds in the capital markets or otherwise to fully effectuate our business plan; ● maintain our management team; ● determine that the processes and technologies that we have developed or will develop are commercially viable; and/or ● attract, enter into or maintain contracts with potential commercial partners such as licensors of technology and suppliers or licensees of our technologies.

~~Our~~Any of ~~current~~the ~~business~~foregoing ~~model relies~~risks onmay ~~strategic~~adversely ~~collaborations~~affect ~~with~~the ~~commercial~~Company ~~partners~~and toresult ~~provide~~in the ~~resources~~failure ~~and~~of ~~infrastructure~~our tobusiness. ~~manufacture~~In ~~and~~addition, ~~ultimately~~we expect to encounter ~~market~~unforeseen expenses, difficulties, complications, delays and~~/or~~ ~~sell~~other ~~our~~known ~~technologies~~and unknown factors. WeOver ~~may~~the ~~have~~next ~~difficulty~~several inquarters, ~~timing~~we ~~the~~will need ~~establishment~~to ofcontinue ~~these~~broadening ~~partnerships~~our focus from a research and development company to ~~achieve~~a ~~the~~company ~~greatest economic~~capable ~~benefit~~of ~~for~~supporting ~~the~~clinical ~~Company~~trials and commercial activities, or inenter ~~establishing~~into ~~these~~collaborations ~~partnerships~~with atpartners ~~all~~that may provide those capabilities. We may not be able to reach such achievements, which would have a material adverse effect on our Company.

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

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

~~We will face an inherent risk~~If of product liability aslawsuits ~~a result of the ongoing and upcoming human clinical testing and commercialization of our product candidates. For example, we may be sued if our product candidates cause or~~ are ~~perceived~~brought toagainst ~~cause injury or are found to be otherwise unsuitable during clinical testing~~us, manufacturing, marketing or sale. Any such product liability claims may include allegations of defects in manufacturing, defects in design, a failure to warn of dangers inherent in the product, negligence, strict liability or a breach of warranties. Claims could also be asserted under state consumer protection acts. If we ~~cannot successfully defend ourselves against product liability claims, we~~ may incur substantial liabilities orand may be required to limit ~~or cease~~ commercialization of our product candidates. ~~Even successful defense would require significant financial and management resources. Regardless of the merits or eventual outcome, liability claims may result in:~~

●We will ~~decreased~~face ~~demand~~an ~~for~~inherent risk of product liability as a result of the ongoing and upcoming human clinical testing and commercialization of our product candidates;. ●For ~~injury~~example, towe may be sued if our ~~reputation;~~product ●candidates ~~withdrawal~~cause ofor are perceived to cause injury or are found to be otherwise unsuitable during clinical ~~trial~~testing, ~~participants;~~manufacturing, ●marketing ~~initiation~~or sale. Any such product liability claims may include allegations of ~~investigations~~defects byin ~~regulators;~~manufacturing, ●defects ~~costs~~in design, a failure to ~~defend~~warn of dangers inherent in the ~~related~~product, ~~litigation;~~negligence, ●strict liability or a ~~diversion~~breach of ~~management’s~~warranties. ~~time~~Claims ~~and~~could ~~our~~also ~~resources;~~be ●asserted ~~substantial~~under ~~monetary~~state ~~awards~~consumer toprotection ~~clinical~~acts. ~~trial~~If ~~participants~~we orcannot ~~patients;~~successfully ●defend ourselves against product ~~recalls~~liability claims, ~~withdrawals~~we ormay ~~labeling,~~incur ~~marketing~~substantial liabilities or ~~promotional~~be ~~restrictions;~~required ●to ~~loss~~limit ofor ~~potential~~cease ~~revenue;~~commercialization ~~● exhaustion~~ of ~~any~~our ~~available~~product candidates. ~~insurance~~Even ~~and~~successful ~~our~~defense ~~capital~~would ~~resources;~~require ●significant ~~the~~financial ~~inability~~and tomanagement ~~commercialize~~resources. ~~any~~Regardless ~~product~~of ~~candidate;~~the ~~and~~merits ●or aeventual outcome, ~~decline~~liability inclaims ~~our~~may ~~share~~result ~~price.~~in:

~~While~~● wedecreased ~~carry~~demand ~~product~~for ~~liability insurance,~~our ~~claims could be asserted that could result in damages in excess of such insurance coverage. If we do not maintain sufficient~~ product ~~liability~~candidates; ~~insurance~~● atinjury ~~an acceptable cost~~ to ~~protect~~our ~~against~~reputation; ~~potential~~● ~~product~~withdrawal ~~liability claims, the lack~~ of ~~sufficient~~clinical ~~coverage could~~trial ~~prevent~~participants; or● ~~inhibit~~initiation ~~the development and commercialization~~ of ~~any~~investigations ~~products~~by ~~we develop, alone or with corporate collaborators.~~regulators;

~~If we cannot license rights to use technologies on reasonable terms, we may not be able to commercialize new products in the future.~~11

In● ~~the~~costs ~~future, we may identify third-party technology we need, including~~ to ~~develop~~defend orthe ~~commercialize~~related ~~new~~litigation; ~~products~~● ora ~~services.~~diversion ~~In return for the use~~ of ~~a third party~~management’s ~~technology,~~ wetime ~~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~~resources; or● ~~services.~~substantial Wemonetary ~~may~~awards ~~also need~~ to ~~negotiate~~clinical ~~licenses~~trial toparticipants ~~patents~~ or ~~patent~~patients; ~~applications before~~● ~~or after introducing a commercial~~ product. Werecalls, ~~may~~withdrawals ~~not be able to obtain necessary licenses to patents~~ or ~~patent applications~~labeling, ~~and our~~marketing ~~business~~or ~~may~~promotional ~~suffer~~restrictions; if● weloss ~~are~~of ~~unable~~potential torevenue; ~~enter~~● ~~into~~exhaustion ~~the~~of ~~necessary licenses on acceptable terms or at all, if~~ any ~~necessary~~available ~~licenses are~~insurance ~~subsequently~~and ~~terminated,~~our ifcapital ~~the~~resources; ~~licensors~~● ~~fail to abide by~~ the ~~terms~~inability ~~of the licenses or fail~~ to ~~prevent~~commercialize ~~infringement~~any byproduct ~~third~~candidate; ~~parties, or~~and if● ~~the~~a ~~licensed~~decline ~~patents~~in orour ~~other~~share ~~rights are found to be invalid or unenforceable~~price.

12While we carry product liability insurance, claims could be asserted that could result in damages in excess of such insurance coverage. If we 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 with corporate collaborators.

~~Biotechnology and pharmaceutical~~If ~~product~~we ~~development~~cannot islicense arights ~~highly~~to ~~speculative~~use ~~undertaking~~technologies ~~and~~on ~~involves~~reasonable aterms, ~~substantial~~we ~~degree~~may ofnot ~~uncertainty.~~be Weable ~~have~~to ~~never~~commercialize ~~generated~~new ~~any revenue from biotechnology and pharmaceutical product sales and our biotechnology and pharmaceutical~~ products ~~may~~in ~~never~~the ~~be profitable~~future.

WeIn the ~~are~~future, inwe ~~the~~may ~~early~~identify ~~discovery stage~~third-party oftechnology ~~developing~~we ~~vaccines~~need, ~~against~~including ~~high-incidence~~to ~~malignancies~~develop ~~such~~or ascommercialize ~~lung,~~new ~~colon~~products ~~and~~or ~~prostate~~services. ~~cancers,~~In inreturn for the ~~pre-clinical~~use ~~stage~~ of ~~developing~~ ~~our~~a ~~ovarian~~third ~~cancer~~party’s ~~vaccine~~ technology, ~~and~~we inmay agree to pay the ~~clinical~~licensor ~~stage~~royalties ~~with~~based on sales of our ~~CAR-T~~products ~~therapeutic~~or ~~technology~~services. Royalties are a component of cost of products or services and ~~with~~affect the margins on our ~~breast~~products ~~cancer vaccine~~or ~~technology~~services. ~~Our~~We ~~ability~~may also need to ~~generate~~negotiate licenses ~~revenue~~to ~~depends~~patents inor ~~large~~patent ~~part~~applications onbefore ~~our~~or ~~ability,~~after ~~alone~~introducing ora ~~with~~commercial ~~partners,~~product. We may not be able to ~~successfully~~obtain ~~complete~~necessary licenses ~~the~~to ~~development~~patents ofor patent applications, ~~obtain~~and our business may suffer if we are unable to enter into the necessary ~~regulatory~~licenses ~~approvals~~on ~~for,~~acceptable ~~and~~terms or ~~commercialize~~at all, ~~product~~if ~~candidates.~~any Wenecessary dolicenses ~~not~~are ~~anticipate~~subsequently ~~generating revenues~~terminated, ~~from~~if ~~sales~~the oflicensors ~~such~~fail ~~products~~to ~~for~~abide by the ~~foreseeable~~terms ~~future.~~of ~~Our~~the ~~ability~~licenses or fail to ~~generate~~prevent ~~future~~infringement ~~revenues~~by ~~from~~third ~~product~~parties, ~~sales~~or ofif ~~our~~the ~~technologies depends~~licensed ~~heavily~~patents onor ~~our~~other ~~success~~rights ~~in:~~are found to be invalid or unenforceable.

● progressing our discovery stage programs into pre-clinical testing; ● progressing our pre-clinical programs into human clinical trials; ● completing requisite clinical trials through all phases of clinical development of our product candidates; ● seeking Biotechnology and ~~obtaining~~pharmaceutical ~~marketing approvals for our~~ product ~~candidates~~development ~~that~~is ~~successfully~~a ~~complete~~highly ~~clinical~~speculative ~~trials,~~undertaking ~~if any; ● launching~~ and ~~commercializing~~involves ~~our~~a ~~product~~substantial ~~candidates~~degree ~~for~~of ~~which~~uncertainty. weWe ~~obtain~~have never ~~marketing~~generated ~~approval, if~~ any, ~~with~~revenue afrom ~~partner~~biotechnology ~~or, if launched independently, successfully establishing a manufacturing, sales force, marketing~~ and ~~distribution~~pharmaceutical ~~infrastructure; ● identifying and developing new~~ product ~~candidates;~~sales ~~● establishing~~ and ~~maintaining supply and manufacturing relationships with third parties; ● maintaining, protecting, expanding and enforcing~~ our ~~intellectual~~biotechnology ~~property;~~ and ●pharmaceutical ~~attracting,~~products ~~hiring~~may never ~~and~~be ~~retaining qualified personnel~~profitable.

~~Because of the numerous risks~~We ~~and uncertainties associated with biologic and pharmaceutical product development, we~~ are ~~unable~~in ~~to predict~~ the ~~likelihood~~early ordiscovery ~~timing~~stage ~~for when we may receive regulatory approval~~ of ~~our~~developing ~~product~~vaccines ~~candidates~~against orhigh-incidence ~~when~~malignancies wesuch ~~will~~as belung, ~~able~~colon toand ~~achieve~~prostate ~~or maintain profitability~~cancers, ~~if ever.~~ Ifin wethe ~~are~~pre-clinical ~~unable~~stage toof ~~establish~~developing aour ~~development~~ovarian ~~and~~cancer orvaccine ~~commercialization~~technology ~~partnership,~~and orin dothe ~~not~~clinical ~~receive~~stage ~~regulatory~~with ~~approvals,~~ our ~~business, prospects,~~CAR-T ~~financial~~therapeutic ~~condition~~ technology and ~~results~~with ofour ~~operations~~breast ~~will~~cancer bevaccine ~~adversely affected~~technology. ~~Even~~Our ifability ~~we or a partner obtain the regulatory approvals~~ to ~~market~~generate ~~and~~revenue ~~sell~~depends ~~one~~in orlarge ~~more~~part ofon our ~~product candidates~~ability, wealone ~~may~~or ~~never~~with ~~generate~~partners, to ~~significant~~successfully ~~revenues~~complete ~~from~~the ~~any~~development ~~commercial sales for several reasons~~of, ~~including~~obtain ~~because~~ the ~~market~~necessary ~~for~~regulatory ~~our~~approvals ~~products~~for, ~~may~~and ~~be smaller than we anticipate~~commercialize, orproduct ~~products~~candidates. ~~may~~We do not beanticipate ~~adopted~~generating byrevenues ~~physicians and~~from ~~payors~~sales orof ~~because~~such ~~our~~ products ~~may~~for ~~not~~the beforeseeable ~~as efficacious or safe as other treatment options~~future. IfOur weability ~~fail~~ to ~~successfully commercialize one or more products, by ourselves or through a partner, we may be unable to~~ generate ~~sufficient~~future revenues from toproduct ~~sustain~~sales ~~and~~of ~~grow~~ our ~~business and~~technologies ~~our~~depends ~~business,~~heavily ~~prospects,~~on ~~financial~~our ~~condition~~success ~~and results of operations will be adversely affected.~~in:

~~Cancer~~● ~~vaccines~~progressing ~~are~~our ~~novel~~ discovery stage programs into pre-clinical testing; ● progressing our pre-clinical programs into human clinical trials; ● completing requisite clinical trials through all phases of clinical development of our product candidates; ● seeking and ~~present~~obtaining ~~significant~~marketing ~~challenges~~approvals for our product candidates that successfully complete clinical trials, if any; ● launching and commercializing our product candidates for which we obtain marketing approval, if any, with a partner or, if launched independently, successfully establishing a manufacturing, sales force, marketing and distribution infrastructure; ● identifying and developing new product candidates; ● establishing and maintaining supply and manufacturing relationships with third parties; ● maintaining, protecting, expanding and enforcing our intellectual property; and ● attracting, hiring and retaining qualified personnel.

~~The~~Because of ~~development~~the ofnumerous ~~preventive~~ risks and ~~therapeutic~~uncertainties ~~cancer~~associated ~~vaccines~~with isbiologic ~~difficult,~~and ~~with~~pharmaceutical ~~very~~product ~~few~~development, ~~cancer~~we ~~vaccines~~are ~~successfully~~unable ~~reaching~~to predict the likelihood ~~market.~~or ~~The~~timing ~~only~~for ~~vaccines~~when ~~shown to~~we bemay ~~effective~~receive inregulatory ~~preventing~~approval ~~cancer~~of ~~have~~our ~~been~~product ~~vaccines~~candidates ~~against~~or ~~cancer~~when ~~causing~~we ~~agents,~~will ~~not~~be ~~the~~able ~~cancer~~to ~~itself~~achieve or maintain profitability, if ever. ~~Vaccines~~If ~~work~~we byare ~~exposing~~ unable to establish a ~~benign~~development ~~form~~and ofor acommercialization ~~disease~~partnership, ~~agent~~or todo annot ~~individual’s~~receive ~~immune~~regulatory approvals, ~~system~~our business, prospects, financial condition and results of operations will be adversely affected. ~~The~~Even ~~immune~~if ~~system~~we ~~identifies~~or ~~the~~a ~~agent~~partner obtain ~~and~~the ~~learns~~regulatory approvals to ~~attack~~market and ~~destroy~~ ~~it,~~sell ~~retaining~~one aor ~~memory~~more of ~~the~~our ~~agent~~product socandidates, ~~the~~we ~~immune~~may ~~system~~never ~~knows~~generate tosignificant ~~react~~revenues from ~~quickly~~any ifcommercial ansales ~~individual~~for isseveral ~~exposed~~reasons, toincluding because the ~~disease~~market ~~agent months~~for orour ~~years~~products ~~later.~~may ~~Most~~be ~~vaccines~~smaller ~~attack~~than ~~pathogens~~we anticipate, ~~such~~or asproducts may ~~viruses~~not ~~and~~be ~~bacteria.~~adopted ~~The~~by ~~immune~~physicians ~~system~~and ispayors ~~better~~or ~~able~~because toour ~~assail~~products ~~these agents~~may ~~because~~not ~~they~~be ~~come~~as ~~from~~efficacious ~~outside~~or ~~the~~safe ~~body.~~as ~~Cancer,~~other ~~however,~~treatment isoptions. ~~caused~~If we byfail ~~aberrant~~to ~~cells~~successfully ~~that~~commercialize ~~arise~~one ~~out~~or ofmore ~~our~~products, ~~resident~~by ~~cells,~~ourselves ~~which can~~or ~~make~~through ita ~~difficult~~partner, ~~for~~we ~~our~~may ~~immune~~be ~~system~~unable to ~~find~~generate ~~the~~sufficient revenues ~~diseased~~to ~~cells,~~sustain ~~especially~~and asgrow ~~advancing~~our ~~age~~business ~~weakens~~and our ~~immune~~business, ~~system.~~prospects, ~~Once~~financial ~~these aberrant~~condition ~~cells~~and ~~gain~~results ~~critical~~of ~~mass,~~operations ~~they~~will ~~become~~be ~~cancer~~adversely affected.

1312

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

~~CAR-T~~The development ~~product~~of ~~candidates~~preventive ~~represent~~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 ~~relatively~~benign ~~new~~form ~~field~~of a disease agent to an individual’s immune system. The immune system identifies the agent and learns to attack and destroy it, retaining a memory of ~~cellular~~the ~~immunotherapy~~agent so the immune system knows to react quickly if an individual is exposed to the disease agent months or years later. ~~Advancing~~Most ~~this~~vaccines ~~novel~~attack pathogens, such as viruses and ~~personalized~~bacteria. ~~therapy~~The ~~creates~~immune ~~significant~~system ~~challenges~~is better able to assail these agents because they come from outside the body. Cancer, however, is caused by aberrant cells that arise out of our resident cells, which can make it difficult for usour immune system to find the diseased cells, especially as advancing age weakens orour aimmune ~~partner~~system. Once these aberrant cells gain critical mass, ~~including:~~they become cancer.

~~● obtaining regulatory approval, as the FDA and other regulatory authorities have limited experience with commercial development of~~ CAR-T cell therapies ~~for~~are cancer; ● sourcing clinical and, if approved, commercial supplies for the materials used to manufacture and process our product candidates; ● developing a consistent and reliable process, while limiting contamination risks, for engineering and manufacturing T cells ex vivo and infusing the engineered T cells into the patient; ● educating medical personnel regarding the potential benefits, as well as the challenges, of incorporating our product candidates into their treatment regimens; ● establishing sales and marketing capabilities upon obtaining any regulatory approval to gain market acceptance of a novel ~~therapy;~~ and ●present ~~the~~significant ~~availability of coverage and adequate reimbursement from third-party payors for our novel and personalized therapy~~challenges.

~~Our inability to successfully develop~~ CAR-T product ~~cell~~candidates ~~therapies~~represent ora ~~develop~~relatively ~~processes~~new ~~related~~field toof ~~the~~cellular ~~manufacture,~~immunotherapy. ~~sales~~Advancing ~~and~~this ~~marketing~~novel ofand ~~these~~personalized ~~therapies~~therapy ~~would~~creates significant ~~adversely~~challenges ~~affect our~~for ~~business~~us, ~~results~~or ofa ~~operations~~partner, ~~and prospects.~~including:

~~While~~● ~~CAR-T~~obtaining ~~technology~~regulatory ~~has shown~~approval, ~~positive~~as ~~results~~the inFDA Band other regulatory authorities have limited experience with commercial development of T cell ~~cancers~~therapies byfor ~~others~~cancer; ● sourcing clinical and, ~~its~~if ~~safety~~approved, commercial supplies for the materials used to manufacture and ~~efficacy~~process ~~has~~our ~~not~~product ~~been~~candidates; ~~seen~~● indeveloping ~~solid~~a ~~tumors~~consistent and wereliable ~~cannot~~process, ~~guarantee our~~while ~~CAR-~~limiting contamination risks, for engineering and manufacturing T ~~technology~~cells ~~will~~ex bevivo ~~safe~~and orinfusing ~~effective~~the inengineered ~~ovarian~~T orcells ~~other~~into ~~cancers~~the patient; ● educating medical personnel regarding the potential benefits, as well as the challenges, of incorporating our product candidates into their treatment regimens; ● establishing sales and marketing capabilities upon obtaining any regulatory approval to gain market acceptance of a novel therapy; and ● the availability of coverage and adequate reimbursement from third-party payors for our novel and personalized therapy.

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

While ~~pre~~ CAR-~~clinical~~T ~~testing and~~technology ~~the~~has ~~limited~~shown ~~human~~positive ~~clinical~~results ~~testing~~in ofB ~~our~~cell ~~product~~cancers ~~candidates~~by others, its safety and efficacy has not been ~~positive,~~seen in solid tumors and we ~~may~~cannot ~~experience~~guarantee ~~unfavorable~~our ~~results~~CAR-T ~~once~~technology wewill ~~collect statistically~~be ~~significant~~safe ~~data~~or ~~from~~effective ~~human~~in ~~clinical~~ovarian ~~trials~~or other cancers.

WeCAR-T therapies ~~have~~function ~~limited~~through ~~human~~the ~~clinical data~~binding ~~from~~of ~~our~~a ~~breast~~genetically ~~cancer~~engineered ~~vaccine~~killer ~~and~~T ~~our~~cell ~~CAR-T~~to ~~ovarian~~a cancer ~~therapeutic~~cell. However, ~~and~~these weengineered ~~have~~T ~~not~~cells destroy ~~initiated~~the ~~clinical~~cell ~~trials~~they ~~for~~are ~~our~~bound ~~ovarian cancer~~to ~~vaccine~~whether ~~and~~it weis ~~may~~a ~~not~~cancer becell ~~able~~or toa ~~commence~~healthy ~~clinical~~cell. ~~trials~~Therefore, on the ~~time~~engineered ~~frames~~T wecells ~~expect.~~must ~~Further,~~be ~~our~~designed to ~~new~~only ~~vaccine~~bind ~~research~~to ~~programs in~~either ~~high-incidence~~cancer ~~cancers~~cells ofor ~~the~~other ~~lung,~~target ~~colon~~cells ~~and~~to ~~prostate~~minimize ~~are~~toxicity. inOur ~~the~~CAR-T ~~early~~technology ~~discovery~~relies ~~stage,~~on ~~and~~the ~~have~~natural ~~generated~~affinity noof FSH ~~data~~ to ~~date~~FSH-Receptor. AsResearch ~~our pre-clinical~~by ~~stage~~others ~~product candidate~~ has ~~only~~shown ~~been~~that ~~tested~~ in ~~animals~~women ~~and~~the ~~our~~FSH-Receptor ~~clinical~~protein ~~stage~~is ~~candidates~~found ~~currently~~on ~~have~~ovary ~~limited~~cells ~~human data, we face significant uncertainty regarding how effective~~ and ~~safe~~generally ~~they will be~~ in ~~human~~no other ~~patients~~healthy tissue, and ~~the~~therefore, ~~results~~we ~~from~~engineer ~~pre-clinical~~our ~~studies may~~T ~~not~~cells bewith ~~indicative of the results of clinical trials~~FSH. ~~Pre-clinical~~However, ~~and~~as ~~clinical~~the ~~data~~research ~~are~~in ~~often~~this ~~susceptible~~field tois ~~varying~~still ~~interpretations and analyses~~new, ~~and~~we ~~many~~cannot guarantee ~~companies~~ that ~~have~~there ~~believed~~is ~~their~~no ~~product candidates performed satisfactorily in pre~~FSH-~~clinical~~Receptor ~~studies~~on ~~and~~any ~~clinical trials~~other ~~have~~healthy ~~nonetheless~~tissue ~~failed~~in tothe ~~obtain~~human ~~marketing approval for their products~~body.

~~Even if~~ While pre-clinical ~~trials~~testing ~~are~~and ~~successfully completed,~~ the ~~FDA~~limited orhuman ~~foreign regulatory authorities may not interpret the results as we do, and more~~ clinical ~~trials~~testing ~~could~~of ~~be required before we submit~~ our product candidates ~~for~~has ~~approval.~~been ~~To the extent that the results of our clinical trials are not satisfactory to the FDA or foreign regulatory authorities for support of a marketing application~~positive, ~~approval~~we ~~of our product candidates~~ may beexperience ~~significantly~~unfavorable ~~delayed,~~results oronce we ~~may~~collect bestatistically ~~required to expend~~ significant ~~additional~~data ~~resources,~~from ~~which~~human ~~may not be available to us, to conduct additional~~ clinical ~~trials~~ ~~in support of potential approval of our product candidates~~trials.

1413

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

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

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

~~Switching~~We depend orand ~~adding~~will ~~third~~continue ~~parties~~to depend upon independent investigators and collaborators, such as universities, medical institutions, and strategic partners such as Moffitt for lira-cel and Cleveland Clinic for our cancer vaccines to conduct our pre-clinical studies and clinical trials ~~involves~~under ~~substantial~~agreements ~~cost~~with us. Negotiations of budgets and ~~requires~~contracts ~~extensive~~with ~~management~~study ~~time~~sites may result in delays to our development timelines and ~~focus~~increased costs. InWe ~~addition~~will rely heavily on these third parties over the course of our clinical trials, ~~there~~and we control only certain aspects of their activities. Nevertheless, we are responsible for ensuring that each of our studies is aconducted ~~natural~~in accordance ~~transition~~with ~~period~~applicable ~~when~~protocol, alegal, ~~new~~regulatory and scientific standards, and our reliance on third ~~party~~parties ~~commences~~does ~~work~~not relieve us of our regulatory responsibilities. AsWe aand ~~result~~these third parties are required to comply with current good clinical practices, ~~delays~~or ~~occur~~cGCPs, which ~~can~~are ~~materially~~regulations and ~~impact~~guidelines enforced by the FDA and comparable foreign regulatory authorities for product candidates in clinical development. Regulatory authorities enforce these cGCPs through periodic inspections of clinical trial sponsors, principal investigators and clinical trial sites. If we or any of these third parties fail to comply with applicable cGCP regulations, the clinical data generated in our ~~ability~~clinical trials may be deemed unreliable and the FDA or comparable foreign regulatory authorities could require us to ~~meet~~perform additional clinical trials before approving our marketing applications. It is possible that, upon inspection, such regulatory authorities could determine that any ~~desired~~of our clinical ~~development~~trials ~~timelines~~fail to comply with the cGCP regulations. In addition, our clinical trials must be conducted with biologic product produced under current good manufacturing practices, or cGMPs, and will require a large number of test patients. Our failure or any failure by these third parties to comply with these regulations or to recruit a sufficient number of patients may require us to repeat clinical trials, which would delay the regulatory approval process. Moreover, our business may be implicated if any of these third parties violates federal or state fraud and abuse or false claims laws and regulations or healthcare privacy and security laws.

IfAny third weparties ~~encounter~~conducting ~~difficulties~~our clinical trials are not and will not be our employees and, except for remedies available to us under our ~~enrolling~~agreements ~~patients~~with inthese third parties, we cannot control whether they devote sufficient time and resources to our ongoing pre-clinical, clinical ~~trials~~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 our behalf. If these third parties do not successfully carry out their contractual duties or obligations or meet expected deadlines, if they need to be replaced or if the quality or accuracy of the clinical data they obtain is compromised due to the failure to adhere to our clinical protocols or regulatory requirements or for other reasons, our clinical trials may be extended, delayed or ~~otherwise~~terminated ~~adversely~~and ~~affected~~we may not be able to complete development of, obtain regulatory approval of or successfully commercialize our product candidates. As a result, our financial results and the commercial prospects for our product candidates would be harmed, our costs could increase and our ability to generate revenue could be delayed.

We may experience difficulties in patient enrollment in our clinical trials for a variety of reasons. The timely completion of clinical trials in accordance with their protocols depends, among other things, on our ability to enroll a sufficient number of patients who remain in the study until its conclusion. The enrollment of patients depends on many factors, including:14

●Switching or ~~the~~adding ~~patient~~third ~~eligibility~~parties ~~criteria~~to ~~defined~~conduct inour ~~the~~ clinical ~~trial~~trials ~~protocol;~~involves ●substantial ~~the~~cost ~~size~~and ofrequires ~~the~~extensive ~~patient~~management ~~population~~time ~~required~~and ~~for~~focus. ~~analysis~~In addition, ofthere ~~the~~is ~~trial’s~~a ~~primary~~natural ~~endpoints;~~transition ●period ~~the~~when ~~proximity~~a ofnew ~~patients~~third toparty ~~the~~commences ~~study~~work. ~~site;~~As ●a ~~the~~result, ~~design~~delays ofoccur, ~~the~~which ~~clinical~~can ~~trial;~~materially impact ● our ability to ~~retain~~meet ~~clinical trial investigators with the appropriate competencies and experience; ●~~ our ~~ability~~desired ~~to obtain and maintain patient consents; ● the risk that patients enrolled in~~ clinical ~~trials~~development ~~will drop out of the clinical trials before completion; and ● competing clinical trials and approved therapies available for patients~~timelines.

15If we encounter difficulties enrolling patients in our clinical trials, our clinical development activities could be delayed or otherwise adversely affected.

~~In particular, our Phase 1 CAR-T~~We ~~ovarian~~may ~~cancer~~experience ~~clinical~~difficulties ~~trial~~in ispatient ~~enrolling~~enrollment ~~patients~~in ~~with~~our ~~late-stage ovarian cancer who have failed conventional treatment, and are willing and able to be treated at Moffitt. Our Phase 1a breast cancer vaccine~~ clinical ~~trial~~trials isfor ~~enrolling~~a ~~patients~~variety ~~who have undergone standard~~ of ~~care treatment for TNBC~~reasons. ~~Our~~The ~~Phase~~timely 1bcompletion ~~breast~~of ~~cancer vaccine~~ clinical trials ~~trial~~in isaccordance ~~enrolling~~with ~~healthy~~their ~~women~~protocols ~~who~~depends, ~~as a result of,~~ among other things, ~~testing~~on ~~positive~~our ~~for~~ability ~~the~~to ~~BRCA1,~~enroll ~~BRCA2~~a orsufficient ~~PALB2~~number ~~gene mutations which are leading predictors~~ of ~~future~~patients ~~incidence~~who ~~of breast cancer,~~remain ~~have~~in ~~elected~~the tostudy ~~have~~until ~~prophylactic~~its ~~mastectomies~~conclusion. ~~Our~~The ~~Phase~~enrollment 1cof ~~breast cancer vaccine clinical trial is enrolling post-operative TNBC~~ patients ~~who~~ ~~have~~depends ~~residual~~on ~~disease~~many ~~following~~factors, ~~neoadjuvant chemo-immunotherapy and are being treated with pembrolizumab (Keytruda®). These potential trial participants must be willing and able to undergo treatment at the Cleveland Clinic.~~including:

~~Our~~● ~~clinical~~the ~~trials~~patient ~~will~~eligibility ~~compete with~~criteria ~~other~~defined ~~companies’~~in the clinical ~~trials~~trial ~~for~~protocol; ~~product~~● ~~candidates~~the ~~that~~size ~~are~~of in the ~~same~~patient ~~therapeutic~~population ~~areas~~required asfor ~~our~~analysis ~~product~~of ~~candidates,~~the ~~and this~~trial’s ~~competition~~primary ~~will~~endpoints; ~~reduce~~● the ~~number~~proximity ~~and types~~ of patients ~~available~~ to ~~us,~~the ~~because~~study ~~some~~site; ~~patients~~● ~~who~~the ~~might~~design ~~have~~of ~~opted~~the ~~to enroll in our~~ clinical ~~trials may instead opt to enroll in a~~ trial; ~~being~~● ~~conducted by one of~~ our ~~competitors.~~ability ~~We expect~~ to ~~conduct~~retain ~~our~~ clinical ~~trials~~ ~~at the same clinical~~ trial ~~sites~~investigators ~~that~~with ~~some of our competitors may use, which will reduce~~ the ~~number~~appropriate ofcompetencies ~~patients~~and ~~who~~experience; ~~are~~● ~~available for~~ our ~~clinical~~ability ~~trial~~to inobtain ~~these clinical trial sites. Moreover, because our product candidates represent a departure from more commonly used methods for cancer treatment, potential patients~~ and ~~their~~maintain ~~doctors~~patient ~~may~~consents; be● ~~inclined~~the torisk ~~use experimental therapies~~ that ~~use conventional technologies, such as chemotherapy and antibody therapy, rather than enroll~~ patients enrolled in ~~our~~ clinical trials. ~~Patients~~will ~~may~~drop ~~also~~out beof ~~unwilling to~~the ~~participate in our~~ clinical trials ~~because~~before ofcompletion; ~~negative~~and ~~publicity~~● ~~from~~competing ~~adverse~~clinical ~~events~~trials inand ~~the~~approved ~~biotechnology~~therapies oravailable ~~gene~~for ~~therapy industries~~patients.

~~Delays in patient enrollment may~~In ~~result~~particular, inour ~~increased~~Phase ~~costs~~1 orclinical ~~may~~trial ~~affect the timing or outcome~~ of ~~our~~lira-cel ~~planned~~is ~~clinical~~enrolling ~~trials,~~patients ~~which~~with ~~could~~late-stage ~~prevent~~ovarian ~~completion~~cancer ofwho ~~the~~have ~~clinical~~failed conventional ~~trials~~treatment, and ~~adversely~~are ~~affect~~willing ~~our~~and ~~ability~~able to ~~advance~~undergo ~~the~~treatment ~~development~~at ~~of our ovarian cancer CAR-T therapy and our breast cancer vaccine~~Moffitt.

~~Any~~Our clinical ~~adverse~~trials ~~developments~~ will compete with other companies’ clinical trials for product candidates that ~~occur~~are ~~during~~in ~~any~~the same therapeutic areas as our product candidates, and this competition will reduce the number and types of patients available to us, because some patients who might have opted to enroll in our clinical trials may instead opt to enroll in a trial being conducted by ~~academic~~one ~~investigators,~~of our ~~collaborators~~competitors. orWe expect ~~other~~to ~~entities~~conduct ~~conducting~~our clinical trials ~~under~~ ~~independent~~at ~~IND~~the ~~applications~~same clinical trial sites that some of our competitors may ~~negatively~~use, ~~affect~~which ~~the~~will ~~conduct~~reduce the number of patients who are available for our clinical ~~trials~~trial orin these clinical trial sites. Moreover, because our ~~ability~~product candidates represent a departure from more commonly used methods for cancer treatment, potential patients and their doctors may be inclined to ~~obtain~~use ~~regulatory~~experimental therapies ~~approvals~~that use conventional technologies, such as chemotherapy and antibody therapy, rather than enroll patients in our clinical ortrials. ~~commercialize~~Patients may also be unwilling to participate in our ~~product~~clinical ~~candidates~~trials because of negative publicity from adverse events in the biotechnology or gene therapy industries.

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

~~Adverse~~Any adverse ~~side~~developments ~~effects~~that occur during any clinical trials conducted by academic investigators, our collaborators or other ~~safety~~entities ~~risks~~conducting clinical ~~associated~~trials ~~with~~under ~~our~~independent ~~product~~IND ~~candidates~~applications ~~could~~may ~~cause~~negatively usaffect tothe ~~suspend~~conduct orof ~~discontinue~~our clinical trials or ~~delay~~our orability ~~preclude~~to obtain ~~approval~~regulatory approvals or commercialize our product candidates.

InCAR-T, vaccines and other immuno-therapy technologies are being used by third ~~party~~parties in clinical trials for which we are collaborating or in ~~involving~~clinical ~~CAR-T~~trials ~~cell~~which ~~therapies,~~are ~~the~~completely ~~most~~independent ~~prominent~~of ~~acute~~our ~~toxicities~~development ~~included~~programs. ~~symptoms~~We ~~thought~~have little to beno ~~associated~~control ~~with~~over the ~~release~~conduct of ~~cytokines,~~those ~~such~~clinical astrials. ~~fever,~~If ~~low~~serious ~~blood~~adverse ~~pressure~~events ~~and~~occur ~~kidney~~during ~~dysfunction.~~these ~~Some~~or ~~patients~~any ~~also~~other ~~experienced~~clinical ~~toxicity~~trials ofusing ~~the~~technologies ~~central~~similar ~~nervous~~to ~~system~~ours, ~~such~~the FDA asand ~~confusion,~~other ~~cranial~~regulatory ~~nerve~~authorities ~~dysfunction~~may ~~and~~delay ~~speech~~our ~~impairment.~~clinical ~~Adverse~~trial, ~~side~~or ~~effects~~could ~~attributed~~delay, tolimit ~~CAR-T~~or ~~therapies~~deny ~~were~~approval ~~severe~~of ~~and~~our ~~life-threatening~~product candidates or require inus ~~some~~to ~~patients.~~conduct ~~The~~additional ~~life-threatening~~clinical ~~events~~trials ~~were~~as ~~related~~a condition to ~~kidney~~marketing ~~dysfunction~~approval, ~~and~~which ~~toxicities~~would ofincrease ~~the~~our ~~central~~costs. ~~nervous~~If ~~system~~we orreceive ~~other~~regulatory ~~organ~~approval ~~failure.~~for ~~Severe~~any product candidate and ~~life-threatening~~a ~~toxicities~~new ~~occurred~~and ~~primarily~~serious safety issue is identified in connection with clinical trials conducted by third parties, the ~~first~~applicable ~~two~~regulatory ~~weeks~~authorities ~~after~~may ~~cell~~withdraw ~~infusion~~their ~~and~~approval ~~generally~~of ~~resolved~~our products or otherwise restrict our ability to market ~~within~~and ~~three~~sell ~~weeks~~our products. In ~~the past~~addition, ~~several~~treating ~~patients~~physicians ~~have~~may ~~also~~be ~~died~~less inwilling ~~clinical~~to ~~trials~~administer byour ~~others~~products ~~involving~~due ~~CAR-T~~to ~~cell~~concerns ~~therapies~~over such adverse events, which would limit our ability to commercialize our products.

Side effects of our breast cancer vaccine may include mild effects such as injection site pain or irritation, or more severe side effects such as fever, inflammation, organ failure or other adverse effects.15

16Adverse side effects or other safety risks associated with our product candidates could cause us to suspend or discontinue clinical trials or delay or preclude approval.

~~Undesirable side effects observed~~In inthird ~~our~~party clinical trials, ~~whether~~involving orCAR-T ~~not~~cell ~~they~~therapies, ~~are~~the ~~caused~~most byprominent ~~our~~acute ~~product~~toxicities ~~candidates,~~included ~~could~~symptoms ~~result~~thought into ~~the~~be ~~delay,~~associated with ~~suspension~~the orrelease ~~termination~~ of ~~clinical trials~~cytokines, bysuch ~~the~~as ~~FDA~~fever, orlow ~~other~~blood ~~regulatory~~pressure ~~authorities~~and orkidney usdysfunction. ~~for~~Some apatients ~~number~~also experienced toxicity of ~~reasons.~~the central Innervous ~~addition~~system, ~~because~~such ~~the~~as ~~patients~~confusion, ~~who~~cranial ~~will be~~nerve ~~enrolled~~dysfunction inand ~~our~~speech ~~clinical~~impairment. ~~trials~~Adverse ~~may~~side beeffects ~~suffering~~attributed ~~from~~to ~~a life~~CAR-~~threatening~~T therapies ~~disease~~were severe and ~~may~~life-threatening ~~often~~in besome ~~suffering~~patients. ~~from~~The ~~multiple~~life-threatening ~~complicating conditions~~events itwere ~~may~~related ~~be difficult~~ to ~~accurately~~kidney ~~assess~~dysfunction ~~the relationship between our product candidate~~ and ~~adverse events experienced by very~~toxicities ~~ill~~of ~~patients.~~the Ifcentral wenervous ~~elect~~system or ~~are~~other ~~required~~organ tofailure. ~~delay,~~Severe ~~suspend~~and orlife-threatening ~~terminate~~toxicities ~~any~~occurred ofprimarily ~~our~~in ~~clinical trials,~~ the ~~commercial~~first ~~prospects~~two ~~of such~~weeks ~~therapy~~after ~~will~~cell beinfusion ~~harmed~~ and ~~our~~generally ~~ability~~resolved towithin ~~generate~~three ~~product~~weeks. ~~revenues~~In ~~from~~the ~~such~~past, ~~therapy~~several ~~will~~patients behave ~~delayed~~also ordied ~~eliminated.~~in Inclinical ~~addition,~~trials ~~serious~~by others ~~adverse~~involving ~~events~~CAR-T ~~observed~~cell intherapies. ~~clinical~~While ~~trials~~we ~~could~~have ~~hinder~~not orobserved ~~prevent~~any ~~market~~adverse ~~acceptance~~side ofeffects ~~the~~in ~~product~~our ~~candidate~~clinical attrial ~~issue.~~of ~~Any~~lira-cel ofto ~~these~~date, ~~occurrences~~as we ~~may~~continue ~~harm~~dose ~~our business~~escalation, ~~prospects,~~future ~~financial~~trial ~~condition~~participants ~~and~~may ~~results~~experience ofadverse ~~operations~~side ~~significantly~~effects.

~~Clinical~~Side effects ~~trials~~of ~~are~~our ~~expensive~~breast cancer vaccine may include mild effects such as injection site pain or irritation, or more severe side effects ~~time~~such ~~consuming~~as ~~and~~fever, ~~difficult~~inflammation, organ failure or other adverse effects. In the Phase 1 clinical trial of our breast cancer vaccine, the side effects observed were limited to ~~design~~injection ~~and~~site ~~implement~~reactions.

~~Human~~Undesirable side effects observed in our clinical trials, ~~are~~whether ~~expensive and~~or ~~difficult~~not tothey ~~design~~are ~~and~~caused ~~implement~~by our product candidates, could result in ~~part~~the ~~because~~delay, ~~they~~suspension or ~~are~~termination ~~subject~~of toclinical ~~rigorous~~trials, by the FDA or other regulatory ~~requirements~~authorities or us for a number of reasons. ~~Because~~In ~~our~~addition, ~~CAR-T~~because ~~ovarian~~the ~~cancer~~patients ~~therapy~~who iswill ~~based~~be onenrolled ~~relatively~~in ~~new~~our ~~technology~~clinical ~~and~~trials ~~engineered~~may onbe suffering from a ~~patient~~life-~~by-patient~~threatening ~~basis,~~disease weand ~~expect~~may ~~that~~often itbe ~~will~~suffering ~~have substantial~~from ~~manufacturing~~multiple ~~and~~complicating ~~processing~~conditions ~~costs.~~it Inmay ~~addition,~~be ~~costs~~difficult to ~~treat~~accurately ~~patients~~assess ~~with~~the ~~relapsed/refractory~~relationship ~~cancer~~between ~~and~~our toproduct ~~treat~~candidate ~~potential~~and ~~side effects~~adverse ~~that~~events ~~may~~experienced ~~result~~by ~~from~~very ~~therapies~~ill ~~such~~patients. asIf ~~our~~we ~~current~~elect ~~and~~or ~~future~~are ~~product~~required ~~candidates~~to ~~can~~delay, besuspend ~~significant.~~or ~~Accordingly,~~terminate any of our clinical ~~trial~~trials, ~~costs~~the commercial ~~are~~prospects ~~likely~~of tosuch therapy will be ~~significantly~~harmed ~~higher~~and ~~than~~our ~~for~~ability ~~more~~to ~~conventional~~generate ~~therapeutic~~product ~~technologies~~revenues orfrom ~~drug~~such ~~products.~~therapy will be delayed or eliminated. In addition, ~~our~~serious ~~proposed personalized~~adverse ~~product~~events ~~candidates~~observed ~~involve~~in ~~several~~clinical ~~complex~~trials ~~and~~could ~~costly~~hinder ~~manufacturing~~or ~~and~~prevent ~~processing~~market ~~steps,~~acceptance of the ~~costs~~product candidate at issue. Any of ~~which~~these ~~will~~occurrences bemay ~~borne by~~harm usour business, prospects, financial condition and results of operations significantly.

~~In one of our breast cancer vaccine~~Vaccine ~~clinical trials~~hesitancy, wemisinformation ~~will~~about ~~treat~~vaccine ~~healthy women who~~safety, asand aevolving ~~result~~positions of ~~testing~~public ~~positive~~health ~~for~~authorities ~~certain~~on ~~gene~~vaccines ~~mutations,~~could ~~have~~adversely ~~elected to have prophylactic~~affect ~~mastectomies.~~the ~~Delivering~~development ~~an experimental treatment to a healthy individual is more complex~~ and ~~subject~~commercial tosuccess ~~more rigorous regulatory requirements and is more difficult to design and implement. In addition, in future clinical trials we will need to determine efficacy~~ of ~~the~~our ~~breast~~ cancer vaccine asproduct ~~a cancer prevention which will be a considerably more complex clinical trial and will have significantly greater costs~~candidates.

~~The~~Our cancer ~~costs~~vaccines depend on the willingness of ~~our~~patients, ~~clinical~~caregivers, ~~trials may~~physicians, ~~increase~~payors ifand ~~the~~regulators ~~FDA~~to ~~does~~accept ~~not~~vaccination ~~agree~~as ~~with~~a ~~our~~safe and ~~clinical~~effective ~~development~~approach ~~plans~~to preventing or ~~requires~~treating uscancer. toPublic ~~conduct~~confidence ~~additional~~in ~~clinical~~vaccines ~~trials~~has tobeen ~~demonstrate~~challenged in recent years by highly ~~the~~publicized debates about vaccine safety, ~~and~~the ~~efficacy~~spread of misinformation and disinformation on traditional and social media, and increasing skepticism toward public health institutions. These trends, often described collectively as “vaccine hesitancy,” could materially and adversely impact our ~~product~~ability ~~candidates~~to successfully develop, obtain regulatory approval for, and commercialize our cancer vaccines.

WeU.S. public ~~face~~health ~~significant~~authorities, ~~competition~~including the Department of Health and Human Services (“HHS”), the FDA, and the Centers for Disease ~~from~~Control ~~other~~and ~~biotechnology~~Prevention (“CDC”), have consistently stated that vaccines that meet regulatory standards are safe and ~~pharmaceutical~~effective, that ~~companies~~vaccination is one of the most important tools to prevent serious disease, and ~~our~~that ~~operating~~for ~~results~~licensed ~~will~~vaccines ~~suffer~~the benefits are expected to 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. Regulatory agencies may update product labeling, add warnings or contraindications, restrict indications or age groups, or modify recommended dosing schedules as new data emerge. Any such actions with respect to vaccines generally, or to products that use similar technologies or delivery platforms to ours, even if wenot ~~fail~~directly related to ~~compete~~our ~~effectively~~product candidates, could negatively affect public perception of vaccine safety and reduce willingness to receive our cancer vaccines.

~~The biopharmaceutical industry~~Negative ispublicity ~~characterized~~about byvaccine ~~intense~~safety, ~~competition~~whether ~~and~~accurate ~~rapid~~or ~~innovation.~~inaccurate, ~~Our~~could ~~competitors~~also ~~may~~reduce beenrollment ~~able~~and toretention ~~develop~~in ~~other~~our ~~compounds~~clinical ortrials, ~~drugs that are~~particularly ~~able~~if topatients ~~achieve similar~~ or ~~better~~investigators ~~results.~~are ~~Our~~reluctant ~~potential~~to ~~competitors~~participate ~~include~~in ~~major~~studies ~~multinational~~labeled ~~pharmaceutical~~as ~~companies~~“vaccine” trials, ~~established biotechnology~~or ~~companies,~~if ~~specialty~~competing ~~pharmaceutical~~cancer therapies ~~companies~~are ~~and~~perceived ~~universities~~as ~~and~~safer ~~other~~or ~~research~~more ~~institutions~~familiar. ~~Many~~Even ofif our ~~competitors have~~cancer ~~substantially~~vaccines ~~greater~~demonstrate ~~financial,~~an ~~technical~~acceptable ~~and~~safety ~~other~~profile ~~resources,~~in ~~such~~clinical ~~as larger research and development staff and experienced marketing~~trials and ~~manufacturing~~receive ~~organizations~~regulatory ~~and~~approval, ~~well-established~~vaccine ~~sales~~hesitancy ~~forces.~~could ~~Smaller~~limit orphysician ~~early-stage companies may also prove to be significant competitors~~prescribing, ~~particularly~~ ~~through~~patient ~~collaborative arrangements with large~~acceptance, ~~established companies. Mergers~~ and ~~acquisitions~~payor incoverage. ~~the~~This ~~biotechnology and pharmaceutical~~risk ~~industries~~ may ~~result~~be inheightened ~~even~~if ~~more resources being concentrated in~~ our ~~competitors.~~products ~~Competition~~are ~~may~~used ~~increase further as a result of advances~~ in ~~the~~earlier-stage ~~commercial~~disease, ~~applicability of technologies and greater availability of capital for investment~~ in ~~these~~adjuvant ~~industries.~~or ~~Our~~prophylactic ~~competitors~~settings, ~~either~~ ~~alone~~ or ~~with collaborative partners, may succeed~~ in ~~developing,~~combination ~~acquiring~~with ~~or licensing on an exclusive basis drug or biologic~~other ~~products that are more effective~~therapies, ~~safer,~~where ~~more~~both ~~easily~~patients ~~commercialized~~and orclinicians ~~less costly than our product candidates or~~ may ~~develop~~have ~~proprietary technologies~~lower ortolerance ~~secure patent protection that we may need~~ for ~~the~~perceived ~~development~~safety ofconcerns ~~our~~relative ~~technologies~~to ~~and~~expected ~~products~~benefit.

~~Cell-based therapies rely on the availability of specialty raw materials, which may not be available to us on acceptable terms or at all.~~16

~~Gene-modified~~Furthermore, evolving ~~cell~~recommendations, ~~therapy~~public ~~manufacturing requires~~statements, ~~many~~or ~~specialty~~guidance ~~raw~~from ~~materials~~HHS, ~~some~~FDA, ofCDC, ~~which~~or ~~are~~other ~~manufactured~~health byauthorities ~~small~~regarding ~~companies~~vaccine ~~with~~safety, ~~limited~~benefit-risk assessment, ~~resources~~or ~~and~~target ~~experience~~populations tomay ~~support a~~lead ~~commercial~~to ~~product.~~changes ~~Some~~in ~~suppliers~~standard-of-care ~~typically~~vaccination ~~support~~practices, ~~biomedical~~reimbursement ~~researchers~~policies, or ~~blood-based~~clinical trial ~~hospital~~design ~~businesses~~expectations ~~and~~that ~~may~~are ~~not~~difficult ~~have~~to ~~the capacity~~anticipate. toIf ~~support~~public ~~commercial~~health ~~products~~authorities ~~manufactured~~adopt ~~under~~more ~~cGMP~~conservative bypositions ~~biopharmaceutical~~toward ~~firms.~~vaccines or ~~The~~certain ~~suppliers~~vaccine ~~may~~technologies, beimpose ~~ill-equipped~~more tostringent ~~support our~~evidentiary ~~needs~~requirements, ~~especially~~or inprioritize ~~non-routine~~alternative ~~circumstances~~modalities ~~like~~for ~~FDA~~cancer ~~inspections~~ prevention or ~~medical crises~~treatment, ~~such~~our asdevelopment ~~widespread~~strategy ~~contamination.~~could Webecome ~~also~~less ~~do not~~attractive ~~have~~or ~~commercial~~more ~~supply~~costly ~~arrangements~~to ~~with~~pursue. ~~many~~Any of ~~these~~the ~~suppliers,~~foregoing ~~and~~could ~~may~~materially ~~not~~and adversely beaffect ~~able~~our ability to ~~contract~~obtain ~~with~~and ~~them~~maintain onregulatory ~~acceptable~~approvals ~~terms~~for ~~or at~~our ~~all.~~cancer ~~Accordingly~~vaccine candidates, wethe ~~may~~size ~~experience~~of ~~delays~~the inaddressable market ~~receiving~~for ~~key~~our ~~raw~~products, ~~materials~~and, toultimately, ~~support~~our ~~clinical~~business, orfinancial ~~commercial~~condition, ~~manufacturing~~and results of operations.

17Clinical trials are expensive, time consuming and difficult to design and implement.

InHuman clinical ~~addition~~trials are expensive and difficult to design and implement, ~~some~~in ~~raw~~part ~~materials~~ because they are ~~currently~~subject ~~available~~to ~~from~~rigorous aregulatory ~~single~~requirements. Because ~~supplier,~~lira-cel oris abased ~~small~~on ~~number~~relatively ofnew ~~suppliers.~~technology Weand ~~cannot~~engineered beon ~~sure~~a ~~that~~patient-by-patient ~~these~~basis, ~~suppliers~~we expect that it will ~~remain~~have insubstantial ~~business~~manufacturing and processing costs. In addition, orcosts ~~that~~to ~~they~~treat ~~will~~patients ~~not~~with berelapsed/refractory ~~purchased~~cancer byand ~~one~~to oftreat potential side effects that may result from therapies such as our ~~competitors~~current orand ~~another~~future ~~company~~product ~~that~~candidates iscan ~~not~~be ~~interested~~significant. inAccordingly, ~~continuing~~our clinical trial costs are likely to ~~produce these~~be ~~materials~~significantly higher than for more conventional therapeutic technologies or drug products. In addition, our ~~intended~~proposed ~~purpose~~personalized product candidates involve several complex and costly manufacturing and processing steps, the costs of which will be borne by us.

WeIn future ~~may~~clinical ~~form~~trials orof ~~seek~~our ~~strategic alliances~~breast orcancer ~~enter~~vaccine ~~into~~we ~~additional~~will ~~licensing~~need ~~arrangements~~to indetermine efficacy of the ~~future,~~breast cancer vaccine as a cancer prevention which will be a considerably more complex clinical trial and wewill ~~may~~have ~~not~~significantly ~~realize~~greater ~~the~~costs ~~benefits~~than ofa ~~such~~trial ~~alliances~~designed orto ~~licensing~~assess therapeutic ~~arrangements~~effect.

~~We may form or seek strategic~~The ~~alliances,~~costs ~~create~~of ~~joint ventures or collaborations and enter into additional licensing arrangements with third parties that we believe will complement or augment~~ our ~~development~~clinical ~~and~~trials ~~commercialization efforts with respect to our product candidates and any future product candidates that we~~ may ~~develop. Any of these relationships may require us to incur non-recurring and other charges,~~ increase ~~our~~if 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~~FDA ~~process~~does ~~is time-consuming and complex. Moreover, we may~~ not beagree ~~successful~~with in our ~~efforts~~clinical todevelopment ~~establish~~plans ~~a strategic partnership~~ or ~~other~~requires ~~alternative~~us ~~arrangements for our product candidates because they may be deemed~~ to beconduct ~~at too early of a stage of development for collaborative effort and third parties may not view our product~~additional ~~candidates~~clinical astrials ~~having the requisite potential~~ to demonstrate the safety and efficacy. ~~If we license products or businesses, we may not be able to realize the benefit~~ of ~~such transactions if we are unable to successfully integrate them with~~ our existing operations and company culture. It is possible that, following a strategic transaction or license, we may not achieve the revenue or specific net income that justifies such transaction. Any delays in entering into new strategic partnership agreements related to our product candidates could delay the development and commercialization of our product candidates in certain geographies for certain indications, which would harm our business prospects, financial condition and results of operations.

~~The~~We face ~~FDA~~significant ~~regulatory~~competition ~~approval process~~from isother ~~lengthy~~biotechnology and ~~time-consuming~~pharmaceutical companies, and weour ~~may~~operating ~~experience~~results ~~significant~~will ~~delays~~suffer inif ~~the~~we ~~clinical development and regulatory approval of~~fail ~~our~~to ~~product~~compete ~~candidates~~effectively.

WeThe biopharmaceutical ~~have~~industry ~~not~~is ~~previously~~characterized ~~submitted a~~by ~~Biologics~~intense ~~License~~competition ~~Application~~and ~~(“BLA”)~~rapid orinnovation. aOur ~~New~~competitors ~~Drug~~may ~~Application~~be ~~(“NDA”)~~able to ~~the~~develop ~~FDA,~~other compounds or ~~similar~~drugs ~~approval~~that ~~filings~~ are able to ~~other~~achieve ~~foreign~~similar ~~authorities.~~or Abetter ~~BLA~~results. orOur ~~NDA~~potential ~~must~~competitors include ~~extensive~~major ~~pre-clinical~~multinational ~~and~~pharmaceutical companies, ~~clinical~~established ~~data~~biotechnology companies, specialty pharmaceutical companies and ~~supporting~~universities ~~information~~and toother ~~establish~~research institutions. ~~the~~Many ~~product~~of ~~candidate’s~~our ~~safety~~competitors have substantially greater financial, ~~purity~~technical and ~~potency~~other ~~for~~resources, ~~each~~such ~~desired~~as ~~indication~~larger research and development staff and experienced marketing and manufacturing organizations and well-established sales forces. ItSmaller ~~must~~or early-stage companies may also ~~include~~prove ~~significant~~to ~~information~~be ~~regarding the~~significant ~~chemistry~~competitors, ~~manufacturing~~particularly ~~and~~through ~~controls~~collaborative ~~for~~arrangements ~~the~~with ~~product~~large, established companies. WeMergers and ~~expect~~acquisitions in the ~~novel~~biotechnology ~~nature~~and ofpharmaceutical ~~our~~industries ~~product~~may ~~candidates~~result toin ~~create~~even ~~further~~more ~~challenges in~~resources ~~obtaining~~being ~~regulatory~~concentrated ~~approval~~in our competitors. Competition ~~For~~may ~~example,~~increase ~~the~~further ~~FDA~~as ~~has~~a ~~limited~~result ~~experience~~of ~~with~~advances in the commercial ~~development~~applicability of Ttechnologies ~~cell~~and ~~therapies~~greater ~~and~~availability ~~vaccines~~of capital for ~~cancer~~investment in these industries. ~~The~~Our ~~regulatory~~competitors, ~~approval~~either ~~pathway~~alone ~~for~~or ~~our~~with ~~product~~collaborative ~~candidates~~partners, may besucceed ~~uncertain,~~in ~~complex~~developing, acquiring ~~expensive~~or ~~and~~licensing ~~lengthy~~on an exclusive basis drug or biologic products that are more effective, ~~and~~safer, ~~approval~~more easily commercialized or less costly than our product candidates or may ~~not~~develop beproprietary ~~obtained~~technologies or secure patent protection that we may need for the development of our technologies and products.

WeCell-based therapies ~~may~~rely ~~also~~on ~~experience~~the ~~delays in~~availability ~~completing~~of ~~planned~~specialty ~~clinical~~raw ~~trials~~materials, ~~for~~which amay ~~variety~~not ofbe ~~reasons,~~available ~~including~~to ~~delays~~us ~~related~~on ~~to:~~acceptable terms or at all.

●Gene-modified cell ~~the~~therapy ~~availability~~manufacturing ofrequires ~~financial~~many ~~resources~~specialty toraw ~~commence~~materials, ~~and~~some ~~complete~~of ~~our~~which ~~planned~~are ~~clinical~~manufactured ~~trials;~~by ●small ~~reaching~~companies ~~agreement~~with onlimited ~~acceptable~~resources and ~~terms~~experience ~~with~~to ~~prospective~~support ~~clinical~~a ~~trial~~commercial ~~sites,~~product. ~~the~~Some ~~terms~~suppliers oftypically ~~which~~support ~~can~~biomedical beresearchers ~~subject~~or toblood-based ~~extensive~~hospital ~~negotiation~~ businesses and may ~~vary~~not ~~significantly~~have ~~among~~the ~~different~~capacity ~~clinical~~to ~~trial~~support ~~sites;~~commercial ●products ~~recruiting~~manufactured ~~suitable~~under ~~patients~~cGMP toby ~~participate~~biopharmaceutical infirms. aThe ~~clinical~~suppliers ~~trial;~~may ●be ill-equipped ~~having~~to ~~patients~~support ~~complete~~our aneeds, ~~clinical~~especially ~~trial~~in ornon-routine ~~return~~circumstances ~~for~~like ~~post-treatment~~FDA ~~follow-up;~~inspections ●or ~~clinical~~medical ~~trial~~crises, ~~sites~~such ~~deviating~~as ~~from~~widespread contamination. ~~clinical~~We ~~trial~~also ~~protocol,~~do ~~failing~~not tohave ~~follow~~commercial ~~cGCPs,~~supply orarrangements ~~dropping~~with ~~out~~many of athese ~~clinical~~suppliers, ~~trial;~~and ●may ~~adding~~not ~~new~~be ~~clinical~~able ~~trial~~to ~~sites;~~contract orwith them ●on ~~manufacturing~~acceptable ~~sufficient~~terms ~~quantities~~or ofat ~~qualified~~all. ~~materials~~Accordingly, ~~under~~we ~~cGMPs~~may ~~and~~experience ~~applying~~delays ~~them~~in onreceiving akey ~~subject-by-subject~~raw ~~basis~~materials ~~for~~to ~~use~~support in clinical ~~trials~~or commercial manufacturing.

1817

~~Also~~In addition, ~~before~~some araw ~~clinical~~materials ~~trial can~~are ~~begin~~currently atavailable anfrom ~~NIH-funded~~a ~~institution,~~single ~~that institution’s independent institutional review board~~supplier, or ~~IRB,~~a ~~and~~small ~~its~~number ~~Institutional Biosafety~~of ~~Committee~~suppliers. ~~must~~We ~~review~~cannot ~~the~~be ~~proposed~~sure ~~clinical~~that ~~trial~~these suppliers towill ~~assess~~remain ~~the~~in ~~safety~~business, ofor ~~the~~that ~~trial.~~they Inwill ~~addition,~~not ~~adverse~~be ~~developments~~purchased inby ~~clinical trials~~one of ~~gene~~our ~~therapy~~competitors ~~products~~or ~~conducted~~another bycompany ~~others~~that ~~may~~is ~~cause~~not ~~the~~interested in ~~FDA~~continuing ~~or other regulatory bodies~~ to ~~change~~produce ~~the~~these ~~requirements~~materials for ~~approval of any of~~ our ~~product~~intended ~~candidates~~purpose.

We ~~could also encounter delays~~ if physicians encounter unresolved ethical issues associated with enrolling patients in clinical trials of our product candidates in lieu of prescribing existing treatments that have established safety and efficacy profiles. Further, a clinical trial may beform ~~suspended~~ or ~~terminated by~~seek ~~us,~~strategic ~~the~~alliances ~~IRBs for the institutions in which such clinical trials are being conducted, the Data Monitoring Committee for such clinical trial,~~ or byenter ~~the~~into ~~FDA~~additional orlicensing ~~other~~arrangements ~~regulatory~~in ~~authorities due to a number of factors, including failure to conduct~~ the ~~clinical trial in accordance with regulatory requirements or our clinical protocols~~future, ~~inspection~~and ofwe ~~the~~may ~~clinical~~not ~~trial~~realize ~~operations or clinical trial site by~~ the ~~FDA~~benefits ~~or other regulatory authorities resulting in the imposition~~ of asuch ~~clinical~~alliances ~~hold, unforeseen safety issues~~ or ~~adverse~~licensing ~~side effects, failure to demonstrate a benefit from using a product candidate, changes in governmental regulations or administrative actions or lack of adequate funding to continue the clinical trial~~arrangements. If we experience termination of, or delays in the completion of, any clinical trial of our product candidates, the commercial prospects for our product candidates will be harmed, and our ability to generate product revenue will be delayed. In addition, any delays in completing our clinical trials will increase our costs, slow down our product development and approval process and jeopardize our ability to commence product sales and generate revenue.

~~Many~~We may ofform ~~the~~or ~~factors~~seek ~~that~~strategic ~~cause~~alliances, create joint ventures or collaborations and enter into additional licensing arrangements with third parties that we believe will complement or ~~lead~~augment our development and commercialization efforts with respect to our product candidates and any future product candidates that we may develop. Any of these relationships may require us to incur non-recurring and other charges, increase aour ~~delay~~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 ~~commencement~~negotiation process is time-consuming and complex. Moreover, we may not be successful in our efforts to establish a strategic partnership or ~~completion~~other alternative arrangements for our product candidates because they may be deemed to be at too early of ~~clinical~~a ~~trials~~stage of development for collaborative effort and third parties may ~~ultimately~~not ~~lead~~view our product candidates as having the requisite potential to demonstrate safety and efficacy. If we license products or businesses, we may not be able to realize the ~~denial~~benefit of ~~regulatory~~such ~~approval~~transactions ofif we are unable to successfully integrate them with our existing operations and company culture. It is possible that, following a strategic transaction or license, we may not achieve the revenue or specific net income that justifies such transaction. Any delays in entering into new strategic partnership agreements related to our product candidates could delay the development and commercialization of our product candidates in certain geographies for certain indications, which would harm our business prospects, financial condition and results of operations.

~~Even~~The FDA ~~if we obtain~~ regulatory approval ofprocess ~~our~~is ~~product~~lengthy ~~candidates~~and time-consuming, ~~the~~and ~~products~~we may ~~not~~experience ~~gain~~significant ~~market~~delays ~~acceptance~~in ~~among~~the ~~physicians,~~clinical ~~patients,~~development ~~hospitals, cancer treatment~~and ~~centers,~~regulatory ~~third-party~~approval ~~payors~~of ~~and~~our ~~others~~product ~~in the medical community~~candidates.

~~The~~We have ~~use~~not ofpreviously ~~engineered~~submitted Ta ~~cells as~~Biologics License Application (“BLA”) or a ~~potential~~New ~~cancer~~Drug ~~treatment~~Application ~~and~~(“NDA”) to the FDA, ~~use~~or ofsimilar ~~therapeutic~~approval ~~and~~filings ~~prophylactic~~to ~~cancer~~other ~~vaccines~~foreign ~~are~~authorities. ~~recently~~A ~~developed~~BLA ~~technologies~~or NDA must include extensive pre-clinical and ~~may~~clinical data and ~~not~~supporting ~~become~~information ~~broadly~~to ~~accepted~~establish bythe ~~physicians,~~product ~~patients,~~candidate’s ~~hospitals~~safety, ~~cancer~~purity ~~treatment~~and ~~centers,~~potency ~~third-party~~for ~~payors~~each desired indication. It must also include significant information regarding the chemistry, manufacturing and ~~others~~controls for the product. We expect the novel nature of our product candidates to create further challenges in obtaining regulatory approval. For example, the ~~medical~~FDA has limited experience with commercial ~~community~~development of T cell therapies and vaccines for cancer. ~~Many~~The ~~factors~~regulatory ~~will~~approval ~~influence~~pathway ~~whether~~for our product candidates ~~are~~may ~~accepted~~be inuncertain, complex, ~~the~~expensive ~~market~~and lengthy, ~~including:~~and approval may not be obtained.

●We may ~~the~~also ~~clinical~~experience ~~indications~~delays for which our product candidates are approved; ● physicians, hospitals, cancer treatment centers and patients considering our product candidates as a safe and effective treatment; ● the potential and perceived advantages of our product candidates over alternative treatments; ● the prevalence and severity of any side effects; ● product labeling or product insert requirements of the FDA or other regulatory authorities; ● limitations or warnings contained in ~~the~~completing ~~labeling~~planned ~~approved by the FDA or other regulatory authorities; ● the extent and quality of the~~ clinical ~~evidence~~trials ~~supporting~~for ~~the~~a ~~efficacy~~variety ~~and safety~~ of our product candidates; ● the timing of market introduction of our product candidates as well as competitive products; ● the cost of treatment in relation to alternative treatments; ● the availability of adequate reimbursement and pricing by third-party payors and government authorities; ● the willingness and ability of patients to pay out-of-pocket in the absence of coverage by third-party payorsreasons, including ~~government~~delays ~~authorities;~~related ~~● relative convenience and ease of administration, including as compared~~ to ~~alternative treatments and competitive therapies; and ● the effectiveness of our or any of our strategic partners’ sales and marketing efforts.~~:

If● ~~our~~the ~~product~~availability ~~candidates~~of ~~are approved~~financial ~~but~~resources ~~fail~~ to ~~achieve~~commence ~~market~~and ~~acceptance~~complete ~~among~~our ~~physicians,~~planned ~~patients,~~clinical ~~hospitals,~~trials; ~~cancer~~● ~~treatment~~reaching ~~centers~~agreement oron ~~others~~acceptable interms ~~the~~with ~~medical community~~prospective clinical trial sites, wethe ~~will~~terms ~~not~~of which can be ~~able~~subject to ~~generate~~extensive ~~significant~~negotiation ~~revenue.~~and ~~Even~~may ifvary ~~our~~significantly ~~products~~among ~~achieve~~different ~~market~~clinical ~~acceptance,~~trial wesites; ~~may~~● ~~not~~recruiting besuitable ~~able~~patients to ~~maintain~~ ~~that~~participate ~~market~~in ~~acceptance~~a ~~over~~clinical ~~time~~trial; if● ~~new~~having ~~products~~patients complete a clinical trial or ~~technologies~~return ~~are~~for ~~introduced~~post-treatment ~~that~~follow-up; ~~are~~● ~~more~~clinical ~~favorably~~trial ~~received~~sites ~~than~~deviating ~~our~~from ~~products~~clinical trial protocol, ~~are~~ ~~more~~failing ~~cost~~to ~~effective~~follow cGCPs, or ~~render~~dropping ~~our~~out ~~products~~of ~~obsolete~~a clinical trial; ● adding new clinical trial sites; or ● manufacturing sufficient quantities of qualified materials under cGMPs and applying them on a subject-by-subject basis for use in clinical trials.

1918

~~Risks~~Also, before ~~Related~~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 ~~Our~~assess ~~Intellectual~~the ~~Property~~safety of the trial. In addition, adverse developments in clinical trials of gene therapy products conducted by others may cause the FDA or other regulatory bodies to change the requirements for approval of any of our product candidates.

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

~~Our ability to compete and to~~Many 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. We expect to rely on a combination of ~~patent~~the ~~protection,~~factors ~~copyrights,~~that ~~trademarks~~cause, ~~trade~~or ~~secrets,~~lead ~~know-how, and regulatory approvals~~ to ~~protect our technologies. Our intellectual property strategy is intended to help develop and maintain our competitive position. While we have been granted multiple patents related to our technologies~~, ~~there~~a isdelay noin ~~assurance~~the ~~that~~commencement ~~we will be able to obtain further patent protection for our technologies~~ or ~~any~~completion ~~other~~of ~~technologies,~~clinical ~~nor~~trials ~~can~~may weultimately belead ~~certain~~to ~~that~~ the ~~steps we will have taken will prevent the misappropriation and unauthorized~~denial ~~use~~ of ~~our~~regulatory ~~technologies.~~approval Ifof ~~we are not able to obtain and maintain patent protection~~ our ~~competitive position may be harmed, including our ability to license any~~ product ~~if we choose to have other parties commercialize them~~candidates.

~~Third parties may initiate~~Even ~~legal~~if ~~proceedings alleging that~~ we ~~are~~obtain ~~infringing~~regulatory ~~their~~approval ~~intellectual~~of ~~property~~our ~~rights~~product candidates, the ~~outcome~~products ofmay ~~which~~not ~~would~~gain bemarket ~~uncertain~~acceptance ~~and~~among ~~could~~physicians, patients, hospitals, ~~have~~cancer atreatment ~~material~~centers, ~~adverse~~third-party ~~effect~~payors onand ~~the~~others ~~success~~in ofthe ~~our~~medical ~~business~~community.

~~Our commercial success depends~~The ~~upon~~use ~~our~~of ~~ability~~engineered ~~to develop, manufacture, market and sell our CAR-~~T ~~therapeutics,~~cells ~~our~~as ~~breast~~a ~~cancer~~potential ~~vaccine, our ovarian~~ cancer ~~vaccine and~~treatment ~~other proprietary discoveries~~ and ~~technologies without infringing, misappropriating or otherwise violating~~ the ~~proprietary~~use ~~rights or intellectual property~~ of ~~third~~therapeutic ~~parties.~~and Weprophylactic ~~may become party to, or be threatened with, future adversarial proceedings or litigation regarding intellectual property rights with respect to our CAR-T therapeutics, our breast~~ cancer ~~vaccine,~~vaccines ~~our~~are ~~ovarian~~recently ~~cancer vaccine and~~developed ~~other~~technologies ~~proprietary discoveries~~ and ~~technologies. Third parties~~ may ~~assert~~not ~~infringement~~become ~~claims~~broadly ~~against~~accepted usby ~~based on existing patents or patents that may be granted in the future. If we are found to infringe a third party’s intellectual property rights~~physicians, ~~we could be required to obtain a license from such third party to continue developing our CAR-T therapeutics~~patients, ~~our breast cancer vaccine~~hospitals, ~~our ovarian~~ cancer ~~vaccine~~ ~~and~~treatment ~~other proprietary discoveries and technologies. However~~centers, wethird-party ~~may~~payors ~~not be able to obtain any required license on commercially~~and ~~reasonable~~others ~~terms~~in orthe atmedical ~~all~~community. ~~Even~~Many iffactors wewill ~~were~~influence ~~able~~whether ~~to obtain a license, it could be non-exclusive, thereby giving~~ our ~~competitors~~product ~~access to~~candidates ~~the~~are ~~same~~accepted ~~technologies~~in ~~licensed to us. We could be forced, including by court order, to cease developing~~ the ~~infringing technology or product. In addition~~market, ~~we could be found liable for monetary damages. Claims that we have misappropriated the confidential information or trade secrets of third parties can have a similar negative impact on our business.~~including:

We● ~~rely~~the onclinical ~~licenses~~indications ~~from Wistar~~ for which our ~~CAR-T~~product ~~technology~~candidates ~~and~~are ~~Cleveland~~approved; ~~Clinic~~● ~~for~~physicians, ~~our~~hospitals, cancer ~~vaccine~~treatment ~~technologies,~~centers and ifpatients weconsidering ~~lose~~our product candidates as a safe and effective treatment; ● the potential and perceived advantages of our product candidates over alternative treatments; ● the prevalence and severity of any side effects; ● product labeling or product insert requirements of ~~these~~the ~~licenses~~FDA weor ~~may be~~other ~~subjected~~regulatory authorities; ● limitations or warnings contained in the labeling approved by the FDA or other regulatory authorities; ● the extent and quality of the clinical evidence supporting the efficacy and safety of our product candidates; ● the timing of market introduction of our product candidates as well as competitive products; ● the cost of treatment in relation to ~~future~~alternative ~~litigation~~treatments; ● the availability of adequate reimbursement and pricing by third-party payors and government authorities; ● the willingness and ability of patients to pay out-of-pocket in the absence of coverage by third-party payors, including government authorities; ● relative convenience and ease of administration, including as compared to alternative treatments and competitive therapies; and ● the effectiveness of our or any of our strategic partners’ sales and marketing efforts.

WeIf our product candidates are ~~party~~approved but fail to ~~royalty-bearing license~~achieve ~~agreements~~market ~~that~~acceptance ~~grant~~among usphysicians, ~~rights~~patients, tohospitals, ~~use~~cancer ~~certain~~treatment ~~intellectual~~centers or ~~property~~others in the medical community, ~~including~~we ~~patents~~will ~~and~~not ~~patent~~be ~~applications~~able to generate significant revenue. WeEven ~~may~~if ~~need~~our toproducts achieve market acceptance, ~~obtain~~we ~~additional~~may ~~licenses~~not ~~from~~be ~~others~~able to ~~advance~~maintain ~~our~~that ~~research,~~market ~~development~~acceptance ~~and~~over ~~commercialization~~time ~~activities.~~if ~~Our~~new ~~license~~products ~~agreements~~or ~~impose, and~~technologies weare ~~expect~~introduced that ~~future~~are ~~license~~more ~~agreements~~favorably received ifthan ~~necessary~~our ~~will impose~~products, ~~various~~are ~~development,~~more ~~diligence,~~cost ~~commercialization~~effective ~~and~~or ~~other~~render ~~obligations on~~our usproducts obsolete.

In spite of our efforts, our licensors might conclude that we have materially breached our obligations under such license agreements and might therefore terminate the license agreements, thereby removing or limiting our ability to develop and commercialize products and technology covered by these license agreements. If these in-licenses are terminated, or if the underlying patents fail to provide the intended exclusivity, competitors or other third parties might have the freedom to seek regulatory approval of, and to market, products identical to ours and we may be required to cease our development and commercialization activities. Any of the foregoing could have a material adverse effect on our competitive position, business, financial conditions, results of operations and prospects.19

~~Moreover, disputes may arise with~~Risks ~~respect~~Related to ~~any~~Our ~~one~~Intellectual ~~of our licensing agreements, including:~~Property

●If we ~~the~~are ~~scope~~unable ofto ~~rights~~obtain ~~granted~~and ~~under~~maintain ~~the~~intellectual ~~license~~property ~~agreement~~protection, ~~and~~our ~~other~~competitive ~~interpretation-related~~position ~~issues;~~will be harmed.

20Our ability 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. We expect to rely on a combination of patent protection, copyrights, trademarks, trade secrets, know-how, and regulatory approvals to protect our technologies. Our intellectual property strategy is intended to help develop and maintain our competitive position. While we have been granted multiple patents related to our technologies, there is no assurance that we will be able to obtain further patent protection for our technologies or any other technologies, nor can we be certain that the steps we will have taken will prevent the misappropriation and unauthorized use of our technologies. If we are not able to obtain and maintain patent protection our competitive position may be harmed, including our ability to license any product if we choose to have other parties commercialize them.

●Third parties ~~the~~may ~~extent~~initiate tolegal ~~which~~proceedings ~~our~~alleging ~~product~~that ~~candidates,~~we ~~technology~~are ~~and~~infringing ~~processes~~their ~~infringe on~~ intellectual property ofrights, the ~~licensor~~outcome ~~that is not subject to the licensing agreement; ● the sublicensing~~ of ~~patent~~which ~~and~~would be ~~other~~uncertain ~~rights under the licensing agreement~~ and ~~our~~could ~~collaborative~~have ~~development~~a ~~relationships;~~material ●adverse ~~our~~effect ~~diligence~~on ~~obligations under~~ the ~~license~~success ~~agreement and what activities satisfy those diligence obligations; ● the inventorship and ownership~~ of ~~inventions and know-how resulting from the joint creation or use of intellectual property by~~ our ~~licensors and us and our partners; and ● the priority of invention of patented technology~~business.

Our commercial 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 violating the proprietary rights or intellectual property of third parties. We may become party to, or be threatened with, future adversarial proceedings or litigation regarding intellectual property rights with respect to our CAR-T therapeutics, our breast cancer vaccine, our ovarian cancer vaccine and other proprietary discoveries and technologies. Third parties may assert infringement claims against us based on existing patents or patents that may be granted in the future. If we doare ~~not~~found ~~prevail~~to ininfringe a third party’s intellectual property rights, we could be required to obtain a license from such ~~disputes~~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 ~~lose~~not be able to obtain any ofrequired ~~such~~license on commercially reasonable terms or at all. Even if we were able to obtain a license, ~~agreements~~it could be non-exclusive, thereby giving our competitors access to the same technologies licensed to us. We could be forced, including by court order, to cease developing the infringing technology or product. In addition, we could be found liable for monetary damages. Claims that we have misappropriated the confidential information or trade secrets of third parties can have a similar negative impact on our business.

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

~~Our failure to maintain such licenses~~We ~~could~~are ~~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~~royalty-bearing ~~by the terms of the~~ license, oragreements ifthat ~~the~~grant ~~licensor~~us ~~fails~~rights to ~~prevent~~use ~~infringement~~certain byintellectual ~~third~~property, ~~parties or~~including ~~if the licensed~~ patents orand ~~other rights are found to be invalid or unenforceable~~patent applications. ~~Absent~~We ~~the license agreements, we~~ may ~~infringe~~need ~~patents subject~~ to ~~those~~obtain ~~agreements,~~additional ~~and~~licenses iffrom ~~the~~others ~~license~~to ~~agreements~~advance ~~are~~our ~~terminated~~research, wedevelopment ~~may~~and becommercialization ~~subject to litigation by the licensor~~activities. ~~Litigation~~ ~~could~~Our ~~result~~license inagreements ~~substantial~~impose, ~~costs~~ and ~~be a distraction to management. If~~ we doexpect ~~not~~that ~~prevail,~~future welicense ~~may~~agreements beif ~~required~~necessary towill ~~pay damages~~impose, ~~including treble~~various ~~damages~~development, ~~attorneys’ fees~~diligence, ~~costs and expenses, royalties or, be enjoined from selling our products, which could adversely~~ ~~affect~~commercialization ~~our ability to offer products, our ability to continue operations~~ and ~~our~~other ~~financial~~obligations ~~condition~~on us.

IfIn spite of our efforts, toour ~~protect~~licensors might conclude that we have materially breached our obligations under such license agreements and might therefore terminate the ~~proprietary~~license ~~nature~~agreements, ofthereby removing or limiting our ~~technologies~~ability to develop and commercialize products and technology covered by these license agreements. If these in-licenses are ~~not~~terminated, ~~adequate~~or if the underlying patents fail to provide the intended exclusivity, competitors or other third parties might have the freedom to seek regulatory approval of, and to market, products identical to ours and we may ~~not~~ be ~~able~~required to ~~compete~~cease ~~effectively~~our indevelopment and commercialization activities. Any of the foregoing could have a material adverse effect on our ~~market~~competitive position, business, financial conditions, results of operations and prospects.

Any disclosure to or misappropriation by third parties of our confidential proprietary information could enable competitors to quickly duplicate or surpass our technological achievements, thus eroding our competitive position in our markets. Certain intellectual property which is covered by our in-license agreements has been developed at academic institutions which have retained non-commercial rights to such intellectual property.20

~~There~~Moreover, disputes ~~are~~may ~~several~~arise ~~pending~~with ~~U.S. and~~respect ~~foreign~~to ~~patent~~any ~~applications~~one inof our ~~portfolio,~~licensing ~~and we anticipate additional patent applications will be filed both in the U.S. and in other countries~~agreements, ~~as appropriate. However, we cannot predict~~including:

● ifthe ~~and~~scope ~~when~~of ~~patents~~rights ~~will~~granted ~~issue~~under the license agreement and other interpretation-related issues; ● the ~~degree~~extent to which our product candidates, technology and ~~range~~processes infringe on intellectual property of ~~protection~~the ~~any~~licensor ~~issued~~that ~~patents~~is ~~will~~not ~~afford~~subject usto ~~against~~the ~~competitors~~licensing ~~including~~agreement; ~~whether~~● ~~third~~the ~~parties~~sublicensing ~~will~~of ~~find~~patent ~~ways~~and toother ~~invalidate~~rights orunder ~~otherwise~~the ~~circumvent~~licensing agreement and our ~~patents~~collaborative development relationships; ● ~~whether~~our ordiligence ~~not~~obligations ~~others~~under ~~will~~the ~~obtain~~license ~~patents~~agreement ~~claiming~~and ~~aspects~~what ~~similar~~activities tosatisfy those ~~covered~~diligence byobligations; ~~our~~● ~~patents~~the inventorship and ~~patent~~ownership ~~applications;~~of inventions and know-how resulting from the joint creation or ●use ~~whether~~of weintellectual ~~will~~property ~~need~~by toour ~~initiate~~licensors ~~litigation~~and orus ~~administrative~~and ~~proceedings~~our ~~which~~partners; ~~may~~and be● ~~costly~~the ~~whether~~priority weof ~~win~~invention orof ~~lose~~patented technology.

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

21In addition, the agreements under which we currently license intellectual property or technology from third parties are complex, and certain provisions in such agreements may be susceptible to multiple interpretations. The resolution of any contract interpretation disagreement that may arise could narrow what we believe to be the scope of our rights to the relevant intellectual property or technology, or increase what we believe to be our financial or other obligations under the relevant agreement, either of which could have a material adverse effect on our business, financial condition, results of operations and prospects. Moreover, if disputes over intellectual property that we have licensed prevent or impair our ability to maintain our current licensing arrangements on commercially acceptable terms, we may be unable to successfully develop and commercialize the affected product candidates, which could have a material adverse effect on our business, financial conditions, results of operations and prospects.

~~The~~Our failure ~~strength~~to ofmaintain ~~patents~~such inlicenses ~~the biotechnology~~could ~~and~~have ~~pharmaceutical~~a ~~field~~material ~~involves~~adverse ~~complex~~effect ~~legal~~on ~~and~~our ~~scientific~~business, ~~questions~~financial condition and ~~can~~results beof ~~uncertain~~operations. ~~The patent applications that~~ weAny ~~own~~of orthese ~~in-license~~licenses ~~may~~could ~~fail~~be toterminated, ~~result~~such inas ~~issued~~if ~~patents~~either ~~with~~party ~~claims~~fails ~~that~~to ~~cover~~abide ~~our~~by ~~product~~the ~~candidates~~terms orof ~~uses thereof in~~ the ~~U.S.~~license, or in ~~other foreign countries. Even~~ if the ~~patents~~licensor dofails to ~~successfully~~prevent ~~issue,~~infringement by third parties ~~may~~or ~~challenge~~if the ~~validity,~~licensed ~~enforceability~~patents or ~~scope thereof,~~other ~~which~~rights ~~may~~are ~~result~~found into ~~such~~be ~~patents~~invalid ~~being narrowed, invalidated~~ or ~~held~~ unenforceable. ~~Furthermore,~~Absent the ~~even~~license ~~if they are unchallenged~~agreements, ~~patents~~ inwe ~~our portfolio~~ may ~~not~~infringe ~~adequately~~patents ~~exclude~~subject ~~third parties from practicing relevant technology or prevent others from designing around our claims. If the breadth or strength of our intellectual property position with respect~~ to ~~our~~those ~~product candidates is threatened~~agreements, it ~~could dissuade companies from collaborating with us to develop,~~ and ~~threaten~~if ~~our~~the ~~ability~~license toagreements ~~commercialize,~~are ~~our product candidates. Further~~terminated, if we ~~encounter~~may ~~delays~~be subject into ~~our~~litigation ~~clinical~~by ~~trials,~~ the ~~period~~licensor. ofLitigation ~~time during which we~~ could ~~market~~result ~~our~~in ~~product~~substantial ~~candidates~~costs ~~under~~and ~~patent protection would~~ be ~~reduced.~~a ~~Since~~distraction ~~patent~~to ~~applications in the U~~management.S. ~~and~~If ~~most~~we ~~other~~do ~~countries are confidential for a period of time after~~not ~~filing~~prevail, itwe ~~is possible that patent applications in our portfolio~~ may ~~not~~ be ~~the~~required ~~first filed patent applications related~~ to ~~our~~pay ~~product candidates. Furthermore~~damages, ~~for~~including ~~U.S.~~treble ~~applications~~damages, inattorneys’ ~~which~~fees, ~~all~~costs ~~claims~~and ~~are entitled to a priority date before March 16~~expenses, ~~2013,~~royalties ~~an interference proceeding can be provoked by a third-party~~ or ~~instituted by the USPTO~~, tobe ~~determine who was the first to invent any of the subject matter~~enjoined ~~covered~~from byselling ~~the patent claims of~~ our ~~applications.~~products, ~~For~~which ~~U.S.~~could ~~applications~~adversely ~~containing~~affect aour ~~claim~~ability ~~not entitled~~ to ~~priority~~offer ~~before March 16~~products, ~~2013, there~~our isability ~~a greater level of uncertainty in the patent law with the passage of the America Invents Act (2012) which brings into effect significant changes~~ to ~~the~~continue ~~U.S.~~operations ~~patent laws that are yet untried~~ and ~~untested,~~our ~~and which introduces new procedures for challenging pending~~financial ~~patent applications and issued patents~~condition. A primary change under this reform is the creation of a “first to file” system in the U.S. This will require us to be cognizant going forward of the time from invention to filing of a patent application.

~~Obtaining and maintaining~~If our ~~patents~~efforts ~~depends~~to onprotect ~~compliance~~the ~~with~~proprietary ~~various~~nature ~~procedural,~~of ~~document~~our ~~submission,~~technologies ~~fee~~are ~~payment~~not ~~and other requirements imposed by governmental patent agencies~~adequate, ~~and~~we ~~our~~may ~~patent~~not ~~position could~~ be ~~reduced~~able orto ~~eliminated~~compete ~~for~~effectively ~~non-compliance~~in ~~with these requirements~~our market.

~~Periodic maintenance fees on any~~Any ~~issued~~disclosure ~~patent are due~~ to beor ~~paid~~misappropriation toby ~~the~~third ~~USPTO~~parties ~~and foreign patent agencies in several stages over the lifetime~~ of ~~the~~our ~~patent.~~confidential ~~The~~proprietary ~~USPTO and~~information ~~various~~could ~~foreign~~enable ~~governmental~~competitors ~~patent~~to ~~agencies~~quickly ~~require compliance with a number of procedural, documentary, fee payment and other similar~~duplicate ~~provisions during the patent application process. While an inadvertent lapse can in many cases be cured by payment of a late fee~~ or ~~by other~~surpass ~~means~~our intechnological ~~accordance with the applicable rules~~achievements, ~~there~~thus ~~are~~eroding ~~situations~~our incompetitive ~~which~~position ~~noncompliance can result~~ in ~~abandonment~~our ~~or lapse of the patent or patent application, resulting in partial or complete loss of patent rights in the relevant jurisdiction~~markets. ~~Noncompliance~~Certain ~~events that~~intellectual ~~could~~property ~~result in abandonment or lapse of a patent or patent application include, but are not limited to, failure to respond to official~~which ~~actions~~is ~~within~~covered ~~prescribed~~by ~~time~~our ~~limits, non~~in-~~payment~~license ofagreements ~~fees~~has ~~and~~been ~~failure~~developed toat ~~properly~~academic ~~legalize~~institutions ~~and~~which ~~submit~~have ~~formal~~retained ~~documents. Such noncompliance events are outside of our direct control for i)~~ non-~~U.S.~~commercial ~~patents~~rights ~~and patent applications owned by us, and ii) 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~~intellectual ~~on our business~~property.

~~Issued~~There are ~~patents~~several ~~covering~~ pending U.S. and foreign patent applications in our ~~product~~portfolio, ~~candidates~~and ~~could~~we beanticipate ~~found~~additional ~~invalid~~patent orapplications ~~unenforceable~~will ifbe ~~challenged~~filed both in ~~court~~the orU.S. ~~the~~and ~~USPTO~~in other countries, as appropriate. However, we cannot predict:

If● weif orand ~~one~~when ofpatents ~~our~~will ~~licensing partners~~issue; ~~initiate~~● ~~legal proceedings against a third party to enforce a patent covering one of our product candidates,~~ the ~~defendant~~degree ~~could counterclaim that the patent covering our product candidate, as applicable, is invalid~~ and~~/or~~ ~~unenforceable.~~range Inof ~~patent~~protection ~~litigation~~any inissued ~~the U.S.,~~patents ~~defendant~~will ~~counterclaims~~afford ~~alleging~~us ~~invalidity~~against ~~and/or~~competitors ~~unenforceability~~including ~~are~~whether ~~commonplace, and there are numerous grounds upon which a~~ third ~~party can assert invalidity or unenforceability of a patent. Third~~ parties ~~may~~will ~~also~~find ~~raise~~ways ~~similar~~to ~~claims~~invalidate ~~before administrative bodies in the U.S.~~ or ~~abroad,~~otherwise ~~even~~circumvent ~~outside~~our ~~the~~patents; ~~context~~● ofwhether ~~litigation.~~or ~~Such~~not ~~mechanisms~~others ~~include~~will ~~re-examination,~~obtain ~~post~~patents ~~grant~~claiming ~~review,~~aspects ~~and~~similar ~~equivalent proceedings~~to inthose ~~foreign~~covered ~~jurisdictions,~~by ~~for example, opposition proceedings. Any such proceedings could result in revocation or amendment to~~ our patents ~~in such a way that they no longer cover our product candidates. The outcome following legal assertions of invalidity~~ and ~~unenforceability~~ ispatent ~~unpredictable.~~applications; ~~With~~or ~~respect~~● towhether ~~the validity question, for example,~~ we ~~cannot be certain that there is no invalidating prior art and that prior art that was cited during prosecution, but not relied on by the patent examiner,~~ will ~~not~~need ~~be revisited. If a defendant were~~ to ~~prevail~~initiate onlitigation ~~a legal assertion of invalidity and/~~or ~~unenforceability,~~administrative weproceedings ~~would~~which ~~lose~~may atbe ~~least~~costly ~~part,~~whether ~~and~~we ~~perhaps~~win ~~all,~~or ~~of the patents directed to our product candidates~~lose. ~~A loss of patent rights could have a material adverse impact on our business.~~

22Composition of matter patents for biological and pharmaceutical products are generally considered to be the strongest form of intellectual property. We cannot be certain that the claims in our pending patent applications directed to compositions of matter for our product candidates will be considered patentable by the U.S. Patent and Trademark Office (the “USPTO”) or by patent offices in foreign countries, or that the claims in any of our issued patents will be considered valid by courts in the U.S. or foreign countries. Method of use patents have claims directed to the use of a product for the specified method. This type of patent does not prevent a competitor from making and marketing a product that is identical to our product for an indication that is outside the scope of the patented method. Moreover, even if competitors do not actively promote their product for our targeted indications, physicians may prescribe these products “off-label.” Although off-label prescriptions may infringe or contribute to the infringement of method of use patents, the practice is common and such infringement is difficult to prevent or prosecute.

~~Changes in U.S. patent law could diminish the value of patents in general, thereby impairing our ability to protect our products.~~21

AsThe strength isof patents in the ~~case~~biotechnology ~~with~~and ~~other~~pharmaceutical ~~biopharmaceutical companies,~~field ~~our~~involves ~~success~~complex islegal ~~heavily~~and ~~dependent~~scientific onquestions ~~intellectual~~and ~~property,~~can ~~particularly~~be ~~patents~~uncertain. The ~~Obtaining~~patent ~~and~~applications ~~enforcing~~that ~~patents~~we own or in-license ~~the~~may ~~biopharmaceutical industry~~fail ~~involve~~to ~~both~~result ~~technological~~in ~~and~~issued ~~legal~~patents ~~complexity,~~with ~~and~~claims isthat ~~therefore~~cover ~~costly,~~our ~~time-consuming~~product ~~and~~candidates or ~~inherently~~uses ~~uncertain.~~thereof Inin ~~addition,~~ the U.S. ~~has~~or ~~recently~~in ~~enacted~~other ~~and~~foreign iscountries. ~~currently~~Even ~~implementing~~if ~~wide-ranging~~the ~~patent~~patents ~~reform~~do ~~legislation.~~successfully ~~Recent~~issue, ~~U.S.~~third ~~Supreme~~parties ~~Court~~may ~~rulings~~challenge the ~~have~~validity, ~~narrowed~~enforceability ~~the~~or scope ofthereof, ~~patent~~which ~~protection~~may ~~available~~result in ~~certain~~such ~~circumstances~~patents ~~and~~being ~~weakened~~narrowed, ~~the~~invalidated ~~rights~~or ofheld ~~patent~~unenforceable. ~~owners~~Furthermore, even if they are unchallenged, patents in ~~certain~~our ~~situations.~~portfolio may not adequately exclude third parties from practicing relevant technology Inor ~~addition~~prevent others from designing around our claims. If the breadth or strength of our intellectual property position with respect to our ~~increasing~~product ~~uncertainty~~candidates is threatened, it could dissuade companies from collaborating with ~~regard~~us to develop, and threaten our ability to commercialize, ~~obtain~~our ~~patents~~product candidates. Further, if we encounter delays in ~~the~~our ~~future~~clinical trials, ~~this~~the ~~combination~~period of ~~events~~time ~~has~~during ~~created~~which we could ~~uncertainty~~market ~~with~~our ~~respect~~product tocandidates ~~the~~under ~~value~~patent ofprotection ~~patents,~~would ~~once~~be ~~obtained~~reduced. ~~Depending~~Since onpatent ~~decisions~~applications byin the U.S. ~~Congress,~~and ~~the~~most ~~federal~~other ~~courts, and~~countries ~~the~~are ~~USPTO,~~confidential ~~the~~for ~~laws~~a ~~and~~period ~~regulations~~of ~~governing~~time ~~patents~~after ~~could~~filing, ~~change~~it inis ~~unpredictable~~possible ~~ways~~ that ~~would~~patent ~~weaken~~applications in our ~~ability~~portfolio tomay ~~obtain~~not ~~new~~be ~~patents~~the first filed orpatent toapplications ~~enforce~~related to our ~~existing~~product ~~patents~~candidates. ~~and~~Furthermore, ~~patents~~for ~~that~~U.S. weapplications ~~might~~in ~~obtain~~which inall ~~the~~claims ~~future.~~are ~~For~~entitled ~~example~~to a priority date before March 16, in2013, an interference proceeding can be provoked by a third-party or instituted by the ~~case~~USPTO, ~~Assoc.~~to ~~for~~determine ~~Molecular Pathology~~who v.was ~~Myriad~~the ~~Genetics,~~first ~~Inc.,~~to invent any of the subject matter covered by the patent claims of our applications. For U.S. ~~Supreme~~applications ~~Court~~containing a ~~held~~claim ~~that~~not ~~certain~~entitled ~~claims~~ to ~~DNA~~priority ~~molecules~~before ~~are~~March ~~not~~16, ~~patentable.~~2013, ~~While~~there weis doa ~~not~~greater ~~believe that~~level ~~any~~ of uncertainty in the ~~patents~~patent ~~owned~~law orwith ~~licensed~~the bypassage usof the ~~will~~America beInvents ~~found~~Act ~~invalid~~(2012) ~~based~~which onbrings ~~this~~into ~~decision~~effect significant changes to the U.S. patent laws that are yet untried and untested, and wewhich ~~cannot~~introduces ~~predict~~new ~~how~~procedures ~~future~~for ~~decisions~~challenging bypending patent applications and issued patents. A primary change under this reform is the ~~courts,~~creation of a “first to file” system in the U.S. ~~Congress~~This orwill ~~the~~require ~~USPTO~~us ~~may~~to ~~impact~~be cognizant going forward of the ~~value~~time from invention to filing of ~~our~~a ~~patents~~patent application.

WeObtaining and ~~have~~maintaining ~~limited~~our ~~foreign intellectual~~patents ~~property~~depends ~~rights~~on compliance with various procedural, document submission, fee payment and ~~may~~other ~~not~~requirements beimposed by ~~able~~governmental topatent ~~protect~~agencies, and our ~~intellectual~~patent ~~property~~position ~~rights~~could ~~throughout~~be ~~the~~reduced ~~world~~or eliminated for non-compliance with these requirements.

WePeriodic maintenance ~~have~~fees ~~limited~~on ~~intellectual~~any ~~property rights~~issued ~~outside~~patent ~~the~~are ~~U.S.~~due ~~Filing,~~to ~~prosecuting~~be ~~and~~paid ~~defending~~to ~~patents~~the onUSPTO ~~product~~and ~~candidates~~foreign patent agencies in ~~all~~several ~~countries~~stages ~~throughout~~over the ~~world~~lifetime of ~~would~~the ~~be prohibitively~~patent. ~~expensive,~~The USPTO and ~~our~~various ~~intellectual~~foreign ~~property~~governmental ~~rights~~patent inagencies ~~some~~require ~~countries~~compliance ~~outside~~with ~~the~~a ~~U.S.~~number ~~can~~of beprocedural, ~~less~~documentary, fee ~~extensive~~payment ~~than~~and ~~those~~other insimilar ~~the U.S.~~provisions Induring ~~addition,~~ the ~~laws~~patent ofapplication ~~some~~process. ~~foreign~~While ~~countries~~an doinadvertent ~~not~~lapse ~~protect~~can ~~intellectual~~in ~~property~~many tocases ~~the~~be ~~same~~cured by ~~extent~~payment asof ~~federal~~a ~~and~~late ~~state~~fee ~~laws in~~or ~~the~~by ~~U.S.~~other ~~Consequently,~~means wein ~~may~~accordance ~~not~~with bethe ~~able~~applicable torules, ~~prevent~~there ~~third~~are ~~parties~~situations ~~from~~in ~~practicing~~which ~~our~~noncompliance ~~inventions~~can result in ~~all~~abandonment ~~countries~~or ~~outside~~lapse of the ~~U.S.,~~ patent or ~~from~~patent ~~selling~~application, orresulting ~~importing~~in ~~products~~partial ~~made~~or ~~using~~complete ~~our~~loss ~~inventions~~of inpatent ~~and~~rights ~~into~~in the Urelevant jurisdiction.S. Noncompliance orevents ~~other~~that ~~jurisdictions.~~could ~~Competitors~~result ~~may~~in ~~use~~abandonment ~~our~~or ~~technologies in~~lapse ~~jurisdictions~~of ~~where~~a wepatent ~~have~~or patent application include, but are not ~~obtained~~limited ~~patents~~to, failure to ~~develop~~respond ~~their~~to ~~own~~official ~~products~~actions ~~and~~within ~~further~~prescribed time limits, ~~may~~non-payment ~~export~~of ~~otherwise~~fees ~~infringing~~and ~~products~~ failure to ~~territories~~properly ~~where~~legalize weand ~~have~~submit ~~patents,~~formal documents. ~~but~~Such ~~enforcement~~noncompliance isevents ~~not~~are asoutside ~~strong~~of asour ~~that~~direct incontrol ~~the~~for i) non-U.S. ~~These~~patents ~~products~~and ~~may~~patent ~~compete~~applications ~~with~~owned ~~our~~by ~~products~~us, and ii) patents and ~~our~~patent ~~patents~~applications orlicensed ~~other~~to ~~intellectual~~us ~~property~~by ~~rights~~another ~~may~~entity. ~~not~~In besuch ~~effective~~an orevent, ~~sufficient~~our competitors might be able to ~~prevent~~enter ~~them~~the ~~from~~market, which ~~competing~~would have a material adverse effect on our business.

~~Many companies have encountered~~Issued significant problems in protecting and defending intellectual property in foreign jurisdictions. The legal systems of certain countries, particularly China and certain developing countries, do not favor the enforcement of patents, ~~trade~~covering ~~secrets and other intellectual property, particularly those relating to biopharmaceutical products, which could make it difficult for us to stop the infringement of~~ our ~~patents or~~product ~~marketing~~candidates of competing products in violation of our proprietary rights generally. To date, we have not sought to enforce any issued patents in these foreign jurisdictions. Proceedings to enforce our patent rights in foreign jurisdictions could ~~result~~be infound ~~substantial costs~~invalid ~~and divert our efforts and attention from other aspects of our business, could put our patents at risk of being invalidated~~ or ~~interpreted narrowly~~unenforceable and our patent applications at risk of not issuing and could provoke third parties to assert claims against us. We may not prevail in any lawsuits that we initiate, and the damages or other remedies awarded, if ~~any,~~challenged ~~may not be commercially meaningful. The requirements for patentability may differ~~ in ~~certain~~court ~~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~~USPTO. Certain countries in Europe and developing countries, including China and India, have compulsory licensing laws under which a patent owner may be compelled to grant licenses to third parties. In those countries, we and our licensors may have limited remedies if patents are infringed or if we or our licensors are compelled to grant a license to a third party, which could materially diminish the value of those patents. This could limit our potential revenue opportunities. Accordingly, our efforts to enforce our intellectual property rights around the world may be inadequate to obtain a significant commercial advantage from the intellectual property that we develop or license.

23If we or one of our licensing partners initiate legal proceedings against a third party to enforce a patent covering one of our product candidates, the defendant could counterclaim that the patent covering our product candidate, as applicable, is invalid and/or unenforceable. In patent litigation in the U.S., defendant counterclaims alleging invalidity and/or unenforceability are commonplace, and there are numerous grounds upon which a third party can assert invalidity or unenforceability of a patent. Third parties may also raise similar claims before administrative bodies in the U.S. or abroad, even outside the context of litigation. Such mechanisms include re-examination, post grant review, and equivalent proceedings in foreign jurisdictions, for example, opposition proceedings. Any such proceedings could result in revocation or amendment to our patents in such a way that they no longer cover our product candidates. The outcome following legal assertions of invalidity and unenforceability is unpredictable. With respect to the validity question, for example, we cannot be certain that there is no invalidating prior art and that prior art that was cited during prosecution, but not relied on by the patent examiner, will not be revisited. If a defendant were to prevail on a legal assertion of invalidity and/or unenforceability, we would lose at least part, and perhaps all, of the patents directed to our product candidates. A loss of patent rights could have a material adverse impact on our business.

~~Risks Related to Our Common Stock~~22

~~The issuance or sale of~~We ~~shares~~have inlimited ~~the~~foreign ~~future~~intellectual toproperty ~~raise~~rights ~~money~~and ormay ~~for~~not ~~strategic~~be ~~purposes~~able ~~could~~to ~~reduce~~protect ~~the~~our ~~market~~intellectual ~~price~~property ofrights ~~our~~throughout ~~common~~the ~~stock~~world.

InWe have ~~the~~limited ~~future,~~intellectual weproperty ~~may~~rights ~~issue~~outside ~~securities to~~the ~~raise~~U.S. ~~cash for operations~~Filing, toprosecuting ~~pay~~and ~~down~~defending ~~then~~patents ~~existing~~on ~~indebtedness,~~product ascandidates ~~consideration~~in ~~for~~all countries throughout the ~~acquisition~~world ofwould ~~assets,~~be asprohibitively ~~consideration for~~expensive, ~~receipt~~and ofour ~~goods~~intellectual orproperty ~~services,~~rights toin ~~pay~~some ~~for~~countries outside the ~~development~~U.S. ofcan ~~our~~be less ~~CAR-T~~extensive ~~cancer~~than ~~therapeutics,~~those toin ~~pay~~the ~~for~~U.S. In addition, the ~~development~~laws of ~~our~~some ~~cancer vaccines~~foreign ~~and~~countries ~~for~~do ~~acquisitions~~not ofprotect ~~companies.~~intellectual Weproperty ~~have~~to ~~an at-~~the~~-market~~ ~~equity~~same extent ~~offering~~as ~~under~~federal ~~which,~~and asstate oflaws ~~January~~in ~~10,~~the ~~2025~~U.S. Consequently, we may ~~issue up~~not be able to ~~approximately~~prevent ~~$97~~third ~~million~~parties offrom ~~common~~practicing ~~stock,~~our ~~which~~inventions in isall ~~currently~~countries ~~effective~~outside the U.S., ~~and~~or ~~which~~from ~~may~~selling ~~remain~~or ~~available~~importing toproducts usmade using our inventions in and into the ~~future~~U.S. Weor other jurisdictions. ~~also~~Competitors ~~have,~~may ~~and~~use our technologies in ~~the~~jurisdictions ~~future~~where ~~may,~~we ~~issue~~have ~~securities~~not ~~convertible~~obtained ~~into~~patents ~~our~~to ~~common~~develop ~~stock.~~their ~~Any~~own ofproducts ~~these~~and ~~events~~further, may export ~~dilute~~otherwise ~~stockholders’ ownership~~infringing ~~interests~~products into ~~our~~territories ~~company~~where ~~and~~we have anpatents, ~~adverse~~but ~~impact~~enforcement onis not as strong as that in the ~~price~~U.S. ofThese products may compete with our ~~common~~products ~~stock~~and our patents or other intellectual property rights may not be effective or sufficient to prevent them from competing.

InMany companies ~~addition~~have encountered significant problems in protecting and defending intellectual property in foreign jurisdictions. The legal systems of certain countries, ~~sales~~particularly China and certain developing countries, do not favor the enforcement of apatents, ~~substantial~~trade secrets ~~amount~~and other intellectual property, particularly those relating to biopharmaceutical products, which could make it difficult for us to stop the infringement of our ~~common~~patents ~~stock~~or marketing of competing products in ~~the~~violation ~~public~~of ~~market~~our proprietary rights generally. To date, we have not sought to enforce any issued patents in these foreign jurisdictions. Proceedings to enforce our patent rights in foreign jurisdictions could result in substantial costs and divert our efforts and attention from other aspects of our business, could put our patents at risk of being invalidated or ~~the~~interpreted ~~perception~~narrowly and our patent applications at risk of not issuing and could provoke third parties to assert claims against us. We may not prevail in any lawsuits that ~~these~~we ~~sales~~initiate, and the damages or other remedies awarded, if any, may ~~occur~~not be commercially meaningful. The requirements for patentability may differ in certain countries, ~~could~~particularly ~~reduce~~developing countries. Furthermore, generic drug manufacturers or other competitors may challenge the ~~market~~scope, ~~price~~validity or enforceability of our ~~common~~or our licensors’ patents, ~~stock~~requiring us or our licensors to engage in complex, lengthy and costly litigation or other proceedings. ~~This~~Certain ~~could~~countries ~~also~~in ~~impair~~Europe and developing countries, including China and India, have compulsory licensing laws under which a patent owner may be compelled to grant licenses to third parties. In those countries, we and our ~~ability~~licensors may have limited remedies if patents are infringed or if we or our licensors are compelled to ~~raise~~grant ~~additional~~a ~~capital~~license ~~through~~to a third party, which could materially diminish the ~~sale~~value of those patents. This could limit our ~~securities~~potential revenue opportunities. Accordingly, our efforts to enforce our intellectual property rights around the world may be inadequate to obtain a significant commercial advantage from the intellectual property that we develop or license.

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

WeThe issuance ~~may~~or ~~fail~~sale toof ~~meet~~shares ~~market expectations~~in ~~because~~the offuture ~~fluctuations~~to inraise ~~quarterly~~money ~~operating~~or ~~results,~~for ~~which~~strategic purposes could ~~cause~~reduce the market price of our common stock ~~to decline~~.

~~Our~~In the ~~reported~~future, ~~revenues~~we ~~and~~may ~~operating results~~issue ~~have~~securities ~~fluctuated~~to inraise ~~the~~cash ~~past~~for ~~and~~operations, ~~may continue~~ to ~~fluctuate~~pay ~~significantly~~down ~~from~~then ~~quarter~~existing toindebtedness, ~~quarter~~as inconsideration for the ~~future~~acquisition of assets, ~~specifically~~ as we ~~continue~~consideration for receipt of goods or services, to ~~devote~~pay ~~our~~for ~~resources~~the ~~towards~~development ~~our~~of ~~CAR~~lira-Tcel, ~~cancer~~to ~~therapeutics~~pay ~~and~~for ~~our~~the development of our cancer vaccines and for acquisitions of companies. ItWe ishave ~~possible~~an ~~that~~at-the-market inequity ~~future~~offering ~~periods~~under which, as of January 12, 2026 we ~~will~~may issue ~~have~~up noto ~~revenue~~approximately ~~or,~~$98.6 inmillion ~~any~~of ~~event~~common stock, ~~revenues~~which ~~could~~is ~~fall~~currently ~~below~~effective, orand ~~expenses~~which ~~could~~may ~~rise~~remain ~~above~~available ~~the~~to ~~expectations~~us ofin ~~securities~~the ~~analysts~~future. orWe ~~investors~~also have, ~~which~~and ~~could~~in ~~cause~~ the ~~market~~future ~~price~~may, ofissue securities convertible into our common stock ~~to decline~~. ~~The~~Any ~~following~~of ~~are~~these ~~among~~events ~~the~~may ~~factors~~dilute ~~that~~stockholders’ ownership ~~could~~interests ~~cause~~ in our ~~operating~~company ~~results~~and tohave ~~fluctuate~~an ~~significantly~~adverse ~~from~~impact ~~period~~on tothe ~~period:~~price of our common stock.

●In addition, ~~patient~~sales ~~enrollment~~of ~~rates~~a ~~for~~substantial ~~our~~amount ~~clinical~~of ~~trials; ● delays with respect to~~ our ~~clinical~~common ~~trials;~~stock ●in ~~clinical~~the ~~trial~~public ~~results~~market, ~~relating~~or tothe ~~our~~perception ~~CAR-T~~that ~~cancer~~these ~~therapeutics;~~sales ●may ~~clinical~~occur, ~~trial~~could reduce ~~results~~the ~~relating~~market toprice ~~our breast cancer vaccine; ● results~~ of ~~pre-clinical studies relating to~~ our ~~ovarian~~common ~~cancer~~stock. ~~vaccine;~~This ●could ~~results~~also ofimpair our ~~new~~ability ~~vaccine~~to ~~discovery~~raise ~~efforts;~~additional ●capital ~~progress~~through ~~with regulatory authorities towards~~ the ~~certification/approval~~sale of our ~~CAR-T cancer therapeutics, our breast cancer vaccine or our ovarian cancer vaccine; and ● costs related to acquisitions, alliances and licenses~~securities.

~~Biotechnology company stock prices are especially volatile, and this volatility may depress the price of our common stock.~~23

~~The~~Any actual ~~stock~~or ~~market~~anticipated ~~has~~sales ~~experienced significant~~of ~~price~~shares ~~and~~by ~~volume~~our ~~fluctuations,~~stockholders ~~and~~may cause the ~~market~~trading ~~prices~~price of ~~biotechnology~~our ~~companies~~common ~~have~~stock ~~been~~to ~~highly volatile~~decline. WeThe ~~believe~~sale ~~that various~~of ~~factors~~a ~~may~~substantial number ~~cause~~of ~~the~~shares ~~market price~~ of our common stock toby ~~fluctuate~~our stockholders, ~~perhaps~~or ~~substantially,~~anticipation ~~including,~~of ~~among~~such ~~others~~sales, could make it more difficult for us to sell equity or equity-related securities in the ~~following:~~future at a time and at a price that we might otherwise wish to effect sales.

●We may ~~announcements~~fail ofto ~~developments~~meet inmarket ~~the~~expectations ~~fields~~because of ~~CAR-T~~fluctuations ~~therapeutics or cancer vaccines; ● developments~~ in ~~relationships~~quarterly ~~with~~operating ~~third~~results, ~~party~~which ~~vendors~~could ~~and~~cause ~~laboratories;~~the ●price ~~developments~~of ~~or disputes concerning~~ our ~~patents~~common stock ~~and~~to ~~other intellectual property; ● our or our competitors’ technological innovations; ● variations in our quarterly operating results;~~decline.

24Our reported revenues and operating results have fluctuated in the past and may continue to fluctuate significantly from quarter to quarter in the future, specifically as we continue to devote our resources towards our CAR-T cancer therapeutics and our cancer vaccines. It is possible that in future periods, we will have no revenue or, in any event, revenues could fall below or expenses could rise above the expectations of securities analysts or investors, which could cause the market price of our common stock to decline. The following are among the factors that could cause our operating results to fluctuate significantly from period to period:

● ~~our~~patient ~~failure~~enrollment torates ~~meet~~for orour ~~exceed~~clinical ~~securities~~trials; ~~analysts’~~● ~~expectations~~delays ofwith respect to our ~~financial~~clinical ~~results~~trials; ● aclinical ~~change~~trial inresults ~~financial~~relating ~~estimates~~to orlira-cel; ~~securities~~● ~~analysts’~~clinical ~~recommendations;~~trial ●results ~~changes~~relating into ~~management’s~~our orbreast ~~securities~~cancer ~~analysts’~~vaccine; ~~estimates~~● results of pre-clinical studies relating to our ~~financial~~ovarian ~~performance~~cancer vaccine; ● ~~announcements~~results byof usour ornew ~~our~~vaccine ~~competitors~~discovery ofefforts; ~~significant~~● ~~contracts,~~progress ~~acquisitions,~~with ~~strategic~~regulatory ~~partnerships,~~authorities ~~joint~~towards ~~ventures,~~the ~~capital~~certification/approval ~~commitments~~of lira-cell, ~~new~~our ~~technologies,~~breast orcancer ~~patents;~~vaccine ~~and~~or ●our ~~the~~ovarian ~~timing~~cancer ofvaccine; orand ~~our~~● ~~failure~~costs related to ~~complete~~acquisitions, ~~significant~~alliances ~~transactions~~and licenses.

~~In addition, we believe that fluctuations~~Biotechnology incompany ~~our~~ stock ~~price~~prices ~~during~~are ~~applicable~~especially ~~periods~~volatile, ~~can~~and ~~also~~this bevolatility ~~impacted~~may bydepress ~~changes in governmental regulations in~~ the ~~drug~~price ~~development~~of ~~industry and/or court rulings and/or other developments in~~ our ~~remaining~~common ~~patent licensing and enforcement actions~~stock.

InThe stock ~~the~~market ~~past,~~has ~~companies~~experienced ~~that~~significant ~~have experienced~~price ~~volatility~~and involume fluctuations, and the market ~~price~~prices of ~~their~~biotechnology ~~stock~~companies have been ~~the objects of securities class action litigation~~highly volatile. IfWe ~~our~~believe ~~common~~that ~~stock was~~various ~~the~~factors ~~object~~may ofcause ~~securities class action litigation due to volatility in~~ the market price of our common stock, itto ~~could~~fluctuate, ~~result~~perhaps insubstantially, ~~substantial~~including, ~~costs~~among ~~and a diversion of management’s attention and resources~~others, ~~which~~the ~~could materially harm our business and financial results.~~following:

~~Our~~● ~~common~~announcements ~~stock~~of isdevelopments ~~currently listed~~in onthe ~~NASDAQ~~fields ~~Capital~~of ~~Market,~~CAR-T ~~however~~therapeutics ifor cancer vaccines; ● developments in relationships with third party vendors and laboratories; ● developments or disputes concerning our ~~common~~patents ~~stock~~and isother ~~delisted~~intellectual ~~for~~property; ~~any~~● ~~reason,~~our itor ~~will~~our ~~become~~competitors’ ~~subject~~technological innovations; ● announcements of our or our competitors’ clinical trial results; ● variations in our quarterly operating results; ● our failure to ~~the~~meet ~~SEC~~or exceed securities analysts’ expectations of our financial results; ● a change in financial estimates or securities analysts’ recommendations; ● changes in management’s ~~penny stock~~or ~~rules~~securities ~~which~~analysts’ ~~may~~estimates ~~make~~of our ~~shares~~financial ~~more~~performance; ~~difficult~~● announcements by us or our competitors of significant contracts, acquisitions, strategic partnerships, joint ventures, capital commitments, new technologies, or patents; and ● the timing of or our failure to ~~sell~~complete significant transactions.

~~If our common stock is delisted~~In ~~from NASDAQ Capital Market~~addition, ~~our~~we ~~common~~believe ~~stock~~that ~~will~~fluctuations ~~then fit the definition of a penny stock and therefore would be subject to the rules adopted by the SEC regulating broker-dealer practices~~ in ~~connection with transactions in penny stocks. The SEC rules may have the effect of reducing trading activity in~~ our ~~common~~ stock ~~making~~price itduring ~~more~~applicable ~~difficult~~periods ~~for~~can ~~investors~~also tobe ~~sell~~impacted their shares. The SEC’s rules require a broker or dealer proposing to effect a transaction in a penny stock to deliver the customer a risk disclosure document that provides certain information prescribed by ~~the~~changes ~~SEC, including, but not limited to, the nature and level of risks~~ in ~~the~~governmental ~~penny stock market. The~~regulations ~~broker or dealer must also disclose the aggregate amount of any compensation received or receivable by him~~ in ~~connection with such transaction prior to consummating~~ the ~~transaction.~~drug Indevelopment ~~addition,~~industry ~~the SEC’s rules also require a broker~~ and/or ~~dealer~~court torulings ~~make a special written determination that the penny stock is a suitable investment for the purchaser~~ and/or ~~receive~~other ~~the~~developments ~~purchaser’s written agreement to the transaction before completion of the transaction. The existence of the SEC’s rules may result~~ in aour ~~lower~~remaining ~~trading~~patent ~~volume~~licensing ~~of our common stock~~ and ~~lower~~enforcement ~~trading prices~~actions.

WeIn the ~~have~~past, ~~issued~~companies athat ~~significant number~~have ofexperienced ~~securities~~volatility ~~pursuant~~in tothe ~~our~~market ~~incentive~~price ~~plans~~of ~~and~~their ~~may~~stock ~~continue~~have tobeen dothe soobjects inof ~~the~~securities ~~future~~class action litigation. ~~The~~If ~~vesting~~our ~~and,~~common ifstock ~~applicable,~~was ~~exercise of~~the ~~these~~object of securities ~~and~~class ~~the~~action ~~sale~~litigation ofdue to volatility in the ~~shares~~market price of ~~common~~our stock, it ~~issuable~~could ~~thereunder~~result ~~may~~in ~~dilute~~substantial ~~stockholders’~~costs ~~percentage ownership interest~~ and ~~may~~a ~~also~~diversion ~~result~~of inmanagement’s ~~downward~~attention ~~pressure~~and onresources, ~~the~~which ~~price~~could ofmaterially harm our ~~common~~business and ~~stock~~financial results.

As of the date of this Report, we have issued and outstanding options to purchase 13,488,062 shares of our common stock with a weighted average exercise price of $3.53. Further, as of the date of this Report, our Board of Directors and Compensation Committee have the authority to issue awards totaling an additional 645,000 shares of our common stock which is replenished on a yearly basis in accordance with the provisions of our plan. Additionally, we have registered for resale all of the shares of common stock issuable under our incentive plans. Because the market for our common stock is thinly traded, the sales and/or the perception that those sales may occur, could adversely affect the market price of our common stock. Furthermore, the mere existence of a significant number of shares of common stock issuable upon vesting and, if applicable, exercise of these securities may be perceived by the market as having a potential dilutive effect, which could lead to a decrease in the price of our common stock.24

25Our common stock is currently listed on NASDAQ Capital Market, however if our common stock is delisted for any reason, it will become subject to the SEC’s penny stock rules which may make our shares more difficult to sell.

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

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

WeAs of dothe ~~not~~date ~~anticipate~~of ~~declaring~~this Report, we have issued and outstanding options to purchase 13,897,094 shares of our common stock with a weighted average ~~any~~exercise ~~cash~~price ~~dividends~~of on$3.53. Further, as of the date of this Report, our Board of Directors and Compensation Committee have the authority to issue awards totaling an additional 1,295,000 shares of our common stock which is replenished on a yearly basis in accordance with the provisions of our plan. Additionally, we have registered for resale all of the shares of common stock issuable under our incentive plans. Because the market for our common stock is thinly traded, the sales and/or the perception that those sales may occur, could adversely ~~impact~~affect the market price of our common stock. Furthermore, the mere existence of a significant number of shares of common stock issuable upon vesting and, if applicable, exercise of these securities may be perceived by the market as having a potential dilutive effect, which could lead to a decrease in the price of our common stock.

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

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

~~None~~We do not anticipate declaring any cash dividends on our common stock which may adversely impact the market price of our stock.

~~Item~~We have 1Cnever declared or paid cash dividends on our common stock and do not plan to pay any cash dividends in the near future. ~~Cybersecurity~~Our current policy is to retain all funds and any earnings for use in the operation and expansion of our business. If we do not pay dividends, our stock may be less valuable to you because a return on your investment will only occur if our stock price appreciates.

~~Overview~~25

~~Our IT and related systems are~~Item ~~critical to the efficient operation of our business and essential to our ability to perform day to day processes~~1B. WeUnresolved ~~face~~Staff persistent security threats, including threats to our IT infrastructure and unlawful attempts to gain access to our confidential or otherwise proprietary information, or that of our employees, via phishing/malware campaigns and other cyberattack methods.Comments

~~Our security policies and processes are based on industry best practices and are revisited regularly to ensure their appropriateness based on risk, threats and current technological capabilities~~None. We regularly assess our threat landscape and monitor our systems and other technical security controls, maintain information security practices and ensure maintenance of backup and protective systems. We review System and Organization Controls 1 (SOC 1 Type II) certifications where relevant from key third party partners and other service providers with access to information assets at least annually.

~~Our internal controls and procedures~~Item ~~address cybersecurity and include processes intended to ensure that security breaches are reported to appropriate personnel and, if warranted, analyzed for potential disclosure~~1C. We also maintain insurance coverage that is intended to address certain aspects of cybersecurity risks. To date, there have not been any cybersecurity threats that have materially affected the Company.Cybersecurity

~~Governance~~Overview

~~Board~~Our IT ~~Oversight~~and related systems are critical to the efficient operation of ~~Cybersecurity~~our ~~Matters~~business and essential to our ability to perform day-to-day processes. We face persistent security threats, including threats to our IT infrastructure and unlawful attempts to gain access to our confidential or otherwise proprietary information, or that of our employees, via phishing/malware campaigns and other cyberattack methods.

~~Assessing~~Our security policies and ~~managing~~processes ~~information~~are based on industry best practices and are revisited regularly to ensure their appropriateness based ~~security~~on ~~matters~~risk, isthreats ~~the~~and ~~responsibility~~current oftechnological capabilities. We regularly assess our ~~Audit~~threat ~~Committee.~~landscape ~~The~~and ~~Audit~~monitor ~~Committee~~our ~~meets~~systems ~~with~~and ~~the~~other ~~senior~~technical security ~~executives~~controls, ~~specifically~~maintain ~~the Chief~~information ~~Executive~~security ~~Officer~~practices and ~~Chief~~ensure ~~Financial~~maintenance ~~Officer~~of onbackup atand ~~least~~protective ansystems. ~~annual~~We ~~basis~~review toSystem and ~~discuss~~Organization ~~cybersecurity~~Controls ~~posture.~~1 ~~The~~(SOC ~~Audit~~1 ~~Committee may~~Type ~~also~~II) ~~periodically~~certifications ~~receive~~where ~~targeted~~relevant ~~briefings~~from ~~related~~key tothird ~~cybersecurity~~party partners and ~~reviews~~other ~~our~~service ~~incident~~providers ~~response~~with access ~~capabilities~~to information assets at least annually.

26Our internal controls and procedures address cybersecurity and include processes intended to ensure that security breaches are reported to appropriate personnel and, if warranted, analyzed for potential disclosure. We also maintain insurance coverage that is intended to address certain aspects of cybersecurity risks. To date, there have not been any cybersecurity threats that have materially affected the Company.

~~Management of Cybersecurity Risks~~Governance

~~The~~Board ~~senior~~Oversight executives work to protect our information systems from cybersecurity threats and to promptly assist in coordinating a response to any cybersecurity incidents in accordance with our cybersecurity incident response and recovery plans. We have engaged an IT Managed Service Provider who assists in the oversight of ~~our~~Cybersecurity corporate-wide data security, including developing, implementing and enforcing security policies to manage our overall cybersecurity risks. The senior executives regularly meet with our IT Managed Service Provider during the course of the year to review and discuss cybersecurity issues.Matters

~~Strategy~~Assessing and managing information security matters is the responsibility of our Audit Committee. The Audit Committee meets with the senior executives, specifically the Chief Executive Officer and Chief Financial Officer on at least an annual basis to discuss cybersecurity posture. The Audit Committee may also periodically receive targeted briefings related to cybersecurity and reviews our incident response capabilities.

~~Our~~Management of ~~Security~~Cybersecurity ~~Culture~~Risks

WeThe senior executives work to protect our information ~~assets~~ systems from cybersecurity threats and ~~manage~~to ~~risk~~promptly byassist ~~promoting~~in coordinating a ~~culture~~response to ~~that~~any ~~communicates~~cybersecurity ~~security~~incidents ~~risks,~~in ~~designs~~accordance ~~secure~~with ITour ~~systems~~cybersecurity incident response and ~~operates~~recovery ~~according~~plans. toWe ~~approved~~have engaged an IT Managed ~~processes~~Service toProvider ~~reduce~~who ~~the~~assists ~~likelihood~~in ~~and~~the ~~impact~~oversight of our corporate-wide data security, ~~incidents~~including developing, implementing and enforcing security policies to manage our overall cybersecurity risks. WeThe ~~achieve~~senior ~~this~~executives ~~objective~~regularly ~~by:~~meet with our IT Managed Service Provider during the course of the year to review and discuss cybersecurity issues.

● designing, implementing and maintaining solutions with appropriate security controls; ● sustaining solutions with required patching and vulnerability remediation; ● creating and executing controls in support of policy as well as regulatory compliance; ● ensuring that our policies, processes, practices and technologies proactively protect, shield, defend and remediate cyber threats; and ● delivering quality communications and annual training to stakeholders on cyber awareness and computing hygiene.Strategy

~~We believe that the conduct of~~Our ~~our~~Security ~~employees is critical to the success of our information security. We keep our employees apprised of threats, risks and the part that they play in protecting both themselves and the Company.~~Culture

We ~~assess our service providers~~ ~~prior~~protect ~~to allowing~~ our information toassets beand ~~processed,~~manage ~~stored~~risk ~~or transmitted~~ by ~~third~~promoting ~~parties,~~a ~~and~~culture wethat ~~include~~communicates ~~standardized contractual requirements in each contract where appropriate. We validate our service providers’~~ security ~~via questionnaires~~risks, ~~open-source~~designs ~~intelligence~~secure ~~and, where~~IT ~~appropriate,~~systems ~~SOC 1 Type II reports on financially significant third-party service providers. Our process also includes regular monitoring~~and ofoperates ~~risk~~according ~~related~~ to ~~third~~approved ~~parties~~processes onto areduce ~~periodic~~the ~~basis~~likelihood orand ~~when~~impact ~~services~~of orsecurity ~~product~~incidents. ~~purchases~~We ~~expand~~achieve ~~beyond~~this ~~their~~objective ~~original scope or intended use.~~by:

~~Item~~● 2.designing, ~~Properties~~implementing and maintaining solutions with appropriate security controls; ● sustaining solutions with required patching and vulnerability remediation; ● creating and executing controls in support of policy as well as regulatory compliance; ● ensuring that our policies, processes, practices and technologies proactively protect, shield, defend and remediate cyber threats; and ● delivering quality communications and training to stakeholders on cyber awareness and computing hygiene.

We lease approximately 2,000 square feet of office space at 3150 Almaden Expressway, San Jose, California 95118 (our principal executive offices) from an unrelated party pursuant to a lease that expires September 30, 2027, with an option to extend the lease an additional two years. Our base rent is approximately $5,000 per month and the lease provides for annual increases of approximately 3% and an escalation clause for increases in certain operating costs.26

~~Item~~We believe 3that the conduct of our employees is critical to the success of our information security. ~~Legal~~We ~~Proceedings~~keep our employees apprised of threats, risks and the part that they play in protecting both themselves and the Company.

~~Other~~We assess ~~than~~our ~~lawsuits~~service weproviders ~~bring~~prior to ~~enforce~~ allowing our ~~patent~~information ~~rights~~to be processed, stored or transmitted by third parties, and we ~~are~~include standardized ~~not~~contractual arequirements ~~party~~in toeach ~~any~~contract ~~material~~where ~~pending~~appropriate. ~~legal~~We ~~proceedings~~validate our service providers’ security via open-source intelligence and, ~~nor~~where ~~are~~appropriate, weSOC ~~aware~~1 ofType ~~any~~II ~~pending~~reports ~~litigation~~on ~~or legal~~financially ~~proceeding~~significant ~~against~~third-party usservice ~~that~~providers. ~~would~~Our ~~have~~process aalso includes ~~material~~regular ~~adverse~~monitoring ~~effect~~of risk related to third parties on ~~our~~a ~~financial~~periodic ~~position~~basis or ~~results~~when ofservices ~~operations~~or product purchases expand beyond their original scope or intended use.

Item 4 2. ~~Mine Safety Disclosures~~Properties

~~Not~~We lease ~~applicable~~approximately 2,000 square feet of office space at 3150 Almaden Expressway, San Jose, California 95118 (our principal executive offices) from an unrelated party pursuant to a lease that expires September 30, 2027, with an option to extend the lease an additional two years. Our base rent is approximately $5,000 per month and the lease provides for annual increases of approximately 3% and an escalation clause for increases in certain operating costs.

27Item 3. Legal Proceedings

~~PART~~Other than IIlawsuits we bring to enforce our patent rights, we are not a party to any material pending legal proceedings, nor are we aware of any pending litigation or legal proceeding against us that would have a material adverse effect on our financial position or results of operations.

Item 5 4. ~~Market~~Mine ~~for~~Safety ~~the Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities~~Disclosures

~~Market Information~~Not applicable.

~~Our common stock trades under the symbol “ANIX” on the NASDAQ Capital Market.~~27

~~Holders~~PART II

AsItem 5. ofMarket ~~January~~for ~~8, 2025,~~ the ~~approximate number~~Registrant’s ofCommon ~~record~~Equity, ~~holders~~Related ofStockholder ~~our~~Matters ~~common stock was 307~~ and ~~the~~Issuer ~~closing~~Purchases ~~price~~ of ~~our~~Equity ~~common stock was $2.25 per share.~~Securities

~~Securities Authorized for Issuance Under Equity~~Market ~~Compensation Plans~~Information

~~The following is information~~Our ~~as of October 31, 2024 about shares of our~~ common stock ~~that~~trades ~~may~~under ~~be issued upon~~ the ~~exercise~~symbol of“ANIX” ~~options,~~on ~~warrants~~the ~~and~~NASDAQ ~~rights~~Capital ~~under all equity compensation plans in effect as of that date, including our 2010 Share Incentive Plan and our 2018 Share Incentive Plan~~Market. ~~See Note 4 to our Consolidated Financial Statements for more information on these plans.~~

Plan category	Number of securities to be issued upon exercise of outstanding options, warrants and rights (a)		Weighted average exercise price of outstanding options, warrants and rights		Number of securities remaining available for future issuance under equity compensation plans (excluding securities reflected in column (a))
Equity compensation plans not approved by security holders (1)		986,968	$	2.77		-
Equity compensation plans approved by security holders (2)		11,171,094	$	3.74		983,907

Holders

~~(1)~~As of OnJanuary ~~July 14~~9, ~~2010~~2026, the ~~Board~~approximate ~~adopted~~number ~~the~~of ~~2010~~record ~~Share~~holders ~~Incentive Plan. Officers, key employees and non-employee directors~~ of, ~~and~~our ~~consultants~~common ~~to,~~stock ~~the~~was ~~Company~~280 ~~or any of its subsidiaries~~ and ~~affiliates were eligible to participate in~~ the ~~2010~~closing ~~Share~~price ~~Incentive Plan. The 2010 Share Incentive Plan provided for the grant~~ of ~~stock~~our ~~options,~~common stock was ~~appreciation rights, stock awards, and performance awards and stock units~~$3.38 ~~The~~per ~~2010 Share Incentive Plan terminated with respect to additional grants on July 14, 2020~~share.

~~(2)~~Securities Authorized The 2018 Share Incentive Plan was adopted by the Board on January 25, 2018 and approved by our shareholders on March 29, 2018. Officers, key employees and non-employee directors of, and consultants to, the Company or any of its subsidiaries and affiliates are eligible to participate in the 2018 Share Incentive Plan. The 2018 Share Incentive Plan provides for ~~the~~Issuance ~~grant~~Under ofEquity incentive stock options, nonqualified stock options, stock appreciation rights, stock awards, performance awards and stock units (the “2018 Benefits”). The maximum number of shares of common stock available for issuance under the 2018 Share Incentive Plan was initially 5,000,000 shares. Additionally, commencing on the first business day in January 2019 and on the first business day of each calendar year thereafter, the maximum aggregate number of shares available for issuance shall be replenished such that, as of such first business day, the maximum aggregate number of shares available for issuance shall be 2,000,000 shares. The 2018 Share Incentive Plan is administered by the Compensation Committee, which determines the option price, term and provisions of the 2018 Benefits. The 2018 Share Incentive Plan terminates with respect to additional grants on March 28, 2028. The Board may amend, suspend or terminate the 2018 Share Incentive Plan at any time, subject in certain respects to obtaining shareholder approval.Plans

28The following is information as of October 31, 2025 about shares of our common stock that may be issued upon the exercise of options, warrants and rights under all equity compensation plans in effect as of that date, including our 2010 Share Incentive Plan and our 2018 Share Incentive Plan. See Note 4 to our Consolidated Financial Statements for more information on these plans.

Dividend Policy

Plan category	Number of securities to be issued upon exercise of outstanding options, warrants and rights (a)		Weighted average exercise price of outstanding options, warrants and rights		Number of securities remaining available for future issuance under equity compensation plans (excluding securities reflected in column (a))
Equity compensation plans not approved by security holders (1)		786,283	$	2.73		-
Equity compensation plans approved by security holders (2)		12,411,094	$	3.60		721,642

No(1) ~~cash~~On ~~dividends~~July ~~have~~14, ~~been~~2010, ~~paid on~~the ~~our~~Board ~~common~~adopted ~~stock~~the ~~since~~2010 ~~our~~Share ~~inception~~Incentive Plan. WeOfficers, ~~have~~key noemployees ~~present~~and ~~intention~~non-employee directors of, and consultants to, ~~pay~~the Company or any ~~cash~~of ~~dividends~~its subsidiaries and affiliates were eligible to participate in the ~~foreseeable~~2010 ~~future~~Share Incentive Plan. The 2010 Share Incentive Plan provided for the grant of stock options, stock appreciation rights, stock awards, performance awards and stock units. The 2010 Share Incentive Plan terminated with respect to additional grants on July 14, 2020.

~~Recent~~(2) ~~Sales~~The 2018 Share Incentive Plan was adopted by the Board on January 25, 2018 and approved by our shareholders on March 29, 2018. Officers, key employees and non-employee directors of, ~~Unregistered~~and ~~Securities~~consultants to, the Company or any of its subsidiaries and affiliates are eligible to participate in the 2018 Share Incentive Plan. The 2018 Share Incentive Plan provides for the grant of incentive stock options, nonqualified stock options, stock appreciation rights, stock awards, performance awards and stock units (the “2018 Benefits”). The maximum number of shares of common stock available for issuance under the 2018 Share Incentive Plan was initially 5,000,000 shares. Additionally, commencing on the first business day in January 2019 and on the first business day of each calendar year thereafter, the maximum aggregate number of shares available for issuance shall be replenished such that, as of such first business day, the maximum aggregate number of shares available for issuance shall be 2,000,000 shares. The 2018 Share Incentive Plan is administered by the Compensation Committee, which determines the option price, term and provisions of the 2018 Benefits. The 2018 Share Incentive Plan terminates with respect to additional grants on March 28, 2028. The Board may amend, suspend or terminate the 2018 Share Incentive Plan at any time, subject in certain respects to obtaining shareholder approval.

~~The~~Dividend ~~Company did not issue any unregistered securities during the three months ended October 31, 2024.~~Policy

~~Item~~No cash 6dividends have been paid on our common stock since our inception. ~~[Reserved]~~We have no present intention to pay any cash dividends in the foreseeable future.

~~Item~~Recent Sales ~~7. Management’s Discussion and Analysis~~ of ~~Financial~~Unregistered ~~Condition and Results of Operations~~Securities

~~General~~The Company did not issue any unregistered securities during the three months ended October 31, 2025.

~~In reviewing Management’s~~Item ~~Discussion and Analysis of Financial Condition and Results of Operations, you should refer to our Consolidated Financial Statements and the notes related thereto~~6. [Reserved]

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

~~Fiscal Year ended October 31, 2024 compared with Fiscal Year ended October 31, 2023~~General

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

We did not have any revenue in fiscal year 2024. In fiscal year 2023, we recorded revenue of approximately $210,000 from one license agreement related to our encrypted audio/video conference calling technology. The license agreement provided for a one-time, non-recurring, lump sum payment in exchange for a non-exclusive retroactive and future license, and covenant not to sue. Pursuant to the terms of the agreement, we have no further obligations with respect to the granted intellectual property rights, including no obligation to maintain or upgrade the technology, or provide future support or services. Accordingly, the performance obligations from the license were satisfied and 100% of the revenue was recognized upon execution of the license agreement.28

~~Over the past several years, our~~Results ~~revenue, if any, was derived from technology licensing 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 not expect these activities to be a significant part of the Company’s ongoing operations, nor do we expect these activities to require material financial resources or attention of senior management.Operations

~~We have not generated any revenue~~Fiscal toYear ~~date~~ended ~~from~~October ~~our therapeutics or vaccine programs. In addition~~31, ~~while~~2025 wecompared ~~pursue our therapeutics and vaccine programs, we may also make investments in and form new companies to develop additional emerging technologies. We do not expect to begin generating revenue~~ with ~~respect to~~Fiscal ~~any~~Year ofended ~~our~~October current therapy or vaccine programs in the near term. We hope to achieve a profitable outcome by eventually licensing our technologies to large pharmaceutical companies that have the resources and infrastructure in place to manufacture31, 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.2024

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

We did not have any ~~inventor~~revenue ~~royalties, contingent~~in ~~legal~~fiscal ~~fees,~~years ~~litigation~~2025 and ~~licensing~~2024. ~~expenses~~Over ~~related~~the topast ~~patent~~several ~~assertion~~years, ~~activities~~our inrevenue, ~~fiscal~~if ~~year~~any, ~~2024.~~was Inderived ~~fiscal~~from ~~year 2023,~~technology ~~inventor~~licensing ~~royalties,~~and ~~contingent~~the ~~legal~~sale ~~fees~~of patented technologies, ~~litigation~~including ~~and~~revenue ~~licensing~~from ~~expenses~~the ~~related~~settlement toof ~~patent~~litigation. ~~assertion~~As ~~activities~~part ~~were~~of ~~approximately $161~~our legacy operations,~~000.~~ the ~~Inventor~~Company ~~royalties~~remains ~~and~~engaged ~~contingent~~in ~~legal~~limited ~~fees~~patent ~~are~~licensing ~~expensed~~activities in the ~~period~~area ~~that~~of ~~the~~encrypted ~~related~~audio/video ~~revenues~~conference ~~are recognized~~calling. ~~Litigation and~~We ~~licensing~~do ~~expenses~~not expect ~~related~~these activities to ~~patent~~be ~~assertion,~~a ~~other~~significant ~~than~~part ~~contingent~~of ~~legal~~the ~~fees~~Company’s ongoing operations, ~~are~~nor ~~expensed~~do inwe ~~the~~expect ~~period~~these ~~incurred~~activities to require material financial resources or attention of senior management.

29We have not generated any revenue to date from our therapeutics or vaccine programs. In addition, while we pursue our therapeutics and vaccine programs, we may also make investments in and form new companies to develop additional emerging technologies. We do not expect to begin generating revenue with respect to any of our current therapy or vaccine programs in the near term. Our plan is to achieve a profitable outcome by 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.

Research and Development Expenses

~~In fiscal year 2024,~~ Our research and development expenses ~~were~~ are related to the development of our cancer ~~therapeutics~~vaccines and ~~vaccine~~CAR-T therapeutics programs and in fiscal year 2025, the expenses incurred consisted of approximately $3,~~748~~121,000 and $21,~~648~~950,000 for cancer vaccines and CAR-T therapeutics, respectively. In fiscal year ~~2023~~2024, research and development expenses ~~were~~for ~~related to the development of~~ our cancer ~~therapeutics and~~ vaccines, asand ~~well as our anti~~CAR-~~viral~~T therapeutics ~~program,~~were ~~and the expenses incurred consisted of~~ approximately $23,~~682~~748,000, and $12,~~839~~648,000 ~~and $248~~,~~000~~ ~~for cancer vaccines, CAR-T therapeutics and anti-viral therapeutics,~~ respectively.

Research and development expenses ~~increased~~ decreased by approximately $1,~~627~~325,000 to approximately $65,~~396~~071,000 in fiscal year ~~2024~~2025, from approximately $46,~~769~~396,000 in fiscal year ~~2023~~2024. The ~~increase~~decrease in research and development expenses was primarily due to ana ~~increase~~decrease in research and development expenses related to our ~~CAR-T~~ breast cancer vaccine development program as a result of fluctuations in the timing of certain materials manufacturing activities of approximately $~~845~~674,000, ana ~~increase~~decrease in research and development expenses related to our ~~breast cancer vaccine~~CAR-T development program as a result of ~~approximately~~fluctuations in the timing of certain materials manufacturing activities of approximately $~~834~~406,000, ana ~~increase~~decrease in ~~research~~employee stock option expense as a result of decreases in the calculated fair market value of stock options granted during the year and ~~development~~allocations ~~expenses~~of ~~related~~headcount to ~~our~~research ~~new~~and ~~vaccine~~development ~~discover~~activities ~~program~~ of approximately $~~113~~274,000, anand ~~increase~~a decrease in ~~clinical~~employee ~~trial~~compensation ~~consulting~~expense ~~services~~other than stock-based compensation as a result of changes in allocations of headcount to research and development activities of approximately $~~101~~61,000, offset by aan ~~decrease~~increase in research and development expenses related to our ~~ovarian~~new ~~cancer~~ vaccine ~~development~~discovery program ofdue ~~approximately~~to ~~$170,000~~a ~~and~~full ayear ~~decrease~~of inactivity ~~consultant stock~~compared ~~option~~to ~~expense~~the prior year of approximately $~~137~~113,000.

General and Administrative Expenses

General and administrative expenses ~~increased~~ decreased by approximately $1805,~~144,~~000 to approximately $76,~~435~~630,000 in fiscal year ~~2024~~2025, from approximately $67,~~291~~435,000 in fiscal year ~~2023~~2024. The ~~increase~~decrease in general and administrative expenses was principally due to ana ~~increase~~decrease in investor and public relations firm expenses as a result of changes in firms used during the year of approximately $454,000, a decrease in director stock option compensation expense as a result of decreases in the calculated fair market value of stock options granted during the year of approximately $~~629~~359,000, ana ~~increase~~decrease in stock compensation for investor and public relations ~~firm~~firms as a result of changes in firms used during the year of approximately $~~145~~219,000, ana ~~increase~~ decrease in employee stock option compensation ~~and~~expense ~~related~~as ~~costs~~a result of decreases in the calculated fair market value of stock options granted during the year of approximately $106,000, and a decrease in employee compensation expense other than stock-based ~~option~~compensation as a result of changes in allocations of headcount between research and development and general and administrative activities as well as changes in employee compensation ~~expense~~of approximately $54,000, offset by an increase in expenses related to a change in clinical materials manufacturing vendors of approximately $~~141~~244,000, ~~and~~ an increase in ~~employee~~shareholder ~~stock~~relations ~~option~~expenses ~~compensation~~of ~~expense~~approximately $74,000, and an increase in patent prosecution expenses of approximately $~~111~~73,000.

Interest Income

Interest income ~~increased~~decreased to approximately $1673,~~133,~~000 in fiscal year ~~2024~~2025 compared to approximately $1,~~081~~133,000 in fiscal year ~~2023~~2024, due to ana ~~increase~~ decrease in ~~interest~~the ~~rates~~amount ~~and~~of ~~the increased~~short-term ~~average~~investments ~~dollar~~held ~~amount~~and ~~held~~a decrease in ~~short-term~~interest ~~investments~~rates.

~~Net Loss Attributable to Noncontrolling Interest~~29

~~The net loss attributable to noncontrolling~~Net ~~interest,~~Loss ~~representing~~Attributable ~~Wistar’s ownership interest in Certainty’s net loss, increased by approximately $25,000~~ to ~~approximately $144,000~~Noncontrolling ~~in fiscal year 2024, from approximately $119,000 in fiscal year 2023, as Certainty’s net loss increased.~~Interest

~~Liquidity~~The net ~~and~~loss ~~Capital~~attributable ~~Resources~~to noncontrolling interest, representing Wistar’s ownership interest in Certainty’s net loss, decreased by approximately $43,000 to approximately $101,000 in fiscal year 2025, from approximately $144,000 in fiscal year 2024, as Certainty’s net loss decreased.

~~Our primary sources of liquidity~~Liquidity ~~are cash, cash equivalents~~ and ~~short-term~~Capital ~~investments.~~Resources

~~Based on currently available information~~Our asprimary sources of ~~January~~liquidity ~~10,~~are ~~2025, we believe that our existing~~ cash, cash equivalents, ~~short-term investments~~ and expected cash flows will be sufficient to fund our activities for at least the next twelve months. We have implemented a business model that conserves funds by collaborating with third parties to develop our technologies. However, our projections of future cash needs and cash flows may differ from actual results. If current cash on hand, cash equivalents, short-term investments and cash that may be generated from our business operations are insufficient to continue to operate our business, or if we elect to invest in or acquire a company or companies or new technology or technologies that are synergistic with or complementary to our technologies, we may be required to obtain more working capital. During the year ended October 31, 2024, we raised approximately $2,955,000, net of expenses, through an at-the-market equity offering of 785,290 shares of common stock. Under our at-the-market equity program, which is currently effective and may remain available for us to use in the future, as of October 31, 2024, we may sell up to $97 million of common stock. We may seek to obtain working capital during our fiscal year 2025 or thereafter through sales of our equity securities or through bank credit facilities or public or private debt from various financial institutions where possible. We cannot be certain that additional funding will be available on acceptable terms, or at all. If we do identify sources for additional funding, the sale of additional equity securities or convertible debt will result in dilution to our stockholders. We can give no assurance that we will generate sufficient cash flows in the future to satisfy our liquidity requirements or sustain future operations, or that other sources of funding, such as sales of equity or debt, would be available or would be approved by our security holders, if needed, on favorable terms or at all. If we fail to obtain additional working capital as and when needed, such failure could have a material adverse impact on our business, results of operations and financial condition. Furthermore, such lack of funds may inhibit our ability to respond to competitive pressures or unanticipated capital needs, or may force us to reduce operating expenses, which could significantly harm the business and development of operations.

30Based on currently available information as of January 12, 2026, we believe that our existing cash, cash equivalents, short-term investments and expected cash flows will be sufficient to fund our activities for at least the next twelve months. We have implemented a business model that conserves funds by collaborating with third parties to develop our technologies. However, our projections of future cash needs and cash flows may differ from actual results. If current cash on hand, cash equivalents, short-term investments and cash that may be generated from our business operations are insufficient to continue to operate our business, or if we elect to invest in or acquire a company or companies or new technology or technologies that are synergistic with or complementary to our technologies, we may be required to obtain more working capital. During the year ended October 31, 2025, we raised approximately $2,378,000, net of expenses, through an at-the-market equity offering of 772,001 shares of common stock. Under our at-the-market equity program, which is currently effective and 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 may seek to obtain working capital during our fiscal year 2026 or thereafter through sales of our equity securities or through bank credit facilities or public or private debt from various financial institutions where possible. We cannot be certain that additional funding will be available on acceptable terms, or at all. If we do identify sources for additional funding, the sale of additional equity securities or convertible debt will result in dilution to our stockholders. We can give no assurance that we will generate sufficient cash flows in the future to satisfy our liquidity requirements or sustain future operations, or that other sources of funding, such as sales of equity or debt, would be available or would be approved by our security holders, if needed, on favorable terms or at all. If we fail to obtain additional working capital as and when needed, such failure could have a material adverse impact on our business, results of operations and financial condition. Furthermore, such lack of funds may inhibit our ability to respond to competitive pressures or unanticipated capital needs, or may force us to reduce operating expenses, which could significantly harm the business and development of operations.

During the fiscal year ended October 31, ~~2024~~2025, cash used in operating activities was approximately $7,~~335~~173,000. Cash provided by investing activities was approximately $4,~~276~~866,000, resulting from the proceeds on maturities of short-term investments of approximately $6849,~~046~~226,000, which was offset by the purchase of short-term investments of approximately $6344,~~770~~360,000. Cash provided by financing activities was approximately $32,~~415~~280,000, resulting from the sale of ~~785~~772,~~290~~001 shares of common stock in atan at-the-market equity offering of approximately $2,~~955~~378,000, ~~proceeds~~net ~~from the exercise~~ of ~~stock~~expenses ~~options of approximately $456,000~~ and proceeds from the sale of common stock pursuant to an employee stock purchase plan of approximately $107,000, offset by net costs from the ~~purchase~~exercise of ~~treasury~~ stock options of approximately $6105,000. As a result, our cash, cash equivalents, and short-term investments at October 31, ~~2024~~2025 decreased approximately $34,~~920~~750,000 to approximately $1915,~~924~~174,000 from approximately $2319,~~844~~924,000 at the end of fiscal year ~~2023~~2024.

We have expected future cash obligations related to the lease of our offices through 2029, inclusive of extension periods, estimated at approximately $~~312~~256,000.

Off-Balance Sheet Arrangements

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

Critical Accounting Policies

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

We believe that, of the significant accounting policies discussed in Note 2 to our Consolidated Financial Statements, the following accounting policies require our most difficult, subjective, or complex judgments:30

●We believe ~~Revenue~~that, ~~Recognition;~~of ●the ~~Stock-Based~~significant ~~Compensation;~~accounting ~~and~~policies ●discussed ~~Research~~in ~~and~~Note ~~Development~~2 ~~Expense.~~to our Consolidated Financial Statements, the following accounting policies require our most difficult, subjective, or complex judgments:

● Revenue Recognition; ● Stock-Based Compensation; and ● Research and Development Expense.

~~Our revenue has been derived solely from technology licensing and the sale of patented technologies.~~ Revenue ~~is recognized upon transfer of control of intellectual property~~ ~~rights and satisfaction of other contractual performance obligations to licensees in an amount that reflects the consideration we expect to receive.~~Recognition

Our revenue ~~recognition~~has ~~policy requires~~been usderived tosolely ~~make~~from ~~certain~~technology ~~judgments~~licensing and ~~estimates in connection with~~ the ~~accounting~~sale ~~for~~of ~~revenue~~patented technologies. ~~Such~~Revenue ~~areas~~is ~~may~~recognized ~~include~~upon ~~determining~~transfer ~~the~~of ~~existence~~control of aintellectual ~~contract~~property ~~and identifying each party’s~~ rights and ~~obligations~~satisfaction to transfer goods and services, identifying the performance obligations in the contract, determining the transaction price and allocating the transaction price to separate performance obligations, estimating the timing of ~~satisfaction~~other ofcontractual performance obligations, ~~determining whether a promise~~ to ~~grant~~licensees ain ~~license~~an isamount ~~distinct~~that ~~from~~reflects ~~other~~the ~~promised~~consideration ~~goods~~we orexpect ~~services and evaluating whether a license transfers~~ to ~~a customer at a point in time or over time~~receive.

31Our revenue recognition policy requires us to make certain judgments and estimates in connection with the accounting for revenue. Such areas may include determining the existence of a contract and identifying each party’s rights and obligations to transfer goods and services, identifying the performance obligations in the contract, determining the transaction price and allocating the transaction price to separate performance obligations, estimating the timing of satisfaction of performance obligations, determining whether a promise to grant a license is distinct from other promised goods or services and evaluating whether a license transfers to a customer at a point in time or over time.

Our revenue arrangements provide for the payment, within 30 days of execution of the agreement, of contractually determined, one-time, paid-up license fees in settlement of litigation and in consideration for the grant of certain intellectual property rights for patented technologies owned or controlled by the Company. These arrangements typically include some combination of the following: (i) the grant of a non-exclusive, ~~retroactive~~ retroactive and future license to manufacture and/or sell products covered by patented technologies owned or controlled by the Company, (ii) a covenant-not-to-sue, (iii) the release of the licensee from certain claims, and (iv) the dismissal of any pending litigation. In such instances, the intellectual property rights granted have been perpetual in nature, extending until the expiration of the related patents. Pursuant to the terms of these agreements, we have no further obligations with respect to the granted intellectual property rights, including no obligation to maintain or upgrade the technology, or provide future support or services. Licensees obtained control of the intellectual property rights they have acquired upon execution of the agreement. Accordingly, the performance obligations from these agreements were satisfied and 100% of the revenue was recognized upon the execution of the agreements.

Stock-Based Compensation

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

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

The Black-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 weighted average period the stock options are expected to remain outstanding. For employees, we use the simplified method, which is a weighted average of the vesting term and contractual term, to determine expected term. The simplified method was adopted since we do not believe that historical experience is representative of future performance because of the impact of the changes in our operations and the change in terms from historical options. For consultants we use the contract term for expected term. 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 period of time equal to the expected term of the grants. We estimated the risk-free interest rate based on the implied yield available on the applicable grant date of a U.S. Treasury note with a term equal to the expected term of the underlying grants. We made the dividend yield assumption based on our history of not paying dividends and our expectation not to pay dividends in the future.31

~~We will reconsider use of the~~The Black-Scholes pricing model and the Monte Carlo Simulation ifwe ~~additional~~use ~~information~~to ~~becomes~~estimate ~~available~~fair invalue ~~the~~requires ~~future~~valuation ~~that~~assumptions ~~indicates~~of ~~another~~expected term, ~~model~~expected ~~would~~volatility, berisk-free ~~more~~interest ~~appropriate~~rates and expected dividend yield. IfThe ~~factors~~expected ~~change~~term of stock options represents the weighted average period the stock options are expected to remain outstanding. For employees, we use the simplified method, which is a weighted average of the vesting term and contractual term, to determine expected term. The simplified method was adopted since we ~~employ~~do ~~different~~not ~~assumptions~~believe that inwe ~~future~~have ~~periods~~sufficient historical exercise data on which to base our own estimate. For consultants, we use the ~~compensation~~contract ~~expense~~term ~~that~~for expected term. Under the Black-Scholes pricing model, we ~~record~~estimated ~~may~~the ~~differ~~expected ~~significantly~~volatility ~~from~~of ~~what~~our weshares ~~have~~of ~~recorded~~common instock based upon the ~~current~~historical volatility of our share price over a period of time equal to the expected term of the grants. We estimated the risk-free interest rate based on the implied yield available on the applicable grant date of a U.S. Treasury note with a term equal to the expected term of the underlying grants. We made the dividend yield assumption based on our history of not paying dividends and our expectation not to pay dividends in the future.

~~Research~~We will reconsider use of the Black-Scholes pricing model and ~~Development~~the ~~Expense~~Monte Carlo Simulation if additional information becomes available in the 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.

~~We recognize~~Research ~~research~~ and ~~development~~Development expenses as incurred. Advance payments for future research and development activities are deferred and expensed as the services are performed. We recognize our preclinical studies and clinical trial expenses based on the services performed pursuant 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 each service provider in a given period, the time period over which services are expected to be performed, and the level of effort expended in each reporting period.Expense

32We recognize research and development expenses as incurred. Advance payments for future research and development activities are deferred and expensed as the services are performed. We recognize our preclinical studies and clinical trial expenses based on the services performed pursuant 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 each service provider in a given period, the time period over which services are expected to be performed, and the level of effort expended in each reporting period.

At each balance sheet date, management estimates prepaid and accrued research and development costs by discussing progress or stage of completion of 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.

In addition, we allocate certain internal compensation costs to research and development expenses based on management’s estimates of each employee’s time and effort expended.

Effect of Recent Accounting Pronouncements

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

Item 7A. Quantitative and Qualitative Disclosures About Market Risk

Not required for a smaller reporting company.

Item 8. Financial Statements and Supplementary Data

See accompanying “Index to Consolidated Financial Statements.”

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

None.

Item 9A. Controls and Procedures

Disclosure Controls and Procedures

We maintain disclosure controls and procedures, as such term is defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act. Under the supervision and with the participation of our management, including our Chief Executive Officer and our Chief Financial Officer, we evaluated the effectiveness of the design and operation of our disclosure controls and procedures pursuant to Rule 13a-15 and 15d-15 of the Exchange Act. Based upon that evaluation, our Chief Executive Officer and our Chief Financial Officer concluded that our disclosure controls and procedures were effective as of ~~the~~ ~~end~~October of31, ~~fiscal year 2024~~2025.

~~Management’s Report on Internal Control Over Financial Reporting~~32

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

~~Under~~Our management ~~the~~is ~~supervision~~responsible for establishing and ~~with~~maintaining adequate internal control over financial reporting as such term is defined ~~the~~in ~~participation~~Rules 13a-15(f) and 15d-15(f) of ~~our~~the Exchange Act. Our management, including the principal executive officer and principal financial officer, wedoes ~~conducted~~not anexpect ~~evaluation as~~that ~~to the effectiveness of~~ our internal ~~control~~controls over financial reporting aswill ofprevent ~~October~~all ~~31,~~errors ~~2024.~~and Inall ~~making~~fraud. ~~this~~A ~~assessment~~control system, no ~~our~~matter ~~management used~~how ~~the~~well ~~criteria~~designed ~~for~~and ~~effective~~operated, ~~internal~~cannot ~~control~~provide ~~set~~full ~~forth~~assurance bythat the ~~Committee~~objectives of ~~Sponsoring~~the ~~Organizations~~control ofsystem ~~the~~are ~~Treadway~~met, ~~Commission~~and inno evaluation ~~the~~of ~~2013~~controls ~~Internal~~can ~~Control~~provide –absolute ~~Integrated~~assurance ~~Framework.~~that ~~Based~~all oncontrol ~~this~~issues ~~assessment~~and instances of fraud, ~~our~~if ~~management~~any, ~~concluded~~within ~~that~~a ~~our~~company have been detected. Our internal control over financial reporting ~~was~~is ~~effective~~designed asto provide reasonable assurance regarding the reliability of ~~October~~financial ~~31,~~reporting and ~~2024~~the preparation of consolidated financial statements for external purposes in accordance with generally accepted accounting principles.

33Under the supervision and with the participation of our management, including the principal executive officer and principal financial officer, we conducted an evaluation as to the effectiveness of our internal control over financial reporting as of October 31, 2025. In making this assessment, our management used the criteria for effective internal control set forth by the Committee of Sponsoring Organizations of the Treadway Commission in the 2013 Internal Control – Integrated Framework. Based on this assessment, our management concluded that our internal control over financial reporting was effective as of October 31, 2025.

This Annual Report on Form 10-K does not include an attestation report of our independent registered public accounting firm regarding internal control over financial reporting. Management’s report was not subject to attestation by the Company’s independent registered public accounting firm pursuant to 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’s assessment of the effectiveness of our internal control over financial reporting as of October 31, ~~2024~~2025 has not been audited by our ~~auditors,~~independent registered public accounting firm, Haskell & White LLP.

Changes in Internal Control Over Financial Reporting

There were no changes in our internal control over financial reporting during the fourth quarter of fiscal year ~~2024~~2025 that has materially affected, or is reasonably likely to materially affect, the Company’s internal control over financial reporting.

Item 9B. Other Information

None.

PART III

Item 10. Directors, Executive Officers and Corporate Governance

The information required by this Item will be set forth in our Proxy Statement for the ~~2025~~2026 Annual Meeting of Stockholders scheduled for March 2010, ~~2025~~2026 which such Proxy Statement will be filed with the SEC within 120 days of October 31, ~~2024~~2025, and will be incorporated into this Annual Report on Form 10-K by reference.

Item 11. Executive Compensation

~~Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters~~33

~~The information required by this~~ Item ~~will be set forth in our Proxy Statement for the 2025 Annual Meeting of Stockholders scheduled for March 20, 2025 which such Proxy~~ ~~Statement~~12. ~~will~~Security beOwnership ~~filed with the SEC within 120 days~~ of ~~October~~Certain ~~31,~~Beneficial ~~2024,~~Owners and ~~will~~Management beand ~~incorporated~~Related ~~into~~Stockholder ~~this Annual Report on Form 10-K by reference.~~Matters

The information required by this Item ~~13.~~will ~~Certain~~be ~~Relationships~~set ~~and~~forth ~~Related~~in ~~Transactions~~our Proxy Statement for the 2026 Annual Meeting of Stockholders scheduled for March 10, 2026 which such Proxy Statement will be filed with the SEC within 120 days of October 31, 2025, and ~~Director~~will ~~Independence~~be incorporated into this Annual Report on Form 10-K by reference.

~~The information required by this~~ Item ~~will be set forth in our Proxy Statement for the 2025 Annual Meeting of Stockholders scheduled for March 20, 2025 which such Proxy~~ ~~Statement~~13. ~~will~~Certain beRelationships ~~filed~~and ~~with~~Related ~~the SEC within 120 days of October 31~~Transactions, ~~2024,~~ and ~~will~~Director ~~be incorporated into this Annual Report on Form 10-K by reference.~~Independence

The information required by this Item ~~14.~~will ~~Principal~~be ~~Accounting~~set ~~Fees~~forth in our Proxy Statement for the 2026 Annual Meeting of Stockholders scheduled for March 10, 2026 which such Proxy Statement will be filed with the SEC within 120 days of October 31, 2025, and ~~Services~~will be incorporated into this Annual Report on Form 10-K by reference.

~~The information required by this~~ Item ~~will be set forth in our Proxy Statement for the 2025 Annual Meeting of Stockholders scheduled for March 20, 2025 which such Proxy~~ ~~Statement~~14. ~~will~~Principal beAccountant ~~filed~~Fees ~~with the SEC within 120 days of October 31, 2024,~~ and ~~will be incorporated into this Annual Report on Form 10-K by reference.~~Services

34The information required by this Item will be set forth in our Proxy Statement for the 2026 Annual Meeting of Stockholders scheduled for March 10, 2026 which such Proxy Statement will be filed with the SEC within 120 days of October 31, 2025, and will be incorporated into this Annual Report on Form 10-K by reference.

PART IV

Item 15. Exhibits, and Financial Statement Schedules

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

See accompanying “Index to Consolidated Financial Statements.”

(b)

Exhibits

3.1	Certificate of Incorporation, as amended. (Incorporated by reference to Form 10-Q for the fiscal quarter ended July 31, 1992 and Form S-3, dated February 11, 2014.)
3.2	Amendment to the Certificate of Incorporation. (Incorporated by reference to Exhibit 3.2 to our Form 10-K for the fiscal year ended October 31, 2013.)
3.3	Certificate of Amendment to the Certificate of Incorporation. (Incorporated by reference to Exhibit 3.1 to our Form 8-K, dated September 4, 2014.)
3.4	Certificate of Designations, Preferences and Rights of Series A Convertible Preferred Stock. (Incorporated by reference to Exhibit 3.1 to our Form 8-K, dated September 10, 2014.)
3.5	Certificate of Amendment to the Certificate of Incorporation. (Incorporated by reference to Exhibit 3.1 to our Form 8-K, dated June 25, 2015.)
3.6	Certificate of Amendment to the Certificate of Incorporation. (Incorporated by reference to Exhibit 3.1 to our Form 10-Q for the fiscal quarter ended April 30, 2018.)
3.7	Certificate of Amendment to the Certificate of Incorporation. (Incorporated by reference to Exhibit 3.1 to our Form 8-K, dated October 1, 2018.)
3.8	Certificate of Amendment to the Certificate of Incorporation. (Incorporated by reference to Exhibit 3.1 to our Form 8-K, dated August 13, 2020.)
3.9	Amended and Restated By-laws. (Incorporated by reference to Exhibit 3.8 to our Form 10-K for the fiscal year ended October 31, 2019.)
3.10	Amendment to the Amended and Restated Bylaws of the Company. (Incorporated by reference to our Form 8-K, dated April 2, 2021.)
4.1	Form of Underwriter Warrants. (Incorporated by reference to Exhibit 4.1 to our Form 8-K, dated March 24, 2021.)
4.2	Description of the Company’s Securities Registered under Section 12 of the Exchange Act (Incorporated by reference to the description of our common stock contained in our Current Report on Form 8-K filed on March 31, 2014.)
10.1	2010 Share Incentive Plan. (Incorporated by reference to Exhibit 10.1 to our Form 8-K, dated July 20, 2010.)
10.2	Amendment No. 1 to the 2010 Share Incentive Plan. (Incorporated by reference to Exhibit 10.1 to our Form 8-K, dated July 7, 2011.)
10.3	Amendment No. 2 to the 2010 Share Incentive Plan. (Incorporated by reference to Exhibit 10.1 to our Form 8-K, dated September 5, 2012.)
10.4	Amendment No. 3 to the 2010 Share Incentive Plan. (Incorporated by reference to Exhibit 10.1 to our Form 10-Q for the fiscal quarter ended January 31, 2014.)
10.5	2018 Share Incentive Plan. (Incorporated by reference to Exhibit 4.13 to our Form S-8 dated October 1, 2018.)
10.6	License Agreement, dated November 13, 2017, between Certainty Therapeutics, Inc. and The Wistar Institute of Anatomy and Biology. (Incorporated by reference to Exhibit 10.14 to our Form 10-K, dated January 9, 2018.) (Portions of this exhibit have been redacted pursuant to a request for confidential treatment. The redacted portions have been separately filed with the Securities and Exchange Commission.)
10.7	Amendment to License Agreement between Certainty Therapeutics, Inc. and The Wistar Institute of Anatomy and Biology. (Incorporated by reference to Exhibit 10.1 to our Form 10-Q for the fiscal quarter ended January 31, 2021.) (Certain information has been redacted in the marked portions of the exhibit.)
10.8	Amended and Restated Master Collaboration Agreement, dated November 1, 2021, between Certainty Therapeutics, Inc. and H. Lee Moffitt Cancer Center and Research Institute, Inc. (Incorporated by reference to Exhibit 10.8 to our Form 10-K for the fiscal year ended October 31, 2021.)
10.9	Exclusive License Agreement, dated July 8, 2019, between the Company and The Cleveland Clinic Foundation. (Incorporated by reference to Exhibit 10.1 to our Form 10-Q for the fiscal quarter ended July 31, 2019.) (Certain information has been redacted in the marked portions of the exhibit.)

3534

10.3	Amendment No. 2 to the 2010 Share Incentive Plan. (Incorporated by reference to Exhibit 10.1 to our Form 8-K, dated September 5, 2012.)
10.4	Amendment No. 3 to the 2010 Share Incentive Plan. (Incorporated by reference to Exhibit 10.1 to our Form 10-Q for the fiscal quarter ended January 31, 2014.)
10.5	2018 Share Incentive Plan. (Incorporated by reference to Exhibit 4.13 to our Form S-8 dated October 1, 2018.)
10.6	License Agreement, dated November 13, 2017, between Certainty Therapeutics, Inc. and The Wistar Institute of Anatomy and Biology. (Incorporated by reference to Exhibit 10.14 to our Form 10-K, dated January 10, 2018.) (Portions of this exhibit have been redacted pursuant to a request for confidential treatment. The redacted portions have been separately filed with the Securities and Exchange Commission.)
10.7	Amendment to License Agreement between Certainty Therapeutics, Inc. and The Wistar Institute of Anatomy and Biology. (Incorporated by reference to Exhibit 10.1 to our Form 10-Q for the fiscal quarter ended January 31, 2021.) (Certain information has been redacted in the marked portions of the exhibit.)
10.8	Amended and Restated Master Collaboration Agreement, dated November 1, 2021, between Certainty Therapeutics, Inc. and H. Lee Moffitt Cancer Center and Research Institute, Inc. (Incorporated by reference to Exhibit 10.8 to our Form 10-K for the fiscal year ended October 31, 2021.)
10.9	Exclusive License Agreement, dated July 8, 2019, between the Company and The Cleveland Clinic Foundation. (Incorporated by reference to Exhibit 10.1 to our Form 10-Q for the fiscal quarter ended July 31, 2019.) (Certain information has been redacted in the marked portions of the exhibit.)
10.10	Amendment to Exclusive License Agreement between the Company and The Cleveland Clinic Foundation. (Incorporated by reference to Exhibit 10.10 to our Form 10-K, for the fiscal year ended October 31, 2023.)
10.11	Exclusive License Agreement, dated October 20, 2020, between the Company and The Cleveland Clinic Foundation. (Incorporated by reference to Exhibit 10.14 to our Form 10-K, for the fiscal year ended October 31, 2020.) (Certain information has been redacted in the marked portions of the exhibit.)
10.12	Amendment No. 1 to Exclusive License Agreement between the Company and The Cleveland Clinic Foundation. (Incorporated by reference to Exhibit 10.1 to our Form 10-Q for the fiscal quarter ended July 31, 2022.) (Certain information has been redacted in the marked portions of the exhibit.)
10.13	Joint Development and Option Agreement, dated May 3, 2024, between the Company and The Cleveland Clinic Foundation. (Incorporated by reference to Exhibit 10.1 to our Form 10-Q for the fiscal quarter ended April 30, 2024.) (Certain information has been redacted in the marked portions of the exhibit.)
10.14	Form of Controlled Equity OfferingSM Sales Agreement (Incorporated by reference to Exhibit 10.1 to our Form S-3 dated September 9, 2022.)
14	Code of Conduct (~~Filed~~Incorporated ~~herewith~~by reference to Exhibit 14 to our Form 10-K, for the fiscal year ended October 31, 2024.)
19	Insider Trading Policy (Incorporated by reference to Exhibit 19 to our Form 10-K, for the fiscal year ended October 31, 2023.)
21	Subsidiaries of Anixa Biosciences, Inc. (Incorporated by reference to Exhibit 21 to our Form 10-K, for the fiscal year ended October 31, 2020.)
23.1	Consent of Haskell & White LLP. (Filed herewith.)
31.1	Certification of Chief Executive Officer, pursuant to Section 302 of the Sarbanes-Oxley Act of 2002, dated January 1012, ~~2025~~2026. (Filed herewith.)
31.2	Certification of Chief Financial Officer, pursuant to Section 302 of the Sarbanes-Oxley Act of 2002, dated January 1012, ~~2025~~2026. (Filed herewith.)
32.1	Statement of Chief Executive Officer, pursuant to Section 1350 of Title 18 of the United States Code, dated January 1012, ~~2025~~2026. (Filed herewith.)
32.2	Statement of Chief Financial Officer, pursuant to Section 1350 of Title 18 of the United States Code, dated January 1012, ~~2025~~2026. (Filed herewith.)
99.1	Clawback Policy (Incorporated by reference to Exhibit 99.1 to our Form 10-K, for the fiscal year ended October 31, 2023.)

Item 16. Form 10-K Summary

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

3635

SIGNATURES

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

	Anixa Biosciences, Inc.
	By:	/s/ Amit Kumar
		Dr. Amit Kumar
		Chairman of the Board and
January 10, 2025		Chief Executive Officer
January 12, 2026		Chief Executive Officer

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

	By:	/s/ Amit Kumar
		Dr. Amit Kumar
		Chairman of the Board and
		Chief Executive Officer
January 10, 2025		(Principal Executive Officer)
January 12, 2026		(Principal Executive Officer)
	By:	/s/ Michael J. Catelani
		Michael J. Catelani
		President, Chief Operating Officer and
		Chief Financial Officer
January 10, 2025		(Principal Financial and Accounting Officer)
January 12, 2026		(Principal Financial and Accounting Officer)
	By:	/s/ Lewis H. Titterton, Jr.
		Lewis H. Titterton, Jr.
January 10, 2025		Director
January 12, 2026		Director
	By:	/s/ Arnold Baskies
		Dr. Arnold Baskies
January 10, 2025		Director
January 12, 2026		Director
	By:	/s/ Emily Gottschalk
		Emily Gottschalk
January 10, 2025		Director
January 12, 2026		Director

3736

ANIXA BIOSCIENCES, INC. AND SUBSIDIARIES

INDEX TO CONSOLIDATED FINANCIAL STATEMENTS

OCTOBER 31, ~~2024~~2025

	Page
Report of Independent Registered Public Accounting Firm (PCAOB ID: 200)	F-12
Consolidated Balance Sheets as of October 31, 2024 and 2023	F-3
Consolidated Balance Sheets as of October 31, 2025 and 2024	F-3
Consolidated Statements of Operations for the years ended October 31, 2024 and 2023	F-4
Consolidated Statements of Operations for the years ended October 31, 2025 and 2024	F-4
Consolidated Statements of Equity for the years ended October 31, 2024 and 2023	F-5
Consolidated Statements of Equity for the years ended October 31, 2025 and 2024	F-5
Consolidated Statements of Cash Flows for the years ended October 31, 2024 and 2023	F-6
Consolidated Statements of Cash Flows for the years ended October 31, 2025 and 2024	F-6
Notes to Consolidated Financial Statements	F-7

Additional information required by schedules called for under Regulation S-X is either not applicable or is included in the consolidated financial statements or notes thereto.

38F-1

REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

To the Board of Directors and Shareholders

Anixa Biosciences, Inc.

Opinion on the Consolidated Financial Statements

We have audited the accompanying consolidated balance sheets of Anixa Biosciences, Inc. (the “Company”) as of October 31, ~~2024~~ 2025 and ~~2023~~2024, and the related consolidated statements of operations, equity, and cash flows for each of the two years in the period ended October 31, ~~2024~~2025, and the related notes (collectively, the “consolidated financial statements”). In our opinion, the consolidated financial statements present fairly, in all material respects, the consolidated financial position of the Company as of October 31, ~~2024~~ 2025 and ~~2023~~2024, and the consolidated results of its operations and its cash flows for each of the years in the two year period ended October 31, ~~2024~~2025, in conformity with accounting principles generally accepted in the United States of America.

Basis for Opinion

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

We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audits to obtain reasonable 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 part of our audits, we are required to obtain an understanding of internal control over financial reporting, but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.

Our audits included performing procedures to assess the risks of material misstatement of the consolidated financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence supporting the amounts and disclosures in the consolidated financial statements. Our audits also included evaluating the accounting principles used 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.

Critical Audit ~~Matter~~Matters

~~The~~Critical ~~critical~~ audit ~~matter~~matters ~~communicated~~are ~~below~~matters ~~is a matter~~ arising from the current period audit of the ~~consolidated~~ financial statements that ~~was~~were communicated or required to be communicated to the audit committee and that: (1) relate to accounts or disclosures that are material to the ~~consolidated~~ financial statements, and (2) involved our especially challenging, subjective, or complex judgments. ~~The~~We ~~communication~~determined ofthat ~~the~~there ~~critical audit matter does not alter in any way our opinion on the consolidated financial statements, taken as a whole, and we~~ are ~~not,~~no ~~by communicating the~~ critical audit ~~matter below, providing separate opinions on the critical audit matter or on the accounts or disclosures to which it relates~~matters.

~~Research~~/s/ ~~and~~Haskell ~~Development~~& ~~Expenses~~White –LLP ~~Refer~~HASKELL to& ~~Note~~WHITE ~~2 of the consolidated financial statements~~LLP

~~Critical~~We have ~~Audit~~served ~~Matter~~as ~~Description:~~the Company’s auditor since 2013.

The Company recognizes research and development expenses as incurred. Advance payments for future research and development activities are deferred and expensed as the services are performed. The Company recognizes its preclinical studies and clinical trial expenses based on the services performed pursuant to contracts with research institutionsIrvine, clinical research organizations (“CROs”), clinical manufacturing organizations (“CMOs”), and other parties that conduct and manage various stages of research and development activities on the Company’s behalf. Fees for such services are recognized based on management’s estimates after considering the activities and tasks completed by each service provider in a given period, the time period over which services are expected to be performed, and the level of effort expended in each reporting period.California

~~F-1~~January 12, 2026

At each balance sheet date, management estimates prepaid and accrued research and development costs by discussing progress or stage of completion of activities with internal personnel and external service providers, and comparing this information to payments made, invoices received, and the agreedF-~~upon contractual fee to be paid for such services in the applicable contract or statements of work.~~2

~~In addition~~ANIXA BIOSCIENCES, ~~the~~INC. ~~Company~~AND ~~allocates certain internal compensation costs to research and development expenses based on management’s estimates of each employee’s time and effort expended.~~SUBSIDIARIES

~~How~~CONSOLIDATED ~~the~~BALANCE ~~Critical Matter was Addressed in the Audit:~~SHEETS

~~The~~(in thousands, ~~primary~~except ~~procedures~~share weand ~~performed~~per toshare ~~address this critical audit matter included the following:~~data)

§ We obtained an understanding, and evaluated the design and implementation, of controls relating to research and development costs, including controls over the review of third-party contracts, the process of gathering information from external and internal sources and management’s review thereof, and the determination of prepaid positions, period-end accruals, and expense allocations. § For the Company’s significant third-party contracts, we performed the following procedures:

	October 31,			October 31,
	2025			2024
ASSETS
Current assets:
Cash and cash equivalents	$	1,244		$	1,271
Short–term investments		13,930			18,653
Receivables		-			173
Prepaid expenses and other current assets		713			1,265
Total current assets		15,887			21,362

Operating lease right-of-use asset		193			229

Total assets	$	16,080		$	21,591

LIABILITIES AND EQUITY
Current liabilities:
Accounts payable	$	165		$	525
Accrued expenses		1,761			1,946
Operating lease liability		41			29
Total current liabilities		1,967			2,500

Operating lease liability, non-current		163			203
Total liabilities		2,130			2,703

Commitments and contingencies (Note 6)		-			-

Equity:
Shareholders’ equity:
Preferred stock, par value $100 per share; 19,860 shares authorized; no shares issued or outstanding		-			-
Series A convertible preferred stock, par value $100 per share; 140 shares authorized; no shares issued or outstanding		-			-
Preferred stock, value		-			-
Common stock, par value $.01 per share; 100,000,000 shares authorized; 33,013,829 and 32,196,862 shares issued and outstanding as of October 31, 2025 and 2024, respectively		330			322
Additional paid-in capital		266,508			260,432
Accumulated deficit		(251,677	)		(240,750	)
Treasury stock, 2,000 shares at cost as of October 31, 2024		-			(6	)
Total shareholders’ equity		15,161			19,998
Noncontrolling interest (Note 2)		(1,211	)		(1,110	)
Total equity		13,950			18,888

Total liabilities and equity	$	16,080		$	21,591

○The accompanying Wenotes ~~obtained~~are ~~and~~an ~~read~~integral ~~related~~part ~~master service agreements, statements~~ of ~~work,~~these ~~or other supporting agreements with the research institution, CRO, or CMO~~statements. ○ We performed corroborating inquiries with management personnel responsible for the oversight of the activities regarding the nature and status of work performed. ○ We evaluated evidence of services provided by third parties including invoices regarding activities completed, and we inspected evidence supporting payments made by the Company. ○ We compared the data and evidence obtained from internal and external sources to the amounts recorded by management and recalculated the related research and development expense and prepaid research and development expense.

~~§ For the Company’s internal compensation allocations, we performed the following procedures:~~F-3

○ We performed corroborating inquiries with management personnel responsible for the oversight of the activities regarding the nature of employee services performed. ○ We evaluated the reasonableness of allocations estimated by management by comparisons with prior periodsANIXA BIOSCIENCES, ~~evaluating the reasonableness of significant changes made by management, and performing sensitivity analysis~~INC. ○AND ~~We obtained written representations from management regarding the appropriateness of allocation estimates.~~SUBSIDIARIES

~~/s/~~CONSOLIDATED STATEMENTS ~~Haskell~~OF ~~& White LLP HASKELL & WHITE LLP~~OPERATIONS

We(in thousands, ~~have~~except ~~served~~per asshare ~~the Company’s auditor since 2013.~~data)

Irvine, California


	For the years ended October 31,
	2025			2024

Revenue	$	-		$	-

Operating costs and expenses:
Research and development expenses (including non-cash stock-based compensation expenses of $1,560 and $1,859, respectively)		5,071			6,396
General and administrative expenses (including non-cash stock-based compensation expenses of $2,250 and $2,923, respectively)		6,630			7,435

Total operating costs and expenses		11,701			13,831

Loss from operations		(11,701	)		(13,831	)

Interest income		673			1,133

Net loss		(11,028	)		(12,698	)

Less: Net loss attributable to noncontrolling interest		(101	)		(144	)

Net loss attributable to common shareholders	$	(10,927	)	$	(12,554	)

Net loss per share:
Basic and diluted	$	(0.34	)	$	(0.39	)

Weighted average common shares outstanding:
Basic and diluted		32,454			31,898

~~January~~The accompanying ~~10,~~notes ~~2025~~are an integral part of these statements.

F-24

~~ANIXA BIOSCIENCES, INC. AND SUBSIDIARIES~~ \

~~CONSOLIDATED~~ANIXA BIOSCIENCES, ~~BALANCE~~INC. ~~SHEETS~~AND SUBSIDIARIES

~~(in thousands, except share~~CONSOLIDATED ~~and~~STATEMENTS ~~per~~OF ~~share data)~~EQUITY

	October 31,			October 31,
	2024			2023
ASSETS
Current assets:
Cash and cash equivalents	$	1,271		$	915
Short–term investments		18,653			22,929
Receivables		173			270
Prepaid expenses and other current assets		1,265			1,242
Total current assets		21,362			25,356
Operating lease right-of-use asset		229			166
Total assets	$	21,591		$	25,522
LIABILITIES AND EQUITY
Current liabilities:
Accounts payable	$	525		$	206
Accrued expenses		1,946			1,770
Operating lease liability		29			52
Total current liabilities		2,500			2,028
Operating lease liability, non-current		203			123
Total liabilities		2,703			2,151
Commitments and contingencies (Note 6)		-			-
Equity:
Shareholders’ equity:
Preferred stock, par value $100 per share; 19,860 shares authorized; no shares issued or outstanding		-			-
Series A convertible preferred stock, par value $100 per share; 140 shares authorized; no shares issued or outstanding		-			-
Preferred stock, value		-			-
Common stock, par value $.01 per share; 100,000,000 shares authorized; 32,196,862 and 31,145,219 shares issued and outstanding as of October 31, 2024 and 2023, respectively		322			311
Additional paid-in capital		260,432			252,222
Accumulated deficit		(240,750	)		(228,196	)
Treasury stock, 2,000 shares at cost		(6	)		-
Total shareholders’ equity		19,998			24,337
Noncontrolling interest (Note 2)		(1,110	)		(966	)
Total equity		18,888			23,371
Total liabilities and equity	$	21,591		$	25,522

FOR THE YEARS ENDED OCTOBER 31, 2025 AND 2024

~~The~~(in thousands, ~~accompanying~~except ~~notes~~share ~~are an integral part of these statements.~~data)

F-3


	Common Stock					Additional									Total			Non-
	Shares			Par Value		Paid-in Capital			Accumulated Deficit			Treasury Stock			Shareholders’ Equity			controlling Interest			Total Equity

BALANCE, October 31, 2023		31,145,219		$	311	$	252,222		$	(228,196	)	$	-		$	24,337		$	(966	)	$	23,371

Stock option compensation to employees and directors		-			-		4,420			-			-			4,420			-			4,420
Stock options issued to consultants		-			-		125			-			-			125			-			125
Common stock issued upon exercise of stock options		173,031			2		454			-			-			456			-			456
Common stock issued to consultants		89,336			1		254			-			-			255			-			255
Common stock issued in an at-the-market offering, net of offering expenses of $168		785,290			8		2,947			-			-			2,955			-			2,955
Common stock issued pursuant to employee stock purchase plan		3,986			-		10			-			-			10			-			10
Purchase of treasury stock		-			-		-			-			(6	)		(6	)		-			(6	)
Net loss		-			-		-			(12,554	)		-			(12,554	)		(144	)		(12,698	)

BALANCE, October 31, 2024		32,196,862		$	322	$	260,432		$	(240,750	)	$	(6	)	$	19,998		$	(1,110	)	$	18,888

Stock option compensation to employees and directors		-			-		3,681			-			-			3,681			-			3,681
Stock options issued to consultants		-			-		129			-			-			129			-			129
Common stock issued upon exercise of stock options		43,930			-		(105	)		-			-			(105	)		-			(105	)
Common stock issued in an at-the-market offering, net of offering expenses of $183		772,001			8		2,370			-			-			2,378			-			2,378
Common stock issued pursuant to employee stock purchase plan		3,036			-		7			-			-			7			-			7
Cancelation of treasury shares		(2,000	)		-		(6	)		-			6			-			-			-
Net loss		-			-		-			(10,927	)		-			(10,927	)		(101	)		(11,028	)
BALANCE, October 31, 2025		33,013,829		$	330	$	266,508		$	(251,677	)	$	-		$	15,161		$	(1,211	)	$	13,950

~~ANIXA~~The accompanying ~~BIOSCIENCES,~~notes ~~INC. AND~~are ~~SUBSIDIARIES~~an integral part of these statements.

~~CONSOLIDATED STATEMENTS OF OPERATIONS~~F-5

~~(in thousands~~ANIXA BIOSCIENCES, ~~except~~INC. ~~per share~~AND ~~data)~~SUBSIDIARIES

	For the years ended October 31,
	2024			2023
Revenue	$	-		$	210
Operating costs and expenses:
Inventor royalties, contingent legal fees, litigation and licensing expenses		-			161
Research and development expenses (including non-cash stock-based compensation expenses of $1,859 and $2,037, respectively)		6,396			4,769
General and administrative expenses (including non-cash stock-based compensation expenses of $2,923 and $2,698, respectively)		7,435			6,291
Total operating costs and expenses		13,831			11,221
Loss from operations		(13,831	)		(11,011	)
Interest income		1,133			1,081
Net loss		(12,698	)		(9,930	)
Less: Net loss attributable to noncontrolling interest		(144	)		(119	)
Net loss attributable to common shareholders	$	(12,554	)	$	(9,811	)
Net loss per share:
Basic and diluted	$	(0.39	)	$	(0.32	)
Weighted average common shares outstanding:
Basic and diluted		31,898			30,980

CONSOLIDATED STATEMENTS OF CASH FLOWS

~~The accompanying notes are an integral part of these~~(in ~~statements.~~thousands)

F-4


	For the years ended October 31,
	2025			2024
Cash flows from operating activities:
Reconciliation of net loss to net cash used in operating activities:
Net loss	$	(11,028	)	$	(12,698	)
Stock option compensation to employees and directors		3,681			4,420
Stock options issued to consultants		129			125
Common stock issued to consultants		-			255
Amortization of operating lease right-of-use asset		36			37
Amortization of discount on held-to-maturity securities		(143	)		-
Change in operating assets and liabilities:
Receivables		173			97
Prepaid expenses and other current assets		552			(23	)
Accounts payable		(360	)		319
Accrued expenses		(185	)		176
Operating lease liability		(28	)		(43	)
Net cash used in operating activities		(7,173	)		(7,335	)

Cash flows from investing activities:
Disbursements to acquire short-term investments		(44,360	)		(63,770	)
Proceeds from maturities of short-term investments		49,226			68,046
Net cash provided by investing activities		4,866			4,276

Cash flows from financing activities:
Proceeds from sale of common stock in an at-the-market offering, net of offering expenses of $183 and $168, for the years ended October 31, 2025 and 2024, respectively		2,378			2,955
Proceeds from sale of common stock pursuant to employee stock purchase plan		7			10
Net (costs) proceeds from exercise of stock options		(105	)		456
Disbursements for purchases of treasury stock		-			(6	)
Net cash provided by financing activities		2,280			3,415

Net (decrease) increase in cash and cash equivalents		(27	)		356
Cash and cash equivalents at beginning of year		1,271			915
Cash and cash equivalents at end of year	$	1,244		$	1,271

Supplemental cash flow information:
Cash proceeds from interest income	$	686		$	1,230

Supplemental disclosure of non-cash investing activity:
Modification to operating lease right-of-use asset	$	-		$	(100	)

Supplemental disclosure of non-cash financing activity:
Modification to operating lease liability	$	-		$	100

~~ANIXA~~The accompanying ~~BIOSCIENCES,~~notes ~~INC.~~are ~~AND~~an ~~SUBSIDIARIES~~integral part of these statements.

~~CONSOLIDATED STATEMENTS OF EQUITY~~F-6

~~FOR THE YEARS ENDED OCTOBER 31~~ANIXA BIOSCIENCES, ~~2024~~INC. AND ~~2023~~SUBSIDIARIES

~~(in~~NOTES TO ~~thousands,~~CONSOLIDATED ~~except~~FINANCIAL ~~share data)~~STATEMENTS

	Common Stock				Additional Paid-in		Accumulated			Treasury			Total Shareholders’			Non- controlling			Total
	Shares		Par Value		Capital		Deficit			Stock			Equity			Interest			Equity
BALANCE, October 31, 2022		30,913,902	$	309	$	247,123	$	(218,385	)	$	-		$	29,047		$	(847	)	$	28,200
Stock option compensation to employees and directors		-		-		4,422		-			-			4,422			-			4,422
Stock options issued to consultants		-		-		221		-			-			221			-			221
Common stock issued upon exercise of stock options		202,647		2		351		-			-			353			-			353
Common stock issued to consultants		24,310		-		92		-			-			92			-			92
Common stock issued pursuant to employee stock purchase plan		4,360		-		13		-			-			13			-			13
Net loss		-		-		-		(9,811	)		-			(9,811	)		(119	)		(9,930	)
BALANCE, October 31, 2023		31,145,219	$	311	$	252,222	$	(228,196	)	$	-		$	24,337		$	(966	)	$	23,371
Balance		31,145,219	$	311	$	252,222	$	(228,196	)	$	-		$	24,337		$	(966	)	$	23,371
Stock option compensation to employees and directors		-		-		4,420		-			-			4,420			-			4,420
Stock options issued to consultants		-		-		125		-			-			125			-			125
Common stock issued upon exercise of stock options		173,031		2		454		-			-			456			-			456
Common stock issued to consultants		89,336		1		254		-			-			255			-			255
Common stock issued in an at-the-market offering, net of offering expenses of $168		785,290		8		2,947		-			-			2,955			-			2,955
Common stock issued pursuant to employee stock purchase plan		3,986		-		10		-			-			10			-			10
Purchase of treasury stock											(6	)		(6	)					(6	)
Net loss		-		-		-		(12,554	)		-			(12,554	)		(144	)		(12,698	)
BALANCE, October 31, 2024		32,196,862	$	322	$	260,432	$	(240,750	)	$	(6	)	$	19,998		$	(1,110	)	$	18,888
Balance		32,196,862	$	322	$	260,432	$	(240,750	)	$	(6	)	$	19,998		$	(1,110	)	$	18,888

1. BUSINESS AND FUNDING

~~The accompanying notes are an integral part~~ Description of ~~these statements.~~Business

~~F-5~~As used herein, “we,” “us,” “our,” the “Company” or “Anixa” means Anixa Biosciences, Inc. and its consolidated subsidiaries.

~~ANIXA~~Anixa Biosciences, ~~BIOSCIENCES~~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”), ~~INC~~a chimeric endocrine receptor-T cell therapy, which is a novel form of chimeric antigen receptor-T cell (“CAR-T”) technology, initially focused on treating ovarian cancer, that is being developed at our subsidiary, Certainty Therapeutics, Inc. ~~AND~~(“Certainty”). ~~SUBSIDIARIES~~Our vaccine programs include (i) the development of a vaccine against breast cancer, (ii) the development of a vaccine against ovarian cancer, and (iii) a vaccine discovery program utilizing the same mechanism as our breast and ovarian cancer vaccines to develop additional cancer vaccines to address many intractable cancers, including high incidence malignancies in lung, colon and prostate.

~~CONSOLIDATED~~Our subsidiary, ~~STATEMENTS~~Certainty, OFis ~~CASH~~developing ~~FLOWS~~immuno-therapy drugs against cancer. Certainty holds an exclusive worldwide, royalty-bearing license to use certain intellectual property owned or controlled by The Wistar Institute (“Wistar”), the nation’s first independent biomedical research institute and a leading National Cancer Institute (“NCI”) designated cancer research center, relating to Wistar’s chimeric endocrine receptor targeted therapy technology. We have initially focused on the development of a treatment for 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 development milestones. With respect to Certainty’s equity obligations to Wistar, Certainty issued to Wistar shares of its common stock equal to five percent (5%) of the common stock of Certainty, such equity stake is subject to dilution by further funding of Certainty’s activities by the Company. Due to such Company funding, Wistar’s equity stake in Certainty was 4.1% as of October 31, 2025.

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

	For the years ended October 31,
	2024			2023
Cash flows from operating activities:
Reconciliation of net loss to net cash used in operating activities:
Net loss	$	(12,698	)	$	(9,930	)
Stock option compensation to employees and directors		4,420			4,422
Stock options issued to consultants		125			221
Common stock issued to consultants		255			92
Amortization of operating lease right-of-use asset		37			46
Change in operating assets and liabilities:
Receivables		97			(224	)
Prepaid expenses and other current assets		(23	)		(775	)
Accounts payable		319			(59	)
Accrued expenses		176			44
Operating lease liability		(43	)		(46	)
Net cash used in operating activities		(7,335	)		(6,209	)
Cash flows from investing activities:
Disbursements to acquire short-term investments		(63,770	)		(44,411	)
Proceeds from maturities of short-term investments		68,046			38,809
Net cash provided by (used in) investing activities		4,276			(5,602	)
Cash flows from financing activities:
Proceeds from sale of common stock in an at-the-market offering, net of offering expenses of $168		2,955			-
Proceeds from sale of common stock pursuant to employee stock purchase plan		10			13
Proceeds from exercise of stock options		456			353
Disbursements for purchases of treasury stock		(6	)		-
Net cash provided by financing activities		3,415			366
Net increase (decrease) in cash and cash equivalents		356			(11,445	)
Cash and cash equivalents at beginning of year		915			12,360
Cash and cash equivalents at end of year	$	1,271		$	915
Supplemental cash flow information:
Cash proceeds from interest income	$	1,230		$	838
Supplemental disclosure of non-cash investing activity:
Modification to operating lease right-of-use asset	$	(100	)	$	-
Supplemental disclosure of non-cash financing activity:
Modification to operating lease liability	$	100		$	-

While the 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, including one 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-dosing was approved by the FDA, and we administered her second treatment in October 2024. This second treatment was well-tolerated by the patient.

~~The accompanying notes are an integral part of these statements.~~F-7

FThis study is a dose-6escalation trial with two arms based on route of delivery—intraperitoneal or intravenous—to determine the maximum tolerated dose in patients with recurrent epithelial ovarian cancer and to assess persistence, expansion and efficacy of the modified T cells. The study is being conducted at Moffitt and will consist of up to 24 to 48 patients who have received at least two prior lines of chemotherapy. The study is estimated to be completed in two to three years depending on multiple factors including when the maximum tolerated dose is reached, the rate of patient enrollment, the significance of efficacy data and how long we maintain the two different delivery methods.

~~ANIXA~~We hold ~~BIOSCIENCES~~an exclusive worldwide, ~~INC~~royalty-bearing license to use certain intellectual property owned or controlled by The Cleveland Clinic Foundation (“Cleveland Clinic”) relating to certain breast cancer vaccine technology developed at Cleveland Clinic. ~~AND~~The ~~SUBSIDIARIES~~license agreement requires us to make certain cash payments to Cleveland Clinic upon achievement of specific development milestones. Utilizing this 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 vaccine is a specific protein, α-lactalbumin, that is only expressed during lactation in a healthy woman’s mammary tissue. This protein disappears when the woman is no longer lactating, but reappears in many forms of breast cancer, especially TNBC. Studies have shown that vaccinating against this protein prevents breast cancer in mice.

~~NOTES~~In October TO2021, ~~CONSOLIDATED~~following ~~FINANCIAL~~the ~~STATEMENTS~~FDA’s authorization to proceed, we commenced dosing patients in a Phase 1 clinical trial of our breast cancer vaccine. This study, which has been fully funded by a U.S. Department of Defense grant to Cleveland Clinic, is a multiple-ascending dose Phase 1 trial to determine the maximum tolerated dose (“MTD”) of the vaccine in patients with early-stage, triple-negative breast cancer as well as monitor immune response. The study has been conducted at Cleveland Clinic. During the course of the Phase 1 study, participants received three vaccinations, each two weeks apart, and have been closely monitored for side effects and immune response. The first segment of the study, Phase 1a, consisted of approximately 24 patients who had completed treatment for early-stage, triple-negative breast cancer within the past three years and were currently tumor-free but at high risk for recurrence. Studies show that 42% of TNBC patients will have a recurrence of their cancer, with most of the recurrences occurring in the first two to three years after standard of care treatment. In January 2023, the number of participants in each dose cohort was expanded, and as of August 2023, we had completed vaccinating all patients in these expanded cohorts. Subsequently, we began vaccinating participants in additional dose cohorts at varying dose levels of the different key components of the vaccine. Further, in November 2023, we commenced vaccination of participants in the second segment of the trial, Phase 1b, that included participants who have never had cancer, but carry certain mutations in genes such as BRCA1, BRCA2 or PALB2, that indicate a greater risk of developing TNBC in the future, and had elected to have a prophylactic mastectomy. Finally, in January 2024, we commenced vaccination of participants in the third segment of the trial, Phase 1c, that includes 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. In December 2025, we presented the final data from the Phase 1 trial at the San Antonio Breast Cancer Symposium. The key results presented were that i) all primary study endpoints were met, ii) protocol defined immune responses were observed in 74% of the study subjects, iii) the vaccine was safe and well-tolerated by study participants at the maximum tolerated dose, and iv) immunohistochemistry (IHC) of the subjects’ primary tumors for alpha-lactalbumin protein revealed a range of expression from absent to strong—analysis and correlation to immune response and clinical outcomes is ongoing. The Phase 1 findings are promising, and we are preparing to initiate a Phase 2 clinical trial in the neo-adjuvant setting (pre-surgery) to determine possible therapeutic effect of the vaccine. The Phase 2 trial will commence following FDA consultations, protocol development, manufacturing and clinical site selection.

1We hold an exclusive worldwide, royalty-bearing license to use certain intellectual property owned or controlled by Cleveland Clinic relating to certain ovarian cancer vaccine technology. ~~BUSINESS~~The ~~AND~~license ~~FUNDING~~agreement requires us to make certain cash payments to Cleveland Clinic upon achievement of specific development milestones. This technology pertains to, among other things, the use of vaccines for the treatment or 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-ED naturally and markedly declines during menopause, this protein is expressed at high levels in the ovaries of postmenopausal women with ovarian cancer. Researchers at Cleveland Clinic believe that a vaccine targeting AMHR2-ED could prevent the occurrence of ovarian cancer.

~~Description of Business~~F-8

AsIn May ~~used herein~~2021, ~~“we,” “us,”~~Cleveland “Clinic was granted acceptance for our,” ovarian cancer vaccine technology into the ~~“Company”~~NCI’s orPREVENT program. The NCI is a part of the National Institutes of Health (“~~Anixa~~NIH”). ~~means~~The ~~Anixa~~PREVENT ~~Biosciences~~program is a peer-reviewed agent development program designed to support pre-clinical development of innovative interventions and biomarkers for cancer prevention and interception towards clinical trials. The scientific and financial resources of the PREVENT program are being used for our ovarian cancer vaccine technology to perform virtually all pre-clinical research and development, ~~Inc~~manufacturing and IND enabling studies. This work is being performed at NCI facilities, by NCI scientific staff and ~~its~~with ~~consolidated~~NCI financial resources and will require no material financial expenditures by the ~~subsidiaries~~Company, nor the payment of any future consideration by the Company to NCI.

~~Anixa~~In May ~~Biosciences~~2024, ~~Inc.~~based ison athe ~~biotechnology company~~positive ~~developing~~clinical ~~therapies~~results ~~and~~to ~~vaccines~~date ~~that are focused on critical unmet needs~~ in ~~oncology. Our therapeutics programs include (i)~~ the development of aour ~~chimeric~~breast ~~endocrine~~cancer ~~receptor-T cell therapy~~vaccine, awe ~~novel~~entered ~~form~~into ofa ~~chimeric~~Joint ~~antigen receptor-T cell (“CAR-T”)~~Development ~~technology,~~and ~~initially~~Option ~~focused~~Agreement onwith ~~treating~~Cleveland ~~ovarian~~Clinic ~~cancer,~~to ~~which~~collaborate isin ~~being~~efforts ~~developed~~to atdevelop ~~our~~additional ~~subsidiary,~~vaccines ~~Certainty~~for ~~Therapeutics, Inc. (“Certainty”), and (ii) until March 2023,~~ the ~~development~~prevention ofor ~~anti-viral drug candidates for the~~ treatment of ~~COVID-19~~ cancers. ~~Our~~Working ~~vaccine~~with ~~programs~~Cleveland ~~include~~Clinic ~~(i) the development of a vaccine against breast cancer~~researchers, ~~initially~~we ~~focused~~are focusing on ~~triple negative breast cancer (“TNBC”),~~ the ~~most lethal~~same ~~form~~novel ofscientific ~~breast cancer, (ii) the development of a vaccine against ovarian cancer, and (iii) a vaccine discovery program utilizing the same~~ mechanism as in our breast and ovarian cancer vaccines, and working to ~~develop~~discover additional ~~cancer~~retired ~~vaccines~~proteins tothat ~~address~~may ~~many~~be ~~intractable~~associated ~~cancers~~with other forms of cancer, ~~including~~ specifically high incidence malignancies in the lung, colon and prostate.

~~Our subsidiary, Certainty, is~~Over ~~developing~~the ~~immuno-therapy~~next ~~drugs~~several ~~against cancer. Certainty holds an exclusive worldwide~~quarters, ~~royalty-bearing~~we ~~license~~expect ~~to use certain intellectual property owned or controlled by The Wistar Institute (“Wistar”),~~ the ~~nation’s~~development ~~first~~of ~~independent~~our ~~biomedical~~therapeutics ~~research institute~~ and avaccines ~~leading NCI designated cancer research center, relating~~ to ~~Wistar’s~~be ~~chimeric endocrine receptor targeted therapy technology. We have initially focused on~~ the ~~development~~primary offocus ~~a treatment for ovarian cancer, but we also may pursue applications~~ of the ~~technology~~ ~~for~~Company. ~~the~~As ~~development~~ part of ~~treatments~~our ~~for~~legacy ~~additional~~operations, ~~solid~~the ~~tumors.~~Company ~~The~~remains ~~license~~engaged ~~agreement~~in ~~requires~~limited ~~Certainty~~patent tolicensing ~~make~~activities ~~certain cash and equity payments to Wistar upon achievement~~ of ~~specific~~its ~~development~~various ~~milestones~~patent portfolios. ~~With~~We ~~respect to Certainty’s equity obligations~~do tonot ~~Wistar,~~expect ~~Certainty~~these ~~issued~~activities to ~~Wistar~~be ~~shares~~a ofsignificant ~~its~~part ~~common stock equal to five percent (5%)~~ of the ~~common~~Company’s ~~stock~~ongoing ofoperations ~~Certainty,~~nor ~~such~~do ~~equity stake~~we ~~subject~~expect tothese ~~dilution by further funding of Certainty’s~~ activities ~~by the Company. Due~~ to ~~such Company funding, Wistar’s~~require ~~equity~~material ~~stake~~financial inresources ~~Certainty~~or ~~was~~attention ~~4.4% as~~ of ~~October~~senior ~~31, 2024~~management.

~~Certainty, in collaboration with~~Over the H.past ~~Lee~~several ~~Moffitt Cancer Center and Research Institute~~years, ~~Inc.~~our ~~(“Moffitt”),~~revenue ~~has~~was ~~begun~~derived ~~human~~from ~~clinical~~technology ~~testing~~licensing ofand the ~~CAR-T~~sale ~~technology licensed~~of bypatented ~~Certainty~~technologies, ~~from~~including ~~Wistar~~revenue ~~aimed initially at treating ovarian cancer. After receiving authorization~~ from the ~~FDA,~~settlement ~~we commenced enrollment~~ of ~~patients~~litigation. inWe ahave ~~Phase~~not 1generated ~~clinical~~any ~~trial~~revenue ~~and~~to ~~treated~~date ~~the~~from ~~first~~our ~~patient~~therapeutics inor ~~August~~vaccine ~~2022~~programs. ~~Further,~~In ~~in May 2023 and August 2023~~addition, while we ~~treated~~pursue ~~the~~our ~~second~~therapeutics and ~~third~~vaccine ~~patients in the trial~~programs, ~~respectively,~~we atmay ~~the~~also ~~same~~make ~~dose~~investments ~~level~~in asand ~~the~~form ~~first~~new ~~patient,~~companies ~~and~~to ~~the~~develop ~~treatment~~additional ~~was~~emerging ~~well-tolerated by the patients~~technologies. InWe ~~February~~do ~~2024,~~not ~~May~~expect ~~2024~~to ~~and~~begin ~~June~~generating ~~2024,~~revenue wewith ~~treated~~respect ~~the~~to ~~three~~any ~~patients, respectively,~~ of ~~the~~our ~~second~~current ~~dose cohort,~~therapeutics ~~where~~or ~~the~~vaccine ~~patients~~programs ~~were administered a three-times higher dose of cells than the patients~~ in the near ~~first cohort~~term. ~~The~~We ~~treatment~~hope ~~at this~~to ~~dose~~achieve ~~level~~a ~~has~~profitable ~~also~~outcome ~~been well-tolerated~~ by ~~the~~eventually ~~patients.~~licensing ~~While~~our ~~the~~technologies ~~dose levels in the first two cohorts were expected~~ to belarge ~~sub-therapeutic, two~~pharmaceutical ofcompanies ~~the~~that ~~six patients exhibited some anecdotal signs of efficacy. Both~~ have ~~shown possible signs of tumor necrosis, and one is 20 months~~ ~~past initial treatment. In~~ the ~~case~~resources ofand ~~this~~infrastructure ~~patient,~~in ~~due~~place to ~~the encouraging results with her initial treatment~~manufacture, wemarket ~~sought single patient Investigational New Drug (“IND”) application permission from the FDA to re-dose her. This re-dosing was approved by the FDA,~~ and wesell ~~administered~~our ~~her~~technologies ~~second~~as ~~treatment~~therapeutics inor ~~October 2024~~vaccines. ~~This~~The ~~second treatment appears to have been well-tolerated by the patient. In~~eventual ~~November~~licensing ~~2024,~~of weany ~~treated the first patient in the third dose cohort, where patients are administered a ten-times higher dose~~ of ~~cells than~~our ~~the~~technologies ~~patients~~may intake ~~the~~several ~~first dose cohort. As of January 10~~years, ~~2025,~~if weit ~~have~~is ~~treated~~to ~~two~~occur ~~patients in this dose cohort and the treatment~~ at ~~this dose level appears to be well-tolerated by the patients. We anticipate completing treatment of patients in the third dose cohort in February 2025~~all, and ~~commencing~~may ~~treatment~~depend ofon ~~the~~positive ~~fourth~~results ~~dose~~from ~~cohort—at a three-times higher dose than the third dose cohort—shortly~~human ~~thereafter~~clinical trials.

~~F-7~~Funding and Management’s Plans

~~This~~Based on ~~study~~currently isavailable ainformation ~~dose~~as of January 12, 2026, we believe that our existing cash, cash equivalents, short-~~escalation~~term investments ~~trial~~and expected cash flows will be sufficient to fund our activities for at least the next twelve months. We have implemented a business model that conserves funds by collaborating with ~~two~~third ~~arms~~parties ~~based~~to ondevelop ~~route~~our technologies. However, our projections of ~~delivery—intraperitoneal~~future orcash ~~intravenous—~~needs and cash flows may differ from actual results. If current cash on hand, cash equivalents, short-term investments and cash that may be generated from our business operations are insufficient to ~~determine~~continue ~~the~~to ~~maximum~~operate ~~tolerated~~our ~~dose~~business, or if we elect to invest in ~~patients~~or acquire a company or companies or new technology or technologies that are synergistic with ~~recurrent~~or ~~epithelial~~complementary ~~ovarian~~to ~~cancer~~our ~~and~~technologies, we may be required to ~~assess~~obtain ~~persistence~~more working capital. During the year ended October 31, ~~expansion~~2025, ~~and~~we ~~efficacy~~raised approximately $2,378,000, net of expenses, through an at-the-market ~~modified~~equity Toffering ~~cells~~of 772,001 shares of common stock. ~~The~~Under ~~study~~our at-the-market equity program, which is ~~being~~currently effective ~~conducted~~and atmay ~~Moffitt~~remain ~~and~~available ~~will~~for ~~consist~~us to use in the future, as of October 31, 2025, we may sell up to 24an additional $100 million of common stock. We may seek to 48obtain ~~patients~~working ~~who~~capital ~~have~~during ~~received~~our atfiscal ~~least~~year ~~two~~2026 ~~prior~~or ~~lines~~thereafter through sales of ~~chemotherapy~~our equity securities or through bank credit facilities or public or private debt from various financial institutions where possible. ~~The~~We ~~study~~cannot be certain that additional isfunding ~~estimated~~will be available on acceptable terms, or at all. If we do identify sources for additional funding, the sale of additional equity securities or convertible debt will result in dilution to beour ~~completed~~stockholders. We can give no assurance that we will generate sufficient cash flows in ~~two~~the future to ~~three~~satisfy ~~years~~our ~~depending~~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 ~~multiple~~favorable ~~factors~~terms ~~including~~or at all. If we fail to obtain additional working capital as and when ~~the~~needed, ~~maximum~~such ~~tolerated~~failure ~~dose~~could ishave ~~reached~~a material adverse impact on our business, results ~~the~~of ~~rate~~operations ofand ~~patient~~financial ~~enrollment~~condition. Furthermore, ~~the~~such ~~significance~~lack of ~~efficacy~~funds ~~data~~may ~~and~~inhibit ~~how~~our ~~long~~ability weto ~~maintain~~respond to competitive pressures or unanticipated capital needs, or may force us to reduce operating expenses, which could significantly harm the ~~two~~business ~~different~~and ~~delivery~~development of ~~methods~~operations.

~~We hold an exclusive worldwide, royalty~~F-bearing license to use certain intellectual property owned or controlled by The Cleveland Clinic Foundation (“Cleveland Clinic”) relating to certain breast cancer vaccine technology developed at Cleveland Clinic. The license agreement requires us to make certain cash payments to Cleveland Clinic upon achievement of specific development milestones. Utilizing this technology, we are working in collaboration with Cleveland Clinic to develop a method to vaccinate women against breast cancer, focused initially on TNBC. The focus of this vaccine is a specific protein, α-lactalbumin, that is only expressed during lactation in a healthy woman’s mammary tissue. This protein disappears when the woman is no longer lactating, but reappears in many forms of breast cancer, especially TNBC. Studies have shown that vaccinating against this protein prevents breast cancer in mice.9

In October 2021, following the U.S. Food and Drug Administration’s (“FDA”) authorization to proceed, we commenced dosing patients in a Phase 1 clinical trial of our breast cancer vaccine. This study, which is being fully funded by a U.S. Department of Defense grant to Cleveland Clinic, is a multiple-ascending dose Phase 1 trial to determine the maximum tolerated dose (“MTD”) of the vaccine in patients with early-stage, triple-negative breast cancer as well as monitor immune response. The study is being conducted at Cleveland Clinic. During the course of the Phase 1 study, participants will receive three vaccinations, each two weeks apart, and will be closely monitored for side effects and immune response. The first segment of the study, Phase 1a, will consist of approximately 24 patients who have completed treatment for early-stage, triple-negative breast cancer within the past three years and are currently tumor-free but at high risk for recurrence. Studies show that 42% of TNBC patients will have a recurrence of their cancer, with most of the recurrences occurring in the first two to three years after standard of care treatment. In January 2023, the number of participants in each dose cohort was expanded, and as of August 2023, we had completed vaccinating all patients in these expanded cohorts. In December 2023, we presented the immunological data collected to date at the San Antonio Breast Cancer Symposium. The data presented show that in the vaccinated women who had been tested to date, various levels of antigen-specific T cell responses were observed at all dose levels. Subsequently, we began vaccinating participants in additional dose cohorts at varying dose levels of the different key components of the vaccine. Further, in November 2023, we commenced vaccination of participants in the second segment of the trial, Phase 1b, that includes participants who have never had cancer, but carry certain mutations in genes such as BRCA1, BRCA2 or PALB2, that indicate a greater risk of developing TNBC in the future, and have elected to have a prophylactic mastectomy. Finally, in January 2024, we commenced vaccination of participants in the third segment of the trial, Phase 1c, that includes post-operative TNBC patients that have residual disease following treatment and are currently undergoing treatment with pembrolizumab (Keytruda®). In November 2024, we presented the most recent data from each of the three arms of the trial at the Society for Immunotherapy of Cancer (SITC) Annual Meeting. Key findings presented include i) patients exhibited antigen-specific immune responses at all dose levels and in all three patient groups (Phase 1a, 1b and 1c), ii) patients receiving our vaccine in combination with Keytruda are not showing any additional or more severe adverse side effects, and iii) no adverse side effects were seen other than varying degrees of injection site irritation. These findings are promising, and as we continue the Phase 1 trial, we are preparing to initiate a Phase 2 ~~clinical trial in the neo-adjuvant setting (pre-surgery) to determine possible therapeutic effect of the vaccine~~. We ~~anticipate~~SUMMARY ~~commencing~~OF ~~the~~SIGNIFICANT ~~Phase~~ACCOUNTING ~~2 trial in 2025.~~POLICIES

~~We hold an exclusive worldwide,~~Basis royalty-bearing license to use certain intellectual property owned or controlled by Cleveland Clinic relating to certain ovarian cancer vaccine technology. The license agreement requires us to make certain cash payments to Cleveland Clinic upon achievement of specific development milestones. This technology pertains to among other things, the use of vaccines for the treatment or 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-ED naturally and markedly declines during menopause, this protein is expressed at high levels in the ovaries of postmenopausal women with ovarian cancer. Researchers at Cleveland Clinic believe that a vaccine targeting AMHR2-ED could prevent the occurrence of ovarian cancer.Presentation

~~F-8~~The consolidated financial statements include the accounts of Anixa Biosciences, Inc. and its wholly and majority owned subsidiaries. All intercompany transactions have been eliminated.

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

~~In May 2024, based on the positive~~Noncontrolling ~~clinical~~interest ~~results~~represents toWistar’s ~~date~~equity ownership in ~~the~~Certainty ~~development~~and ofis ~~our~~presented ~~breast~~as ~~cancer vaccine, we entered into~~ a ~~Joint~~component ~~Development and Option Agreement with Cleveland Clinic to collaborate in efforts to develop additional vaccines for the prevention or treatment~~ of ~~cancers~~equity. ~~Working~~The ~~with~~following ~~Cleveland~~table sets ~~Clinic~~forth ~~researchers, we are focusing on~~ the ~~same~~changes ~~novel scientific mechanism as~~ in ~~our~~noncontrolling ~~breast~~interest ~~and~~for ~~ovarian~~the ~~cancer~~two ~~vaccines,~~years ~~and~~ended ~~working~~October ~~to discover additional retired proteins that may be associated with other forms of cancer~~31, ~~specifically~~2025 ~~high incidence malignancies~~ (in ~~the lung, colon and prostate.~~thousands):

~~Over the next several quarters,~~SCHEDULE weOF ~~expect~~CHANGES ~~the~~IN ~~development~~NONCONTROLLING of our therapeutics and vaccines to be the primary focus of the Company. As part of our legacy operations, the Company remains engaged in limited patent licensing activities of its various patent portfolios. We do not expect these activities to be a significant part of the Company’s ongoing operations nor do we expect these activities to require material financial resources or attention of senior management.INTEREST

Over the past several years, our revenue was derived from technology licensing and the sale of patented technologies, including revenue from the settlement of litigation. We have not generated any revenue to date from our vaccine or therapeutics programs. In addition, while we pursue our vaccine and therapeutics programs, we may also make investments in and form new companies to develop additional emerging technologies. We do not expect to begin generating revenue with respect to any of our current vaccine or therapy programs in the near term. We hope to achieve a profitable outcome by eventually licensing our technologies to large pharmaceutical companies that have the resources and infrastructure in place to manufacture, market and sell our technologies as vaccines or therapeutics. 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.

Balance October 31, 2023	$	(966	)
Net loss attributable to noncontrolling interest		(144	)
Balance October 31, 2024		(1,110	)
Net loss attributable to noncontrolling interest		(101	)
Balance October 31, 2025	$	(1,211	)

~~Funding and Management’s Plans~~Revenue Recognition

~~Based on currently available information~~Our asrevenue ofhas ~~January~~been ~~10,~~derived ~~2025,~~solely wefrom ~~believe~~technology ~~that~~licensing ~~our existing cash, cash equivalents, short-term investments~~ and ~~expected cash flows will be sufficient to fund our activities for at least~~ the ~~next~~sale ~~twelve months. We have implemented a business model that conserves funds by collaborating with third parties to develop our technologies. However, our projections~~ of ~~future~~patented cash needs and cash flows may differ from actual results. If current cash on hand, cash equivalents, short-term investments and cash that may be generated from our business operations are insufficient to continue to operate our business, or if we elect to invest in or acquire a company or companies or new technology or technologies ~~that are synergistic with or complementary to our technologies, we may be required to obtain more working capital~~. ~~During~~Revenue ~~the~~is ~~year~~recognized ~~ended~~upon ~~October~~transfer ~~31, 2024, we raised approximately $2,955,000, net~~ of ~~expenses,~~control ~~through an at-the-market equity offering~~ of ~~785,290~~intellectual ~~shares~~property ofrights ~~common stock. Under our at-the-market equity program, which is currently effective~~ and ~~may~~satisfaction ~~remain available for us to use in the future, as~~ of ~~October 31,~~other ~~2024,~~contractual weperformance ~~may~~obligations ~~sell up~~ to ~~$97~~licensees ~~million~~in ofan ~~common~~amount stock. We may seek to obtain working capital during our fiscal year 2025 or thereafter through sales of our equity securities or through bank credit facilities or public or private debt from various financial institutions where possible. We cannot be certain that ~~additional funding will be available on acceptable terms, or at all. If we do identify sources~~ ~~for~~reflects ~~additional funding,~~ the ~~sale~~consideration ~~of additional equity securities or convertible debt will result in dilution to our stockholders. We can give no assurance that~~ we ~~will~~expect ~~generate sufficient cash flows in the future~~ to satisfy our liquidity requirements or sustain future operations, or that other sources of funding, such as sales of equity or debt, would be available or would be approved by our security holders, if needed, on favorable terms or at allreceive. If we fail to obtain additional working capital as and when needed, such failure could have a material adverse impact on our business, results of operations and financial condition. Furthermore, such lack of funds may inhibit our ability to respond to competitive pressures or unanticipated capital needs, or may force us to reduce operating expenses, which could significantly harm the business and development of operations.

~~F-9~~Our revenue recognition policy requires us to make certain judgments and estimates in connection with the accounting for revenue. Such areas may include determining the existence of a contract and identifying each party’s rights and obligations to transfer goods and services, identifying the performance obligations in the contract, determining the transaction price and allocating the transaction price to separate performance obligations, estimating the timing of satisfaction of performance obligations, determining whether a promise to grant a license is distinct from other promised goods or services and evaluating whether a license transfers to a customer at a point in time or over time.

2Our revenue arrangements provide for the payment, within 30 days of execution of the agreement, of contractually determined, one-time, paid-up license fees in settlement of litigation and in consideration for the grant of certain intellectual property rights for patented technologies owned or controlled by the Company. ~~SUMMARY~~These OFarrangements ~~SIGNIFICANT~~typically ~~ACCOUNTING~~include ~~POLICIES~~some combination of the following: (i) the grant of a non-exclusive, retroactive and future license to manufacture and/or sell products covered by patented technologies owned or controlled by the Company, (ii) a covenant-not-to-sue, (iii) the release of the licensee from certain claims, and (iv) the dismissal of any pending litigation. In such instances, the intellectual property rights granted have been perpetual in nature, extending until the expiration of the related patents. Pursuant to the terms of these agreements, we have no further obligations with respect to the granted intellectual property rights, including no obligation to maintain or upgrade the technology, or provide future support or services. Licensees obtained control of the intellectual property rights they have acquired upon execution of the agreement. Accordingly, the performance obligations from these agreements were satisfied and 100% of the revenue was recognized upon the execution of the agreements.

~~Basis~~ Cost of ~~Presentation~~Revenues

~~The~~Cost of ~~consolidated~~revenues ~~financial~~includes ~~statements~~the costs and expenses incurred in connection with our patent licensing and enforcement activities, including inventor ~~include~~royalties ~~the~~paid ~~accounts~~to oforiginal ~~Anixa~~patent ~~Biosciences~~owners, ~~Inc.~~contingent legal fees paid to external counsel, other patent-related legal expenses paid to external counsel, licensing and ~~its~~enforcement ~~wholly~~related research and ~~majority~~consulting ~~owned~~and ~~subsidiaries.~~other ~~All~~expenses ~~intercompany~~paid ~~transactions~~to ~~have~~third ~~been~~parties. These costs are ~~eliminated~~included under the caption “Operating costs and expenses” in the accompanying consolidated statements of operations.

~~Noncontrolling Interest~~F-10

~~Noncontrolling interest represents~~Research ~~Wistar’s equity ownership in Certainty~~ and isDevelopment ~~presented as a component of equity. The following table sets forth the changes in noncontrolling interest for the two years ended October 31, 2024 (in thousands):~~Expenses

~~SCHEDULE~~Research OFand ~~CHANGES~~development INexpenses ~~NONCONTROLLING~~consist ~~INTEREST~~ primarily of employee compensation, payments to third parties for research and development activities and other direct costs associated with developing our therapeutics and vaccines. We recognize research and development expenses as incurred. Advance payments for future research and development activities are deferred and expensed as the services are performed. We recognize our preclinical studies and clinical trial expenses based on the services performed pursuant 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 each service provider in a given period, the time period over which services are expected to be performed, and the level of effort expended in each reporting period.

Balance October 31, 2022	$	(847	)
Net loss attributable to noncontrolling interest		(119	)
Balance October 31, 2023		(966	)
Net loss attributable to noncontrolling interest		(144	)
Balance October 31, 2024	$	(1,110	)

~~Revenue~~In addition, ~~Recognition~~we allocate certain internal compensation costs to research and development expenses based on management’s estimates of each employee’s time and effort expended.

~~Our revenue~~Investment has been derived solely from technology licensing and the sale of patented technologies. Revenue is recognized upon transfer of control of intellectual property rights and satisfaction of other contractual performance obligations to licensees in an amount that reflects the consideration we expect to receive.Policy

~~Our revenue~~The ~~recognition~~Company’s investment policy ~~requires~~is usdesigned to ~~make~~optimize ~~certain~~returns ~~judgments~~while ~~and~~managing ~~estimates~~risk inand ~~connection~~liquidity. ~~with~~The ~~the~~policy ~~accounting~~allows for ~~revenue. Such areas may include~~investments ~~determining~~in ~~the existence of~~ a ~~contract~~diversified ~~and~~range ~~identifying~~of ~~each~~financial ~~party’s rights and obligations to transfer goods and services~~instruments, ~~identifying the~~including ~~performance~~U.S. ~~obligations~~government indebt ~~the~~securities ~~contract,~~with ~~determining~~fixed ~~the~~maturities ~~transaction price~~ and ~~allocating~~contractual ~~the transaction price to separate performance~~cash ~~obligations~~flows, ~~estimating~~as ~~the~~well ~~timing~~as ofalternative ~~satisfaction~~investments ofsuch ~~performance~~as ~~obligations,~~Bitcoin ~~determining whether a promise to grant a license is distinct from other promised goods or services~~ and ~~evaluating~~Bitcoin-based ~~whether~~exchange atraded ~~license~~funds ~~transfers~~(collectively, tothe a“Bitcoin ~~customer at a point in time or over time~~Assets”).

~~Our revenue~~The ~~arrangements~~Company ~~provide~~acquires ~~for~~U.S. ~~the~~government ~~payment,~~debt ~~within~~securities 30that ~~days~~it ofhas ~~execution of~~ the ~~agreement,~~positive ofintent ~~contractually determined, one-time, paid-up license fees in settlement of litigation~~ and inability ~~consideration~~to ~~for~~hold ~~the~~to ~~grant of certain intellectual property rights for patented technologies owned or controlled by the Company~~maturity. These ~~arrangements~~securities ~~typically include some combination of the following: (i) the grant of a non-exclusive,~~are ~~retroactive~~recorded ~~and~~at ~~future~~amortized ~~license to manufacture and/or sell products covered by patented technologies owned or controlled by the Company~~cost, ~~(ii)~~ anet ~~covenant-not-to-sue, (iii) the release~~ of ~~the licensee from certain claims, and (iv) the dismissal of~~ any ~~pending~~applicable ~~litigation.~~discount ~~In such~~which ~~instances,~~is ~~the~~amortized ~~intellectual~~to ~~property~~interest ~~rights granted have been perpetual in nature~~income, ~~extending~~and ~~until~~are ~~the~~accounted ~~expiration~~for ofas ~~the related~~held-to-maturity ~~patents~~securities. ~~Pursuant~~The toCompany’s ~~the~~Bitcoin ~~terms~~Assets ofare ~~these~~measured ~~agreements,~~at wefair ~~have~~value nobased ~~further~~on ~~obligations~~quoted ~~with~~prices ~~respect~~on toactive ~~the~~exchanges. ~~granted~~The ~~intellectual~~Company ~~property rights,~~recognizes ~~including~~changes noin ~~obligation to maintain or upgrade~~ the ~~technology,~~fair orvalue ~~provide future support or services. Licensees obtained control~~ of ~~the intellectual~~Bitcoin ~~property~~Assets ~~rights~~as ~~they~~gains ~~have~~or ~~acquired~~losses ~~upon~~in ~~execution of~~ the ~~agreement.~~statement ~~Accordingly, the performance obligations from these agreements were satisfied and 100%~~ of ~~the~~operations ~~revenue~~during ~~was recognized upon~~ the ~~execution~~period ofin ~~the~~which ~~agreements~~they occur.

~~Cost~~Fair Value ~~of Revenues~~Measurements

~~Cost~~Accounting Standards ofCodification ~~revenues~~(“ASC”) ~~include~~820, ~~the~~Fair ~~costs~~ Value Measurements and ~~expenses~~Disclosures ~~incurred~~(“ASC in820”), ~~connection~~defines ~~with~~fair ~~our~~value, establishes ~~patent~~a ~~licensing~~framework ~~and~~for ~~enforcement~~measuring ~~activities,~~fair ~~including~~value ~~inventor~~under ~~royalties~~U.S. ~~paid~~generally toaccepted ~~original~~accounting principles (GAAP), and expands disclosures ~~patent~~about ~~owners~~fair value measurements. In accordance with ASC 820, ~~contingent~~we ~~legal~~have ~~fees~~categorized ~~paid~~our tofinancial ~~external~~assets ~~counsel~~and liabilities, ~~other~~based ~~patent-related~~on ~~legal~~the ~~expenses~~priority of ~~paid~~the inputs to ~~external~~the ~~counsel~~valuation technique, ~~licensing and~~into ~~enforcement~~a ~~related~~three-level ~~research~~fair ~~and~~value ~~consulting~~hierarchy ~~and~~as ~~other~~set ~~expenses~~forth ~~paid~~below. If the inputs used to ~~third-parties.~~measure ~~These~~the financial ~~costs~~instruments ~~are~~fall ~~included~~within ~~under~~different levels of the ~~caption~~hierarchy, ~~“Operating costs~~the ~~and~~categorization ~~expenses”~~is inbased on the ~~accompanying~~lowest ~~consolidated~~level ~~statements~~input that is significant to the fair value measurement of ~~operations~~the instrument.

~~F-10~~Financial assets and liabilities recorded in the accompanying consolidated balance sheets are categorized based on the inputs to the valuation techniques as follows:

~~Research~~Level 1 ~~and~~– ~~Development~~Financial ~~Expenses~~instruments whose values are based on unadjusted quoted prices for identical assets or liabilities in an active market which we have the ability to access at the measurement date.

~~Research and development expenses~~Level ~~consist~~2 ~~primarily~~– ofFinancial ~~employee~~instruments ~~compensation,~~whose ~~payments~~values to third parties for research and development activities and other direct costs associated with developing our therapeutics and vaccines. We recognize research and development expenses as incurred. Advance payments for future research and development activities are ~~deferred and expensed as the services are performed. We recognize our preclinical studies and clinical trial expenses~~ based on ~~the~~quoted ~~services~~market ~~performed~~prices ~~pursuant~~in tomarkets ~~contracts~~where ~~with~~trading ~~research~~occurs ~~institutions,~~infrequently ~~clinical~~or ~~research organizations~~whose ~~(“CROs”),~~values ~~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~~quoted ~~estimates~~prices ~~after considering~~of ~~the~~instruments ~~activities~~with ~~and~~similar ~~tasks~~attributes ~~completed by each service provider~~ in aactive ~~given period, the time period over which services are expected to be performed, and the level of effort expended in each reporting period~~markets.

~~At each~~Level ~~balance~~3 ~~sheet~~– ~~date,~~Financial ~~management~~instruments ~~estimates~~whose ~~prepaid~~values ~~and~~are ~~accrued~~based ~~research~~on ~~and~~prices ~~development costs by discussing progress~~ or ~~stage~~valuation oftechniques ~~completion of~~that ~~activities~~require ~~with~~inputs ~~internal~~that ~~personnel~~are ~~and~~both ~~external service providers,~~ unobservable and ~~comparing~~significant ~~this information~~ to ~~payments~~the ~~made,~~overall ~~invoices~~fair ~~received, and~~value ~~the~~measurement. ~~agreed-upon~~These ~~contractual~~inputs ~~fee~~reflect tomanagement’s beown ~~paid~~assumptions ~~for~~about ~~such~~the ~~services~~assumptions a inmarket ~~the~~participant ~~applicable~~would ~~contract~~use orin ~~statements~~pricing ofthe ~~work~~instrument.

~~In addition, we allocate certain internal compensation costs to research and development expenses based on management’s estimates of each employee’s time and effort expended.~~F-11

~~Investment~~The following ~~Policy~~table presents the hierarchy for our financial assets measured at fair value as of October 31, 2025 (in thousands):

~~The Company’s investment~~SCHEDULE ~~policy~~OF isFAIR ~~designed~~VALUE to optimize returns while managing risk and liquidity. The policy allows for investments in a diversified range of financial instruments, including U.S. government debt securities with fixed maturities and contractual cash flows, as well as alternative investments such as Bitcoin and Bitcoin-based exchange traded funds (collectively, the “Bitcoin Assets”).MEASUREMENTS

The Company acquires U.S. government debt securities that it has the positive intent and ability to hold to maturity. These securities are recorded at amortized cost, net of any applicable discount which is amortized to interest income, and are accounted for as held-to-maturity securities. The Company’s Bitcoin Assets are measured at fair value based on quoted prices on active exchanges. The Company recognizes changes in the fair value of Bitcoin Assets as gains or losses in the statement of operations during the period in which they occur. The Company has no Bitcoin Assets as of October 31, 2024 and 2023.

	Level 1		Level 2		Level 3		Total
Money market funds:
Cash equivalents	$	1,197	$	-	$	-	$	1,197
Bitcoin exchange traded funds:
Short term investments		-		11		-		11
U.S. treasury bills:
Short term investments		-		13,887		-		13,887
Total financial assets	$	1,197	$	13,898	$	-	$	15,095

~~Fair~~The following ~~Value~~table ~~Measurements~~presents the hierarchy for our financial assets measured at fair value as of October 31, 2024 (in thousands):

Accounting Standards Codification (“ASC”) 820, Fair Value Measurements and Disclosures (“ASC 820”), defines fair value, establishes a framework for measuring fair value under U.S. generally accepted accounting principles (GAAP), and expands disclosures about fair value measurements. In accordance with ASC 820, we have categorized our financial assets and liabilities, based on the priority of the inputs to the valuation technique, into a three-level fair value hierarchy as set forth below. If the inputs used to measure the financial instruments fall within different levels of the hierarchy, the categorization is based on the lowest level input that is significant to the fair value measurement of the instrument.

	Level 1		Level 2		Level 3		Total
Money market funds:
Cash equivalents	$	1,170	$	-	$	-	$	1,170
U.S. treasury bills:
Short term investments		-		18,792		-		18,792
Total financial assets	$	1,170	$	18,792	$	-	$	19,962

~~Financial~~As ~~assets~~noted ~~and~~above, ~~liabilities recorded~~the Company classifies its investments in ~~the~~U.S. ~~accompanying~~treasury ~~consolidated~~bills ~~balance~~as ~~sheets~~short-term investments that are ~~categorized~~held-to-maturity, ~~based~~and accordingly, are presented on the ~~inputs~~accompanying toconsolidated ~~the~~balance ~~valuation~~sheets ~~techniques~~at asamortized ~~follows:~~cost.

~~Level~~Our non-financial 1assets –that ~~Financial~~are ~~instruments~~measured ~~whose values~~at ~~are~~fair ~~based~~value on ~~unadjusted~~a ~~quoted~~non-recurring ~~prices~~basis ~~for~~are ~~identical~~property and equipment and other assets which are measured using fair value techniques whenever events or ~~liabilities~~changes in ancircumstances ~~active~~indicate ~~market~~a ~~which~~condition weof ~~have~~impairment ~~the~~exists. ~~ability~~The toestimated ~~access~~fair atvalue of prepaid expenses and other current assets, accounts payable and accrued expenses approximates their individual carrying amounts due to the ~~measurement~~short-term ~~date~~nature of these measurements. Cash equivalents are stated at carrying value which approximates fair value.

~~Level 2 – Financial instruments whose~~Cash ~~values are based on quoted market prices in markets where trading occurs infrequently or whose values are based on quoted prices of instruments with similar attributes in active markets.~~Equivalents

~~Level 3 – Financial instruments whose~~Cash ~~values~~equivalents ~~are~~consist ~~based~~of onhighly ~~prices~~liquid, orshort-term ~~valuation~~investments ~~techniques~~with ~~that~~maturities ~~require~~of ~~inputs~~three ~~that~~months ~~are~~or ~~both~~less ~~unobservable~~when ~~and significant to the overall fair value measurement~~purchased. ~~These inputs reflect management’s own assumptions about the assumptions a market participant would use in pricing the instrument.~~

FShort-11term Investments

~~The~~At October ~~following~~31, ~~table~~2025 ~~presents~~and ~~the hierarchy~~2024, ~~for~~we ~~our~~held ~~financial~~United ~~assets~~States ~~measured~~treasury atbills ~~fair~~with ~~value~~maturities ongreater athan ~~recurring~~90 ~~basis~~days asand less than 12 months when acquired with amortized costs of approximately $13,930,000 and $18,653,000, respectively, that were classified as short-term investments. Furthermore, at October 31, ~~2024~~2025, ~~(in~~we ~~thousands):~~held Bitcoin Assets with fair value of approximately $11,000 that were classified as short-term investments.

~~SCHEDULE~~Income ~~OF FAIR VALUE MEASUREMENTS~~Taxes

	Level 1		Level 2		Level 3		Total
Money market funds:
Cash equivalents	$	1,170	$	-	$	-	$	1,170
U.S. treasury bills:
Short term investments		-		18,653		-		18,653
Total financial assets	$	1,170	$	18,653	$	-	$	19,823

We recognize deferred tax assets and liabilities for the estimated future tax effects of events that have been recognized in our financial statements or tax returns. Under this method, deferred tax assets and liabilities are determined based on the difference between the financial statement and tax bases of assets and liabilities using enacted tax rates in effect in the years in which the differences are expected to reverse. A valuation allowance is established, when necessary, to reduce deferred tax assets to the amount expected to be realized. We have provided a full valuation allowance against out deferred tax asset due to our historical pre-tax losses and the uncertainty regarding the realizability of these deferred tax assets.

~~The following table presents the hierarchy for our financial assets measured at fair value on a recurring basis as of October 31, 2023 (in thousands):~~F-12

	Level 1		Level 2		Level 3		Total
Money market funds:
Cash equivalents	$	778	$	-	$	-	$	778
Certificates of deposit:
Short term investments		-		720		-		720
U.S. treasury bills:
Short term investments		-		22,209		-		22,209
Total financial assets	$	778	$	22,929	$	-	$	23,707

Stock-Based Compensation

~~Our~~We ~~non-financial~~maintain ~~assets~~equity ~~that~~incentive ~~are~~plans ~~measured~~under atwhich ~~fair~~we ~~value~~may ongrant aincentive stock options, non-~~recurring~~qualified ~~basis~~stock ~~are~~options, ~~property~~stock ~~and~~appreciation ~~equipment and other assets which are~~rights, ~~measured~~stock ~~using~~awards, ~~fair~~performance ~~value~~awards, ~~techniques whenever events~~ or ~~changes~~stock inunits ~~circumstances~~to ~~indicate a condition of impairment exists. The estimated fair value of prepaid expenses and other current assets~~employees, ~~accounts~~directors ~~payable~~ and ~~accrued expenses approximates their individual carrying amounts due to the short-term nature of these measurements~~consultants. ~~Cash equivalents are stated at carrying value which approximates fair value.~~

~~Cash~~Stock Option ~~Equivalents~~Compensation Expense

~~Cash~~We account ~~equivalents~~for ~~consist~~stock ofoptions ~~highly liquid~~granted to employees, ~~short~~directors and consultants using the accounting guidance in ASC 718, Stock Compensation (“ASC 718”). We estimate the fair value of service-~~term~~based ~~investments~~stock ~~with~~options ~~maturities~~on the date of ~~three~~grant, ~~months~~using orthe ~~less~~Black-Scholes ~~when~~pricing model, ~~purchased~~and recognize compensation expense over the requisite service period of the grant.

~~Short~~We recorded stock-~~term~~based ~~Investments~~compensation expense, related to service-based stock options granted to employees and directors, of approximately $3,681,000 and $4,420,000, during the years ended October 31, 2025 and 2024, respectively. Included in stock-based compensation cost for service-based options granted to employees and directors during the years ended October 31, 2025 and 2024 was approximately $3,023,000 and $3,187,000, respectively, related to the amortization of compensation cost for stock options granted in prior periods but not yet vested. As of October 31, 2025, there was unrecognized compensation cost related to non-vested service-based stock options granted to employees and directors of approximately $3,166,000, which will be recognized over a weighted-average period of 1.6 years.

AtWe recorded ~~October~~consulting 31expense, ~~2024~~related ~~and~~to ~~2023~~service-based stock options granted to consultants, we ~~had~~during ~~certificates~~the ofyears ~~deposit~~ended October 31, 2025 and 2024 ~~United~~of ~~States~~approximately ~~treasury~~$129,000 ~~bills~~and ~~with~~$125,000, ~~maturities~~respectively. ~~greater~~Included ~~than~~in 90stock-based ~~days~~consulting ~~and~~expense ~~less~~for ~~than~~the 12years ~~months~~ended ~~when~~October ~~acquired~~31, of2025 and 2024 was approximately $1894,~~653,~~000 and $22120,~~929,~~000, respectively, ~~that~~related ~~were~~to ~~classified~~compensation ascost ~~short~~for stock options granted in prior periods but not yet vested. As of October 31, 2025, there was unrecognized consulting expense related to non-~~term~~vested ~~investments~~service-based stock options granted to consultants of approximately $108,000, which will be recognized over a weighted-average period of 1.2 years.

~~Income~~Fair Value ~~Taxes~~Determination

We use ~~recognize~~the ~~deferred~~Black-Scholes ~~tax~~pricing ~~assets and~~model ~~liabilities~~in ~~for~~estimating the ~~estimated~~fair ~~future~~value ~~tax effects~~ of ~~events~~stock ~~that~~options ~~have~~granted ~~been~~to ~~recognized in our financial statements or tax returns. Under this method~~employees, ~~deferred~~directors ~~tax assets~~ and ~~liabilities~~consultants ~~are~~which vest ~~determined~~over ~~based~~a onspecific ~~the~~period ~~difference between the financial statement and tax bases~~ of ~~assets~~time. ~~and~~The ~~liabilities~~stock ~~using~~options ~~enacted~~we ~~tax~~granted ~~rates~~during ineach ~~effect~~of in the years inended ~~which~~October ~~the~~31, ~~differences~~2025 ~~are~~and ~~expected~~2024 ~~to reverse. A valuation~~consisted ~~allowance~~of isawards ~~established,~~with ~~when~~5-year ~~necessary,~~and to10-year ~~reduce~~terms ~~deferred~~that ~~tax~~vest ~~assets~~over to3 ~~the amount expected~~ to be36 ~~realized~~months.

~~Stock-Based~~The following ~~Compensation~~weighted average assumptions were used in estimating the fair value of stock options granted during the years ended October 31, 2025 and 2024:

~~We maintain equity incentive plans~~SCHEDULE ~~under~~OF ~~which~~WEIGHTED weAVERAGE ~~may~~ASSUMPTIONS ~~grant~~USED ~~incentive~~IN ~~stock~~ESTIMATING ~~options,~~FAIR ~~non-qualified~~VALUE ~~stock~~OF ~~options,~~STOCK ~~stock appreciation rights, stock awards, performance awards, or stock units to employees, directors and consultants.~~OPTIONS

F-12

	For the Year Ended October 31,
	2025			2024
Weighted average fair value at grant date	$	1.62		$	2.94
Valuation assumptions:
Expected life (years)		5.8			5.7
Expected volatility		75.7	%		76.5	%
Risk-free interest rate		4.4	%		3.9	%
Expected dividend yield		0.0	%		0.0	%

~~Stock~~The expected ~~Option~~term ~~Compensation~~of ~~Expense~~stock options represents the weighted average period the stock options are expected to remain outstanding. For employees and directors, we use the simplified method, which is a weighted average of the vesting term and contractual term, to determine expected term. The simplified method was adopted since we do not believe that historical experience is representative of future performance because of the impact of the changes in our operations and the change in terms from historical operations. 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 period of time equal to the expected term of the options. We estimated the risk-free interest rate based on the implied yield available on the applicable grant date of a U.S. Treasury note with a term equal to the expected term of the underlying grants. We made the dividend yield assumption based on our history of not paying cash dividends and our expectation not to pay dividends in the future.

~~We account for stock options granted to employees, directors and consultants using the accounting guidance in ASC 718, Stock Compensation (“ASC 718”). We estimate the fair value of service~~F-~~based stock options on the date of grant, using the Black-Scholes pricing model, and recognize compensation expense over the requisite service period of the grant.~~13

~~We recorded stock-based compensation~~Under ~~expense,~~ASC ~~related to service-based stock options granted to employees and directors~~718, ~~of approximately $4,420,000 and $4,422,000, during~~ the ~~years~~amount ~~ended~~of ~~October 31, 2024 and 2023, respectively. Included in~~ stock-based compensation ~~cost~~expense ~~for~~recognized ~~service-~~is based ~~options~~on ~~granted~~the ~~to employees~~portion ~~and~~of ~~directors during~~ the ~~years~~awards ~~ended~~that ~~October~~are ~~31,~~ultimately ~~2024~~expected to ~~and~~vest. ~~2023 was approximately $3~~Accordingly,~~187,000~~ ~~and~~if ~~$3,023,000,~~deemed ~~respectively~~necessary, ~~related to~~we reduce the ~~amortization~~fair value of ~~compensation~~the ~~cost for~~ stock ~~options~~option ~~granted~~awards infor ~~prior~~expected ~~periods~~forfeitures, ~~but~~which ~~not~~are ~~yet vested. As~~ forfeitures of ~~October~~the ~~31,~~unvested ~~2024,~~portion ~~there was~~of ~~unrecognized~~surrendered ~~compensation~~options. ~~cost~~Based ~~related~~on toour ~~non-vested~~historical ~~service-based~~experience ~~stock options granted to employees~~ and ~~directors~~future ~~of approximately $4~~expectations,~~843,000,~~ ~~which~~we ~~will~~have benot ~~recognized~~reduced ~~over~~the aamount of ~~weighted~~stock-~~average~~based ~~period~~compensation ofexpenses ~~1.7~~for ~~years~~anticipated forfeitures.

We ~~recorded consulting expense,~~ ~~related~~will toreconsider ~~service-based~~use ~~stock~~of ~~options granted to consultants, during~~ the ~~years~~Black-Scholes ~~ended~~pricing ~~October~~model ~~31,~~if ~~2024~~additional ~~and~~information ~~2023~~becomes ofavailable ~~approximately $125,000 and $221,000, respectively. Included~~ in ~~stock-based~~the ~~consulting~~future ~~expense~~that ~~for~~indicates ~~the~~another model ~~years~~would ~~ended~~be ~~October~~more ~~31,~~appropriate. ~~2024~~If ~~and~~factors ~~2023~~change ~~was approximately $120,000~~ and ~~$209,000,~~we ~~respectively,~~employ ~~related~~di

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