Anixa Biosciences, Inc. (ANIX): PESTLE Analysis [Nov-2025 Updated]

You're holding Anixa Biosciences, Inc. (ANIX), a clinical-stage biotech, and the external environment-not just the lab results-will dictate its trajectory. In 2025, the company's push with its breast cancer vaccine and CAR-T platform faces a dual reality: massive tailwinds from growing public demand for preventative medicine and increased US government research funding, but also stiff headwinds from high interest rates increasing the cost of capital and stricter FDA approval pathways. We'll map out the near-term risks, like reliance on dilutive financing, and the defintely huge opportunities, like their Phase 1 data, so you can see the full strategic picture.

Anixa Biosciences, Inc. (ANIX) - PESTLE Analysis: Political factors

Increased US government funding for cancer research and vaccine development.

You might think that the national push to cure cancer means a huge, guaranteed funding bump every year, but the reality for Fiscal Year (FY) 2025 is more nuanced. While the rhetoric is strong, the actual appropriations are showing restraint. The National Cancer Institute (NCI) budget for FY2025 was set at approximately $7.22 billion, which represents flat funding compared to the previous fiscal year, despite requests for significant increases to accelerate the Cancer Moonshot initiative. This flat funding means competition for grants remains fierce.

For Anixa Biosciences, the direct impact is mitigated by your current funding structure. Your groundbreaking breast cancer vaccine trial, developed with Cleveland Clinic, is fully funded by a U.S. Department of Defense (DoD) grant. This is a massive advantage, effectively bypassing the competitive NCI grant process for a core asset. The DoD's Peer Reviewed Cancer Research Program (PRCRP) alone was appropriated $130 million for FY2025, demonstrating an alternative, mission-critical funding stream for cancer research that you are already tapping into.

• DoD funding insulates the vaccine program from NCI budget flatness.
• Flat NCI budget increases the pressure on new, unfunded programs.

Stricter US Food and Drug Administration (FDA) approval pathways for novel oncology treatments.

The FDA's regulatory environment for novel oncology treatments like Anixa's CAR-T and vaccine programs is not simply getting 'stricter'; it's becoming more complex, offering both accelerated pathways and increased scrutiny. The agency is actively trying to speed up approvals for personalized medicine. In November 2025, the FDA unveiled a new plausible mechanism pathway for highly individualized therapies, such as gene-editing and bespoke treatments, which could potentially grant approval without traditional randomized controlled trials if a clear biological benefit is shown in consecutive patients.

However, this flexibility comes with political risk. Critics argue that increasing regulatory flexibility, especially under new leadership like Commissioner Marty Makary, could erode public trust and patient safety standards. For your CAR-T program targeting ovarian cancer, which is a highly personalized approach, this new pathway represents an opportunity to accelerate your timeline from a Phase 1 trial (currently underway with Moffitt Cancer Center) to market, assuming your data is compelling. But you must be defintely prepared for intense public and political debate over the data's rigor.

Here's a quick look at the dual nature of the 2025 regulatory environment:

Geopolitical tensions affecting global supply chains for specialized clinical trial materials.

Geopolitical instability is no longer a distant threat; it's a direct operational risk, especially for advanced therapies. For a biotech company like Anixa, which relies on specialized, often single-source materials for its CAR-T and vaccine programs, supply chain resilience is a prime political concern. The industry is shifting from a 'just-in-time' to a 'just-in-case' inventory model in 2025 to safeguard against shortages caused by regionalization of trade and global conflict.

Your CAR-T program is particularly vulnerable, as cell therapies require highly specialized reagents and a strict cold chain for logistics, which is susceptible to international shipping disruptions. The fact that Anixa recently secured a Chinese patent for the breast cancer vaccine technology in October 2025, while a positive for market access, also exposes the company to potential US-China trade tensions that could impact the sourcing of raw materials or manufacturing components. Your lean operating model, with a total cash burn of only $7 million in the last fiscal year, means any significant clinical trial delay due to supply chain issues would disproportionately impact your cash runway of over $17 million.

Potential for 'Right to Try' legislation to influence clinical trial design and patient access.

The 'Right to Try' (RTT) movement is evolving, and the new 'RTT 2.0' legislation gaining traction in state chambers in 2025 is highly relevant to your pipeline. RTT 2.0 focuses narrowly on individualized genetic treatments, which directly relates to the nature of your CAR-T therapy for ovarian cancer.

The core challenge for Anixa is that the federal RTT Act, which allows terminally ill patients to access investigational drugs that have cleared Phase 1, expressly prohibits the FDA from using RTT-derived clinical data in the evaluation of future marketing applications. This is a critical disincentive. If a significant number of patients access your drug through RTT instead of the formal Phase 1/2 trial, you gain no usable data for your eventual New Drug Application (NDA).

This creates a political and ethical tightrope walk: you want to provide access to desperate patients, but you cannot allow it to derail the formal trial that is necessary to get the drug approved for the broader population. Your CAR-T program is currently in Phase 1, the exact stage where RTT access becomes legally possible.

Anixa Biosciences, Inc. (ANIX) - PESTLE Analysis: Economic factors

The economic environment for Anixa Biosciences, Inc. in 2025 is a classic biotech paradox: capital-efficient operations buffer against a volatile market, but the pre-revenue status still forces a reliance on external funding. The company's financial health is strong for its stage-it is debt-free-but the cost and availability of future capital are the primary economic risks.

Here's the quick math: with a cash burn of about $7 million in the most recent fiscal year and over $17 million in cash and no debt as of May 2025, the company has a runway of more than two years. That's a huge advantage in this sector.

High interest rates increasing the cost of capital for future financing rounds.

While the Federal Reserve began to ease monetary policy with a rate cut in September 2024, the overall interest rate environment remains elevated compared to the low-rate era that fueled the 2020-2021 biotech boom. This high-rate environment makes debt financing (bank loans, corporate bonds) significantly more expensive, which is a critical consideration for a development-stage company like Anixa Biosciences.

For Anixa, which is currently debt-free, the direct impact is minimal, but the indirect effect is substantial. Higher interest rates increase the cost of capital for potential partners and large pharmaceutical companies (Big Pharma) looking to acquire or license assets, which can cool down mergers and acquisitions (M&A) activity. This is important because M&A is the primary exit strategy for a company with a business model focused on licensing its platform technologies.

The good news is that the prospect of further rate reductions in 2025 has already started to boost investor optimism, potentially lowering the cost of all capital, including equity.

Reliance on dilutive equity financing, given a lack of significant revenue in 2025.

Anixa Biosciences is a clinical-stage company, and its core oncology programs are pre-revenue. The company reported $0 in revenue for the first quarter of fiscal year 2025 (ending January 31, 2025) and the third quarter of 2025 (ending July 31, 2025), and analysts forecast $0 for the fourth quarter. This means the company must raise capital to cover its operating expenses, which resulted in a net loss of approximately $6.47 million in Q3 2025, and a trailing 12-month net loss of -$11.12 million ending July 31, 2025.

The primary mechanism for funding this deficit is the sale of equity securities, like common stock, which is dilutive to existing shareholders. To be fair, Anixa has been very disciplined, with only approximately 32 million common shares outstanding as of May 2025 and no warrants, a very clean capital structure for an early-stage biotech.

Volatility in the biotech sector impacting the company's market capitalization.

The biotechnology sector is notoriously volatile, and small-cap companies like Anixa Biosciences are particularly exposed. The company's market capitalization was approximately $109.52 million as of June 2025. This valuation is sensitive to broader market sentiment, political uncertainty (e.g., drug pricing policies), and, most importantly, clinical trial results.

The sector has been under pressure, but there are signs of a recovery. Venture capital funding in the biopharma industry saw a 70.9% increase in total deal value from Q2 2025 to Q3 2025, reaching $3.1 billion in Q3 2025. This influx of capital suggests investor confidence is improving, which could translate to a more favorable environment for Anixa's stock price and future secondary offerings.

Opportunities for non-dilutive grants, like those from the National Institutes of Health (NIH).

A significant economic opportunity for Anixa Biosciences lies in securing non-dilutive funding-money that does not require the company to sell shares or take on debt. They have already executed on this strategy successfully, which is a major positive signal.

• U.S. Department of Defense (DoD) Grant: The Phase 1 clinical trial for the breast cancer vaccine is fully funded by a grant from the U.S. Department of Defense to Cleveland Clinic, its research partner. This is a direct, non-dilutive offset to R&D expenses.
• NIH Funding: The National Institutes of Health remains the largest public funder of biomedical research in the world. While the proposed Presidential Fiscal Year 2026 Budget includes a significant reduction in the NIH's discretionary budget to $27.5 billion (a 39% cut from FY 2025), the National Cancer Institute (NCI), which is highly relevant to Anixa's work, is slated to be retained as a core institute. This means targeted opportunities for oncology-focused research grants will still exist, but competition will likely intensify.

This grant-funded model, where the partner institution secures the funding, allows Anixa to advance its clinical programs while maintaining its capital-disciplined approach. That's defintely a smart way to manage early-stage risk.

Anixa Biosciences, Inc. (ANIX) - PESTLE Analysis: Social factors

You're looking at Anixa Biosciences, Inc. (ANIX) as a pure-play biotech, so the social environment is the ultimate market for its pipeline. The core takeaway is that powerful demographic and public health trends-specifically the rising demand for prevention and the aging cancer survivor population-are creating a massive, receptive market for Anixa's two main programs, but the ethical and financial access debates around gene therapy still pose a significant headwind for the CAR-T platform.

Here's the quick math on the need: The U.S. is projected to see 316,950 new invasive breast cancer cases in 2025, and the cancer survivor population is aging rapidly. This social urgency is the company's biggest non-financial asset, offsetting the current development-stage financial profile, which included a Q3 2025 net loss of $6.47 million and R&D costs of $2.99 million.

Growing public demand for preventative medicine, boosting interest in the breast cancer vaccine program

The public's appetite for preventative medicine, especially in oncology, is surging, and Anixa's breast cancer vaccine program is perfectly positioned to capitalize on this shift. The vaccine, developed in collaboration with Cleveland Clinic, targets a massive unmet need: primary prevention. With 42,170 expected breast cancer deaths in the U.S. in 2025, the focus is increasingly on stopping the disease before it starts.

This social demand is quantified by the projected growth of the global cancer vaccine market, which analysts estimate will grow at a 12.6% Compound Annual Growth Rate (CAGR) from 2025 to 2035, reaching $38.55 billion by 2035. The social acceptance of vaccines, broadly bolstered by the recent pandemic, provides a favorable backdrop for a prophylactic (preventative) cancer product. The preliminary Phase 1 results, showing that >70% of participants had protocol-defined immune responses, are defintely a key data point that will fuel public and investor excitement when the full results are presented in December 2025.

Increased awareness and acceptance of personalized medicine, supporting the CAR-T platform

The social and medical acceptance of personalized medicine-treatments tailored to an individual's genetic or cellular profile-is now mainstream. Anixa's chimeric endocrine receptor-T cell (CER-T) technology, a novel type of CAR-T therapy, is a direct beneficiary of this trend. This is not a niche concept anymore; it's a monumental shift in healthcare.

The company's CAR-T product, liraltagene autoleucel (lira-cel), which targets recurrent ovarian cancer, is a highly complex, personalized cellular therapy. The World Health Organization (WHO) approved the International Nonproprietary Name (INN) for lira-cel on November 17, 2025, a critical step that provides global recognition and streamlines future commercial communications. This INN approval is a social signal that the therapy is advancing from pure research into a recognized medicinal entity. The ongoing Phase 1 trial with Moffitt Cancer Center is currently progressing to the 5th dose cohort, demonstrating clinical momentum that builds confidence in the technology's viability.

Shifting demographics in the US, with an aging population needing more advanced cancer therapies

The aging U.S. population is the primary demographic tailwind for all oncology companies, including Anixa Biosciences. As of January 1, 2025, there are approximately 18.6 million Americans living with a history of cancer, a number projected to exceed 22 million by January 1, 2035.

The critical factor is that nearly four out of five (79%) of these cancer survivors are aged 60 years and older. This demographic segment drives the highest demand for both advanced treatment options (like CAR-T for recurrent cancer) and long-term preventative strategies (like the breast cancer vaccine). The sheer volume of the target market for the vaccine is compelling: the number of female breast cancer survivors alone is projected to increase by nearly 1 million from 2025 to reach 5.3 million by 2035. This is a huge, growing patient pool.

Ethical debates around gene therapy and CAR-T treatments influencing public perception

While the science is exciting, the social and ethical scrutiny of gene and cell therapies (CGTs) remains a major factor for Anixa's CAR-T program. The fundamental debate revolves around access and safety.

The cost of these therapies is a central ethical flashpoint, creating a risk of widening healthcare disparities, as the high price tags make them inaccessible to much of the global patient population. Anixa must be prepared to address this head-on as lira-cel advances toward later-stage trials.

Key ethical concerns in the CAR-T space include:

• Accessibility and reimbursement issues due to high costs.
• Managing the severe toxicities and side effects associated with CAR-T therapies.
• Ensuring truly informed consent, given that gene therapies are often a 'one and done,' irreversible treatment.

The public perception of risk is still evolving, and any serious adverse event in a CAR-T trial-even a competitor's-can create a significant, albeit temporary, social headwind for the entire sector. Anixa's strategy must include transparent communication of the safety data from the ongoing Phase 1 trial to build trust and manage patient expectations.

Anixa Biosciences, Inc. (ANIX) - PESTLE Analysis: Technological factors

Phase 1 data for the breast cancer vaccine showing strong immunogenicity is a key asset.

The core technological strength for Anixa Biosciences, Inc. is the promising early clinical data from its alpha-lactalbumin (aLA) breast cancer vaccine program, developed in partnership with Cleveland Clinic. You're looking for proof of concept, and the Phase 1 trial delivered a strong signal: preliminary findings, based on the final patient visits completed on October 7, 2025, showed that >70% of the 35 participants demonstrated protocol-defined immune responses. That's a defintely solid immunogenicity rate for a first-in-human vaccine targeting a retired protein.

The full data from this trial, which was funded by a U.S. Department of Defense grant, is set for presentation on December 11, 2025, at the San Antonio Breast Cancer Symposium (SABCS). This data is the critical technical foundation for advancing to Phase 2 trials, which will focus on efficacy in preventing recurrence or primary cancer. It validates the novel mechanism of action-targeting a protein that is typically only present during lactation but aberrantly expressed in certain breast cancers, like triple-negative breast cancer (TNBC).

Rapid advancements in chimeric antigen receptor T-cell (CAR-T) manufacturing reducing costs and time.

The broader CAR-T therapy landscape is in a rapid technological shift, which presents both an opportunity and a threat to Anixa Biosciences, Inc.'s autologous (patient-specific) chimeric endocrine receptor-T cell (CER-T) program for ovarian cancer. The global CAR-T market is projected to reach approximately $12.9 billion in 2025, but the complexity of autologous manufacturing remains a major restraint, with the average cost per patient ranging from $300,000 to $500,000. That's a huge barrier to access.

New manufacturing technologies, like automation, closed-loop systems, and non-viral vectors (e.g., CRISPR), are emerging to drive down costs. The biggest trend is the move toward allogeneic (off-the-shelf) CAR-T, where competitors like Allogene Therapeutics are expanding capacity to produce up to 60,000 doses annually, aiming to lower the per-dose price to around $150,000 by 2030. This competitive pressure means Anixa Biosciences, Inc. must find ways to reduce the vein-to-vein time for its autologous CER-T, which some rapid manufacturing platforms are now claiming can be completed in as little as one day.

Competition from large pharmaceutical companies with established oncology pipelines.

Anixa Biosciences, Inc. operates in an oncology space dominated by large, well-capitalized pharmaceutical companies. These giants are not standing still; they are aggressively acquiring and developing competing technologies in both cell therapy and novel immunotherapies. In 2025, oncology heavyweights like Roche, AstraZeneca, and Bristol Myers Squibb are leading the R&D pipeline race, backed by significant financial resources.

For example, Bristol Myers Squibb inked an $11 billion deal with BioNTech in June 2025 to co-develop a bispecific antibody for solid tumors, including a Phase 3 trial planned for triple-negative breast cancer-a direct competitive overlap with Anixa Biosciences, Inc.'s vaccine target. This is the reality: your breakthrough technology will face a wall of capital and established market presence. The current list of FDA-approved autologous CAR-T products, such as Yescarta (Kite Pharma/Gilead) and Abecma (Bristol Myers Squibb/2seventy bio), shows the formidable market leaders you are up against.

Need to defend and expand intellectual property (IP) around novel vaccine and CAR-T targets.

Given the intense competition, the intellectual property (IP) portfolio is Anixa Biosciences, Inc.'s primary defense. The company has been very active in 2025 to defend and expand this moat, which is crucial for a clinical-stage biotech.

The IP strategy is centered on two novel targets: the 'retired' protein alpha-lactalbumin for the vaccine and the Follicle Stimulating Hormone Receptor (FSHR) for the CAR-T (known as CER-T). The company secured a new U.S. patent (Patent Number 12,384,826) for its CAR-T technology in August 2025, extending protection until 2045. Similarly, a key U.S. patent (Patent Number 12,472,205) for the breast cancer vaccine is set to issue on November 18, 2025, which also extends protection into the mid-2040s. This is smart, aggressive IP management.

The global expansion of this protection is also a priority:

• U.S. CAR-T patent protection extended to 2045.
• U.S. Breast Cancer Vaccine patent protection extended into the mid-2040s.
• Chinese patent allowance for the breast cancer vaccine secured in August 2025, extending protection until 2040.

This strong, decades-long patent protection is what will allow Anixa Biosciences, Inc. to negotiate favorable licensing or acquisition terms down the road. It's the only way a small biotech can compete with the deep pockets of big pharma.

Anixa Biosciences, Inc. (ANIX) - PESTLE Analysis: Legal factors

Patents expiring or being challenged for key technologies could expose the company to competition.

Intellectual property (IP) protection is the bedrock of a clinical-stage biotech like Anixa Biosciences, Inc. You're essentially betting your entire valuation on the strength and longevity of these patents. The good news is that Anixa Biosciences has been actively strengthening its core IP in 2025, pushing out the major expiration risks that often plague the sector.

Specifically, the U.S. Patent and Trademark Office (USPTO) issued a new patent, U.S. Patent No. 12,472,205, on November 18, 2025, which covers key methods for the breast cancer vaccine technology. This single action extends the foundational IP protection for that program well into the mid-2040s. Also, the proprietary CAR-T technology received U.S. Patent No. 12,384,826 on August 12, 2025, extending its protection to 2045. That's a defintely strong competitive moat.

What this patent strength hides, however, is the constant risk of legal challenge, especially as programs advance. A competitor could still file an Inter Partes Review (IPR) to challenge patent validity, diverting significant capital. Given the company reported a $6.47 million net loss in Q3 2025, a protracted patent battle would be a serious drain on cash.

Strict compliance with Health Insurance Portability and Accountability Act (HIPAA) for patient data in trials.

Managing patient data during clinical trials is a high-stakes legal and ethical responsibility, particularly under the Health Insurance Portability and Accountability Act (HIPAA) in the US. The core risk here is managing the secure transfer and storage of protected health information (PHI) as trial sponsorship changes hands.

In a critical legal step, Anixa Biosciences executed a Data Transfer Agreement (DTA) with Cleveland Clinic on November 5, 2025. This DTA is necessary to transfer all relevant data and the Investigational New Drug (IND) application sponsorship for the breast cancer vaccine from Cleveland Clinic to Anixa Biosciences for the planned Phase 2 trial. The DTA itself is the legal mechanism to ensure the data transfer adheres to privacy and security rules.

Any failure to maintain strict control over this data-from anonymization protocols to physical security-could lead to severe penalties, reputational damage, and even the suspension of the clinical trial. You simply cannot afford a HIPAA violation in a Phase 2 trial. The company's 2025 filings acknowledge the general risk that clinical trials could fail to comply with cGCP (current Good Clinical Practice) regulations, which encompasses compliant data management.

Need to secure global regulatory approvals (e.g., European Medicines Agency (EMA)) for market expansion.

The path to global commercialization requires navigating stringent international regulatory bodies, most notably the European Medicines Agency (EMA). For Anixa Biosciences, this expansion is still a future opportunity, not a current regulatory hurdle, as there is no public record of a Marketing Authorisation Application (MAA) submission to the EMA as of late 2025.

The first concrete step toward global recognition for the CAR-T program occurred on November 17, 2025, when the World Health Organization (WHO) approved the International Non-Proprietary Name (INN) liraltagene autoleucel (lira-cel) for the novel FSHR-targeted CAR-T therapy. Securing an INN is a mandatory global milestone that simplifies regulatory communication and prescribing worldwide, paving the way for eventual EMA and other foreign filings.

The risk is the delay and cost. European market entry means new trials or bridging studies, plus managing the EMA's complex Clinical Trials Information System (CTIS). The company must allocate future capital to this process, which will be substantial considering their current financial position with a negative free cash flow of approximately -$3,293,000 as of April 2025.

Licensing agreements with partners, like the Cleveland Clinic, requiring careful management and adherence.

Anixa Biosciences operates on a partner-driven model, which means its legal structure is built on a complex web of exclusive, royalty-bearing licensing agreements. These contracts are the lifeblood of the company, but they also introduce significant legal and financial obligations.

Key licensing agreements include:

• Breast and Ovarian Cancer Vaccines: Exclusively licensed from Cleveland Clinic. The Clinic is entitled to royalties and other commercialization revenues from Anixa Biosciences.
• CAR-T Technology (CER-T): Exclusively licensed from The Wistar Institute.

The recent November 5, 2025, Data Transfer Agreement with Cleveland Clinic is a prime example of the continuous legal management required. This agreement is a formal step in transferring the IND sponsorship, which keeps the licensing agreement in good standing and allows the Phase 2 trial to proceed under Anixa Biosciences' control. Adherence to development milestones in these agreements is non-negotiable; failure to meet them could lead to loss of exclusive rights.

Here's the quick math on the financial side of these legal arrangements:

The next step is for Anixa Biosciences to complete the full transfer of the IND sponsorship for the breast cancer vaccine to finalize the legal transition of the Phase 2 trial.

Anixa Biosciences, Inc. (ANIX) - PESTLE Analysis: Environmental factors

You are a clinical-stage biotech, so your direct environmental footprint is small, but your indirect footprint-the supply chain for your CAR-T therapy, liraltagene autoleucel, and your vaccine programs-is a massive, unpriced risk. The key environmental challenge for Anixa Biosciences is managing the waste and energy intensity of your partners' manufacturing and clinical trial sites, especially as you advance toward potential commercialization.

Your business model, which relies on strategic collaborations, means you inherit the Environmental, Social, and Governance (ESG) risks of partners like Moffitt Cancer Center and The Wistar Institute. Given your focus on fiscal discipline and a low average annual cash burn of approximately $5-6 million, establishing a comprehensive, in-house environmental program is not a current priority, but the market will demand it post-approval.

Need for sustainable sourcing of reagents and materials for large-scale manufacturing post-approval.

The autologous CAR-T (Chimeric Antigen Receptor T-cell) process for liraltagene autoleucel is inherently resource-intensive, relying on a complex, patient-specific supply chain. While you are in Phase 1 trials, the industry trend is a shift toward sustainable sourcing to reduce the massive use of single-use plastics and reagents. Laboratories globally generate up to 5.5 million metric tons of plastic waste each year, which is a significant environmental liability you will assume at scale.

Scaling up your CAR-T therapy will require a move from transient transfection systems, which work for small clinical batches, to more efficient, closed, and scalable bioreactor systems. This transition is crucial for both cost and environmental reasons. The supply of critical raw materials, such as lentiviral vectors, is already unstable and capacity-constrained, forcing a sustainability-linked focus on a 'circular economy' for material reuse among suppliers.

Disposal regulations for biohazardous waste generated during CAR-T production and clinical trials.

The clinical trials for your CAR-T and vaccine candidates at sites like Moffitt Cancer Center generate regulated biohazardous waste, classified under federal and state rules. This includes bulk human blood, genetically modified T-cells, and sharps (needles, syringes). The disposal process is rigorous and costly, requiring specialized handling and incineration.

For every patient dosed in your Phase 1 CAR-T trial, the waste stream must be meticulously managed. The standard protocol involves:

• Segregating waste streams to maximize recycling of non-hazardous lab plastics.
• Double-bagging contaminated materials in red biohazard bags.
• Disposing of sharps in dedicated, rigid containers.

This is a non-negotiable compliance cost that will rise linearly with patient enrollment and exponentially upon commercial launch. You defintely must ensure your partners' waste management systems are fully compliant to avoid regulatory fines and reputational damage.

Pressure from investors and stakeholders to report on Environmental, Social, and Governance (ESG) metrics.

The market is increasingly demanding transparency on ESG performance, and your current disclosures primarily emphasize financial efficiency. Your Q1 2025 net loss of $3.213 million and cash position of over $17 million (as of May 2025) demonstrate capital discipline, but not environmental stewardship.

In the broader pharmaceutical sector, 90% of a company's total emissions are categorized as Scope 3, meaning they originate in the supply chain-the very area your CAR-T logistics fall under. Investors are actively driving this shift: a 2023 survey found that 30% of respondents cited pressure from investors as the main reason for adopting an ESG strategy. The absence of a formal ESG report or public environmental targets for Anixa Biosciences is a growing risk that could deter large, ESG-mandated institutional capital down the line.

Climate change potentially disrupting clinical trial sites or supply chain logistics in the long run.

Climate change introduces a significant, quantifiable risk to the time-sensitive, autologous 'vein-to-vein' supply chain for liraltagene autoleucel. Extreme weather events, such as floods or severe cold snaps, can damage infrastructure, ground flights, and disrupt the transport of the patient's cells and the final product.

The CAR-T supply chain relies on an unbroken cold chain for cryopreservation, which is extremely vulnerable to power outages or delays. The market for cold chain monitoring is expected to grow to more than $10 billion by 2026 just to manage this risk. Any disruption that compromises the temperature control of a patient's T-cells means losing the entire batch-a catastrophic failure for the patient and a substantial financial loss for the company.

Action: Finance/Operations must model the cost of a 14-day delay in the CAR-T supply chain due to a climate event, including the cost of lost product and re-dosing, and draft a formal climate resilience plan by Q2 2026.