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What changed in Anixa Biosciences Inc's 10-K — 2023 vs 2024

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Paragraph-level year-over-year comparison of Anixa Biosciences Inc's 2023 and 2024 10-K annual filings, covering the Business, Risk Factors, Legal Proceedings, Cybersecurity, MD&A and Market Risk sections. Every new, removed and edited paragraph is highlighted side-by-side so you can see exactly what management changed in the 2024 report.

+208 added−185 removedSource: 10-K (2024-10-31) vs 10-K (2024-01-16)

Top changes in Anixa Biosciences Inc's 2024 10-K

208 paragraphs added · 185 removed · 155 edited across 7 sections

Item 1. Business

Business — how the company describes what it does

58 edited+26 added−21 removed23 unchanged
Biggest changeIt has been estimated that in 2023, 20,000 new cases of ovarian cancer would be diagnosed and 13,000 American women would die from this disease. Despite continuous advances made in the field of cancer research every year, we believe there remains a significant unmet medical need, as the overall five-year relative survival rate for ovarian cancer patients is 50%.
Biggest changeDespite continuous advances made in the field of cancer research every year, there remains a significant unmet medical need, as the overall five-year relative survival rate for ovarian cancer patients is 51%, but ranges from 42% among Black women to 61% among Asian American/Pacific Islander women. 6 The market for prophylactic cancer vaccines is sizable—bigger in fact than the market for any type of cancer therapeutic.
Item 1. Business. Overview Anixa Biosciences, Inc. is a biotechnology company developing vaccines and therapies that are focused on critical unmet needs in oncology.
Item 1. Business Overview Anixa Biosciences, Inc. is a biotechnology company developing therapies and vaccines that are focused on critical unmet needs in oncology.
We may have difficulty in timing the establishment of these partnerships to achieve the greatest economic benefit for the Company, or in establishing these partnerships at all. ● If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit commercialization of our product candidates. ● We have never generated any revenue from biotechnology and pharmaceutical product sales and our biotechnology and pharmaceutical products may never be profitable. ● The therapeutics and vaccines that we are developing are novel and present significant challenges to successfully reaching market. ● While pre-clinical testing and the limited human clinical testing of our product candidates has been positive, we may experience unfavorable results once we collect statistically significant data from human clinical trials. ● We are dependent on third parties to conduct our pre-clinical and clinical trials. ● If we encounter difficulties enrolling patients in our clinical trials, our clinical development activities could be delayed or otherwise adversely affected. ● We face significant competition from other biotechnology and pharmaceutical companies, and our operating results will suffer if we fail to compete effectively.
We may have difficulty in timing the establishment of these partnerships to achieve the greatest economic benefit for the Company, or in establishing these partnerships at all. ● If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit commercialization of our product candidates. ● We have never generated any revenue from biotechnology and pharmaceutical product sales and our biotechnology and pharmaceutical products may never be profitable. ● The therapeutics and vaccines that we are developing are novel and present significant challenges to successfully reaching market. 8 ● While pre-clinical testing and the limited human clinical testing of our product candidates has been positive, we may experience unfavorable results once we collect statistically significant data from human clinical trials. ● We are dependent on third parties to conduct our pre-clinical and clinical trials. ● If we encounter difficulties enrolling patients in our clinical trials, our clinical development activities could be delayed or otherwise adversely affected. ● We face significant competition from other biotechnology and pharmaceutical companies, and our operating results will suffer if we fail to compete effectively.
The license agreement requires us to make certain cash payments to Cleveland Clinic upon achievement of specific development milestones. Utilizing this technology, we are working in collaboration with Cleveland Clinic to develop a method to vaccinate women against contracting breast cancer, focused initially on TNBC.
The license agreement requires us to make certain cash payments to Cleveland Clinic upon achievement of specific development milestones. Utilizing this technology, we are working in collaboration with Cleveland Clinic to develop a method to vaccinate women against breast cancer, focused initially on TNBC.
The FSH-Receptor has been shown to be a very exclusive protein found on a large percentage of ovarian cancer cells, but not on a significant number of non-ovarian healthy tissues in adult females. Studies have shown that the FSH-Receptor is also expressed in endothelial cells of the vasculature of neoplasias.
The FSH-Receptor has been shown to be a very exclusive protein found on a large percentage of ovarian cancer cells, but not on a significant number of non-ovarian healthy tissues in adult females. 4 Studies have shown that the FSH-Receptor is also expressed in endothelial cells of the vasculature of neoplasias.
We anticipate performing further studies to evaluate the ability of our CAR-T to disrupt the vasculature of other cancers, after we have analyzed data from clinical trials of this technology against ovarian cancer. 6 We have been working with researchers at Moffitt to develop our CAR-T therapy.
We anticipate performing further studies to evaluate the ability of our CAR-T to disrupt the vasculature of other cancers, after we have analyzed data from clinical trials of this technology against ovarian cancer. We have been working with researchers at Moffitt to develop our CAR-T therapy.
In October 2021, following the U.S. Food and Drug Administration’s (“FDA”) authorization to proceed, we commenced dosing patients in a Phase 1 clinical trial of our breast cancer vaccine. This study, which is being funded by a U.S.
In October 2021, following the U.S. Food and Drug Administration’s (“FDA”) authorization to proceed, we commenced dosing patients in a Phase 1 clinical trial of our breast cancer vaccine. This study, which is being fully funded by a U.S.
Once these aberrant cells gain critical mass, they become cancer. Despite the lack of success with cancer vaccines, recently gained knowledge about the human immune system has led to the development, approval and commercialization of revolutionary immuno-therapy drugs.
Once these aberrant cells gain critical mass, they become cancer. 5 Despite the lack of success with cancer vaccines, recently gained knowledge about the human immune system has led to the development, approval and commercialization of revolutionary immuno-therapy drugs.
The study is being conducted at Moffitt and will consist of 24 to 48 patients who have received at least two prior lines of chemotherapy.
The study is being conducted at Moffitt and will consist of up to 24 to 48 patients who have received at least two prior lines of chemotherapy.
This study is a dose-escalation trial with two arms based on delivery method—intraperitoneal or intravenous—to determine the maximum tolerated dose in patients with recurrent epithelial ovarian cancer and to assess persistence, expansion and efficacy of the modified T cells.
This study is a dose-escalation trial with two arms based on route of delivery—intraperitoneal or intravenous—to determine the maximum tolerated dose in patients with recurrent epithelial ovarian cancer and to assess persistence, expansion and efficacy of the modified T cells.
The Ovarian Cancer Market According to American Cancer Society statistics, ovarian cancer accounts for just 2% of all female cancer cases, but nearly 5% of cancer deaths in women due to the disease’s low survival rate.
The Ovarian Cancer Market According to American Cancer Society statistics, in the U.S., ovarian cancer accounts for just 2% of all female cancer cases, but nearly 5% of cancer deaths in women due to the disease’s low survival rate.
Alternatively, you may also access our reports at the SEC’s website at www.sec.gov . 9
Alternatively, you may also access our reports at the SEC’s website at www.sec.gov .
The first segment of the study, Phase 1a, will consist of 18 to 24 patients who have completed treatment for early-stage, triple-negative breast cancer within the past three years and are currently tumor-free but at high risk for recurrence.
The first segment of the study, Phase 1a, will consist of approximately 24 patients who have completed treatment for early-stage, triple-negative breast cancer within the past three years and are currently tumor-free but at high risk for recurrence.
With respect to Certainty’s equity obligations to Wistar, Certainty issued to Wistar shares of its common stock equal to five percent (5%) of the common stock of Certainty, such equity stake subject to dilution by further funding of Certainty’s activities by the Company. Due to such Company funding, Wistar’s equity stake in Certainty was 4.6% as of October 31, 2023.
With respect to Certainty’s equity obligations to Wistar, Certainty issued to Wistar shares of its common stock equal to five percent (5%) of the common stock of Certainty, such equity stake subject to dilution by further funding of Certainty’s activities by the Company. Due to such Company funding, Wistar’s equity stake in Certainty was 4.4% as of October 31, 2024.
Further, we have commenced vaccination of participants in the second segment of the trial, Phase 1b, that includes participants who have never had cancer, but carry certain genetic mutations such as BRCA1, BRCA2 or PALB2, that indicate a greater risk of developing TNBC in the future, and have elected to have a prophylactic mastectomy.
Further, in November 2023, we commenced vaccination of participants in the second segment of the trial, Phase 1b, that includes participants who have never had cancer, but carry certain mutations in genes such as BRCA1, BRCA2 or PALB2, that indicate a greater risk of developing TNBC in the future, and have elected to have a prophylactic mastectomy.
The focus of this vaccine is a specific protein, α-lactalbumin, that is only expressed during lactation in a healthy mother’s mammary tissue. This protein disappears when the mother is no longer lactating, but reappears in many forms of breast cancer, especially TNBC. Studies have shown that vaccinating against this protein prevents breast cancer in mice.
The focus of this vaccine is a specific protein, α-lactalbumin, that is only expressed during lactation in a healthy woman’s mammary tissue. This protein disappears when the woman is no longer lactating, but reappears in many forms of breast cancer, especially TNBC. Studies have shown that vaccinating against this protein prevents breast cancer in mice.
Despite continuous advances made in the field of cancer research every year, invasive female breast cancer incidence rates have been increasing by approximately 0.5% per year over the past 15 years. The market for prophylactic cancer vaccines is sizable—bigger in fact than the market for any type of cancer therapeutic.
Despite continuous advances made in the field of cancer research every year, invasive female breast cancer incidence rates have been increasing by approximately 0.6% per year over the past 20 years. The market for prophylactic cancer vaccines is sizable—bigger in fact than the market for any type of cancer therapeutic.
While in the U.S., 20,000 women were estimated to be diagnosed with ovarian cancer in 2023, there are approximately 41 million women age 60 and over—the time in life when women face an increased risk of developing ovarian cancer. Worldwide, the number is dramatically larger.
While in the U.S., approximately 20,000 women were estimated to be diagnosed with ovarian cancer in 2024, there are approximately 42 million women age 60 and over—the time in life when women face an increased risk of developing ovarian cancer. Worldwide, the number is dramatically larger.
While in the U.S., 301,000 women were estimated to be diagnosed with breast cancer in 2023, there are approximately 82 million women age 40 and over—the time in life when women face an increased risk of developing breast cancer. Worldwide, the number is dramatically larger.
While in the U.S., approximately 314,000 women were estimated to be diagnosed with breast cancer in 2024, there are approximately 84 million women age 40 and over—the time in life when women face an increased risk of developing breast cancer. Worldwide, the number is dramatically larger.
Certainty holds an exclusive worldwide, royalty-bearing license to use certain intellectual property owned or controlled by The Wistar Institute (“Wistar”), the nation’s first independent biomedical research institute and a leading NCI designated cancer research center, relating to Wistar’s chimeric endocrine receptor targeted therapy technology.
Our subsidiary, Certainty, is developing immuno-therapy drugs against cancer. Certainty holds an exclusive worldwide, royalty-bearing license to use certain intellectual property owned or controlled by The Wistar Institute (“Wistar”), the nation’s first independent biomedical research institute and a leading NCI designated cancer research center, relating to Wistar’s chimeric endocrine receptor targeted therapy technology.
The Breast Cancer Market According to American Cancer Society statistics, breast cancer accounts for over 30% of all female cancer cases, and 15% of cancer deaths in women. It has been estimated that in 2023, 301,000 new cases of breast cancer would be diagnosed in the U.S. and 43,000 women would die from this disease.
The Breast Cancer Market According to American Cancer Society statistics, in the U.S., breast cancer accounts for over 30% of all female cancer cases, and 15% of cancer deaths in women. It has been estimated that in 2024, approximately 314,000 new cases of breast cancer would be diagnosed in the U.S. and approximately 42,000 women would die from this disease.
This protein is only expressed during lactation in healthy women, but may also be expressed in individuals with certain breast cancers, most notably TNBC, the most lethal form of breast cancer. Further, we have licensed certain technology from Cleveland Clinic to develop vaccines for the treatment or prevention of ovarian cancers which express AMHR2-ED.
Cancer vaccines We licensed certain technology from Cleveland Clinic to develop vaccines for the treatment or prevention of TNBC and other breast cancers which express the α-lactalbumin protein. This protein is only expressed during lactation in healthy women, but may also be expressed in individuals with certain breast cancers, most notably TNBC, the most lethal form of breast cancer.
After all, doctors administer cancer drugs only after a patient has been diagnosed, while a prophylactic vaccine may be administered to all people who have a possibility of developing the disease.
Cancer therapies are only administered after a patient has been diagnosed, while a prophylactic vaccine may be administered to all people who have a possibility of developing the disease.
Finally, we are currently enrolling participants in the third segment of the trial, Phase 1c, that includes post-operative TNBC patients that have residual disease following neoadjuvant chemo-immunotherapy and are currently undergoing treatment with pembrolizumab (Keytruda®).
Finally, in January 2024, we commenced vaccination of participants in the third segment of the trial, Phase 1c, that includes post-operative TNBC patients that have residual disease following treatment and are currently undergoing treatment with pembrolizumab (Keytruda®).
Further, in May 2023 and August 2023, we treated the second and third patients in the trial, respectively, at the same dose level as the first patient, and the treatment appears to have been well-tolerated by all patients treated to date.
Further, in May 2023 and August 2023, we treated the second and third patients in the trial, respectively, at the same dose level as the first patient, and the treatment was well-tolerated by the patients.
In October 2021, Cleveland Clinic began treating patients in a Phase 1 clinical trial of our breast cancer vaccine. In addition, we and our partners at Cleveland Clinic continue working with the NCI who are or will be performing pre-clinical research and development, manufacturing and IND-enabling studies to advance our ovarian cancer vaccine technology toward human clinical testing.
In addition, we and our partners at Cleveland Clinic continue working with the NCI who are or will be performing pre-clinical research and development, manufacturing and IND-enabling studies to advance our ovarian cancer vaccine technology toward human clinical testing.
In November 2020, we executed a license agreement with Cleveland Clinic pursuant to which the Company was granted an exclusive worldwide, royalty-bearing license to use certain intellectual property owned or controlled by Cleveland Clinic relating to certain ovarian cancer vaccine technology. The license agreement requires us to make certain cash payments to Cleveland Clinic upon achievement of specific development milestones.
We hold an exclusive worldwide, royalty-bearing license to use certain intellectual property owned or controlled by Cleveland Clinic relating to certain ovarian cancer vaccine technology. The license agreement requires us to make certain cash payments to Cleveland Clinic upon achievement of specific development milestones.
In May 2021, Cleveland Clinic was granted acceptance for our ovarian cancer vaccine technology into the National Cancer Institute’s (“NCI”) PREVENT program. The NCI is a part of the National Institutes of Health (“NIH”).
Researchers at Cleveland Clinic believe that a vaccine targeting AMHR2-ED could prevent the occurrence of ovarian cancer. 3 In May 2021, Cleveland Clinic was granted acceptance for our ovarian cancer vaccine technology into the National Cancer Institute’s (“NCI”) PREVENT program. The NCI is a part of the National Institutes of Health (“NIH”).
The data presented show that in the vaccinated women who had been tested to date, various levels of antigen-specific T cell responses were observed at all dose levels.
In December 2023, we presented the immunological data collected to date at the San Antonio Breast Cancer Symposium. The data presented show that in the vaccinated women who had been tested to date, various levels of antigen-specific T cell responses were observed at all dose levels.
Our therapeutics programs include (i) the development of a chimeric endocrine receptor T cell therapy, a novel form of chimeric antigen receptor T cell (“CAR-T”) technology, initially focused on treating ovarian cancer, which is being developed at our subsidiary, Certainty Therapeutics, Inc.
Our therapeutics programs include (i) the development of a chimeric endocrine receptor-T cell therapy, a novel form of chimeric antigen receptor-T cell (“CAR-T”) technology, initially focused on treating ovarian cancer, which is being developed at our subsidiary, Certainty Therapeutics, Inc. (“Certainty”), and (ii) until March 2023, the development of anti-viral drug candidates for the treatment of COVID-19.
While expression of AMHR2-ED naturally and markedly declines during menopause, this protein is expressed at high levels in the ovaries of postmenopausal women with ovarian cancer. Researchers at Cleveland Clinic believe that a vaccine targeting AMHR2-ED could prevent the occurrence of ovarian cancer.
While expression of AMHR2-ED naturally and markedly declines during menopause, this protein is expressed at high levels in the ovaries of postmenopausal women with ovarian cancer.
Our competitors also may obtain FDA or other regulatory approvals for their products more rapidly than we may obtain approvals for ours, which could result in our competitors establishing a strong market position before we are able to enter the market.
Our competitors also may obtain FDA or other regulatory approvals for their products more rapidly than we may obtain approvals for ours, which could result in our competitors establishing a strong market position before we are able to enter the market. Employees As of October 31, 2024, we had five full-time employees working for our Company and subsidiaries.
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.
In the future, we hope to achieve a profitable outcome by eventually licensing our technology to a large pharmaceutical company that has the resources and infrastructure in place to manufacture, market and sell our technology as a cancer treatment.
We anticipate that we will face intense and increasing competition as new drugs and vaccines enter the market and advanced technologies become available. We expect any vaccines that we develop and commercialize to compete on the basis of, among other things, efficacy, safety, convenience of administration and delivery, price and the availability of reimbursement from government and other third-party payers.
We expect any therapies and vaccines that we develop and commercialize to compete on the basis of, among other things, efficacy, safety, convenience of administration and delivery, price and the availability of reimbursement from government and other third-party payers.
In addition, while we pursue our vaccine and therapeutics 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 vaccine or therapy programs in the near term.
We have not generated any revenue to date from our vaccine or therapeutics programs. In addition, while we pursue our vaccine and therapeutics programs, we may also make investments in and form new companies to develop additional emerging technologies.
This protein regulates growth and development of egg-containing follicles in the ovary and its expression naturally and markedly declines after menopause. However, AMHR2-ED is expressed at high levels in the ovaries of postmenopausal women with ovarian cancer. Typically, vaccines harness the immune system to protect people from infectious diseases.
Further, we have licensed certain technology from Cleveland Clinic to develop vaccines for the treatment or prevention of ovarian cancers which express AMHR2-ED. This protein regulates growth and development of egg-containing follicles in the ovary and its expression naturally and markedly declines after menopause. However, AMHR2-ED is expressed at high levels in the ovaries of postmenopausal women with ovarian cancer.
While we believe that our proprietary FSH-Receptor targeted immuno-therapy platform for treating solid tumors and scientific expertise in the field of cell therapy provide us with competitive advantages, we face potential competition from various sources, including larger and better-funded pharmaceutical and biotechnology companies, as well as from academic institutions, governmental agencies and public and private research institutions. 7 Many of our competitors, either alone or with their strategic partners, have substantially greater financial, technical and human resources than we do and significantly greater experience in the discovery and development of product candidates, obtaining FDA and other regulatory approvals of treatments and commercializing those treatments.
While we believe that our proprietary FSH-Receptor targeted immuno-therapy platform for treating solid tumors, our proprietary cancer vaccine technologies and our scientific expertise in the field of cell therapy provide us with competitive advantages, we face potential competition from various sources, including larger and better-funded pharmaceutical and biotechnology companies, as well as from academic institutions, governmental agencies and public and private research institutions.
The scientific and financial resources of the PREVENT program are being used for our ovarian cancer vaccine technology to perform virtually all pre-clinical research and development, manufacturing and Investigational New Drug (“IND”) application enabling studies.
The PREVENT program is a peer-reviewed agent development program designed to support pre-clinical development of innovative interventions and biomarkers for cancer prevention and interception towards clinical trials. The scientific and financial resources of the PREVENT program are being used for our ovarian cancer vaccine technology to perform virtually all pre-clinical research and development, manufacturing and IND enabling studies.
This work is being performed at NCI facilities, by NCI scientific staff and with NCI financial resources and will require no material financial expenditures by the Company, nor the transfer of any rights of the Company’s assets. 2 Our subsidiary, Certainty, is developing immuno-therapy drugs against cancer.
This work is being performed at NCI facilities, by NCI scientific staff and with NCI financial resources and will require no material financial expenditures by the Company, nor the payment of any future consideration by the Company to NCI.
Moffitt is one of the top cancer centers in the country with pre-clinical and clinical expertise with CAR-T technology. Moffitt has conducted many of the highest profile CAR-T trials in the world. We performed numerous studies in preparation for human clinical studies.
Moffitt is one of the top cancer centers in the country with pre-clinical and clinical expertise with CAR-T technology. Moffitt has conducted many of the highest profile CAR-T trials in the world. In August 2022, Moffitt began treating patients in a Phase 1 clinical trial of our CAR-T therapy.
Risks Relating to Our Financial Condition and Operations ● We have a history of losses and may incur additional losses in the future. ● We will 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 our stockholders. ● We may have difficulty in raising capital and may consume resources faster than expected. 8 Risks Related to our Research & Development, Clinical and Commercialization Activities ● Our therapeutic and vaccine programs are pre-revenue, and subject to the risks of an early-stage biotechnology company. ● Our current business model relies on strategic collaborations with commercial partners to provide the resources and infrastructure to manufacture and ultimately market and/or sell our technologies.
Risks Relating to Our Financial Condition and Operations ● We have a history of losses and may incur additional losses in the future. ● We will 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 our stockholders. ● We may have difficulty in raising capital and may consume resources faster than expected.
Summary Risk Factors The risk factors described below are a summary of the principal risk factors associated with an investment in us. These are not the only risks we face.
In addition, we work with research teams at Moffitt and Cleveland Clinic, as well as their and our subcontractors, to develop each of our projects. Summary Risk Factors The risk factors described below are a summary of the principal risk factors associated with an investment in us. These are not the only risks we face.
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. 3 Breast and Ovarian Cancer vaccines We licensed certain technology from Cleveland Clinic to develop vaccines for the treatment or prevention of TNBC and other breast cancers which express the α-lactalbumin protein.
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 Market We believe that our CAR-T technology may be used as an effective treatment against multiple solid tumor types, however, we have initially focused on ovarian cancer. According to American Cancer Society statistics, ovarian cancer accounts for just 2% of all female cancer cases, but nearly 5% of cancer deaths in women due to the disease’s low survival rate.
The Market We believe that our CAR-T technology may be used as an effective treatment against multiple solid tumor types, however, we have initially focused on ovarian cancer.
Accordingly, our competitors may be more successful than us in obtaining approval for vaccines and achieving widespread market acceptance. Our competitors’ vaccines may be more effective, or more effectively marketed and sold, than any vaccine we may commercialize and may render our vaccines obsolete or non-competitive before we can recover the expenses of developing and commercializing any of our vaccines.
Our competitors’ therapies and vaccines may be more effective, or more effectively marketed and sold, than any therapy or vaccine we may commercialize and may render our therapies and vaccines obsolete or non-competitive before we can recover the expenses of developing and commercializing any of our therapies and vaccines. 7 Mergers and acquisitions in the biotechnology and pharmaceutical industries may result in even more resources being concentrated among a smaller number of our competitors.
It has been estimated that in 2023, approximately 20,000 new cases of ovarian cancer would be diagnosed and 13,000 American women would die from this disease. Despite continuous advances made in the field of cancer research every year, there remains a significant unmet medical need, as the overall five-year relative survival rate for ovarian cancer patients is 50%.
Despite continuous advances made in the field of cancer research every year, there remains a significant unmet medical need, as the overall five-year relative survival rate for ovarian cancer patients is 51%, but ranges from 42% among Black women to 61% among Asian American/Pacific Islander women.
As part of our legacy operations, the Company remains engaged in limited patent licensing activities of its various patent portfolios. 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 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. Over the past several years, our revenue was derived from technology licensing and the sale of patented technologies, including revenue from the settlement of litigation.
The study is estimated to be completed in two to four years depending on multiple factors including when maximum tolerated dose is reached, the rate of patient enrollment, and how long we maintain the two different delivery methods.
The study is estimated to be completed in two to three years depending on multiple factors including when the maximum tolerated dose is reached, the rate of patient enrollment, the significance of efficacy data and how long we maintain the two different delivery methods. 2 We hold an exclusive worldwide, royalty-bearing license to use certain intellectual property owned or controlled by The Cleveland Clinic Foundation (“Cleveland Clinic”) relating to certain breast cancer vaccine technology developed at Cleveland Clinic.
Studies show that 42% of TNBC patients will have a recurrence of their cancer, with most of the recurrences occurring in the first two to three years after standard of care treatment. During the course of the Phase 1a study, participants will receive three vaccinations, each two weeks apart, and will be closely monitored for side effects and immune response.
During the course of the Phase 1 study, participants will receive three vaccinations, each two weeks apart, and will be closely monitored for side effects and immune response.
While we believe that our proprietary breast and ovarian cancer vaccine technologies and scientific expertise in the field of cell therapy provide us with competitive advantages, we face potential competition from various sources, including larger and better-funded pharmaceutical and biotechnology companies, as well as from academic institutions, governmental agencies and public and private research institutions. 5 Many of our competitors, either alone or with their strategic partners, have substantially greater financial, technical and human resources than we do and significantly greater experience in the discovery and development of product candidates, obtaining FDA and other regulatory approvals of vaccines and commercializing those vaccines.
Many of our competitors, either alone or with their strategic partners, have substantially greater financial, technical and human resources than we do and significantly greater experience in the discovery and development of product candidates, obtaining FDA and other regulatory approvals of therapies and vaccines and commercializing those therapies and vaccines.
We continue to prosecute our U.S. patent applications of this technology and may decide to restart development at some time in the future. Over the next several quarters, we expect the development of our vaccines and therapeutics to be the primary focus of the Company.
Over the next several quarters, we expect the development of our therapeutics and vaccines to be the primary focus of the Company. As part of our legacy operations, the Company remains engaged in limited patent licensing activities of its various patent portfolios.
Our vaccine programs include (i) the development of a preventative vaccine against triple negative breast cancer (“TNBC”), the most lethal form of breast cancer, as well other forms of breast cancer and (ii) the development of a preventative vaccine against ovarian cancer.
Our vaccine programs include (i) the development of a vaccine against breast cancer, initially focused on triple negative breast cancer (“TNBC”), the most lethal form of breast cancer, (ii) the development of a vaccine against ovarian cancer, and (iii) a vaccine discovery program utilizing the same mechanism as our breast and ovarian cancer vaccines, to develop additional cancer vaccines to address many intractable cancers, including high incidence malignancies in lung, colon and prostate.
In January 2023, the number of participants in each dose cohort was expanded, and as of August 2023, we had completed vaccinating all patients in these expanded cohorts. In December 2023, we presented the immunological data collected to date at the San Antonio Breast Cancer Symposium.
Studies show that 42% of TNBC patients will have a recurrence of their cancer, with most of the recurrences occurring in the first two to three years after standard of care treatment. In January 2023, the number of participants in each dose cohort was expanded, and as of August 2023, we had completed vaccinating all patients in these expanded cohorts.
However, ovarian cancer survival varies substantially by age, with the overall five-year survival rate for women 65 and older of only 32%. Competition The biopharmaceutical industry is characterized by intense and dynamic competition to develop new technologies and proprietary therapies.
The 5-year relative survival rate is nearly 100% for men diagnosed with localized- or regional-stage prostate cancer, but drops to 34% for those diagnosed with distant-stage disease. Competition The biopharmaceutical industry is characterized by intense and dynamic competition to develop new technologies and proprietary therapies.
Accordingly, our competitors may be more successful than us in obtaining approval for treatments and achieving widespread market acceptance. Our competitors’ treatments may be more effective, or more effectively marketed and sold, than any treatment we may commercialize and may render our treatments obsolete or non-competitive before we can recover the expenses of developing and commercializing any of our treatments.
Accordingly, our competitors may be more successful than us in obtaining approval for therapies and vaccines and achieving widespread market acceptance.
We anticipate that we will face intense and increasing competition as new drugs enter the market and advanced technologies become available. We expect any treatments that we develop and commercialize to compete on the basis of, among other things, efficacy, safety, convenience of administration and delivery, price and the availability of reimbursement from government and other third-party payers.
We anticipate that we will face intense and increasing competition as new drugs and vaccines enter the market and advanced technologies become available.
Data on this technology, including animal studies showing efficacy, was published in November 2017 in the journal, Cancer Prevention Research. 4 While the data thus far for both of our cancer vaccines has been positive, there are many uncertainties in drug development, and most drugs fail to reach commercialization.
While the results to date have been positive, there are many uncertainties in drug development, and most drugs fail to reach commercialization.
While these results are positive, there are many uncertainties in drug development, and most drugs fail to reach commercialization. In the future, we hope to achieve a profitable outcome by eventually licensing our technology to a large pharmaceutical company that has the resources and infrastructure in place to manufacture, market and sell our technology as a cancer treatment.
While the results to date have been positive, there are many uncertainties in drug development, and most drugs fail to reach commercialization.
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(“Certainty”), and (ii) until March 2023, the development of anti-viral drug candidates for the treatment of COVID-19 focused on inhibiting certain protein functions of the virus. We hold an exclusive worldwide, royalty-bearing license to use certain intellectual property owned or controlled by The Cleveland Clinic Foundation (“Cleveland Clinic”) relating to certain breast cancer vaccine technology developed at Cleveland Clinic.
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In February 2024, May 2024 and June 2024, we treated the three patients, respectively, of the second dose cohort, where the patients were administered a three-times higher dose of cells than the patients in the first cohort. The treatment at this dose level has also been well-tolerated by the patients.
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We have begun vaccinating participants in up to three additional dose cohorts at dose levels higher than the currently determined MTD and lower than the highest dose where we observed dose limiting toxicity.
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While the dose levels in the first two cohorts were expected to be sub-therapeutic, two of the six patients exhibited some anecdotal signs of efficacy. Both have shown possible signs of tumor necrosis, and one is 20 months past initial treatment.
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The PREVENT program is a peer-reviewed agent development program designed to support pre-clinical development of innovative interventions and biomarkers for cancer prevention and interception towards clinical trials.
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In the case of this patient, due to the encouraging results with her initial treatment, we sought single patient Investigational New Drug (“IND”) application permission from the FDA to re-dose her. This re-dosing was approved by the FDA, and we administered her second treatment in October 2024. This second treatment appears to have been well-tolerated by the patient.
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We anticipate that we will begin enrolling the successive patient cohort, that we expect to give a three-times higher dose of cells, in the first calendar quarter of 2024.
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In November 2024, we treated the first patient in the third dose cohort, where patients are administered a ten-times higher dose of cells than the patients in the first dose cohort. As of January 10, 2025, we have treated two patients in this dose cohort and the treatment at this dose level appears to be well-tolerated by the patients.
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In April 2020, we entered into a collaboration with OntoChem GmbH (“OntoChem”) which was later assigned to MolGenie GmbH, a company spun-out from OntoChem focused on drug discovery and development, to discover and ultimately develop anti-viral drug candidates against COVID-19.
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We anticipate completing treatment of patients in the third dose cohort in February 2025, and commencing treatment of the fourth dose cohort—at a three-times higher dose than the third dose cohort—shortly thereafter.
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Through this collaboration, we identified compounds that appeared to be effective in disrupting the main protease of SARS-CoV-2, the virus that causes the disease COVID-19. While our compounds have shown promise as an effective treatment, results of animal studies indicate that there is not sufficient oral bioavailability, and it is unclear whether an orally delivered treatment may be developed.
Added
Subsequently, we began vaccinating participants in additional dose cohorts at varying dose levels of the different key components of the vaccine.
Removed
We do not currently believe that there is a viable market for an injectable treatment given the current oral treatments available. Furthermore, we believe the needed additional investment in research for alternative delivery methods would divert resources from more promising projects. Therefore, in March 2023, we decided to pause further development of our COVID-19 therapeutic.
Added
In November 2024, we presented the most recent data from each of the three arms of the trial at the Society for Immunotherapy of Cancer (SITC) Annual Meeting.
Removed
Over the past several years, our revenue was derived from technology licensing and the sale of patented technologies, including revenue from the settlement of litigation (during the year ended October 31, 2023, we derived approximately $210,000 of revenue from these activities). We have not generated any revenue to date from our vaccine or therapeutics programs.
Added
Key findings presented include i) patients exhibited antigen-specific immune responses at all dose levels and in all three patient groups (Phase 1a, 1b and 1c), ii) patients receiving our vaccine in combination with Keytruda are not showing any additional or more severe adverse side effects, and iii) no adverse side effects were seen other than varying degrees of injection site irritation.
Removed
However, ovarian cancer survival varies substantially by age, with the overall five-year survival rate for women 65 and older of only 32%. The market for prophylactic cancer vaccines is sizable—bigger in fact than the market for any type of cancer therapeutic.
Added
These findings are promising, and as we continue 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. We anticipate commencing the Phase 2 trial in 2025.
Removed
Competition The biopharmaceutical industry is characterized by intense and dynamic competition to develop new technologies and proprietary therapies. Any product candidates that we successfully develop and commercialize will have to compete with existing therapies and new therapies that may become available in the future.
Added
In May 2024, based on the positive clinical results to date in the development of our breast cancer vaccine, we entered into a Joint Development and Option Agreement with Cleveland Clinic to collaborate in efforts to develop additional vaccines for the prevention or treatment of cancers.
Removed
Mergers and acquisitions in the biotechnology and pharmaceutical industries may result in even more resources being concentrated among a smaller number of our competitors.
Added
Working with Cleveland Clinic researchers, we are focusing on the same novel scientific mechanism as in our breast and ovarian cancer vaccines, and working to discover additional retired proteins that may be associated with other forms of cancer, specifically high incidence malignancies in the lung, colon and prostate.

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Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

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Biggest changeDelays 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 therapy and our breast cancer vaccine. 17 Any adverse developments that occur during any clinical trials conducted by academic investigators, our collaborators or other entities conducting clinical trials under independent IND applications may negatively affect the conduct of our clinical trials or our ability to obtain regulatory approvals or commercialize our product candidates.
Biggest changeAny adverse developments that occur during any clinical trials conducted by academic investigators, our collaborators or other entities conducting clinical trials under independent IND applications may negatively affect the conduct of our clinical trials or our ability to obtain regulatory approvals or commercialize our product candidates.
We believe that various factors may cause the market price of our common stock to fluctuate, perhaps substantially, including, among others, the following: ● announcements of developments in the fields of CAR-T therapeutics or cancer vaccines; ● developments in relationships with third party vendors and laboratories; ● developments or disputes concerning our patents and other intellectual property; ● our or our competitors’ technological innovations; ● variations in our quarterly operating results; ● our failure to meet or exceed securities analysts’ expectations of our financial results; ● a change in financial estimates or securities analysts’ recommendations; ● changes in management’s or securities analysts’ estimates of our financial performance; ● announcements by us or our competitors of significant contracts, acquisitions, strategic partnerships, joint ventures, capital commitments, new technologies, or patents; and ● the timing of or our failure to complete significant transactions.
We believe that various factors may cause the market price of our common stock to fluctuate, perhaps substantially, including, among others, the following: ● announcements of developments in the fields of CAR-T therapeutics or cancer vaccines; ● developments in relationships with third party vendors and laboratories; ● developments or disputes concerning our patents and other intellectual property; ● our or our competitors’ technological innovations; ● variations in our quarterly operating results; 24 ● our failure to meet or exceed securities analysts’ expectations of our financial results; ● a change in financial estimates or securities analysts’ recommendations; ● changes in management’s or securities analysts’ estimates of our financial performance; ● announcements by us or our competitors of significant contracts, acquisitions, strategic partnerships, joint ventures, capital commitments, new technologies, or patents; and ● the timing of or our failure to complete significant transactions.
Moreover, disputes may arise with respect to any one of our licensing agreements, including: ● the scope of rights granted under the license agreement and other interpretation-related issues; ● the extent to which our product candidates, technology and processes infringe on intellectual property of the licensor that is not subject to the licensing agreement; ● the sublicensing of patent and other rights under the licensing agreement and our collaborative development relationships; ● our diligence obligations under the license agreement and what activities satisfy those diligence obligations; ● the inventorship and ownership of inventions and know-how resulting from the joint creation or use of intellectual property by our licensors and us and our partners; and ● the priority of invention of patented technology.
Moreover, disputes may arise with respect to any one of our licensing agreements, including: ● the scope of rights granted under the license agreement and other interpretation-related issues; 20 ● the extent to which our product candidates, technology and processes infringe on intellectual property of the licensor that is not subject to the licensing agreement; ● the sublicensing of patent and other rights under the licensing agreement and our collaborative development relationships; ● our diligence obligations under the license agreement and what activities satisfy those diligence obligations; ● the inventorship and ownership of inventions and know-how resulting from the joint creation or use of intellectual property by our licensors and us and our partners; and ● the priority of invention of patented technology.
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. 18 In one of our breast cancer vaccine clinical trials, we will treat healthy women who, as a result of testing positive for certain gene mutations, have elected to have prophylactic mastectomies.
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 one of our breast cancer vaccine clinical trials, we will treat healthy women who, as a result of testing positive for certain gene mutations, have elected to have prophylactic mastectomies.
We may also experience delays in completing planned clinical trials for a variety of reasons, including delays related to: ● the availability of financial resources to commence and complete our planned clinical trials; ● reaching agreement on acceptable terms with prospective clinical trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different clinical trial sites; ● recruiting suitable patients to participate in a clinical trial; ● having patients complete a clinical trial or return for post-treatment follow-up; ● clinical trial sites deviating from clinical trial protocol, failing to follow cGCPs, or dropping out of a clinical trial; ● adding new clinical trial sites; or ● manufacturing sufficient quantities of qualified materials under cGMPs and applying them on a subject-by-subject basis for use in clinical trials. 20 Also, before a clinical trial can begin at an NIH-funded institution, that institution’s independent institutional review board, or IRB, and its Institutional Biosafety Committee must review the proposed clinical trial to assess the safety of the trial.
We may also experience delays in completing planned clinical trials for a variety of reasons, including delays related to: ● the availability of financial resources to commence and complete our planned clinical trials; ● reaching agreement on acceptable terms with prospective clinical trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different clinical trial sites; ● recruiting suitable patients to participate in a clinical trial; ● having patients complete a clinical trial or return for post-treatment follow-up; ● clinical trial sites deviating from clinical trial protocol, failing to follow cGCPs, or dropping out of a clinical trial; ● adding new clinical trial sites; or ● manufacturing sufficient quantities of qualified materials under cGMPs and applying them on a subject-by-subject basis for use in clinical trials. 18 Also, before a clinical trial can begin at an NIH-funded institution, that institution’s independent institutional review board, or IRB, and its Institutional Biosafety Committee must review the proposed clinical trial to assess the safety of the trial.
In addition, there is a natural transition period when a new third party commences work. As a result, delays occur, which can materially impact our ability to meet our desired clinical development timelines. 16 If we encounter difficulties enrolling patients in our clinical trials, our clinical development activities could be delayed or otherwise adversely affected.
In addition, there is a natural transition period when a new third party commences work. As a result, delays occur, which can materially impact our ability to meet our desired clinical development timelines. If we encounter difficulties enrolling patients in our clinical trials, our clinical development activities could be delayed or otherwise adversely affected.
As our discovery 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.
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.
Accordingly, it will be difficult for us to time the establishment of a strategic partnership to achieve the greatest economic benefit for the Company. 12 If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit commercialization of our product candidates.
Accordingly, it will be difficult for us to time the establishment of a strategic partnership to achieve the greatest economic benefit for the Company. If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit commercialization of our product candidates.
The existence of the SEC’s rules may result in a lower trading volume of our common stock and lower trading prices. 28 We have issued a significant number of securities pursuant to our incentive plans and may continue to do so in the future.
The existence of the SEC’s rules may result in a lower trading volume of our common stock and lower trading prices. We have issued a significant number of securities pursuant to our incentive plans and may continue to do so in the future.
We may not be able to obtain necessary licenses to patents or patent applications, and our business may suffer if we are unable to enter into the necessary licenses on acceptable terms or at all, if any necessary licenses are subsequently terminated, if the licensors fail to abide by the terms of the licenses or fail to prevent infringement by third parties, or if the licensed patents or other rights are found to be invalid or unenforceable. 13 Biotechnology and pharmaceutical product development is a highly speculative undertaking and involves a substantial degree of uncertainty.
We may not be able to obtain necessary licenses to patents or patent applications, and our business may suffer if we are unable to enter into the necessary licenses on acceptable terms or at all, if any necessary licenses are subsequently terminated, if the licensors fail to abide by the terms of the licenses or fail to prevent infringement by third parties, or if the licensed patents or other rights are found to be invalid or unenforceable. 12 Biotechnology and pharmaceutical product development is a highly speculative undertaking and involves a substantial degree of uncertainty.
Our CAR-T ovarian cancer therapeutic and our breast and ovarian cancer vaccines are in their early stages of development, and we still must establish and implement many important functions necessary to commercialize the technologies.
Our CAR-T ovarian cancer therapeutic and our cancer vaccines are in their early stages of development, and we still must establish and implement many important functions necessary to commercialize the technologies.
Accordingly, our efforts to enforce our intellectual property rights around the world may be inadequate to obtain a significant commercial advantage from the intellectual property that we develop or license. 26 Risks Related to Our Common Stock The issuance or sale of shares in the future to raise money or for strategic purposes could reduce the market price of our common stock.
Accordingly, our efforts to enforce our intellectual property rights around the world may be inadequate to obtain a significant commercial advantage from the intellectual property that we develop or license. 23 Risks Related to Our Common Stock The issuance or sale of shares in the future to raise money or for strategic purposes could reduce the market price of our common stock.
Even if our products achieve market acceptance, we may not be able to maintain that market acceptance over time if new products or technologies are introduced that are more favorably received than our products, are more cost effective or render our products obsolete. 21 Risks Related to Our Intellectual Property If we are unable to obtain and maintain intellectual property protection, our competitive position will be harmed.
Even if our products achieve market acceptance, we may not be able to maintain that market acceptance over time if new products or technologies are introduced that are more favorably received than our products, are more cost effective or render our products obsolete. 19 Risks Related to Our Intellectual Property If we are unable to obtain and maintain intellectual property protection, our competitive position will be harmed.
A loss of patent rights could have a material adverse impact on our business. 25 Changes in U.S. patent law could diminish the value of patents in general, thereby impairing our ability to protect our products. As is the case with other biopharmaceutical companies, our success is heavily dependent on intellectual property, particularly patents.
A loss of patent rights could have a material adverse impact on our business. 22 Changes in U.S. patent law could diminish the value of patents in general, thereby impairing our ability to protect our products. As is the case with other biopharmaceutical companies, our success is heavily dependent on intellectual property, particularly patents.
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 would significantly harm the business and development of operations. We may have difficulty in raising capital and may consume resources faster than expected.
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 may have difficulty in raising capital and may consume resources faster than expected.
Further, as of the date of this Report, our Board of Directors and Compensation Committee have the authority to issue awards totaling an additional 665,000 shares of our common stock which is replenished on a yearly basis in accordance with the provisions of our plan.
Further, as of the date of this Report, our Board of Directors and Compensation Committee have the authority to issue awards totaling an additional 645,000 shares of our common stock which is replenished on a yearly basis in accordance with the provisions of our plan.
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 therapy and Cleveland Clinic for our breast and ovarian cancer vaccines to conduct our pre-clinical studies and clinical trials under agreements with us.
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 therapy and Cleveland Clinic for our cancer vaccines to conduct our pre-clinical studies and clinical trials under agreements with us.
Once these aberrant cells gain critical mass, they become cancer. 14 CAR-T cell therapies are novel and present significant challenges. CAR-T product candidates represent a relatively new field of cellular immunotherapy.
Once these aberrant cells gain critical mass, they become cancer. 13 CAR-T cell therapies are novel and present significant challenges. CAR-T product candidates represent a relatively new field of cellular immunotherapy.
Our reported revenues and operating results have fluctuated in the past and may continue to fluctuate significantly from quarter to quarter in the future, specifically as we continue to devote our resources towards our CAR-T cancer therapeutics and our breast and ovarian cancer vaccines.
Our reported revenues and operating results have fluctuated in the past and may continue to fluctuate significantly from quarter to quarter in the future, specifically as we continue to devote our resources towards our CAR-T cancer therapeutics and our cancer vaccines.
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 therapy is based on relatively new technology and engineered on a patient-by-patient basis, we expect that it will require extensive research and development and have substantial manufacturing and processing costs.
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 therapy 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.
Such noncompliance events are outside of our direct control for (1) non-U.S. patents and patent applications owned by us, and (2) patents and patent applications licensed to us by another entity. In such an event, our competitors might be able to enter the market, which would have a material adverse effect on our business.
Such noncompliance events are outside of our direct control for i) non-U.S. patents and patent applications owned by us, and ii) patents and patent applications licensed to us by another entity. In such an event, our competitors might be able to enter the market, which would have a material adverse effect on our business.
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, to pay for the development of our breast cancer vaccine, to pay for the development of our ovarian cancer vaccine and for acquisitions of companies.
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, to pay for the development of our cancer vaccines and for acquisitions of companies.
If current cash on hand, cash equivalents and short-term investments are insufficient to continue to operate our business, or if we elect to invest in or acquire a company or companies that are synergistic with or complementary to our technologies, we may be required to obtain more working capital.
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.
Our current policy is to retain all funds and any earnings for use in the operation and expansion of our business. If we do not pay dividends, our stock may be less valuable to you because a return on your investment will only occur if our stock price appreciates.
Our current policy is to retain all funds and any earnings for use in the operation and expansion of our business. If we do not pay dividends, our stock may be less valuable to you because a return on your investment will only occur if our stock price appreciates. Item 1B. Unresolved Staff Comments None.
We have an at-the-market equity offering under which, as of January 16, 2024 we may issue up to approximately $98 million of common stock, which is currently effective, and which may remain available to us in the future. We also have, and in the future may, issue securities convertible into our common stock.
We have an at-the-market equity offering under which, as of January 10, 2025 we may issue up to approximately $97 million of common stock, which is currently effective, and which may remain available to us in the future. We also have, and in the future may, issue securities convertible into our common stock.
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, 2023, the Company had approximately $23,844,000 in cash, cash equivalents and short-term investments.
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, the Company had approximately $19,924,000 in cash, cash equivalents and short-term investments.
To the extent that the results of our clinical trials are not satisfactory to the FDA or foreign regulatory authorities for support of a marketing application, approval of our product candidates may be significantly delayed, or we may be required to expend significant additional resources, which may not be available to us, to conduct additional clinical trials in support of potential approval of our product candidates.
To the extent that the results of our clinical trials are not satisfactory to the FDA or foreign regulatory authorities for support of a marketing application, approval of our product candidates may be significantly delayed, or we may be required to expend significant additional resources, which may not be available to us, to conduct additional clinical trials in support of potential approval of our product candidates. 14 We are dependent on third parties to conduct our pre-clinical studies and clinical trials.
Our business strategy and potential growth may place a strain on managerial, operational and financial resources and systems. Although we may not grow as we expect, if we fail to manage our growth effectively or to develop and expand our managerial, operational and financial resources and systems, our business and financial results will be materially harmed.
Although we may not grow as we expect, if we fail to manage our growth effectively or to develop and expand our managerial, operational and financial resources and systems, our business and financial results will be materially harmed.
If we do not accurately evaluate the commercial potential or target market for a particular product candidate, we may relinquish valuable rights to that product candidate through strategic collaboration, licensing or other royalty arrangements in cases in which it would have been more advantageous for us to retain sole development and commercialization rights to such product candidate, or we may allocate internal resources to a product candidate which it would have been more advantageous to enter into a partnering arrangement.
If we do not accurately evaluate the commercial potential or target market for a particular product candidate, we may relinquish valuable rights to that product candidate through strategic collaboration, licensing or other royalty arrangements in cases in which it would have been more advantageous for us to retain sole development and commercialization rights to such product candidate, or we may allocate internal resources to a product candidate which it would have been more advantageous to enter into a partnering arrangement. 10 Our ability to use our net operating loss carryforwards and certain other tax attributes may be limited.
We will 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 our stockholders.
As a result, we anticipate that we will incur losses in the future. 9 We will 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 our stockholders.
We may seek to obtain working capital through sales of our equity securities, including through our current at-the-market offering program, 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.
We may seek to obtain working capital during our fiscal year 2025 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.
The following are among the factors that could cause our operating results to fluctuate significantly from period to period: ● patient enrollment rates for our clinical trials; ● delays with respect to our clinical trials; ● clinical trial results relating to our CAR-T cancer therapeutics; ● clinical trial results relating to our breast cancer vaccine; ● results of pre-clinical studies relating to our ovarian cancer vaccine; ● progress with regulatory authorities towards the certification/approval of our CAR-T cancer therapeutics, our breast cancer vaccine or our ovarian cancer vaccine; and ● costs related to acquisitions, alliances and licenses. 27 Biotechnology company stock prices are especially volatile, and this volatility may depress the price of our common stock.
The following are among the factors that could cause our operating results to fluctuate significantly from period to period: ● patient enrollment rates for our clinical trials; ● delays with respect to our clinical trials; ● clinical trial results relating to our CAR-T cancer therapeutics; ● clinical trial results relating to our breast cancer vaccine; ● results of pre-clinical studies relating to our ovarian cancer vaccine; ● results of our new vaccine discovery efforts; ● progress with regulatory authorities towards the certification/approval of our CAR-T cancer therapeutics, our breast cancer vaccine or our ovarian cancer vaccine; and ● costs related to acquisitions, alliances and licenses.
As of the date of this Report, we have issued and outstanding options to purchase 12,735,000 shares of our common stock with a weighted average exercise price of $3.68.
As of the date of this Report, we have issued and outstanding options to purchase 13,488,062 shares of our common stock with a weighted average exercise price of $3.53.
Moreover, even if competitors do not actively promote their product for our targeted indications, physicians may prescribe these products “off-label.” Although off-label prescriptions may infringe or contribute to the infringement of method of use patents, the practice is common and such infringement is difficult to prevent or prosecute.
Moreover, even if competitors do not actively promote their product for our targeted indications, physicians may prescribe these products “off-label.” Although off-label prescriptions may infringe or contribute to the infringement of method of use patents, the practice is common and such infringement is difficult to prevent or prosecute. 21 The strength of patents in the biotechnology and pharmaceutical field involves complex legal and scientific questions and can be uncertain.
Furthermore, the mere existence of a significant number of shares of common stock issuable upon vesting and, if applicable, exercise of these securities may be perceived by the market as having a potential dilutive effect, which could lead to a decrease in the price of our common stock.
Furthermore, the mere existence of a significant number of shares of common stock issuable upon vesting and, if applicable, exercise of these securities may be perceived by the market as having a potential dilutive effect, which could lead to a decrease in the price of our common stock. 25 We are a smaller reporting company and the reduced reporting requirements applicable to smaller reporting companies may make our common stock less attractive to investors.
Over the next several quarters, we will need to continue broadening our focus from a research and development company to a company capable of supporting clinical trials and commercial activities, or enter into collaborations with partners that may provide those capabilities. We may not be able to reach such achievements, which would have a material adverse effect on our Company.
Over the next several quarters, we will need to continue broadening our focus from a research and development company to a company capable of supporting clinical trials and commercial activities, or enter into collaborations with partners that may provide those capabilities.
We do not currently have the resources and infrastructure to manufacture, market or sell our products or technologies. While our technologies have generated interest from multiple potential strategic partners, due to the early stage of development of our technologies, we can give no assurance that we will be able to successfully establish any strategic partnerships.
While our technologies have generated interest from multiple potential strategic partners, due to the early stage of development of our technologies, we can give no assurance that we will be able to successfully establish any strategic partnerships.
On a cumulative basis, we have sustained substantial losses and negative cash flows from operations since our inception. As of October 31, 2023, our accumulated deficit was approximately $228,196,000. As of October 31, 2023, we had approximately $23,844,000 in cash, cash equivalents and short-term investments, and working capital of approximately $23,328,000.
On a cumulative basis, we have sustained substantial losses and negative cash flows from operations since our inception. As of October 31, 2024, our accumulated deficit was approximately $240,750,000, and we had approximately $19,924,000 in cash, cash equivalents and short-term investments, and working capital of approximately $18,862,000.
We also do not have commercial supply arrangements with many of these suppliers, and may not be able to contract with them on acceptable terms or at all. Accordingly, we may experience delays in receiving key raw materials to support clinical or commercial manufacturing.
We also do not have commercial supply arrangements with many of these suppliers, and may not be able to contract with them on acceptable terms or at all.
If we do not prevail, we may be required to pay damages, including treble damages, attorneys’ fees, costs and expenses, royalties or, be enjoined from selling our products, which could adversely affect our ability to offer products, our ability to continue operations and our financial condition. 23 If our efforts to protect the proprietary nature of our technologies are not adequate, we may not be able to compete effectively in our market.
If we do not prevail, we may be required to pay damages, including treble damages, attorneys’ fees, costs and expenses, royalties or, be enjoined from selling our products, which could adversely affect our ability to offer products, our ability to continue operations and our financial condition.
The enrollment of patients depends on many factors, including: ● the patient eligibility criteria defined in the clinical trial protocol; ● the size of the patient population required for analysis of the trial’s primary endpoints; ● the proximity of patients to the study site; ● the design of the clinical trial; ● our ability to retain clinical trial investigators with the appropriate competencies and experience; ● our ability to obtain and maintain patient consents; ● the risk that patients enrolled in clinical trials will drop out of the clinical trials before completion; and ● competing clinical trials and approved therapies available for patients.
The enrollment of patients depends on many factors, including: ● the patient eligibility criteria defined in the clinical trial protocol; ● the size of the patient population required for analysis of the trial’s primary endpoints; ● the proximity of patients to the study site; ● the design of the clinical trial; ● our ability to retain clinical trial investigators with the appropriate competencies and experience; ● our ability to obtain and maintain patient consents; ● the risk that patients enrolled in clinical trials will drop out of the clinical trials before completion; and ● competing clinical trials and approved therapies available for patients. 15 In particular, our Phase 1 CAR-T ovarian cancer clinical trial is enrolling patients with late-stage ovarian cancer who have failed conventional treatment, and are willing and able to be treated at Moffitt.
Generally, losses incurred will carry forward until such losses expire (for losses generated prior to January 1, 2018) or are used to offset future taxable income, if any.
We have incurred net losses since our inception and we may never achieve or sustain profitability. Generally, losses incurred will carry forward until such losses expire (for losses generated prior to January 1, 2018) or are used to offset future taxable income, if any.
The strength of patents in the biotechnology and pharmaceutical field involves complex legal and scientific questions and can be uncertain. The patent applications that we own or in-license may fail to result in issued patents with claims that cover our product candidates or uses thereof in the U.S. or in other foreign countries.
The patent applications that we own or in-license may fail to result in issued patents with claims that cover our product candidates or uses thereof in the U.S. or in other foreign countries.
The stock market has experienced significant price and volume fluctuations, and the market prices of biotechnology companies have been highly volatile.
Biotechnology company stock prices are especially volatile, and this volatility may depress the price of our common stock. The stock market has experienced significant price and volume fluctuations, and the market prices of biotechnology companies have been highly volatile.
Our current business model relies on strategic collaborations with commercial partners to provide the resources and infrastructure to manufacture and ultimately market and/or sell our technologies. We may have difficulty in timing the establishment of these partnerships to achieve the greatest economic benefit for the Company, or in establishing these partnerships at all.
We may have difficulty in timing the establishment of these partnerships to achieve the greatest economic benefit for the Company, or in establishing these partnerships at all. We do not currently have the resources and infrastructure to manufacture, market or sell our products or technologies.
We cannot be sure that these suppliers will remain in business, or that they will not be purchased by one of our competitors or another company that is not interested in continuing to produce these materials for our intended purpose. 19 We may form or seek strategic alliances or enter into additional licensing arrangements in the future, and we may not realize the benefits of such alliances or licensing arrangements.
We cannot be sure that these suppliers will remain in business, or that they will not be purchased by one of our competitors or another company that is not interested in continuing to produce these materials for our intended purpose.
This will require us to be cognizant going forward of the time from invention to filing of a patent application. 24 Obtaining and maintaining our patents depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent position could be reduced or eliminated for non-compliance with these requirements.
Obtaining and maintaining our patents depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent position could be reduced or eliminated for non-compliance with these requirements.
Our license agreements impose, and we expect that future license agreements if necessary will impose, various development, diligence, commercialization and other obligations on us.
We may need to obtain additional licenses from others to advance our research, development and commercialization activities. Our license agreements impose, and we expect that future license agreements if necessary will impose, various development, diligence, commercialization and other obligations on us.
Undesirable side effects observed in our clinical trials, whether or not they are caused by our product candidates, could result in the delay, suspension or termination of clinical trials, by the FDA or other regulatory authorities or us for a number of reasons.
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. 16 Undesirable side effects observed in our clinical trials, whether or not they are caused by our product candidates, could result in the delay, suspension or termination of clinical trials, by the FDA or other regulatory authorities or us for a number of reasons.
In fiscal year 2023, we incurred losses of approximately $9,930,000 and we experienced negative cash flows from operations of approximately $6,209,000. We expect to continue incurring material research and development and general and administrative expenses in connection with our operations. As a result, we anticipate that we will incur losses in the future.
In fiscal year 2024, we incurred losses of approximately $12,698,000 and we experienced negative cash flows from operations of approximately $7,335,000. We expect to continue incurring material research and development and general and administrative expenses in connection with our operations.
As a result, even if we attain profitability, we may be unable to use a material portion of our NOL carryforwards and other tax attributes, which could adversely affect our future cash flows. 11 Risks Related to our Research & Development, Clinical and Commercialization Activities Our therapeutic and vaccine programs are pre-revenue, and subject to the risks of an early-stage biotechnology company.
As a result, even if we attain profitability, we may be unable to use a material portion of our NOL carryforwards and other tax attributes, which could adversely affect our future cash flows.
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. 15 Even if clinical trials are successfully completed, the FDA or foreign regulatory authorities may not interpret the results as we do, and more clinical trials could be required before we submit our product candidates for approval.
Even if clinical trials are successfully completed, the FDA or foreign regulatory authorities may not interpret the results as we do, and more clinical trials could be required before we submit our product candidates for approval.
In addition, some raw materials are currently available from a single supplier, or a small number of suppliers.
Accordingly, we may experience delays in receiving key raw materials to support clinical or commercial manufacturing. 17 In addition, some raw materials are currently available from a single supplier, or a small number of suppliers.
A primary change under this reform is the creation of a “first to file” system in the U.S.
A primary change under this reform is the creation of a “first to file” system in the U.S. This will require us to be cognizant going forward of the time from invention to filing of a patent application.
If we do identify sources for additional funding, the sale of additional equity securities or convertible debt could result in dilution to our stockholders. Additionally, the sale of equity securities or issuance of debt securities may be subject to certain security holder approvals or may result in the downward adjustment of the exercise or conversion price of our outstanding securities.
If we do identify sources for additional funding, the sale of additional equity securities or convertible debt will result in dilution to our stockholders.
There are several pending U.S. and foreign patent applications in our portfolio, and we anticipate additional patent applications will be filed both in the U.S. and in other countries, as appropriate.
Certain intellectual property which is covered by our in-license agreements has been developed at academic institutions which have retained non-commercial rights to such intellectual property. There are several pending U.S. and foreign patent applications in our portfolio, and we anticipate additional patent applications will be filed both in the U.S. and in other countries, as appropriate.
Based on currently available information as of January 16, 2024, we believe that our existing cash, cash equivalents and short-term investments will be sufficient to fund our activities for at least the next 12 months. However, our projections of future cash needs and cash flows may differ from actual results.
Based on currently available information as of January 10, 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. We have implemented a business model that conserves funds by collaborating with third parties to develop our technologies.
We have never generated any revenue from biotechnology and pharmaceutical product sales and our biotechnology and pharmaceutical products may never be profitable. We are in the pre-clinical stage of developing our ovarian cancer vaccine technology and in the clinical stage with our CAR-T therapeutic technology and with our breast cancer vaccine technology.
We have never generated any revenue from biotechnology and pharmaceutical product sales and our biotechnology and pharmaceutical products may never be profitable.
In particular, our Phase 1 CAR-T ovarian cancer clinical trial is enrolling patients with late-stage ovarian cancer who have failed conventional treatment, and are willing and able to be treated at Moffitt. Our Phase 1a breast cancer vaccine clinical trial is enrolling patients who have undergone standard of care treatment for TNBC.
Our Phase 1a breast cancer vaccine clinical trial is enrolling patients who have undergone standard of care treatment for TNBC.
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. 10 Failure to effectively manage our potential growth could place strains on our managerial, operational and financial resources and could adversely affect our business and operating results .
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 are party to royalty-bearing license agreements that grant us rights to use certain intellectual property, including patents and patent applications. We may need to obtain additional licenses from others to advance our research, development and commercialization activities.
We rely on licenses from Wistar for our CAR-T technology and Cleveland Clinic for our cancer vaccine technologies, and if we lose any of these licenses we may be subjected to future litigation. We are party to royalty-bearing license agreements that grant us rights to use certain intellectual property, including patents and patent applications.
Claims that we have misappropriated the confidential information or trade secrets of third parties can have a similar negative impact on our business. 22 We rely on licenses from Wistar for our CAR-T technology and Cleveland Clinic for our breast and ovarian cancer vaccine technologies, and if we lose any of these licenses we may be subjected to future litigation.
In addition, we could be found liable for monetary damages. Claims that we have misappropriated the confidential information or trade secrets of third parties can have a similar negative impact on our business.
Any disclosure to or misappropriation by third parties of our confidential proprietary information could enable competitors to quickly duplicate or surpass our technological achievements, thus eroding our competitive position in our markets. Certain intellectual property which is covered by our in-license agreements has been developed at academic institutions which have retained non-commercial rights to such intellectual property.
If our efforts to protect the proprietary nature of our technologies are not adequate, we may not be able to compete effectively in our market. Any disclosure to or misappropriation by third parties of our confidential proprietary information could enable competitors to quickly duplicate or surpass our technological achievements, thus eroding our competitive position in our markets.
In the past, several patients have also died in clinical trials by others involving CAR-T cell therapies. 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 past, several patients have also died in clinical trials by others involving CAR-T cell therapies.
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Also, we may consume available resources more rapidly than currently anticipated, resulting in the need for additional funding sooner than anticipated.
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However, our projections of future cash needs and cash flows may differ from actual results.
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Our ability to use our net operating loss carryforwards and certain other tax attributes may be limited. We have incurred net losses since our inception and we may never achieve or sustain profitability.
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During the year ended October 31, 2024, we raised approximately $2,955,000, net of expenses, through an at-the-market equity offering of 785,290 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, we may sell up to $97 million of common stock.
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We are dependent on third parties to conduct our pre-clinical studies and clinical trials.
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Failure to effectively manage our potential growth could place strains on our managerial, operational and financial resources and could adversely affect our business and operating results . Our business strategy and potential growth may place a strain on managerial, operational and financial resources and systems.
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In addition, we could be found liable for monetary damages.
Added
Risks Related to our Research & Development, Clinical and Commercialization Activities Our therapeutic and vaccine programs are pre-revenue, and subject to the risks of an early-stage biotechnology company.
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We are a smaller reporting company and the reduced reporting requirements applicable to smaller reporting companies may make our common stock less attractive to investors.
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We may not be able to reach such achievements, which would have a material adverse effect on our Company. 11 Our current business model relies on strategic collaborations with commercial partners to provide the resources and infrastructure to manufacture and ultimately market and/or sell our technologies.
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We are in the early discovery stage of developing vaccines against high-incidence malignancies such as lung, colon and prostate cancers, in the pre-clinical stage of developing our ovarian cancer vaccine technology and in the clinical stage with our CAR-T therapeutic technology and with our breast cancer vaccine technology.
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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.
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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.
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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 therapy and our breast cancer vaccine.
Added
We may form or seek strategic alliances or enter into additional licensing arrangements in the future, and we may not realize the benefits of such alliances or licensing arrangements.

Item 1C. Cybersecurity

Cybersecurity — threats and controls disclosure

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Item 1C. Cybersecurity. We will provide the disclosure required under this Item 1C in our annual report for the year ended October 31, 2024 which is the first annual report for a fiscal year ending on or after December 15, 2023, the date on which disclosure under Item 106 of Regulation S-K is required. 29
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Item 1C. Cybersecurity Overview Our IT and related systems are critical to the efficient operation of our business and essential to our ability to perform day to day processes.
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We face persistent security threats, including threats to our IT infrastructure and unlawful attempts to gain access to our confidential or otherwise proprietary information, or that of our employees, via phishing/malware campaigns and other cyberattack methods.
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Our security policies and processes are based on industry best practices and are revisited regularly to ensure their appropriateness based on risk, threats and current technological capabilities. We regularly assess our threat landscape and monitor our systems and other technical security controls, maintain information security practices and ensure maintenance of backup and protective systems.
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We review System and Organization Controls 1 (SOC 1 Type II) certifications where relevant from key third party partners and other service providers with access to information assets at least annually. Our internal controls and procedures address cybersecurity and include processes intended to ensure that security breaches are reported to appropriate personnel and, if warranted, analyzed for potential disclosure.
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We also maintain insurance coverage that is intended to address certain aspects of cybersecurity risks. To date, there have not been any cybersecurity threats that have materially affected the Company. Governance Board Oversight of Cybersecurity Matters Assessing and managing information security matters is the responsibility of our Audit Committee.
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The Audit Committee meets with the senior executives, specifically the Chief Executive Officer and Chief Financial Officer on at least an annual basis to discuss cybersecurity posture.
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The Audit Committee may also periodically receive targeted briefings related to cybersecurity and reviews our incident response capabilities. 26 Management of Cybersecurity Risks The senior executives work to protect our information systems from cybersecurity threats and to promptly assist in coordinating a response to any cybersecurity incidents in accordance with our cybersecurity incident response and recovery plans.
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We have engaged an IT Managed Service Provider who assists in the oversight of our corporate-wide data security, including developing, implementing and enforcing security policies to manage our overall cybersecurity risks. The senior executives regularly meet with our IT Managed Service Provider during the course of the year to review and discuss cybersecurity issues.
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Strategy Our Security Culture We protect our information assets and manage risk by promoting a culture that communicates security risks, designs secure IT systems and operates according to approved processes to reduce the likelihood and impact of security incidents.
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We achieve this objective by: ● designing, implementing and maintaining solutions with appropriate security controls; ● sustaining solutions with required patching and vulnerability remediation; ● creating and executing controls in support of policy as well as regulatory compliance; ● ensuring that our policies, processes, practices and technologies proactively protect, shield, defend and remediate cyber threats; and ● delivering quality communications and annual training to stakeholders on cyber awareness and computing hygiene.
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We believe that the conduct of our employees is critical to the success of our information security. We keep our employees apprised of threats, risks and the part that they play in protecting both themselves and the Company.
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We assess our service providers prior to allowing our information to be processed, stored or transmitted by third parties, and we include standardized contractual requirements in each contract where appropriate. We validate our service providers’ security via questionnaires, open-source intelligence and, where appropriate, SOC 1 Type II reports on financially significant third-party service providers.
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Our process also includes regular monitoring of risk related to third parties on a periodic basis or when services or product purchases expand beyond their original scope or intended use.

Item 2. Properties

Properties — owned and leased real estate

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Biggest changeItem 2. Properties. We lease approximately 2,000 square feet of office space at 3150 Almaden Expressway, San Jose, California (our principal executive offices) from an unrelated party pursuant to a lease that expires September 30, 2024.
Biggest changeItem 2. Properties We lease approximately 2,000 square feet of office space at 3150 Almaden Expressway, San Jose, California 95118 (our principal executive offices) from an unrelated party pursuant to a lease that expires September 30, 2027, with an option to extend the lease an additional two years.

Item 3. Legal Proceedings

Legal Proceedings — active lawsuits and investigations

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Biggest changeItem 3. Legal Proceedings. Other than lawsuits we bring to enforce our patent rights, we are not a party to any material pending legal proceedings, nor are we aware of any pending litigation or legal proceeding against us that would have a material adverse effect on our financial position or results of operations. Item 4. Mine Safety Disclosures. Not applicable.
Biggest changeItem 3. Legal Proceedings Other than lawsuits we bring to enforce our patent rights, we are not a party to any material pending legal proceedings, nor are we aware of any pending litigation or legal proceeding against us that would have a material adverse effect on our financial position or results of operations. Item 4.
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Mine Safety Disclosures Not applicable. 27 PART II

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

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Biggest changeRecent Sales of Unregistered Securities During the three months ended October 31, 2023, the Company issued an aggregate of 6,756 unregistered shares of our common stock to a company in payment of investor relations services.
Biggest changeRecent Sales of Unregistered Securities The Company did not issue any unregistered securities during the three months ended October 31, 2024. Item 6. [Reserved]
Item 5. Market for the Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities. Market Information Our common stock trades on the NASDAQ Capital Market under the symbol “ANIX”.
Item 5. Market for the Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities Market Information Our common stock trades under the symbol “ANIX” on the NASDAQ Capital Market.
The Board may amend, suspend or terminate the 2018 Share Incentive Plan at any time, subject in certain respects to obtaining shareholder approval. 30 Dividend Policy No cash dividends have been paid on our common stock since our inception. We have no present intention to pay any cash dividends in the foreseeable future.
The Board may amend, suspend or terminate the 2018 Share Incentive Plan at any time, subject in certain respects to obtaining shareholder approval. 28 Dividend Policy No cash dividends have been paid on our common stock since our inception. We have no present intention to pay any cash dividends in the foreseeable future.
Securities Authorized for Issuance Under Equity Compensation Plans The following is information as of October 31, 2023 about shares of our common stock that may be issued upon the exercise of options, warrants and rights under all equity compensation plans in effect as of that date, including our 2010 Share Incentive Plan and our 2018 Share Incentive Plan.
Securities Authorized for Issuance Under Equity Compensation Plans The following is information as of October 31, 2024 about shares of our common stock that may be issued upon the exercise of options, warrants and rights under all equity compensation plans in effect as of that date, including our 2010 Share Incentive Plan and our 2018 Share Incentive Plan.
Plan category Number of securities to be issued upon exercise of outstanding options, warrants and rights (a) Weighted average exercise price of outstanding options, warrants and rights Number of securities remaining available for future issuance under equity compensation plans (excluding securities reflected in column (a)) Equity compensation plans not approved by security holders (1) 1,189,000 $ 2.94 - Equity compensation plans approved by security holders (2) 10,241,000 $ 3.67 750,000 (1) On July 14, 2010, the Board adopted the 2010 Share Incentive Plan.
Plan category Number of securities to be issued upon exercise of outstanding options, warrants and rights (a) Weighted average exercise price of outstanding options, warrants and rights Number of securities remaining available for future issuance under equity compensation plans (excluding securities reflected in column (a)) Equity compensation plans not approved by security holders (1) 986,968 $ 2.77 - Equity compensation plans approved by security holders (2) 11,171,094 $ 3.74 983,907 (1) On July 14, 2010, the Board adopted the 2010 Share Incentive Plan.
Holders As of January 12, 2024, the approximate number of record holders of our common stock was 312 and the closing price of our common stock was $4.39 per share.
Holders As of January 8, 2025, the approximate number of record holders of our common stock was 307 and the closing price of our common stock was $2.25 per share.
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The common stock was issued in reliance on an exemption from registration under Section 4(a)(2) of the Securities Act as they were issued in a private transaction to investors, without a view to distribution, and were not issued through any general solicitation or advertisement. Item 6. [Reserved]

Item 7. Management's Discussion & Analysis

Management's Discussion & Analysis (MD&A) — revenue / margin commentary

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Biggest changeThe decrease in research and development expenses was primarily due to a decrease in employee stock option compensation expense of approximately $1,386,000, a decrease in research and development expenses related to our COVID-19 development program of approximately $485,000 as a result of the suspension of that program in March 2023, a decrease in license fees of approximately $225,000, a decrease in consultant stock option expense of approximately $213,000, a decrease in research and development expenses related to our CAR-T development program of approximately $156,000, and a decrease in research and development expenses related to our ovarian cancer vaccine development program of approximately $130,000, offset by an increase in research and development expenses related to our breast cancer vaccine development program of approximately $563,000 and an increase in employee compensation and related costs, other than stock option compensation expense, of approximately $147,000.
Biggest changeThe increase in research and development expenses was primarily due to an increase in research and development expenses related to our CAR-T development program of approximately $845,000, an increase in research and development expenses related to our breast cancer vaccine development program of approximately $834,000, an increase in research and development expenses related to our new vaccine discover program of approximately $113,000, an increase in clinical trial consulting services of approximately $101,000, offset by a decrease in research and development expenses related to our ovarian cancer vaccine development program of approximately $170,000 and a decrease in consultant stock option expense of approximately $137,000.
Revenue is recognized upon transfer of control of intellectual property rights and satisfaction of other contractual performance obligations to licensees in an amount that reflects the consideration we expect to receive. 34 Our revenue recognition policy requires us to make certain judgments and estimates in connection with the accounting for revenue.
Revenue is recognized upon transfer of control of intellectual property rights and satisfaction of other contractual performance obligations to licensees in an amount that reflects the consideration we expect to receive. Our revenue recognition policy requires us to make certain judgments and estimates in connection with the accounting for revenue.
We may seek to obtain working capital during our fiscal year 2024 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.
We may seek to obtain working capital during our fiscal year 2025 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.
Based on currently available information as of January 16, 2024, 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.
Based on currently available information as of January 10, 2025, 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.
In addition, we allocate certain internal compensation costs to research and development expenses based on management’s estimates of each employee’s time and effort expended. Effect of Recent Accounting Pronouncements We discuss the effect of recently issued pronouncements in Note 2 to the Consolidated Financial Statements.
In addition, we allocate certain internal compensation costs to research and development expenses based on management’s estimates of each employee’s time and effort expended. Effect of Recent Accounting Pronouncements We discuss the potential expected impacts of recently issued pronouncements in Note 2 to the Consolidated Financial Statements. Item 7A.
Interest Income Interest income increased to approximately $1,081,000 in fiscal year 2023 compared to approximately $104,000 in fiscal year 2022, due to an increase in interest rates and the increased dollar amount held in short-term investments.
Interest Income Interest income increased to approximately $1,133,000 in fiscal year 2024 compared to approximately $1,081,000 in fiscal year 2023, due to an increase in interest rates and the increased average dollar amount held in short-term investments.
Net Loss Attributable to Noncontrolling Interest The net loss attributable to noncontrolling interest, representing Wistar’s ownership interest in Certainty’s net loss, decreased by approximately $57,000 to approximately $119,000 in fiscal year 2023, from approximately $176,000 in fiscal year 2022, as Certainty’s net loss decreased. Liquidity and Capital Resources Our primary sources of liquidity are cash, cash equivalents and short-term investments.
Net Loss Attributable to Noncontrolling Interest The net loss attributable to noncontrolling interest, representing Wistar’s ownership interest in Certainty’s net loss, increased by approximately $25,000 to approximately $144,000 in fiscal year 2024, from approximately $119,000 in fiscal year 2023, as Certainty’s net loss increased. Liquidity and Capital Resources Our primary sources of liquidity are cash, cash equivalents and short-term investments.
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 would significantly harm the business and development of operations. 33 During the fiscal year ended October 31, 2023, cash used in operating activities was approximately $6,209,000.
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. 30 During the fiscal year ended October 31, 2024, cash used in operating activities was approximately $7,335,000.
Accordingly, the performance obligations from the license were satisfied and 100% of the revenue was recognized upon execution of the license agreement. We did not have any revenue in fiscal year 2022. 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.
Accordingly, the performance obligations from the license were satisfied and 100% of the revenue was recognized upon execution of the license agreement. 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.
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 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.
As a result, our cash, cash equivalents, and short-term investments at October 31, 2023 decreased approximately $5,843,000 to approximately $23,844,000 from approximately $29,687,000 at the end of fiscal year 2022. We have expected future cash obligations related to the lease of our offices through 2026, estimated at approximately $202,000.
As a result, our cash, cash equivalents, and short-term investments at October 31, 2024 decreased approximately $3,920,000 to approximately $19,924,000 from approximately $23,844,000 at the end of fiscal year 2023. We have expected future cash obligations related to the lease of our offices through 2029 , inclusive of extension periods , estimated at approximately $312,000.
At each balance sheet date, management estimates prepaid and accrued research and development costs by discussing progress or stage of completion of activities with internal personnel and external service providers, and comparing this information to payments made, invoices received, and the agreed-upon contractual fee to be paid for such services in the applicable contract or statements of work.
Fees for such services are recognized based on management’s estimates after considering the activities and tasks completed by each service provider in a given period, the time period over which services are expected to be performed, and the level of effort expended in each reporting period. 32 At each balance sheet date, management estimates prepaid and accrued research and development costs by discussing progress or stage of completion of activities with internal personnel and external service providers, and comparing this information to payments made, invoices received, and the agreed-upon contractual fee to be paid for such services in the applicable contract or statements of work.
General and Administrative Expenses General and administrative expenses decreased by approximately $881,000 to approximately $6,291,000 in fiscal year 2023, from approximately $7,172,000 in fiscal year 2022.
General and Administrative Expenses General and administrative expenses increased by approximately $1,144,000 to approximately $7,435,000 in fiscal year 2024, from approximately $6,291,000 in fiscal year 2023.
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, 2023, we may sell up to $100 million of common stock. We did not sell any shares under our at-the-market equity program during the fiscal year ended October 31, 2023.
During the year ended October 31, 2024, we raised approximately $2,955,000, net of expenses, through an at-the-market equity offering of 785,290 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, we may sell up to $97 million of common stock.
Inventor Royalties, Contingent Legal Fees, Litigation and Licensing Expenses Related to Patent Assertion In fiscal year 2023, inventor royalties, contingent legal fees, litigation and licensing expenses related to patent assertion activities were approximately $161,000. Inventor royalties and contingent legal fees are expensed in the period that the related revenues are recognized.
Inventor Royalties, Contingent Legal Fees, Litigation and Licensing Expenses Related to Patent Assertion We did not have any inventor royalties, contingent legal fees, litigation and licensing expenses related to patent assertion activities in fiscal year 2024. In fiscal year 2023, inventor royalties, contingent legal fees, litigation and licensing expenses related to patent assertion activities were approximately $161,000.
Such areas may include determining the existence of a contract and identifying each party’s rights and obligations to transfer goods and services, identifying the performance obligations in the contract, determining the transaction price and allocating the transaction price to separate performance obligations, estimating the timing of satisfaction of performance obligations, determining whether a promise to grant a license is distinct from other promised goods or services and evaluating whether a license transfers to a customer at a point in time or over time.
Such areas may include determining the existence of a contract and identifying each party’s rights and obligations to transfer goods and services, identifying the performance obligations in the contract, determining the transaction price and allocating the transaction price to separate performance obligations, estimating the timing of satisfaction of performance obligations, determining whether a promise to grant a license is distinct from other promised goods or services and evaluating whether a license transfers to a customer at a point in time or over time. 31 Our revenue arrangements provide for the payment, within 30 days of execution of the agreement, of contractually determined, one-time, paid-up license fees in settlement of litigation and in consideration for the grant of certain intellectual property rights for patented technologies owned or controlled by the Company.
General In reviewing Management’s Discussion and Analysis of Financial Condition and Results of Operations, you should refer to our Consolidated Financial Statements and the notes related thereto. 31 Results of Operations Fiscal Year ended October 31, 2023 compared with Fiscal Year ended October 31, 2022 Revenue In fiscal year 2023, we recorded revenue of approximately $210,000 from one license agreement related to our encrypted audio/video conference calling technology.
Results of Operations Fiscal Year ended October 31, 2024 compared with Fiscal Year ended October 31, 2023 Revenue We did not have any revenue in fiscal year 2024. In fiscal year 2023, we recorded revenue of approximately $210,000 from one license agreement related to our encrypted audio/video conference calling technology.
Research and Development Expenses Research and development expenses incurred in fiscal year 2023 associated with each of our development programs consisted of approximately $1,839,000 for CAR-T therapeutics, approximately $2,682,000 for cancer vaccines, and approximately $248,000 for anti-viral therapeutics. 32 Research and development expenses are related to the development of our cancer therapeutic and vaccine programs, and our anti-viral drug program, and decreased by approximately $1,934,000 to approximately $4,769,000 in fiscal year 2023, from approximately $6,703,000 in fiscal year 2022.
In fiscal year 2023, research and development expenses were related to the development of our cancer therapeutics and vaccines, as well as our anti-viral therapeutics program, 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, respectively.
Cash used in investing activities was approximately $5,602,000, resulting from the purchase of short-term investments of approximately $44,411,000, which was offset by the proceeds on maturities of short-term investments of approximately $38,809,000.
Cash provided by investing activities was approximately $4,276,000, resulting from the proceeds on maturities of short-term investments of approximately $68,046,000, which was offset by the purchase of short-term investments of approximately $63,770,000.
Cash provided by financing activities was approximately $366,000, resulting from proceeds from the exercise of stock options of approximately $353,000 and proceeds from the sale of common stock pursuant to an employee stock purchase plan of approximately $13,000.
Cash provided by financing activities was approximately $3,415,000, resulting from the sale of 785,290 shares of common stock in at at-the-market equity offering of approximately $2,955,000, proceeds from the exercise of stock options of approximately $456,000 and proceeds from the sale of common stock pursuant to an employee stock purchase plan of approximately $10,000, offset by the purchase of treasury stock of approximately $6,000.
If factors change and we employ different assumptions in future periods, the compensation expense that we record may differ significantly from what we have recorded in the current period. Research and Development Expense We recognize research and development expenses as incurred. Advance payments for future research and development activities are deferred and expensed as the services are performed.
Research and Development Expense We recognize research and development expenses as incurred. Advance payments for future research and development activities are deferred and expensed as the services are performed.
The decrease in general and administrative expenses was principally due to a decrease in employee stock option compensation expense of approximately $309,000, a decrease in professional fees of approximately $239,000, a decrease in consultant warrant expense of approximately $221,000, a decrease in employee compensation and related costs, other than stock option compensation expense, of approximately $214,000, and a decrease in patent expenses of approximately $152,000, offset by an increase in director compensation expense, other than stock option compensation expense, of approximately $121,000 and an increase in director stock option compensation expense of approximately $116,000.
The increase in general and administrative expenses was principally due to an increase in investor and public relations firm expenses of approximately $629,000, an increase in stock compensation for investor and public relations firm of approximately $145,000, an increase in employee compensation and related costs, other than stock option compensation expense, of approximately $141,000 and an increase in employee stock option compensation expense of approximately $111,000.
We made the dividend yield assumption based on our history of not paying dividends and our expectation not to pay dividends in the future. 35 We will reconsider use of the Black-Scholes pricing model and the Monte Carlo Simulation if additional information becomes available in the future that indicates another model would be more appropriate.
We will reconsider use of the Black-Scholes pricing model and the Monte Carlo Simulation if additional information becomes available in the future that indicates another model would be more appropriate. If factors change and we employ different assumptions in future periods, the compensation expense that we record may differ significantly from what we have recorded in the current period.
Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations General In reviewing Management’s Discussion and Analysis of Financial Condition and Results of Operations, you should refer to our Consolidated Financial Statements and the notes related thereto.
Litigation and licensing expenses related to patent assertion, other than contingent legal fees, are expensed in the period incurred. We did not have any inventor royalties, contingent legal fees, litigation and licensing expenses related to patent assertion activities in fiscal year 2022.
Litigation and licensing expenses related to patent assertion, other than contingent legal fees, are expensed in the period incurred. 29 Research and Development Expenses In fiscal year 2024, research and development expenses were related to the development of 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.
Removed
Our revenue arrangements provide for the payment, within 30 days of execution of the agreement, of contractually determined, one-time, paid-up license fees in settlement of litigation and in consideration for the grant of certain intellectual property rights for patented technologies owned or controlled by the Company.
Added
Inventor royalties and contingent legal fees are expensed in the period that the related revenues are recognized.
Removed
Fees for such services are recognized based on management’s estimates after considering the activities and tasks completed by each service provider in a given period, the time period over which services are expected to be performed, and the level of effort expended in each reporting period.
Added
Research and development expenses increased by approximately $1,627,000 to approximately $6,396,000 in fiscal year 2024, from approximately $4,769,000 in fiscal year 2023.
Added
Quantitative and Qualitative Disclosures About Market Risk Not required for a smaller reporting company.