ANIX 10-K & 10-Q changes, risk factors and insider trading

Based on currently available information as of January 10,12, 2025,2026, 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 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, 2024,2025, we raised approximately $2,955,000,$2,378,000, net of expenses, through an at-the-market equity offering of 785,290772,001 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, 2024,2025, we may sell up to $97an additional $100 million of common stock. We may seek to obtain working capital during our fiscal year 20252026 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, 2024,2025, the Company had approximately $19,924,000$15,174,000 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 therapeuticlira-cel 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 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 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.

We have limited human clinical data from our breast cancer vaccine and our CAR-T ovarian cancer therapeutic,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 the time frames we expect. Further, our new vaccine research programs in high-incidence cancers of the lung, colon and prostate are in the early discovery stage, and have generated no data to 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 depend upon independent investigators and collaborators, such as universities, medical institutions, and strategic partners such as Moffitt for our CAR-T therapylira-cel and Cleveland Clinic for our cancer vaccines to conduct our pre-clinical studies and clinical trials under agreements with us. Negotiations of budgets and contracts with study sites may result in delays to our development timelines and increased costs. We will rely heavily on these third parties over the course 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 us of our regulatory responsibilities. We and these third parties are required to comply with current good clinical practices, or cGCPs, which are regulations and guidelines enforced by the FDA and comparable foreign regulatory authorities for product candidates in clinical development. Regulatory authorities enforce these cGCPs through periodic inspections of clinical trial sponsors, principal investigators and clinical trial sites. If we or any of these third parties fail to comply with applicable cGCP regulations, the clinical data generated in our clinical trials may be deemed unreliable and the FDA or comparable foreign regulatory authorities could require us to perform additional clinical trials before approving our marketing applications. It is possible that, upon inspection, such regulatory authorities could determine that any of our clinical trials fail to comply with the cGCP regulations. In addition, our clinical trials must be conducted with biologic product produced under current good manufacturing practices, or cGMPs, and will 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.

Any third parties conducting our clinical trials are not and will not be our employees and, except for remedies available to us under our agreements with these third parties, we cannot control whether they devote sufficient time and resources to our ongoing pre-clinical, clinical and nonclinicalnon-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 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.

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

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

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. In the Phase 1 clinical trial of our breast cancer vaccine, the side effects observed were limited to injection site reactions.

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

In the future, we may issue securities to raise cash for operations, to pay down then existing indebtedness, as consideration for the acquisition of assets, as consideration for receipt of goods or services, to pay for the development of our CAR-T cancer therapeutics,lira-cel, to pay for the development of our cancer cancer vaccines and for acquisitions of companies. We have an at-the-market equity offering under which, as of January 10,12, 20252026 we may issue issue up to approximately $97$98.6 million of common stock, which is currently effective, and which may remain available to us in the future. We We also have, and in the future may, issue securities convertible into our common stock. Any of these events may dilute stockholders’ ownership interests in our company and have an adverse impact on the price of our common stock.

We did not have any revenue in fiscal years 2025 and 2024. Over the past several years, our 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.

We 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. WeOur hopeplan 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.

Our research and development expenses are related to the development of our cancer vaccines and CAR-T therapeutics programs and in fiscal year 2025, the expenses incurred consisted of approximately $3,121,000 and $1,950,000 for cancer vaccines and CAR-T therapeutics, respectively. In fiscal year 2024, research and development expenses were related to the development offor our cancer therapeutics and vaccine programs and the expenses incurred consisted of approximately $3,748,000 and $2,648,000 for cancer vaccines and CAR-T therapeutics, respectively. In fiscal year 2023, research and development expensestherapeutics were relatedapproximately to the development of our cancer therapeutics and vaccines, as well as our anti-viral therapeutics program,$3,748,000 and the expenses incurred consisted of approximately $2,682,000, $1,839,000 and $248,000 for cancer vaccines, CAR-T therapeutics and anti-viral therapeutics,$2,648,000, respectively.

The net loss attributable to noncontrolling interest, representing Wistar’s ownership interest in Certainty’s net loss, increased decreased by approximately $25,000$43,000 to approximately $101,000 in fiscal year 2025, from approximately $144,000 in fiscal year 2024, from approximately $119,000 in fiscal year 2023, as Certainty’s net loss increased.decreased.

During the fiscal year ended October 31, 2024,2025, cash used in operating activities was approximately $7,335,000.$7,173,000. Cash provided by investing activities was approximately $4,276,000,$4,866,000, resulting from the proceeds on maturities of short-term investments of approximately $68,046,000,$49,226,000, which was offset by the purchase of short-term investments of approximately $63,770,000.$44,360,000. Cash provided by financing activities was approximately $3,415,000,$2,280,000, resulting from the sale of 785,290772,001 shares of common stock in atan at-the-market equity offering of approximately $2,955,000,$2,378,000 proceeds from the exercisenet of stock options of approximately $456,000expenses and proceeds from the sale of common stock pursuant to an employee stock purchase plan of approximately $10,000,$7,000, offset by bynet costs from the purchaseexercise of treasurystock stockoptions of approximately $6,000.$105,000. As a result, our cash, cash equivalents, and short-term investments at October 31, 20242025 decreased approximately $3,920,000$4,750,000 to approximately $19,924,000$15,174,000 from approximately $23,844,000$19,924,000 at the end of fiscal year 2023.2024.

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 thatwe have sufficient historical experienceexercise isdata representative ofon futurewhich performanceto because of the impact of the changes inbase our operationsown and the change in terms from historical options.estimate. For consultants 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.

Three months ended AprilJuly 30,31, 2026 compared with three months ended AprilJuly 30,31, 2025

We had no revenue during the three-month periods ended AprilJuly 30,31, 2026 and 2025.

During the three months ended AprilJuly 30,31, 2026, research and development expenses related to the development of our cancer vaccines and CAR-T therapeutics therapeutics consisted of approximately $812,000$921,000 and $446,000,$405,000, respectively. During the three months ended AprilJuly 30,31, 20252025, research and development development expenses related to the development of our cancer vaccines and CAR-T therapeutics consisted of approximately $898,000$615,000 and $424,000, $440,000, respectively.

Research and development expenses decreasedincreased by approximately $64,000$271,000 to approximately $1,258,000$1,326,000 in the three months ended AprilJuly 30,31, 2026, from approximately $1,322,000$1,055,000 in the three months ended AprilJuly 30,31, 2025. The decreaseincrease in research and development expenses was primarily due to a decrease in employee stock-based compensation expense of approximately $134,000 and a decrease in employee compensation and related costs, other than stock-based compensation expense, of approximately $94,000, offset by an increase in research and development expenses related to our ovarian cancer CAR-T development program as a result of fluctuations in the timing of clinical trial patient enrollment of approximately $75,000 and an increase in research and development expenses related to our breast cancer vaccine program as a result of fluctuations in the timing of certain materials manufacturing activities of approximately $65,000.$376,000, offset by a decrease in employee stock-based compensation expense of approximately $75,000 and a decrease in employee compensation and related costs, other than stock-based compensation expense, of approximately $24,000.

General and administrative expenses decreasedincreased by approximately $292,000$30,000 to approximately $1,389,000$1,411,000 in the three months ended AprilJuly 30,31, 2026, from from approximately $1,681,000$1,381,000 in the three months ended AprilJuly 30,31, 2025. The decreaseincrease in general and administrative expenses was primarily due dueto toan increase in investor and public relations firm expenses as a result of changes in firms used during the period of approximately $158,000, offset by a decrease in employee stock-based compensation expense of approximately $182,000 and a decrease in patent-related costs of approximately $27,000.$127,000.

Interest income decreased by approximately $79,000$44,000 to approximately $111,000$112,000 in the three months ended AprilJuly 30,31, 2026, from approximately $190,000$156,000 in the three months ended AprilJuly 30,31, 2025, primarily due to a decrease in the amount of short-term investments held and a decrease in interest interest rates.

The net loss attributable to noncontrolling interest, representing Wistar’s ownership interest in Certainty’s net loss, decreased by approximately $3,000 to approximately $20,000$19,000 in the three months ended AprilJuly 30,31, 2026 from approximately $23,000$22,000 in the three months ended AprilJuly 30,31, 2025, as Certainty’s net loss decreased.

SixNine months ended AprilJuly 30,31, 2026 compared with sixnine months ended AprilJuly 30,31, 2025

We had no revenue during the six-monthnine-month periods ended AprilJuly 30,31, 2026 and 2025.

During the sixnine months ended AprilJuly 30,31, 2026, research and development expenses related to the development of our cancer vaccines and CAR-T therapeutics consisted of approximately $1,485,000$2,406,000 and $875,000,$1,280,000, respectively. During the sixnine months ended AprilJuly 30,31, 2025 research and development expenses related to the development of our cancer vaccines and CAR-T therapeutics consisted of approximately $1,873,000$2,489,000 and $1,001,000,$1,440,000, respectively.

Research and development expenses decreased by approximately $514,000$243,000 to approximately $2,360,000$3,686,000 in the sixnine months ended AprilJuly 30,31, 2026, from approximately $2,874,000$3,929,000 in the sixnine months ended AprilJuly 30,31, 2025. The decrease in research and development expenses was primarily due to a decrease in employee stock-based compensation expense of approximately $195,000,$270,000, a decrease in employee compensation and related costs, other than stock-based compensation expense, of approximately $178,000,$202,000, and a decrease in research and development expenses related to our ovarian cancer CAR-T therapeutic of approximately $64,000, offset by an increase in research and development expenses related to our breast cancer vaccine of approximately $124,000,$252,000, and a decrease in research and development expenses related to our ovarian cancer CAR-T therapeutic of approximately $59,000, offset by an increase in legal and other professional fees of approximately $53,000.

General and administrative expenses decreased by approximately $512,000$482,000 to approximately $3,003,000$4,414,000 in the sixnine months ended AprilJuly 30,31, 2026, from approximately $3,515,000$4,896,000 in the sixnine months ended AprilJuly 30,31, 2025. The decrease in general and administrative expenses was primarily due to a decrease in employee stock-based compensation of approximately $316,000,$443,000, a decrease in director stock-based compensation of approximately $77,000, a decrease in patent-related costs of approximately $59,000, and$68,000, a decrease in director compensation, other than stock-based compensation expense, of approximately $59,000, a decrease in other investor and public relations expenses of approximately $46,000, and a decrease in patent-related costs of approximately $44,000, offset by an increase in investor and public relations expensefirm expenses as a result of changes in firms used during the period of approximately $43,000. $251,000.

Interest income decreased by approximately $121,000$165,000 to approximately $242,000$354,000 in the sixnine months ended AprilJuly 30,31, 2026, from approximately $363,000$519,000 in the sixnine months ended AprilJuly 30,31, 2025, primarily due to a decrease in the amount of short-term investments held and a decrease in interest rates.

The net loss attributable to noncontrolling interest, representing Wistar’s ownership interest in Certainty’s net loss, decreased by approximately $12,000$15,000 to approximately $40,000$59,000 in the sixnine months ended AprilJuly 30,31, 2026 from approximately $52,000$74,000 in the sixnine months ended AprilJuly 30,31, 2025, as Certainty’s net loss decreased.

Based on currently available information as of JuneSeptember 10,9, 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. The Company had approximately $13,686,000$13,864,000 of cash, cash equivalents and short-term investments at AprilJuly 30,31, 2026 compared to approximately $15,174,000 at October 31, 2025 which is a reduction of approximately $1,488,000$1,310,000 for the threenine months ended AprilJuly 30,31, 2026. Therefore, the Company believes that it has sufficient cash, cash equivalents and short-term investments to operate its business, as currently contemplated, for significantly longer than 12 months from the date of this Report. We have implemented a business model that conserves funds by collaborating with third parties to develop our technologies. During the sixnine months ended AprilJuly 30,31, 2026, we raised approximately $2,870,000,$4,806,000, net of expenses, through an at-the-market equity offering of 887,1341,548,324 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 AprilJuly 30,31, 2026, we may sell approximately $97$95 million of common stock.

During the sixnine months ended AprilJuly 30,31, 2026, cash used in operating activities was approximately $4,351,000.$6,121,000. Cash provided by investing activities was approximately $1,650,000,$1,405,000, resulting from the maturities of short-term investments of approximately $26,292,000,$35,823,000, offset by purchases of short-term investments of approximately $24,642,000.$34,418,000. Cash provided by financing activities was approximately $2,934,000,$4,870,000, resulting from the sale of 887,1341,548,324 shares of common stock in an at-the-market equity offering of approximately $2,870,000,$4,806,000, net of expenses, proceeds from stock option exercises of approximately $60,000 and proceeds from the sale of common stock pursuant to an employee stock purchase plan of approximately $4,000. As a result, our cash, cash equivalents, and short-term investments at AprilJuly 30,31, 2026 decreased approximately $1,488,000$1,310,000 to approximately $13,686,000$13,864,000 from approximately $15,174,000 at October 31, 2025.