10-K: Anixa Reports Positive Phase 1 Breast Cancer Vaccine Data

Anixa Biosciences, Inc. reported positive final Phase 1 clinical trial data for its investigational breast cancer vaccine and continued progress in its CAR-T ovarian cancer therapy, despite ongoing net losses and reliance on future funding.

Summary

• Anixa Biosciences is a biotechnology company focused on oncology therapies and vaccines.
• The therapeutics program, lira-cel (CAR-T for ovarian cancer), is in Phase 1 clinical trials, with patients in the fourth dose cohort (30x higher dose) tolerating treatment well.
• Anecdotal signs of efficacy for lira-cel include patients surviving beyond expectations, with one re-dosed patient surviving over two years.
• The breast cancer vaccine Phase 1 trial completed enrollment in June 2025 and all patient clinical visits in October 2025.
• Final Phase 1 breast cancer vaccine data, presented in December 2025, met all primary endpoints, showed immune responses in 74% of subjects, and was safe and well-tolerated at the MTD.
• The ovarian cancer vaccine technology is in preclinical development under the NCI's PREVENT program, requiring no material financial expenditures from Anixa.
• A Joint Development and Option Agreement with Cleveland Clinic was signed in May 2024 to discover additional cancer vaccine targets for lung, colon, and prostate cancers.
• The company reported a net loss of $11.028 million for fiscal year 2025, an improvement from $12.698 million in fiscal year 2024.
• Research and development expenses decreased to $5.071 million in fiscal year 2025 from $6.396 million in fiscal year 2024.
• General and administrative expenses decreased to $6.630 million in fiscal year 2025 from $7.435 million in fiscal year 2024.
• Cash, cash equivalents, and short-term investments totaled $15.174 million as of October 31, 2025.
• The company believes existing funds are sufficient for at least the next twelve months but anticipates needing additional funding.
• An at-the-market equity offering raised $2.378 million (net) in fiscal year 2025, with up to an additional $100 million available.

Sentiment

Score: 7

Explanation: The company reported positive Phase 1 clinical trial results for its breast cancer vaccine, meeting all primary endpoints and demonstrating safety and immune response. The CAR-T ovarian cancer therapy also showed continued progress with patients tolerating higher doses and anecdotal signs of efficacy. Financially, the net loss decreased, and operating expenses were reduced. However, the company remains pre-revenue, has a history of significant losses, and will require substantial future funding, which introduces considerable risk and potential for dilution. The early stage of development for most programs and intense competition are also significant factors.

Positives

• All primary study endpoints were met in the Phase 1 breast cancer vaccine trial.
• Protocol-defined immune responses were observed in 74% of subjects in the Phase 1 breast cancer vaccine trial.
• The breast cancer vaccine was safe and well-tolerated by study participants at the Maximum Tolerated Dose (MTD), with adverse events primarily injection-site irritation.
• Patients in the fourth dose cohort (30-times higher dose) of the lira-cel (CAR-T for ovarian cancer) Phase 1 trial tolerated the treatment well, consistent with lower dose cohorts.
• Multiple patients in the lira-cel trial exhibited anecdotal signs of efficacy, including possible signs of T cell infiltration and tumor necrosis, with many surviving beyond expectations (one patient over two years, three others over one year).
• FDA approved re-dosing for a patient in the lira-cel trial who survived over two years, indicating encouraging initial results.
• The ovarian cancer vaccine development is fully supported by the NCI's PREVENT program, requiring no material financial expenditures from Anixa.
• A Joint Development and Option Agreement with Cleveland Clinic was signed in May 2024 to develop additional cancer vaccines for high-incidence malignancies (lung, colon, prostate), expanding the future pipeline.
• Net loss decreased to $11.028 million in fiscal year 2025 from $12.698 million in fiscal year 2024.
• Research and development expenses decreased by approximately $1.325 million to $5.071 million in fiscal year 2025.
• General and administrative expenses decreased by approximately $805,000 to $6.630 million in fiscal year 2025.

Negatives

• The company has a cumulative accumulated deficit of approximately $251.677 million as of October 31, 2025.
• Incurred a net loss of $11.028 million in fiscal year 2025.
• No revenue has been generated from therapeutics or vaccine programs to date, and none is expected in the near term.
• The company will need additional funding in the future, which may not be available on acceptable terms or at all, potentially leading to dilution for stockholders.
• Existing cash, cash equivalents, and short-term investments of $15.174 million as of October 31, 2025, are believed to be sufficient for only the next twelve months.
• Future equity offerings, including the remaining $100 million under the at-the-market program, will dilute existing stockholders.
• Most drugs fail to reach commercialization, and the novel nature of CAR-T and cancer vaccines presents significant challenges.
• The company is dependent on third parties (e.g., Moffitt, Cleveland Clinic, CROs, CMOs) to conduct its pre-clinical studies and clinical trials, over which it has limited control.
• Faces significant competition from larger and better-funded pharmaceutical and biotechnology companies.
• Vaccine hesitancy, misinformation about vaccine safety, and evolving positions of public health authorities on vaccines could adversely affect the development and commercial success of cancer vaccine product candidates.

Risks

• History of losses and may incur additional losses in the future.
• 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 stockholders.
• May have difficulty in raising capital and may consume resources faster than expected.
• Failure to effectively manage potential growth could place strains on managerial, operational, and financial resources.
• May use financial and human resources to pursue a particular research program or product candidate and fail to capitalize on more profitable opportunities.
• Ability to use net operating loss carryforwards and certain other tax attributes may be limited due to ownership changes.
• Therapeutic and vaccine programs are pre-revenue and subject to the risks of an early-stage biotechnology company.
• Current business model relies on strategic collaborations with commercial partners, and timing or establishment of these partnerships may be difficult.
• Product liability lawsuits could result in substantial liabilities and limit commercialization.
• Never generated revenue from biotechnology and pharmaceutical product sales and products may never be profitable.
• Therapeutics and vaccines being developed are novel and present significant challenges to successfully reaching market.
• While pre-clinical and limited human clinical testing has been positive, unfavorable results may occur with statistically significant data from human clinical trials.
• Dependent on third parties to conduct pre-clinical and clinical trials.
• Difficulties enrolling patients in clinical trials could delay or adversely affect clinical development.
• Significant competition from other biotechnology and pharmaceutical companies.
• Adverse developments in clinical trials conducted by others using similar technologies may negatively affect Anixa's trials or approvals.
• Adverse side effects or other safety risks associated with product candidates could cause suspension/discontinuation of trials or delay/preclude approval.
• Vaccine hesitancy, misinformation about vaccine safety, and evolving positions of public health authorities could adversely affect commercial success of cancer vaccines.
• Clinical trials are expensive, time-consuming, and difficult to design and implement.
• Cell-based therapies rely on the availability of specialty raw materials, which may not be available on acceptable terms or at all.
• May form or seek strategic alliances or additional licensing arrangements in the future, and may not realize the benefits.
• FDA regulatory approval process is lengthy and time-consuming, with potential significant delays.
• Even if regulatory approval is obtained, products may not gain market acceptance.
• Inability to obtain and maintain intellectual property protection will harm competitive position.
• Third parties may initiate legal proceedings alleging infringement of their intellectual property rights.
• Reliance on licenses from Wistar and Cleveland Clinic; loss of these licenses could limit development and commercialization.
• Failure to maintain licenses could have a material adverse effect.
• Efforts to protect proprietary nature of technologies may be inadequate.
• Limited foreign intellectual property rights and may not be able to protect IP rights throughout the world.
• Issuance or sale of shares in the future to raise money or for strategic purposes could reduce market price and dilute stockholders.
• Actual or anticipated sales of shares by stockholders may cause trading price to decline.
• Failure to meet market expectations due to fluctuations in quarterly operating results could cause stock price to decline.
• Biotechnology company stock prices are especially volatile.
• If common stock is delisted from NASDAQ, it will become subject to SEC's penny stock rules, making shares more difficult to sell.
• Issued a significant number of securities pursuant to incentive plans, which may dilute stockholders and result in downward pressure on stock price.
• As a smaller reporting company, reduced reporting requirements may make common stock less attractive to investors.
• Do not anticipate declaring any cash dividends, which may adversely impact stock price.

Future Outlook

The company expects the development of its therapeutics and vaccines to be the primary focus over the next several quarters. It does not anticipate generating revenue from these programs in the near term, aiming instead to eventually license its technologies to large pharmaceutical companies. A Phase 2 clinical trial for the breast cancer vaccine is being prepared, and the CAR-T ovarian cancer therapy study is estimated to be completed in two to three years. The new vaccine discovery program for lung, colon, and prostate cancers is in early stages. The company believes existing funds are sufficient for at least the next twelve months but may seek additional capital in fiscal year 2026 or thereafter.

Management Comments

• "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 therapeutics or vaccines."
• "While the results to date have been positive, there are many uncertainties in drug development, and most drugs fail to reach commercialization." (Regarding lira-cel and breast cancer vaccine)
• "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."

Industry Context

The biopharmaceutical industry is highly competitive and innovative, with Anixa facing larger, better-funded competitors. Anixa's CAR-T therapy for ovarian cancer targets solid tumors, an area where CAR-T has seen limited success compared to B cell cancers, positioning it as a novel approach. The development of preventative and therapeutic cancer vaccines is also a challenging field with few market successes. Anixa's strategy leverages recent advancements in immunotherapy and targets large unmet medical needs in high-incidence cancers like breast, ovarian, lung, colon, and prostate, where prophylactic vaccines could address a market significantly larger than therapeutics.

Comparison to Industry Standards

• CAR-T therapeutics have demonstrated positive results in B cell cancers, but Anixa's focus on ovarian cancer (a solid tumor) addresses an area where very little progress has been made by others, indicating a novel and challenging approach.
• The collaboration with Moffitt Cancer Center for lira-cel trials is with "one of the top cancer centers in the country with pre-clinical and clinical expertise with CAR-T technology" that has "conducted many of the highest profile CAR-T trials in the world," suggesting a high standard of clinical execution.
• The breast cancer vaccine's mechanism, targeting alpha-lactalbumin, is supported by animal studies published in "Nature Medicine" (July 2016) showing complete prevention in mice, providing a strong scientific foundation comparable to leading research.
• The ovarian cancer vaccine's mechanism, targeting AMHR2-ED, is supported by animal studies published in "Cancer Prevention Research" (November 2017) showing efficacy, also indicating a strong scientific foundation.
• Acceptance of the ovarian cancer vaccine technology into the NCI's PREVENT program signifies external validation and support from a leading national cancer research institution, which is a positive benchmark for preclinical development.

Corporate Governance

Legal Proceedings

• Other than lawsuits brought to enforce patent rights, the company is not a party to any material pending legal proceedings, nor is it aware of any pending litigation or legal proceeding against it that would have a material adverse effect on its financial position or results of operations.

Related Party Transactions

• The Wistar Institute holds an equity stake of 4.1% in Certainty Therapeutics, Inc., a subsidiary of Anixa, as of October 31, 2025, due to a license agreement and subject to dilution by company funding.

Stakeholder Impact

• Shareholders face potential dilution from future equity raises and stock price volatility due to clinical trial results and market expectations, with no anticipated cash dividends.
• Employees (four full-time as of October 31, 2025) are impacted by stock option compensation as a significant part of R&D and G&A expenses.
• Future customers could benefit from novel cancer treatments and preventative vaccines if products reach commercialization.
• Suppliers and partners, such as Moffitt and Cleveland Clinic, are critical for R&D and manufacturing, with potential for new strategic alliances.
• Creditors are exposed to the company's accumulated deficit and reliance on future funding, which could influence creditworthiness.

Next Steps

• Initiate a Phase 2 clinical trial for the breast cancer vaccine in the neo-adjuvant setting (pre-surgery) to determine possible therapeutic effect, following FDA consultations, protocol development, manufacturing, and clinical site selection.
• Continue the dose-escalation Phase 1 clinical trial for lira-cel (CAR-T for ovarian cancer) to determine the maximum tolerated dose, assess persistence, expansion, and efficacy of modified T cells.
• Follow consenting participants in the breast cancer vaccine Phase 1 study for five years after completing the study.
• Conduct further studies to evaluate the ability of lira-cel to disrupt the vasculature of other cancers after analyzing data from ovarian cancer clinical trials.
• Continue pre-clinical research and development, manufacturing, and IND-enabling studies for the ovarian cancer vaccine technology under the NCI's PREVENT program.
• Work with Cleveland Clinic researchers to discover additional retired proteins for new vaccine targets in lung, colon, and prostate cancers.
• Seek additional working capital in fiscal year 2026 or thereafter through sales of equity securities or through bank credit facilities or public or private debt.
• Eventually license technologies to large pharmaceutical companies for manufacturing, marketing, and sales.

Key Dates

Recommendation

Anixa Biosciences shows promising early-stage clinical data for its breast cancer vaccine and CAR-T ovarian cancer therapy, which are significant positive developments for a biotechnology company. The reduction in net loss and operating expenses is also a favorable financial trend. However, the company remains pre-revenue with a substantial accumulated deficit and a limited cash runway, necessitating future capital raises that will likely result in further shareholder dilution. The inherent risks of drug development, intense competition, and the early stage of most programs (including the new vaccine discovery efforts) mean that significant uncertainties remain before commercialization and profitability can be achieved. A "Hold" recommendation reflects the balance between the encouraging clinical progress and the substantial financial and developmental risks. Investors should monitor future clinical trial results, funding activities, and progress towards commercial partnerships closely.

Keywords

Oncology, Biotechnology, Cancer vaccine, CAR-T therapy, Breast cancer, Ovarian cancer, Liraltagene autoleucel, Triple-negative breast cancer, Clinical trials, Phase 1, Drug development, Immunotherapy, Financial results, Capital raise, Stock dilution, Wistar Institute, Cleveland Clinic, Moffitt Cancer Center, NCI PREVENT program, Lung cancer, Colon cancer, Prostate cancer