Tiziana Life Sciences Ltd (TLSA): PESTLE Analysis [Nov-2025 Updated]

You're tracking Tiziana Life Sciences Ltd (TLSA) because its nasal-delivered drug, foralumab, offers a real advantage in the neuro-inflammatory space, but biotech is a high-stakes game. The near-term investment thesis is defintely defined by external forces: increased US scrutiny on drug pricing and high 2025 interest rates are headwinds, while the technological edge of their non-injectable delivery and growing patient demand are tailwinds. Critically, the company's estimated cash runway of roughly $45 million (Q3 2025 estimate) extends only into late 2026, making the upcoming Phase 2 data readout for Secondary Progressive Multiple Sclerosis (SPMS) an absolute must-watch event. Below is the unvarnished PESTLE map you need to make a sharp decision.

Tiziana Life Sciences Ltd (TLSA) - PESTLE Analysis: Political factors

You're a clinical-stage biotech, so political factors hit you on two fronts: regulatory speed and future pricing power. For Tiziana Life Sciences, the political landscape in late 2025 is a mixed bag-a definite tailwind from regulatory acceleration is battling a strong headwind from persistent drug pricing scrutiny.

The key takeaway is that recent US legislation has strengthened the financial incentive for your lead candidate, intranasal foralumab, which is a major win. But, that win is offset by the administration's continued focus on lowering drug costs for the broader market.

Increased US Congressional scrutiny on drug pricing reform remains a risk.

The political pressure to lower prescription drug costs in the US is not slowing down; in fact, it's getting more focused. While the Inflation Reduction Act (IRA) of 2022 established the Medicare Drug Price Negotiation Program, the political debate in 2025 has centered on expanding its scope and increasing transparency.

For a small-cap biotech like Tiziana Life Sciences, this scrutiny creates significant uncertainty for future revenue models. The risk isn't just Medicare price negotiation; it's the broader political push for price control mechanisms, like the executive order signed in May 2025, which called on drugmakers to cut US medicine prices to match the lowest price offered in other developed nations. This 'Most-Favored-Nation' policy, if fully implemented, would fundamentally disrupt the risk models that support early-stage biotech investment.

Here's the quick math on the company's current financial position against this risk: Tiziana Life Sciences reported a total comprehensive loss of $5.3 million for the six months ended June 30, 2025. This loss is typical for a clinical-stage company, but it means the company is entirely reliant on future pricing power to recoup its R&D investment. Any new, broad price controls could severely devalue the entire pipeline, regardless of its clinical success.

Faster FDA approval pathways (e.g., Fast Track) for neuro-inflammatory diseases could accelerate foralumab.

The political-regulatory environment has been highly supportive of therapies for high-unmet-need conditions, and Tiziana Life Sciences has capitalized on this. The US Food and Drug Administration (FDA) has already granted Fast Track designation for intranasal foralumab for the treatment of non-active Secondary Progressive Multiple Sclerosis (na-SPMS). This designation is a direct political-regulatory benefit, allowing for more frequent meetings with the FDA and a potentially expedited review process.

This regulatory acceleration is a clear opportunity for Tiziana Life Sciences to reach market faster than a typical drug. The company has also received FDA approval for its Investigational New Drug (IND) application to commence a Phase 2a clinical trial for intranasal foralumab in Multiple System Atrophy (MSA) in August 2025, a disease that is also an orphan designated disease in the US. The political will to speed up approval for neuro-inflammatory diseases is a tangible asset for the company.

Geopolitical stability is crucial for international clinical trial sites and supply chain logistics.

While Tiziana Life Sciences is headquartered in London, United Kingdom, and its current Phase 2 clinical trials for na-SPMS are primarily in the US (e.g., Johns Hopkins University, Brigham and Women's Hospital), the company's long-term success requires a stable global environment for manufacturing and commercialization. The company's participation in global events like BIO-Europe 2025 in Vienna, Austria, and the Life Science Innovation Forum 2025 in Riyadh, Saudi Arabia, shows an active push for international partnerships and investment.

The geopolitical risk here centers on the supply chain for a biologic product like foralumab (a fully human anti-CD3 monoclonal antibody). Disruptions in global trade, or political instability in regions hosting key suppliers of raw materials or drug product services, could halt manufacturing. Tiziana Life Sciences' strategy must account for potential supply chain fragmentation, especially as global trade tensions remain high. A single, clean supply chain is defintely the goal, but political reality demands redundancy.

Potential changes in Orphan Drug Act incentives could impact future development strategy.

The good news is the political risk to Orphan Drug Act (ODA) incentives has been largely mitigated, and in fact, improved, in 2025. The Inflation Reduction Act (IRA) initially created a disincentive by limiting the Medicare price negotiation exemption to drugs with only a single orphan disease indication, discouraging companies from pursuing a second rare disease approval.

However, the One Big Beautiful Bill Act (OBBBA), signed into law in July 2025, reversed this. This new legislation expanded the Orphan Drug Exclusion, meaning a drug like foralumab, which has an Orphan Drug Designation for Multiple System Atrophy (MSA), can pursue additional rare disease indications without losing its valuable exemption from mandatory Medicare price negotiation. This change is a powerful, pro-innovation incentive for Tiziana Life Sciences.

The political action directly supports Tiziana Life Sciences' strategy of developing foralumab for multiple neuro-inflammatory and neuro-degenerative conditions, including na-SPMS, MSA, and ALS. This political clarity makes the development path for multiple orphan indications significantly more financially viable.

• Action: Review the new OBBBA provisions to confirm foralumab's eligibility for a complete exemption from Medicare price negotiations, provided it is not approved for any non-orphan uses.
• Owner: Legal & Strategy Team: Confirm OBBBA compliance by December 15, 2025.

Tiziana Life Sciences Ltd (TLSA) - PESTLE Analysis: Economic factors

High interest rates in late 2025 increase the cost of capital for future financing rounds.

The macroeconomic environment in late 2025 presents a clear headwind for clinical-stage companies like Tiziana Life Sciences Ltd, primarily through the elevated cost of capital. The Federal Reserve's target for the federal funds rate was recently lowered to a range of 3.75%-4.00% at its October 2025 meeting, following two cuts this year. While this signals a slight easing, the rate remains historically high, especially compared to the near-zero rates of the past decade. This means any future equity or debt financing-a necessity for a non-revenue-generating biotech-will be more expensive, leading to greater shareholder dilution or higher interest payments.

For Tiziana Life Sciences Ltd, which has no current revenue, the higher discount rate used in a discounted cash flow (DCF) valuation model will naturally compress its present value. Simply put, money you raise today costs more, and future profits are worth less. This is a tough environment for early-stage growth. The average one-year price target for Tiziana Life Sciences Ltd is around $8.16, and a persistent high-rate environment makes meeting that valuation target harder without a major clinical win.

The company's projected cash runway of approximately $45 million (Q3 2025 estimate) extends into late 2026.

You need to be a realist about the company's cash position. While the market might hope for a long runway, the actual cash on hand is significantly lower than the $45 million figure sometimes cited. Tiziana Life Sciences Ltd reported cash and cash equivalents of $7.3 million as of June 30, 2025, with an additional $2 million raised post-period end. This brings the total cash to approximately $9.3 million. The company's total comprehensive loss for the first half of 2025 was $5.3 million. Here's the quick math on their actual runway based on that burn rate:

What this estimate hides is that the runway is closer to 10.5 months, extending only into the third quarter of 2026, not late 2026. This tighter cash position makes the timing and success of their clinical milestones even more critical for securing a non-dilutive partnership or a favorable follow-on financing round.

Near-term valuation is heavily dependent on the Phase 2 data readout for Secondary Progressive Multiple Sclerosis (SPMS).

The single most important economic driver for Tiziana Life Sciences Ltd is the clinical data readout for intranasal foralumab in non-active Secondary Progressive Multiple Sclerosis (na-SPMS). The blinded portion of the Phase 2a trial is expected to be completed by the end of 2025. A positive readout will be the primary catalyst for a significant re-rating of the stock, potentially justifying a much higher valuation and providing leverage for partnership negotiations. Conversely, a negative or inconclusive result would trigger a sharp decline and force a highly dilutive capital raise at a lower valuation.

The valuation hinges on these binary outcomes:

• Positive Data: Confirms the drug's mechanism of action and efficacy, leading to a massive increase in the net present value (NPV) of the asset.
• Negative Data: Immediately shortens the effective cash runway by eliminating the primary catalyst for a non-dilutive funding event.

The market is defintely watching for this end-of-year data. It's the make-or-break moment for the near-term economic trajectory of the company.

Inflationary pressures are raising the cost of clinical trial operations and manufacturing.

Even with inflation cooling slightly, cost pressures remain a major concern for the biotech sector, directly impacting Tiziana Life Sciences Ltd's burn rate. The US Consumer Price Index (CPI) for all items increased 3.0% for the 12 months ending September 2025. More relevantly, clinical trial costs are rising due to high labor demand for specialized staff, increasing material costs for consumables and reagents, and geopolitical factors affecting supply chains.

The medical care index, a proxy for some clinical costs, rose 0.2% in September 2025 alone. This persistent inflation means the company's estimated monthly burn of approximately $0.88 million could creep higher, further shortening the already tight cash runway. The key challenge is that the cost of running the 54-patient na-SPMS Phase 2a trial is subject to these rising costs, increasing the total capital required to reach the next milestone.

Finance: Track monthly actual clinical trial expenses against budget to detect inflationary creep by the 15th of each month.

Tiziana Life Sciences Ltd (TLSA) - PESTLE Analysis: Social factors

You're looking at the social landscape for Tiziana Life Sciences Ltd and its lead candidate, foralumab, and the picture is one of accelerating patient demand and a clear preference shift in treatment methods. This environment is highly favorable for a novel, non-injectable therapy targeting neuroinflammation.

The core social factors-patient awareness, acceptance of new drug delivery, the drive for personalized care, and the simple demographics of an aging global population-are all strong tailwinds for Tiziana Life Sciences' anti-CD3 monoclonal antibody program.

Growing patient advocacy and awareness for neurodegenerative diseases like Multiple Sclerosis (MS) drives demand for novel treatments.

Patient advocacy groups for neurodegenerative diseases are defintely a powerful force, creating urgency and driving funding for new therapies. This heightened awareness translates directly into a larger, more engaged patient pool actively seeking options beyond current standards of care, especially for progressive forms of diseases where options are limited.

Here's the quick math on the sheer scale of the patient burden in the US, which fuels this advocacy:

• An estimated 7.2 million Americans aged 65 and older are living with Alzheimer's Disease (AD) in 2025.
• The US health and long-term care costs for people living with dementia are projected to reach $384 billion in 2025.
• Globally, about 1.89 million people live with Multiple Sclerosis (MS), a burden that is continuously rising.

This massive, growing cost and prevalence has led to national goals, like the US National Alzheimer's Plan, which aims to prevent and effectively treat Alzheimer's disease by 2025. This focus creates a clear market need for a drug like foralumab, which is currently in a Phase 2 trial for early-stage AD.

Increased public acceptance of non-injectable, orally administered therapies (like foralumab's nasal/oral route) is a market advantage.

Patients are tired of needles. The market for chronic disease management, particularly in conditions like MS and Crohn's disease, shows a clear trend toward non-injectable, patient-friendly routes of administration to improve adherence and quality of life. Foralumab's intranasal delivery is a major social and commercial advantage because it bypasses the need for intravenous (IV) infusion or subcutaneous injection.

The entire pharmaceutical industry is chasing this convenience. For example, the FDA's review of Sanofi's oral, brain-penetrant Bruton's tyrosine kinase (BTK) inhibitor, tolebrutinib, for non-relapsing secondary progressive MS (nrSPMS) has a revised target action date of December 28, 2025. This development underscores the market's move toward non-injectable therapies that can target the central nervous system (CNS).

Foralumab's innovative intranasal route is designed to be a safer, more targeted way to modulate the immune system, which is a significant selling point for patients facing lifelong treatment.

Societal focus on personalized medicine could benefit the targeted anti-CD3 mechanism.

The shift from a 'one-size-fits-all' approach to personalized medicine (PM) is a dominant theme in 2025 healthcare strategy. This trend favors Tiziana Life Sciences because foralumab's mechanism of action is inherently targeted.

Foralumab is a fully human anti-CD3 monoclonal antibody that works by stimulating T regulatory cells (Tregs) in the cervical lymph nodes, which then migrate to the CNS to suppress pathogenic inflammation and restore microglial homeostasis. This is precision medicine in action.

The focus is on using biomarkers to guide treatment, and foralumab's trials are measuring reductions in microglial activation, a key marker of neuroinflammation. This aligns perfectly with the societal and scientific push for a stronger precision medicine approach in neurodegenerative diseases.

Global aging population increases the overall prevalence of target diseases like Crohn's and MS.

The demographic reality of an aging global population ensures a continuously expanding patient base for neurodegenerative and autoimmune diseases. The sheer increase in the number of older adults, particularly the aging Baby Boomer generation, is a core driver for the rising prevalence of conditions like Alzheimer's Disease and Multiple System Atrophy (MSA).

While MS and Crohn's disease often onset earlier, their prevalence is also rising, and the chronic nature of these conditions means patients require long-term treatment as they age. This demographic shift guarantees a growing market for Tiziana Life Sciences' pipeline over the next two decades.

The table below illustrates the growing patient populations for foralumab's key target diseases:

The expanding patient population, coupled with the lack of effective treatments for progressive forms of these diseases (like non-active Secondary Progressive MS and MSA), makes the social need for Tiziana Life Sciences' innovative therapy acute and compelling.

Tiziana Life Sciences Ltd (TLSA) - PESTLE Analysis: Technological factors

Nasal and oral mucosal delivery technology for foralumab offers a significant competitive differentiation over traditional injectables

The most significant technological advantage Tiziana Life Sciences has right now is its proprietary nasal and oral mucosal delivery platform for foralumab, which is the only fully human anti-CD3 monoclonal antibody currently administered intranasally. This non-systemic delivery route is a game-changer because it allows the drug to engage the immune system directly in the brain's environment, potentially modulating T regulatory cells (Tregs) with minimal systemic side effects compared to traditional intravenous (IV) infusion.

This technology is not just a convenience; it is a critical differentiator in the neuroinflammatory and autoimmune space. The company is actively testing this platform in multiple Phase 2 clinical trials, demonstrating its broad potential beyond the initial focus on Multiple Sclerosis (MS).

• Intranasal Foralumab Trials (2025 Focus):
  • Non-active Secondary Progressive Multiple Sclerosis (na-SPMS): Phase 2 trial results expected late 2025.
  • Multiple System Atrophy (MSA): Phase 2a trial dosed first patient in August 2025.
  • Early Alzheimer's Disease and ALS: Phase 2 studies are about to commence as of late 2025.

Advancements in biomarker identification could refine patient selection for clinical trials, improving success rates

The industry-wide revolution in biomarker identification is a huge tailwind for Tiziana Life Sciences. Precision medicine, driven by new technologies like single-cell analysis and multi-omics, is moving from a buzzword to a clinical reality, which is defintely critical for a company with a drug targeting the immune system. This allows for a much more accurate selection of patients most likely to respond to foralumab, dramatically improving the odds of a successful trial outcome.

Tiziana Life Sciences is already capitalizing on this trend, announcing the discovery of new immune biomarkers in na-SPMS patients treated with nasal foralumab in January 2025. Identifying these specific immune signatures-like the reduction in microglial activation seen in earlier studies-is how you refine a protocol, cut out non-responders, and make your data cleaner. This is how you make a Phase 2 trial count.

Use of Artificial Intelligence (AI) in clinical trial design is reducing costs and shortening timelines

For a clinical-stage company with a current focus on R&D, embracing Artificial Intelligence (AI) in trial design and execution is not optional; it is a capital preservation strategy. The AI in clinical trials market is experiencing explosive growth, expanding from an estimated $7.73 billion in 2024 to $9.17 billion in 2025. That's a compound annual growth rate of nearly 19%.

Here's the quick math on the opportunity: AI-powered patient recruitment alone has been shown to reduce overall clinical trial costs by up to 70% and expedite timelines by as much as 40%. Given that Tiziana Life Sciences reported a total comprehensive loss of $4.7 million for the six months ended June 30, 2024, any meaningful reduction in the cost of their multi-indication Phase 2 pipeline directly extends their cash runway. They need to use AI to find the right patients fast.

Competition from novel gene therapies and next-generation biologics remains a long-term threat

While foralumab's nasal delivery offers a unique angle, the broader technological landscape of autoimmune and neuroinflammatory diseases is moving incredibly fast, and competition from next-generation therapies is a long-term threat. These competing technologies are also aiming for disease modification, not just symptom management.

The primary competition comes from advanced biologics and cell therapies that are pushing the boundaries of immune system reset.

The risk is that a competitor's next-generation biologic or cell therapy achieves a more profound or durable immune tolerance effect in one of Tiziana Life Sciences' target indications, potentially leapfrogging the nasal delivery advantage.

Tiziana Life Sciences Ltd (TLSA) - PESTLE Analysis: Legal factors

Strict intellectual property (IP) protection for foralumab is critical for attracting a major licensing partner.

The core legal and financial asset for Tiziana Life Sciences Ltd is the intellectual property (IP) surrounding foralumab, which is the only fully human anti-CD3 monoclonal antibody in clinical development. You need to see this IP as the key collateral for any major licensing deal, particularly as the company advances its multiple Phase 2 programs.

The IP for foralumab was in-licensed from Novimmune SA in December 2014. The value of this asset is tied directly to the remaining patent life and the strength of the pending applications for the intranasal delivery method, which is Tiziana's unique differentiator. A major pharmaceutical partner, like a BlackRock portfolio company would look for, requires a minimum of 10-12 years of unencumbered market exclusivity to justify a multi-billion dollar upfront payment and royalty structure. The company's technology for alternative routes of immunotherapy has several patent applications pending, which is defintely a good sign for extending market exclusivity.

Here's the quick math: a licensing deal for a successful Phase 2 asset in a neurodegenerative disease like Multiple Sclerosis can easily involve an upfront payment of $100 million to $500 million, plus milestones, but only if the IP runway is clear.

Ongoing regulatory compliance costs for Phase 2 and Phase 3 trials are substantial.

Tiziana Life Sciences Ltd is currently running multiple Phase 2 clinical trials for intranasal foralumab in high-cost therapeutic areas like non-active Secondary Progressive Multiple Sclerosis (na-SPMS), Multiple System Atrophy (MSA), and Alzheimer's disease. The sheer volume of concurrent trials means regulatory compliance costs are compounding quickly.

The cost of simply running these trials is the primary financial risk for a clinical-stage biotech. A typical Phase 2 efficacy study in 2025 costs an average of $13.5 million, with the range spanning from $7 million to $20 million. Moving to a pivotal Phase 3 trial, which is the next step for na-SPMS, will see costs explode, often exceeding $20 million to $100+ million.

Regulatory compliance-which includes all the necessary documentation, audits, and submissions to bodies like the FDA-accounts for approximately 10% of that total clinical trial budget. This percentage translates to a direct, non-negotiable legal and financial burn. The company's forecasted negative Return on Equity (ROE) of -260.7% and an estimated Earnings Per Share (EPS) of -$0.18 for the fiscal year ending December 2025 underscore that all capital is currently being consumed by R&D and regulatory overhead.

Potential for class-action lawsuits related to drug side effects, common in the biotech sector, requires robust risk management.

The biotech sector is a magnet for litigation, especially securities class actions and product liability claims. This is a clear, near-term risk you must account for. In 2024, there were 52 federal securities class actions filed against life sciences companies, confirming the industry remains the largest target for this type of litigation.

While foralumab has shown a favorable safety profile to date, the transition to larger patient populations in Phase 2 and eventual Phase 3 trials significantly increases the risk exposure to unforeseen side effects. The financial impact of this risk is severe: the average securities class action settlement in the first half of 2025 jumped to $56 million, up 27% from the prior year. The median settlement was $12.5 million.

For context, product liability lawsuits, which are the ultimate risk, have resulted in multi-billion dollar settlements for other companies, such as the Fen-Phen diet drug case settling for $3.75 billion. Tiziana Life Sciences Ltd must maintain robust Directors & Officers (D&O) and product liability insurance policies, and you should review their coverage limits against the current average settlement values. It's a high-stakes game.

Evolving international data privacy laws (e.g., GDPR) complicate global clinical data collection.

As Tiziana Life Sciences Ltd is a Bermuda-incorporated company with its lead candidate in US clinical trials, and potential global commercialization, it must comply with a patchwork of international data privacy laws, most notably the European Union's General Data Protection Regulation (GDPR). This complicates the collection and storage of patient data from global clinical sites.

For a mid-sized, clinical-stage company, the annual cost of maintaining GDPR compliance-covering legal consultation, technical implementation, and ongoing monitoring-averages around €1.3 million ($1.4 million). Even the initial setup and ongoing maintenance for a company of this complexity can range from $100,000 to $500,000.

The penalties for non-compliance are severe and non-negotiable. A significant breach of GDPR can result in fines of up to €20 million or 4% of global annual turnover, whichever is higher, plus the average cost of a data breach remediation, which is about €3.94 million. This legal exposure is a critical, unhedged risk that grows with every new international trial site.

Tiziana Life Sciences Ltd (TLSA) - PESTLE Analysis: Environmental factors

Need for a sustainable supply chain for biologic drug manufacturing, reducing carbon footprint

You are developing a biologic drug, intranasal Foralumab, which is a fully human anti-CD3 monoclonal antibody (mAb). The environmental challenge here is significant, even though Tiziana Life Sciences is currently a clinical-stage company with a TTM Net Income of -$12.84 million as of June 2025, meaning its current operational footprint is small. Once you move to commercial-scale manufacturing, the carbon footprint will spike. The biotechnology and pharmaceutical sector's total carbon emissions reached 193 million metric tons of carbon dioxide equivalent in 2022, and the industry is under pressure to reduce its emissions intensity by roughly 59% from 2015 to 2025 to meet Paris Agreement goals.

Biologic drug manufacturing, which uses cell cultures, is energy-intensive, requiring high-purity water and temperature-controlled logistics (cold chain) for global distribution. This is where the environmental risk lies. Your primary action now is to select contract manufacturing organizations (CMOs) that have already committed to Science Based Targets Initiative (SBTi) goals, or you will inherit their high Scope 3 emissions (supply chain emissions) upon commercial launch.

Here's the quick math on the future challenge for a commercialized biologic:

• Energy Use: Biopharma processes require high-demand, energy-intensive equipment.
• Water: Responsible water management is crucial, especially in regions with water scarcity.
• Cold Chain: Transporting mAbs like Foralumab requires constant refrigeration, significantly increasing logistics-related carbon emissions.

Proper disposal of clinical trial waste and hazardous biological materials is a legal and ethical requirement

Tiziana Life Sciences is actively conducting multiple Phase 2 clinical trials for Foralumab, including in Multiple System Atrophy (MSA) and Mild Alzheimer's Disease, with dosing starting in 2025. These trials generate hazardous biological waste, including used syringes, needles, and contaminated materials from dosing sites like Johns Hopkins University and Brigham and Women's Hospital. Proper disposal is not just an ethical requirement; it's a strict legal mandate under the Resource Conservation and Recovery Act (RCRA) in the US, and non-compliance carries heavy fines.

While only about 15% of total healthcare waste is classified as hazardous, the volume of single-use bioprocessing systems is rising. The industry globally landfills or incinerates approximately 30,000 tons of these single-use products each year. You must ensure your clinical research organizations (CROs) and clinical sites adhere to rigorous waste segregation and disposal protocols, especially for a fully human monoclonal antibody (mAb) like Foralumab, which is considered a biohazard.

Environmental, Social, and Governance (ESG) investor pressure is increasing, requiring transparent reporting on drug access

ESG is no longer a niche concern; it's a critical factor for institutional investors like BlackRock, which manage trillions. While Tiziana Life Sciences is a 'Non-participating company' in the S&P Global Corporate Sustainability Assessment, meaning it lacks a formal, self-reported ESG score, the pressure for transparency is still there. Investors are increasingly looking beyond just the 'E' (Environmental) to the 'S' (Social), specifically drug access, especially for therapies targeting debilitating diseases like Multiple Sclerosis (MS) and ALS, which are key indications for Foralumab.

The market capitalization of Tiziana Life Sciences is relatively small, at approximately $185 million as of June 2025, but attracting large-scale, long-term capital requires a clear ESG narrative. You need to start detailing a clear drug access strategy now, before commercialization, to satisfy this growing investor demand. A lack of transparency can lead to a higher cost of capital down the line. You defintely need a clear plan for your social impact.

Climate change impacts on logistics and manufacturing sites are a minor, but growing, operational risk

For a company like Tiziana Life Sciences, which is not vertically integrated and relies on contract manufacturing and clinical sites, the direct physical risk from climate change is low, but the indirect operational risk is growing. Severe weather events-hurricanes, floods, extreme heat-can disrupt the cold chain logistics required for shipping biologic drug substance or finished product.

The risk is concentrated in two areas:

• Supply Chain Interruption: Delays in shipping clinical trial materials due to weather can impact trial timelines for indications like Mild Alzheimer's Disease and ALS, where Phase 2 trials are slated to begin in the second half of 2025.
• Manufacturing Site Vulnerability: Your CMOs' geographic locations could be prone to climate-related events, impacting production yield and continuity.

This is a low-probability, high-impact risk. You should be stress-testing your supply chain continuity plan against climate-related disruption, especially considering the global trend of less predictable water availability and extreme temperatures.