10-Q: Anixa Biosciences Reports Reduced Net Loss Amidst Advancing Clinical Pipeline, Faces Increased Cash Burn

Anixa Biosciences, a biotechnology company focused on oncology therapies and vaccines, reported a reduced net loss for the six months ended April 30, 2025, while continuing to advance its CAR-T and breast cancer vaccine clinical programs, despite an increase in cash used in operating activities and a decline in total current assets.

Summary

• Anixa Biosciences is a biotechnology company developing therapies and vaccines for critical unmet needs in oncology, including CAR-T cell therapy for ovarian cancer and vaccines for breast and ovarian cancer.
• The company reported a net loss of $6.026 million for the six months ended April 30, 2025, an improvement from a net loss of $6.470 million for the same period in 2024.
• Research and development expenses decreased to $2.874 million for the six months ended April 30, 2025, from $2.995 million in the prior year period.
• General and administrative expenses decreased to $3.515 million for the six months ended April 30, 2025, from $4.081 million in the prior year period.
• Cash and cash equivalents, and short-term investments totaled $15.597 million as of April 30, 2025, a reduction of $4.327 million from $19.924 million at October 31, 2024.
• Cash used in operating activities increased to $4.407 million for the six months ended April 30, 2025, compared to $3.765 million for the same period in 2024.
• The company has not generated any revenue from its therapeutics or vaccine programs to date and does not expect to in the near term.
• In the CAR-T program for ovarian cancer, the Phase 1 trial has treated patients in three dose cohorts, with the third cohort receiving a ten-times higher dose, and all treatments appear well-tolerated.
• Anecdotal signs of efficacy were observed in two of six patients in the first two CAR-T cohorts, with one patient re-dosed after FDA approval and remaining alive two years post-initial treatment.
• The breast cancer vaccine Phase 1 trial has shown antigen-specific immune responses at all dose levels and in all three patient groups (Phase 1a, 1b, 1c), with no severe adverse effects beyond injection site irritation.
• The ovarian cancer vaccine technology was accepted into the NCI's PREVENT program, which is fully funding its pre-clinical development, manufacturing, and IND enabling studies.
• Anixa entered a Joint Development and Option Agreement with Cleveland Clinic in May 2024 to discover additional vaccine targets for lung, colon, and prostate cancers.
• As of May 28, 2025, the company had 32,211,092 shares of common stock outstanding.
• Management believes existing cash, cash equivalents, and short-term investments are sufficient to fund activities for significantly longer than 12 months from May 28, 2025.

Sentiment

Score: 6

Explanation: The sentiment is moderately positive due to significant clinical progress in multiple oncology programs, including promising early efficacy signals and well-tolerated treatments. Strategic collaborations and non-dilutive funding for the ovarian cancer vaccine are strong positives. However, this is tempered by a deteriorating liquidity position, increased cash burn from operations, and continued reliance on future capital raises and licensing for revenue, which are inherent risks for a pre-revenue biotech.

Positives

• Net loss decreased to $6.026 million for the six months ended April 30, 2025, from $6.470 million in the prior year, indicating improved financial performance on the income statement.
• Research and development expenses decreased by $0.121 million for the six months ended April 30, 2025, reflecting cost management.
• General and administrative expenses decreased by $0.566 million for the six months ended April 30, 2025, primarily due to reduced investor relations, director stock-based compensation, and consulting fees.
• The CAR-T Phase 1 clinical trial for ovarian cancer is progressing through dose escalation, with the third dose cohort (10x higher) treated and appearing well-tolerated.
• Anecdotal signs of efficacy, including possible tumor necrosis, were observed in two patients in the CAR-T trial, with one patient still alive two years post-initial treatment and successfully re-dosed.
• The breast cancer vaccine Phase 1 trial demonstrated antigen-specific immune responses across all dose levels and patient groups (Phase 1a, 1b, 1c), with no additional or more severe adverse effects when combined with Keytruda.
• The ovarian cancer vaccine technology is being fully funded for pre-clinical development, manufacturing, and IND enabling studies by the NCI's PREVENT program, significantly reducing Anixa's financial burden.
• A new vaccine discovery program for high incidence malignancies (lung, colon, prostate) has commenced through a joint development agreement with Cleveland Clinic, expanding the company's pipeline.

Negatives

• The company continues to operate at a net loss, reporting $6.026 million for the six months ended April 30, 2025, and has not generated any revenue from its core therapeutic or vaccine programs.
• Cash and cash equivalents, and short-term investments decreased by $4.327 million, from $19.924 million at October 31, 2024, to $15.597 million at April 30, 2025.
• Total current assets decreased by $4.596 million, from $21.362 million at October 31, 2024, to $16.766 million at April 30, 2025.
• Cash used in operating activities increased to $4.407 million for the six months ended April 30, 2025, compared to $3.765 million for the same period in 2024, indicating a higher operational cash burn.
• Cash provided by financing activities significantly decreased to $1,000 for the six months ended April 30, 2025, compared to $3.160 million for the same period in 2024, reflecting less capital raised through equity offerings and option exercises.
• Total equity decreased by $3.982 million, from $18.888 million at October 31, 2024, to $14.906 million at April 30, 2025.
• Interest income decreased by $0.243 million for the six months ended April 30, 2025, primarily due to lower short-term investments and interest rates.

Risks

• The company has not generated any revenue from its vaccine or therapeutics programs to date and does not expect to begin generating revenue in the near term, relying on future licensing agreements which may take several years and depend on positive clinical trial results.
• The eventual licensing of technologies to large pharmaceutical companies may not occur, or may take several years, impacting the company's ability to achieve profitability.
• The completion of the CAR-T Phase 1 study is estimated to take two to three years, dependent on factors such as reaching the maximum tolerated dose, patient enrollment rates, and efficacy data, introducing uncertainty in timelines.
• The company's net operating loss carryforwards could be subject to limitations under Internal Revenue Code section 382, which could affect future tax liabilities.

Future Outlook

Anixa Biosciences expects the development of its therapeutics and vaccines to be the primary focus over the next several quarters. The company does not anticipate generating revenue from its current vaccine or therapy programs in the near term, hoping to achieve profitability through eventual licensing to large pharmaceutical companies, which may take several years and depend on positive clinical trial results. Management believes existing cash, cash equivalents, and short-term investments are sufficient to fund activities for significantly longer than 12 months from May 28, 2025. The company is preparing to initiate a Phase 2 clinical trial for its breast cancer vaccine in the neo-adjuvant setting following final Phase 1 data release, FDA consultations, protocol development, and clinical site selection. The CAR-T Phase 1 study is estimated to be completed in two to three years.

Management Comments

• "Based on currently available information as of May 28, 2025, 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."
• "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."
• "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."
• "The treatment at this dose level [CAR-T second dose cohort] has also been well-tolerated by the patients."
• "Consistent with the lower dose cohorts, the treatment [CAR-T third dose cohort] appears to have been well-tolerated by the patients."
• "The Phase 1 findings to date [breast cancer vaccine] are promising, and as we continue the final stages of 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."

Industry Context

Anixa Biosciences operates within the highly competitive and capital-intensive biotechnology sector, specifically focusing on oncology therapeutics and vaccines. Its strategy of collaborating with academic and research institutions like The Wistar Institute, Moffitt Cancer Center, and Cleveland Clinic, along with leveraging government funding (e.g., DoD grant for breast cancer vaccine, NCI's PREVENT program for ovarian cancer vaccine), is a common approach for smaller biotech firms to conserve capital and de-risk early-stage development. The focus on CAR-T technology and cancer vaccines aligns with major trends in oncology, which are shifting towards targeted immunotherapies and preventative strategies. The company's pre-revenue status and reliance on future licensing deals are typical for early-stage biotechs, highlighting the long development cycles and high investment required before commercialization.

Legal Proceedings

• 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 upon its results of operations or financial condition, other than lawsuits related to the enforcement of its patent rights.

Related Party Transactions

• The Wistar Institute holds a 4.2% equity stake in Certainty Therapeutics, Inc., a subsidiary of Anixa Biosciences, as of April 30, 2025, which is subject to dilution by further funding from Anixa.

Stakeholder Impact

• **Shareholders**: Experience continued dilution risk from the at-the-market equity program and potential future capital raises. The value of their investment is highly dependent on successful clinical trial outcomes and future licensing deals. The decrease in total equity impacts shareholder value.
• **Employees**: Stock-based compensation remains a significant component of compensation, aligning employee incentives with company performance. Continued R&D activities provide job stability in the short term.
• **Customers (Future)**: Potential for new oncology therapies and vaccines could offer significant health benefits to patients with ovarian cancer, triple-negative breast cancer, and other high-incidence malignancies.
• **Creditors**: The company's liquidity position, while sufficient for over 12 months, has decreased, which could be a consideration for future credit assessments.
• **Research Partners (Wistar, Moffitt, Cleveland Clinic, NCI)**: Continued collaboration and funding from Anixa and government programs support ongoing research and development efforts, fostering scientific advancement.

Next Steps

• Enroll patients in the fourth dose cohort of the CAR-T Phase 1 clinical trial for ovarian cancer, administering a 30-times higher dose than the original cohort.
• Continue treatment and monitoring for the breast cancer vaccine Phase 1 trial participants over the next three to four months.
• Anticipate reporting final Phase 1 data for the breast cancer vaccine at the San Antonio Breast Cancer Symposium in December 2025.
• Initiate a Phase 2 clinical trial for the breast cancer vaccine in the neo-adjuvant setting (pre-surgery) following final Phase 1 data release, FDA consultations, protocol development, and clinical site selection.
• Continue pre-clinical research and development, manufacturing, and IND enabling studies for the ovarian cancer vaccine technology under the NCI's PREVENT program.
• Continue efforts to discover additional retired proteins for new cancer vaccines (lung, colon, prostate) under the Joint Development and Option Agreement with Cleveland Clinic.

Key Dates

Recommendation

Keywords

Biotechnology, Oncology, Cancer Therapy, Cancer Vaccine, CAR-T, Chimeric Endocrine Receptor-T Cell Therapy, Ovarian Cancer, Triple Negative Breast Cancer, TNBC, Clinical Trials, Phase 1, Drug Development, Immunotherapy, SEC Filing, 10-Q, Financial Report, Biopharma