Inhibikase Therapeutics, Inc. (IKT): PESTLE Analysis [Nov-2025 Updated]

You're looking for a clear, actionable breakdown of the external forces shaping Inhibikase Therapeutics, Inc. (IKT) right now, because in pre-revenue biotech, macro factors often matter more than the pipeline's science alone. We can't nail down the exact 2025 revenue figures yet, but what we can map is the defintely critical PESTLE terrain, from the 4% estimated rise in clinical trial costs due to inflation to the clear M&A exit opportunities in the neurology space. This isn't just theory; it's the critical framework for understanding IKT's near-term risks, like the high cost of capital, and the tailwinds, such as increased FDA focus on neurological diseases, that will drive their stock performance and operational risks into 2026.

Inhibikase Therapeutics, Inc. (IKT) - PESTLE Analysis: Political factors

US political pressure on drug pricing remains high, impacting future revenue models.

You need to be defintely clear on the political headwinds hitting your future revenue projections. The primary risk for Inhibikase Therapeutics, Inc. (IKT) is the aggressive push by the US administration in 2025 to curb drug prices, which directly threatens the high-margin model for novel neurological therapies.

The administration's focus is on the Most-Favored-Nation (MFN) policy, which ties US drug prices to the lowest prices paid in other developed nations. In May 2025, an Executive Order was signed to advance this. Later, in July 2025, letters were sent to 17 major pharmaceutical companies demanding a binding commitment to MFN pricing for new drugs and for all Medicaid patients. This is a huge, immediate threat to the pricing power of any drug IKT brings to market.

To be fair, some companies are already caving. Pfizer, for instance, signed a deal in September 2025 to sell some of its drugs on a new direct-to-consumer website for about 85% less than the current price. That's the quick math on the potential revenue hit.

The political leverage is real, and it's tied to trade policy, with the threat of up to a 100% tariff on patent-protected drugs being used as a bargaining chip.

Increased FDA funding and focus on neurological diseases could speed approvals.

On the flip side, the regulatory environment for neurological diseases is getting a clear political tailwind. The US Food and Drug Administration (FDA) is prioritizing neurodegenerative conditions, which is exactly where IKT operates.

The FDA's Center for Drug Evaluation and Research (CDER) is leaning heavily on expedited programs (Fast Track, Breakthrough Therapy, Priority Review) to accelerate the review of drugs for serious conditions with unmet needs. In 2024, 66% of all novel drug approvals used one or more of these programs. That's a high-speed lane for a company like Inhibikase Therapeutics, Inc. (IKT).

This focus is translating into tangible approvals in 2025. For example, in February 2025, the FDA approved Supernus Pharmaceuticals' SPN-830 for advanced Parkinson's disease. Fast Track designations were also granted to other therapies for conditions like multiple system atrophy and Alzheimer's, showing the agency is actively identifying and accelerating promising candidates. This political and regulatory focus helps shorten your time-to-market, which is everything in biotech.

Global trade tensions affect supply chains for clinical trial materials.

The geopolitical landscape is making the logistics of running a global clinical trial more expensive and volatile. For IKT, which relies on a global supply chain for its Active Pharmaceutical Ingredients (APIs) and other trial materials, this is a clear near-term risk.

Recent US trade policy shifts have materially increased cost pressures. Specifically, a consolidated tariff of 55% on Chinese imports came into effect in June 2025. Plus, new US tariffs of 15% on medicines from the European Union were agreed upon later in the year. This is not just a theoretical cost; it's a direct inflation on your Cost of Goods Sold (COGS) for clinical supplies.

The dependency is critical:

• Up to 82% of API building blocks for vital drugs come from China and India.
• Tariffs on these inputs cause delays and increase trial budgets.
• Companies are being forced to diversify suppliers or stockpile materials, tying up precious cash flow.

So, your procurement team needs to be actively de-risking the supply chain for IkT-148009's clinical development now.

Government grants for neurodegenerative research are a key non-dilutive funding source.

The political commitment to fight neurodegenerative diseases translates into significant non-dilutive funding opportunities, which is cash that doesn't require giving up equity. The National Institute on Aging (NIA), a primary funder for Alzheimer's Disease and Related Dementias (AD/ADRD) research, has a strong budget for the 2025 fiscal year.

This is a crucial funding avenue for a small-cap biotech like IKT, which can use these grants to offset early-stage research costs.

Here's the quick math on the NIA's AD/ADRD-related budget for FY 2025:

• Research Centers grants: Total funding of $342.3 million, an increase of $68.2 million from FY 2023.
• Research & Development Contracts: Total funding of $207.2 million, an increase of $35.7 million.
• The NIA plans to award a total of 144 Research Centers grants, up by 21 from FY 2023.

This clear, sustained political support for neurodegenerative research means IKT should prioritize applications for Small Business Innovation Research (SBIR) and other non-dilutive grants to extend its cash runway.

Inhibikase Therapeutics, Inc. (IKT) - PESTLE Analysis: Economic factors

High interest rates increase the cost of capital for pre-revenue biotech firms.

You're running a clinical-stage company, Inhibikase Therapeutics, Inc., which means you have no commercial revenue and rely entirely on external financing. That's a tough spot in late 2025 because the sustained high-interest-rate environment has significantly raised your cost of capital (the return investors demand for their money).

Here's the quick math: when the Federal Reserve keeps rates high, investors can get a better, safer return on treasury bonds, so they demand a much higher premium to fund a risky biotech venture. This is why about 40% of public biotech companies are currently operating with less than a year's cash runway, according to mid-2025 estimates. To be fair, you secured a major private placement in October 2024 with gross proceeds of approximately $110 million, which was a smart move to fund your lead program, IKT-001.

Still, any new financing, whether debt or equity, comes at a higher effective cost, either through increased interest payments or greater shareholder dilution. That's a defintely a headwind for long-term R&D planning.

Inflationary pressure raises clinical trial operational costs.

Inflation isn't just hitting the grocery store; it's hitting the lab and the clinic hard. The inflationary pressure, compounded by geopolitical trade policies like expanded U.S. tariffs on APIs (Active Pharmaceutical Ingredients) and lab reagents, is forcing up your operational costs for clinical trials.

The original estimate of a 4% rise is actually too low. Data from mid-2025 shows that tariff-related supply price hikes have inflated input costs for early-phase trials by as much as 8% in some cases. More broadly, the average per-patient trial costs in the U.S. rose by 12% compared to 2023, which is a major jump. For your upcoming Phase 2b IMPROVE-PAH trial, which is expected to enroll 150 participants, this cost creep is a serious budget risk that demands tight management.

This increased cost is driven by several factors:

• Higher costs for reagents and consumables due to tariffs (up to 25% on some goods).
• Increased patient recruitment and retention costs for complex trials.
• Rising salaries for specialized clinical research staff.

Capital market volatility makes secondary offerings a risky funding option.

While the biotech market has shown signs of recovery, volatility remains a clear risk, especially for secondary offerings (selling more stock to the public). You saw this risk play out in real-time in November 2025. Inhibikase Therapeutics announced a proposed underwritten public offering to raise approximately $93.6 million to $100 million to fund your Phase 3 development of IKT-001.

The market's immediate reaction was cautious; your stock fell 2.6% in after-hours trading following the announcement. This drop, even on positive news of advancing to Phase 3, shows how risk-averse investors are to dilution right now. The offering was necessary, but it came at a significant cost to the existing share price, which was already down nearly 53% year-to-date as of November 2025.

The table below summarizes your recent capital market activities:

Strong M&A activity in the neurology space presents a clear exit opportunity.

The good news is that Big Pharma is sitting on a mountain of cash-estimated to be over $1.5 trillion in deal capacity for 2025-and they need to refill their pipelines due to looming patent cliffs. This is driving a resurgence in mergers and acquisitions (M&A), especially in specialized therapeutic areas like neuroscience and rare diseases. Your focus on Pulmonary Arterial Hypertension (PAH) is a rare disease, and your original platform targets Abelson Tyrosine Kinase inhibition, which has applications in neurodegenerative disease.

This creates a clear exit opportunity. We've seen major deals in 2025, such as Sanofi's acquisition of Vigil Neuroscience in August 2025 to strengthen its neurology pipeline. Your lead asset, IKT-001, is a pro-drug of imatinib mesylate for PAH, an orphan indication, which makes it a highly attractive, de-risked asset for a large pharmaceutical company looking for near-term revenue potential and a focused therapeutic expertise. The key now is to hit the clinical milestones in the IMPROVE-PAH trial to maximize that valuation.

Inhibikase Therapeutics, Inc. (IKT) - PESTLE Analysis: Social factors

Aging US population drives demand for Parkinson's and MSA treatments

The most fundamental social driver for Inhibikase Therapeutics, Inc. (IKT) is the rapidly aging US population, which directly correlates with the prevalence of neurodegenerative diseases like Parkinson's disease (PD) and Multiple System Atrophy (MSA). The sheer scale of the patient population creates a massive, enduring market opportunity.

You need to recognize that PD is already a major public health concern, with an estimated 1.1 million people in the U.S. living with the disease today. This number is projected to climb to 1.2 million by 2030, meaning the target market is growing by approximately 90,000 new diagnoses each year. The economic burden is staggering, too; the combined direct and indirect cost of Parkinson's in the U.S. is estimated to be nearing $61.5 billion per year in 2025. That's a huge addressable market for any disease-modifying therapy like IKT's IkT-148009.

MSA, while rarer, also presents a significant unmet need. The Multiple System Atrophy market size is estimated at $155.1 million in 2025 and is projected to grow at a Compound Annual Growth Rate (CAGR) of 4.7%. The U.S. patient pool is estimated to be around 41,122 people, with a prevalence of 12.4 per 100,000 population. The demand for novel treatments for these diseases is defintely not going away.

Growing patient advocacy groups influence clinical trial recruitment and design

Patient Advocacy Groups (PAGs) have evolved from simple support networks into powerful stakeholders that can make or break a clinical trial's timeline. They are the gatekeepers to the patient community, and their influence is felt directly in recruitment and protocol design.

IKT understands this well. The company has actively engaged in a physician and patient awareness campaign for its Phase 2 '201' trial evaluating IkT-148009 in Parkinson's disease, including launching a dedicated online patient portal. This kind of direct engagement, often facilitated by PAGs like the Parkinson's Foundation or The Michael J. Fox Foundation, is now a necessity.

PAGs help a company in several critical ways:

• Accelerate patient enrollment by acting as trusted intermediaries.
• Provide key insights to design patient-centric trials, reducing dropout rates.
• Influence regulatory bodies to accept patient-centric endpoints.

Plus, IKT is seeking grant funding for its '202' trial in Multiple System Atrophy through The National Institute of Neurological Diseases and Stroke (NINDS), which is an area where groups like the MSA Coalition are extremely influential in directing research priorities and patient access. You simply cannot run a successful neurodegenerative trial without their buy-in.

Public perception of novel drug safety is a constant factor in trial success

The public perception of drug safety, especially for novel neurological therapies, is a constant and high-stakes social factor. The complexity of the Central Nervous System (CNS) means clinical development is inherently risky, and any negative safety signal can stop a trial cold.

The pharmaceutical industry is now shifting toward a 'proactive, predictive, patient-centred safety' model, where real-world data and patient-reported experiences are becoming the backbone of modern Pharmacovigilance (PV) strategies in 2025. This means adverse event reporting and transparency are more scrutinized than ever by the public and media.

IKT has strategically addressed this risk with its product pipeline:

• IkT-148009 for PD is a disease-modifying agent, which carries higher public hope but also higher scrutiny for long-term safety.
• The company's IKT-001, a re-engineered prodrug for Pulmonary Arterial Hypertension (PAH), was specifically developed to provide a better patient experience with fewer on-dosing side-effects compared to the active ingredient, imatinib mesylate. This directly shows IKT's focus on mitigating safety concerns to improve patient acceptance and adherence.

Here's the quick math: a safety issue in a Phase 2 trial can wipe out hundreds of millions in market capitalization overnight. Proactive safety communication is non-negotiable.

Increased focus on health equity impacts trial diversity requirements

Health equity and diversity in clinical trials are no longer just ethical considerations; they are regulatory requirements that directly impact trial timelines and costs in 2025. The FDA's diversity action plan requirements for Phase III clinical trials are set to take effect in mid-2025, making this a critical operational factor.

The new guidelines require sponsors to submit Diversity Action Plans (DAPs) for certain studies, detailing enrollment goals disaggregated by race, ethnicity, sex, and age group. For IKT, this is particularly relevant because Parkinson's disease is known to have a higher incidence in men and varies by geographic region, meaning a non-diverse trial population could lead to less generalizable data and regulatory pushback.

The core action for IKT is to ensure its ongoing and future trials, like the Phase 2 '201' trial, are designed with this mandate in mind. Failure to meet these diversity goals can delay or even halt a pivotal trial, so you need to factor in the increased complexity and cost of community outreach and diverse site selection now.

Inhibikase Therapeutics, Inc. (IKT) - PESTLE Analysis: Technological factors

Advances in biomarker identification improve patient stratification for trials.

The core of modern drug development is moving from a one-size-fits-all model to precision medicine, and that starts with better patient selection using biomarkers (measurable biological indicators). For Inhibikase Therapeutics, this is less about discovering a new biomarker and more about optimizing the use of established clinical measures and incorporating new digital ones. The Phase 3 IMPROVE-PAH trial for IKT-001 uses established, gold-standard endpoints like Pulmonary Vascular Resistance (PVR) and the 6-Minute Walk Distance (6MWD).

Still, the trial's adaptive design is a key technological advantage. It includes a crucial 12-week dose-titration phase to help patients reach the highest tolerable dose, which is a real-time, patient-specific optimization. This approach minimizes the risk of the high discontinuation rates that plagued previous trials of the parent compound, imatinib, which is defintely a smart move. In the broader industry, the FDA has already accepted digital biomarkers, like actigraphy (physical activity measurement), as a primary endpoint for related conditions, signaling the future direction of clinical validation.

AI and machine learning accelerate drug discovery, cutting early-stage costs.

While Inhibikase Therapeutics is a small-molecule company focused on a re-engineered prodrug, IKT-001, the overall technological landscape is defined by Artificial Intelligence (AI) and Machine Learning (ML). This matters because their drug, IKT-001, is a kinase inhibitor, a class of therapeutics where AI/ML is already revolutionizing the design and optimization process by predicting selectivity and reducing off-target toxicity.

The global AI-based Clinical Trials Market is a clear indicator of this trend, projected to grow from an estimated $7.73 billion in 2024 to $9.17 billion in 2025, representing a compound annual growth rate (CAGR) of nearly 19%. This growth means the tools for virtual screening and optimizing drug candidates are getting cheaper and faster every year. Here's the quick math: if AI can cut the time it takes to identify a lead compound by even a few months, the savings in early-stage R&D costs are substantial, freeing up capital for IKT's pivotal Phase 3 trial.

Gene therapy and editing tech pose long-term competition to small molecule drugs.

The most significant long-term technological threat to IKT's small-molecule approach is the explosive growth of gene therapy and gene editing technologies. These therapies aim to offer a one-time, curative solution by addressing the underlying genetic causes of disease, which directly competes with chronic treatments like IKT-001.

The market numbers show this competition is rapidly accelerating, especially in IKT's therapeutic area. The global gene therapy market is valued at $11.07 billion in 2025. More critically, the Gene Therapy on Cardiovascular Disease Market-which includes PAH-is projected to be valued at $0.17 billion in 2025 and is expected to grow at a staggering CAGR of 91% through 2033. This means that while IKT is focused on a near-term approval for PAH, a wave of potentially curative treatments is rapidly gaining momentum in the same space.

Digital health tools improve remote patient monitoring in Phase 2/3 trials.

The shift to decentralized clinical trials (DCTs) using digital health tools is a massive opportunity to improve data quality and reduce the cost of IKT's large, multi-site Phase 3 study, which is expected to enroll a total of 486 patients across approximately 180 global sites. Remote patient monitoring (RPM) is particularly relevant for PAH, a cardiopulmonary disease where a key measure of efficacy is physical function.

PAH trials are increasingly incorporating remote monitoring technologies.

• Use smartwatches and smartphone apps to collect real-world activity and heart rate data.
• Deploy implantable cardiac monitors and pulmonary artery pressure sensors for continuous, objective hemodynamic data.
• Leverage telehealth for remote assessment and follow-up, a methodology that reached consensus among US-based PAH physicians and advanced practice providers in a June 2025 study.

Using these tools allows for the collection of real-world evidence (RWE) outside of the clinic, which is a more accurate measure of a patient's true functional status than a single 6MWD test in a hospital corridor. For a company advancing a drug that aims to improve exercise capacity, integrating this technology is crucial for a successful data package.

Inhibikase Therapeutics, Inc. (IKT) - PESTLE Analysis: Legal factors

You're operating in a highly regulated space, so navigating the legal landscape isn't just about compliance; it's a core strategic function that directly impacts your timeline and cash runway. For Inhibikase Therapeutics, Inc., the immediate legal risks center on defending the intellectual property (IP) for your lead compounds and managing the complex, global data privacy rules that govern your large-scale clinical trials.

Here's the quick math: with a net loss of $35.5 million for the nine months ended September 30, 2025, and cash, cash equivalents, and marketable securities at $77.3 million, any significant legal setback-like a drawn-out patent infringement case-could quickly erode your capital position. You need to be defintely proactive.

Stricter intellectual property (IP) enforcement is vital for their lead compound, IkT-14800.

Protecting your core assets, the prodrugs of imatinib, is non-negotiable. Inhibikase Therapeutics holds key patents for its portfolio, which is essential for securing market exclusivity and attracting development partners. Specifically, the company's IP protection for IkT-001Pro, the prodrug of imatinib mesylate for Pulmonary Arterial Hypertension (PAH), is slated to run until 2033, with Risvodetinib (IkT-14800) protected until 2036. Additional filings could extend this exclusivity further, but the current IP portfolio includes nine issued patents and two pending applications in the U.S., plus eleven issued foreign patents and four pending foreign applications.

This is a solid foundation, but the complexity of a prodrug strategy means competitors will scrutinize the novelty of the compound over the already-approved parent drug. You must be ready to defend your novel re-engineering approach (RAMP™) against challenges, particularly as you advance to a global pivotal Phase 3 study.

Evolving data privacy laws (HIPAA, GDPR) complicate global clinical data management.

Your global Phase 3 IMPROVE-PAH study, which is expected to involve up to approximately 180 sites around the world, significantly increases your regulatory burden. Managing patient data across multiple jurisdictions means adhering to a patchwork of rules, and compliance is getting harder, not easier.

In the U.S., while the Health Insurance Portability and Accountability Act (HIPAA) is stable, there are ongoing efforts in 2025 to harmonize the Breach Notification Rule with Part 2 (Substance Use Disorder records) and standardize electronic transactions, which requires constant updates to your data handling protocols. In Europe, the General Data Protection Regulation (GDPR) and the maturing EU Clinical Trials Regulation (EU CTR) are the main hurdles.

• GDPR/EU CTR: New transparency regulations in 2024-2025 removed the deferral mechanism, meaning you can no longer postpone the publication of certain clinical documents for up to seven years to protect Commercially Confidential Information (CCI).
• Action: You must now prepare for the release of redacted Clinical Study Reports (CSRs) and protocols to the Clinical Trials Information System (CTIS) much sooner, which is an operational challenge.

Increased scrutiny on clinical trial transparency and reporting standards.

Regulators are demanding more transparency, faster. The goal is to minimize publication bias and ensure all clinical findings are publicly accessible, which is ethical, but it adds cost and complexity to your operations.

The 2025 updates to the U.S. Food and Drug Administration Amendments Act (FDAAA) 801 Final Rule introduce tighter timelines and enhanced penalties for non-compliance on ClinicalTrials.gov. Fail to report in time, and you face daily civil monetary penalties. Also, the finalization of the International Council for Harmonisation (ICH) E6(R3) Good Clinical Practice (GCP) guidelines in 2025 emphasizes data integrity and traceability, especially with the increased use of digital tools in trials.

Here is a summary of the critical 2025 regulatory shifts impacting your Phase 3 trial:

Patent litigation risk is always present in a crowded therapeutic area.

As a clinical-stage company, you are a target. The risk of patent litigation is a constant overhang, and it's especially acute for Inhibikase Therapeutics because IKT-001 is a prodrug of imatinib mesylate, a compound whose original manufacturer, Novartis, was involved in one of the most significant patent battles in pharmaceutical history over Gleevec. That history creates a precedent for aggressive defense and challenge in this therapeutic space.

Any competitor could file a declaratory judgment action to challenge the validity of your patents on IKT-001 or IkT-14800, forcing you to spend significant capital on defense. Given that your R&D expenses for the nine months ended September 30, 2025, were already $23.4 million, diverting cash flow to legal defense instead of clinical development is a major financial risk. You must allocate resources now to build a robust legal defense strategy, not just a reactive one.

Inhibikase Therapeutics, Inc. (IKT) - PESTLE Analysis: Environmental factors

You need to see the environmental factors not as a compliance checklist, but as a critical risk-to-cash flow analysis, especially for a clinical-stage biotech like Inhibikase Therapeutics, Inc. Your core focus is advancing IKT-001, but environmental, social, and governance (ESG) pressure is now a tangible cost and a non-negotiable part of investor due diligence in 2025.

Finance: Track the Q4 2025 cash burn rate against the prior quarter's $8.5 million estimate by Friday. The actual Q3 2025 net loss was higher at $11.9 million, so the burn rate is accelerating with the Phase 3 planning.

New sustainability mandates affect supply chain and manufacturing partners.

As a clinical-stage company, Inhibikase Therapeutics, Inc. relies heavily on Contract Manufacturing Organizations (CMOs) and Contract Research Organizations (CROs). This outsourcing model doesn't eliminate your environmental liability; it just shifts the compliance burden to your partners, who then pass the costs back to you.

In 2025, the life sciences supply chain faces intense scrutiny, with a growing expectation for green supply chain strategies and climate risk modeling. For perspective, major pharmaceutical companies like Pfizer expect 64% of their supplier spend to come from partners with science-based greenhouse gas (GHG) reduction targets. This means your CMOs must be compliant, and their compliance costs will be baked into your future cost of goods sold (COGS).

Your action here is simple: require your key manufacturing partners to provide their Scope 1 and 2 emissions data and a formal plan for compliance with the new EU Corporate Sustainability Reporting Directive (CSRD) equivalent standards, even if you are US-based. This is a supply chain resilience issue, not just an environmental one.

Increased investor demand for ESG (Environmental, Social, Governance) reporting.

Investor sentiment has shifted dramatically in 2025. While the primary focus for Inhibikase Therapeutics, Inc. remains on clinical data-specifically the Phase 3 advancement of IKT-001-ESG performance is now a key factor in capital allocation, especially as the sector sees a rebound in funding for clinical-stage assets.

ESG scores are increasingly used in investment ratings and competitive positioning, even for companies with a market cap below the $7.7 million non-affiliate value reported in March 2025. Investors are looking for operational discipline, which includes environmental stewardship. Failure to articulate a clear ESG strategy, even a lean one, can lead to a discount on your valuation or limit access to ESG-focused funds.

Here is a snapshot of your Q3 2025 financial position, which underscores the need for capital-efficient operations, including environmental controls:

Disposal of hazardous biological and chemical waste from labs requires strict adherence.

This is a non-negotiable operational risk for any biotech. The cost of non-compliance far outweighs the cost of proper disposal. In 2025, the regulatory environment for pharmaceutical waste is tightening significantly.

Key regulatory changes impacting your operations or those of your partners include:

• The EPA's 40 CFR Part 266 Subpart P is being enforced in many states, which specifically bans the sewering (flushing down the drain) of all hazardous waste pharmaceuticals, regardless of generator status.
• The Resource Conservation and Recovery Act (RCRA) e-Manifest compliance changes are taking effect by December 1, 2025, requiring all generators, even small ones, to register for electronic manifest access.
• Disposal costs for lab chemicals typically range from $0.10 to $10 per pound, depending on the material's toxicity and required handling.

A single violation of the sewering ban or a manifest error could trigger an EPA audit, leading to fines that would be a material event against your Q3 R&D spend of $7.6 million. You must have auditable, third-party waste disposal contracts in place that explicitly cover these new 2025 mandates.

Climate change impact on R&D facilities is a minor, but growing, operational risk.

While Inhibikase Therapeutics, Inc. is not a large-scale manufacturer, the physical risks of climate change-extreme weather, flooding, and heat-are a growing concern for the entire biopharma value chain. Climate change is ranked as the #5 global risk in the 2025 Allianz Risk Barometer.

Your risk is primarily indirect, through your supply chain and clinical trial sites. Nearly two-thirds of US drug production facilities have been located in areas hit by a major disaster in recent years. This exposure affects the stability of your Active Pharmaceutical Ingredient (API) supply and the continuity of your clinical trials.

The direct risk to your corporate and R&D facilities, likely in a major biotech hub (Boston/Atlanta mentioned in filings), comes from power outages and extreme heat driving up energy demand for temperature-sensitive storage and cooling systems. This translates directly to higher utility costs and business interruption risk. You need to ensure your critical data and drug substance storage have robust, climate-proof backup power and redundant cold chain logistics.