Business Overview Anixa Biosciences was founded in 2010 and is headquartered in San Jose, California. The company's journey in cancer research and development began with the acquisition of exclusive worldwide rights to certain intellectual property from The Wistar Institute related to chimeric endocrine receptor targeted therapy technology. This acquisition formed the foundation for Anixa's Certainty Therapeutics subsidiary, which focused on developing a novel CAR-T therapy targeting ovarian cancer.
In 2018, Anixa made a strategic move to expand its portfolio by licensing exclusive worldwide rights to breast cancer vaccine technology from the Cleveland Clinic. This marked a significant shift in the company's focus, as it began to explore cancer prevention strategies in addition to treatment options. The collaboration with Cleveland Clinic researchers led to the development of a vaccine designed to prevent triple-negative breast cancer, an aggressive form of the disease.
Throughout its history, Anixa has faced and overcome various challenges in its pursuit of innovative cancer therapies. In 2021, the company experienced delays in initiating its first-in-human clinical trial for its CAR-T therapy due to regulatory approval processes. Additionally, the COVID-19 pandemic posed obstacles in patient enrollment for the early-stage breast cancer vaccine trial. Despite these hurdles, Anixa persevered and received FDA authorization to proceed with its CAR-T trial in 2022, subsequently commencing the dosing of patients.
The company's CAR-T therapy for the treatment of recurrent ovarian cancer, developed in collaboration with the renowned Moffitt Cancer Center, is currently undergoing a Phase 1 clinical trial to evaluate its safety and efficacy. The trial has shown steady progress, with patients receiving escalating doses of the CAR-T cells, and the treatment has been well-tolerated thus far.
In parallel, Anixa is making significant strides in the field of cancer prevention, spearheading the development of a vaccine targeting triple-negative breast cancer (TNBC), the most aggressive and difficult-to-treat form of breast cancer. Partnering with the Cleveland Clinic, the company has initiated a Phase 1 clinical trial to assess the safety and immunogenicity of this innovative vaccine. Early data from the trial has been promising, with patients exhibiting antigen-specific immune responses at all dose levels.
Beyond its lead programs, Anixa is also leveraging its scientific expertise to explore the development of additional cancer vaccines, focusing on high-incidence malignancies such as lung, colon, and prostate cancer. This diversified approach underscores the company's commitment to addressing the unmet needs of patients across a wide range of cancer types.
Financial Snapshot Anixa Biosciences has maintained a strong financial position, with a robust cash and short-term investment balance of $19.92 million as of October 31, 2024. The company's total assets stood at $21.59 million, while its total liabilities, net of minority interest, amounted to $2.70 million, resulting in a healthy current ratio of 9.35.
During the fiscal year ended October 31, 2024, Anixa reported no revenue, as the company's focus has been on advancing its R&D pipeline rather than generating revenue from its legacy patent licensing activities. The company's net loss for the year was $12.70 million, with a net loss per share of $0.39.
Despite the lack of revenue, Anixa has demonstrated a disciplined approach to managing its cash resources. The company reported an operating cash outflow of $7.34 million for the fiscal year, and a free cash flow of negative $7.34 million, indicating that the company is investing heavily in its research and development efforts.
Anixa's financial performance in the most recent quarter, ended January 31, 2025, showed continued focus on its clinical programs. The company reported no revenue and a net loss of $3.18 million, with a net loss per share of $0.10. While the company's cash and short-term investments decreased to $17.25 million during the quarter, Anixa's management has stated that the existing funds are sufficient to support its operations for at least the next 12 months.
Liquidity Anixa Biosciences has maintained a strong liquidity position, as evidenced by its healthy cash and short-term investment balance. The company's current ratio of 9.35 indicates a solid ability to meet its short-term obligations. With $17.25 million in cash and short-term investments as of January 31, 2025, Anixa has sufficient resources to fund its ongoing clinical trials and research activities for the foreseeable future.
The company's debt-to-equity ratio stands at a low 0.013, reflecting minimal leverage and a conservative financial approach. Both the current ratio and quick ratio are identical at 9.35, further underscoring Anixa's strong liquidity position. The company has not disclosed any available credit lines, suggesting that it primarily relies on equity financing and cash reserves to fund its operations.
Competitive Landscape and Risks Anixa Biosciences operates in the highly competitive and rapidly evolving biotechnology industry, where it faces challenges from both established pharmaceutical giants and emerging biotech players. The company's CAR-T therapy and cancer vaccine programs compete with similar efforts by renowned institutions and well-funded competitors, such as Merck, Pfizer, and Moderna.
A key risk factor for Anixa is the inherent uncertainty and challenges associated with the clinical development of novel therapies and vaccines. The company's success largely depends on the positive outcomes of its ongoing and future clinical trials, which can be influenced by a variety of factors, including patient enrollment, safety, and efficacy. Regulatory approvals and commercial adoption of Anixa's products also pose significant risks, as the company navigates the complex and highly regulated healthcare landscape.
Additionally, Anixa's reliance on partnerships and collaborations with research institutions, such as Moffitt Cancer Center and the Cleveland Clinic, introduces potential risks related to the successful execution of these strategic relationships.
Outlook and Potential Catalysts Despite the challenges, Anixa Biosciences remains optimistic about its future prospects. The company's pipeline of innovative cancer therapies and vaccines holds significant promise, with several key milestones on the horizon.
In the coming years, Anixa plans to continue advancing its CAR-T therapy for ovarian cancer, with the goal of identifying the maximum tolerated dose and assessing the therapy's efficacy. The company also aims to initiate a Phase 2 clinical trial of its breast cancer vaccine in the neoadjuvant setting, further exploring the vaccine's potential to prevent the development of TNBC.
Moreover, Anixa's efforts to expand its vaccine pipeline by targeting other high-incidence cancers, such as lung, colon, and prostate cancer, could unlock additional growth opportunities and diversify the company's risk profile.
The successful execution of these clinical milestones, along with potential partnership agreements and regulatory approvals, could serve as significant catalysts for Anixa Biosciences, driving investor interest and positioning the company as a leader in the cancer treatment and prevention landscape.
Segment Performance Anixa Biosciences operates in three reportable business segments: Cancer Vaccines, CAR-T Therapeutics, and Other.
The Cancer Vaccines segment is focused on developing vaccines against breast and ovarian cancer. The company's breast cancer vaccine, initially targeting triple-negative breast cancer (TNBC), has shown promising results in its Phase 1 clinical trial. As of August 2023, Anixa had completed vaccinating all patients in the expanded dose cohorts, and in November 2023, commenced vaccination of participants in additional cohorts at varying dose levels. The company is preparing to initiate a Phase 2 clinical trial of the breast cancer vaccine in the neo-adjuvant setting in 2025.
For ovarian cancer, Anixa holds an exclusive worldwide, royalty-bearing license from Cleveland Clinic to develop a vaccine targeting the anti-Mullerian hormone receptor 2 (AMHR2) protein, which is highly expressed in ovarian cancer.
The CAR-T Therapeutics segment focuses on developing a chimeric endocrine receptor-T cell (CER-T) therapy for ovarian cancer. In August 2022, Anixa's subsidiary, Certainty Therapeutics, began enrolling patients in a Phase 1 clinical trial to evaluate this therapy. As of March 2025, the company has treated patients in the first three dose cohorts, with the treatment being well-tolerated. Anixa is preparing to enroll patients in the fourth dose cohort, where they will administer a 30-times higher dose than the original cohort.
The Other segment represents Anixa's legacy operations, which include limited patent licensing activities. This segment is not expected to be a significant part of the company's ongoing operations or require substantial financial resources.
Geographic Markets Currently, Anixa Biosciences operates exclusively in the United States. The company has not reported any international operations or revenue from foreign markets.
Conclusion Anixa Biosciences is at the forefront of the battle against cancer, leveraging its innovative CAR-T therapy and groundbreaking cancer vaccine programs to transform the treatment and prevention of this devastating disease. With a strong financial foundation, a diversified pipeline, and a talented team of researchers and clinicians, the company is well-positioned to capitalize on the significant opportunities in the oncology market.
As Anixa continues to advance its clinical trials and explore new frontiers in cancer research, investors will closely follow the company's progress, seeking to capitalize on the potential upside of its pioneering efforts. While the road ahead may present challenges, Anixa's commitment to innovation and its unwavering focus on improving patient outcomes make it a compelling investment opportunity in the dynamic and rapidly evolving biotechnology sector.