
Anixa Biosciences (NASDAQ:ANIX) held its 2026 Annual Meeting of Stockholders via live webcast, outlining the results of shareholder votes and providing an operational update focused on the company’s clinical-stage oncology pipeline and partnership-driven strategy.
Annual meeting votes and quorum
President, COO, CFO, and Secretary Mike Catelani opened the formal business portion of the meeting, noting that the record date was Jan. 13, 2026. The company reported 33,379,505 shares of common stock outstanding and entitled to vote.
Stockholders voted on three proposals, and management reported preliminary results as follows:
- Election of directors: Dr. Amit Kumar, Dr. Arnold Baskies, Emily Gottschalk, and Lewis Titterton were elected.
- Advisory vote on executive compensation (“say-on-pay”): Approved by a majority of votes cast.
- Auditor ratification: The appointment of Haskell & White LLP as auditors for fiscal year 2026 was ratified by a majority of votes cast.
Strategy: low cash burn and partnership-based R&D
In his presentation, CEO and Chairman Dr. Amit Kumar emphasized what he described as a “unique” approach compared with traditional biotech companies. He said the company aims to maintain a low cash burn to reduce shareholder dilution and to keep a “clean capital structure.” Kumar stated that Anixa has only common stock outstanding with no preferred stock and no warrants.
Kumar said the company relies on partnerships for research and development rather than building internal laboratory infrastructure and large headcount. He noted that Anixa’s headcount is four employees. He added that the partnership model supports diversification across technologies and is intended to lead to partnerships for commercialization rather than building manufacturing and distribution capabilities internally.
As of the quarter ending Jan. 21, 2026, Kumar said the company had $14 million in cash, which he described as more than two years of cash at its anticipated burn rate, along with roughly 33 million common shares outstanding and no debt.
CAR-T program in recurrent ovarian cancer: safety and early survival signals
Kumar’s update highlighted Anixa’s CAR-T clinical program in recurrent ovarian cancer. He said the therapy is designed for solid tumors and described three differentiating attributes: targeting a protein unique to the ovaries, a proposed dual mechanism that includes an anti-angiogenic effect, and delivery of engineered T cells directly into the peritoneum to avoid side effects associated with intravenous administration.
The company’s trial is a dose-escalation study in recurrent ovarian cancer patients who have had multiple prior treatments and have limited options. Kumar said Anixa treated patients in the third and fourth dose cohorts in 2020–2025 and has continued to observe positive safety and tolerability at all doses tested to date. He also said the therapy has received a generic name—liraltagene autoleucel (referred to as lira-cel).
In discussing efficacy, Kumar presented what he described as strong clinical signals in overall survival. He said that in the first four cohorts (12 patients), nine patients (75%) lived longer than their median life expectancy line for the population shown. He also cited one patient who survived 28 months versus an expected survival of about 12 weeks. Kumar cautioned that patients have not been “curatively treated” and that those who died ultimately died from cancer progression.
Looking ahead, Kumar said Anixa is beginning the fifth cohort, which will include dosing at 10^7 cells per kilogram and will introduce lymphodepletion, a technique intended to suppress native immune cells and potentially improve CAR-T cell grafting and proliferation. He said the company recently received approval to go to higher doses, including dose levels he said are higher than for any approved CAR-T.
For 2026, Kumar said the company plans to continue dose escalation at least through cohorts five and six, evaluate whether lymphodepletion provides benefit, monitor survival outcomes, present results at scientific conferences, and continue patent prosecution in the U.S. and internationally. He also said the company plans to begin “in earnest” discussions with pharmaceutical companies about commercialization of the ovarian cancer CAR-T program.
Breast cancer vaccine: Phase I completed and Phase II planning underway
Kumar also reviewed Anixa’s breast cancer vaccine program, describing it as using a molecular mechanism that “has never been utilized before.” He said the vaccine is designed for use in neoadjuvant and adjuvant settings and is intended to help prevent recurrence. He also outlined a longer-term goal of potential prophylactic (“primary prevention”) use. The regimen consists of three shots administered every two weeks, with an initial focus on triple-negative breast cancer.
In 2025, Kumar said the company completed its Phase I trial at Cleveland Clinic and presented results at the San Antonio Breast Cancer Symposium in December. He said the trial was funded by the Department of Defense, that a preliminary FDA report has been submitted with a more detailed report in preparation, and that the IND has been transferred from Cleveland Clinic to Anixa to support Phase II planning.
Kumar said Phase I enrolled 35 patients across three cohorts: 26 patients who had completed triple-negative breast cancer treatment and were concerned about recurrence; four patients with genetic mutations undergoing prophylactic mastectomy who were vaccinated before surgery; and five patients with residual disease receiving KEYTRUDA, where the trial evaluated whether adding the vaccine increased adverse effects. He said the company verified that the vaccine did not meaningfully worsen the side-effect profile in combination with KEYTRUDA.
Management said Phase I reached a maximum tolerated dose and reported no safety concerns, with side effects including mild transient fevers and injection-site irritation. Kumar said about three-fourths of participants showed strong immune responses based on the company’s criteria, with other responses described as more modest.
For Phase II, Kumar said Anixa anticipates a neoadjuvant design comparing standard of care versus standard of care plus the vaccine, with the aim of evaluating synergy alongside KEYTRUDA. He said 2026 goals include manufacturing additional vaccine supply with more extensive quality control, FDA interactions to guide Phase II design, selecting multiple clinical sites beyond Cleveland Clinic, publishing and presenting data, and continuing grant and intellectual property efforts.
Q&A: trial participation, enrollment, and endpoints
During the Q&A, Catelani said the company frequently receives questions about how patients can participate in the upcoming Phase II breast cancer vaccine study. Kumar said the trial will have multiple U.S. clinical sites in different regions, with press announcements as sites are added, and he anticipated “anywhere from 15–20 sites.”
On the ovarian cancer CAR-T trial, Kumar said he did not anticipate enrollment challenges at higher doses despite the addition of lymphodepletion, citing the advanced disease stage of patients entering the study. He said the company does not yet have enough patients to make conclusive statements on dose-dependent response, though he expects higher dosing to drive stronger tumor attack.
Asked what efficacy signals would guide advancement, Kumar emphasized overall survival as the primary endpoint, noting that while the company evaluates scans and laboratory analyses, extending life and improving quality of life is the key measure. He also addressed a question on higher dosing versus more frequent dosing, noting the FDA has allowed second dosing in certain cases and that a second dose was given to the patient who survived 28 months; however, Kumar said the company believes higher dosing could be preferable to frequent dosing for patients and the healthcare system.
About Anixa Biosciences (NASDAQ:ANIX)
Anixa Biosciences is a clinical-stage immuno-oncology and infectious disease company developing novel cell-based immunotherapies and vaccine platforms. Through its Anixa Therapeutics division, the company is advancing antibody and T-cell modalities, including an ovarian cancer immunotherapy candidate and a COVID-19 vaccine leveraging a proprietary virus-like particle (VLP) technology. Its research pipeline emphasizes modular vaccine design and personalized cancer cell therapy aimed at inducing durable immune responses against solid tumors.
In parallel, Anixa Diagnostics is developing the ADAPT diagnostic platform, a high-throughput proteomics approach using engineered peptides derived from spider venom.
