NLS Pharmaceutics AG (NLSP): PESTLE Analysis [Nov-2025 Updated]

You're tracking NLS Pharmaceutics AG (NLSP) because the potential for Mazindol (Quilience) in narcolepsy is huge, but for a clinical-stage biotech, the external environment is the real gatekeeper. Right now, the investment thesis boils down to two critical factors: regulatory success and cash runway. With a burn rate near $1.5 million per quarter in 2025, the company has a tight window of six to seven quarters before needing fresh capital. Every external factor-from FDA policies and patent defense to global inflation increasing trial costs-is amplified. Let's map the Political, Economic, Sociological, Technological, Legal, and Environmental forces that will defintely decide if NLSP can turn a promising drug candidate into a market reality.

NLS Pharmaceutics AG (NLSP) - PESTLE Analysis: Political factors

You're a biotech investor, so you know that the political landscape in Washington and Brussels is often more volatile than any Phase 2 trial data. For NLS Pharmaceutics AG, a Zug-based company developing a Central Nervous System (CNS) drug like Quilience (Mazindol ER), political and regulatory decisions are the primary drivers of near-term risk and opportunity.

The biggest political variable is not trade, but the timing of regulatory approval, plus the rapidly shifting US drug pricing environment. Honestly, the policy changes in 2025 are creating a new financial reality for every company launching a high-value drug.

FDA and EMA regulatory timelines are the single biggest risk factor for Quilience approval.

The most critical political factor for NLS Pharmaceutics AG is simply the speed and final decision of the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA). The company's lead candidate, Quilience, is in the AMAZE Phase 3 program, which consists of two trials (NLS-1031 and NLS-1032) that began enrollment in mid-2023. Each trial involves approximately 50 adult patients with narcolepsy and a short, 8-week treatment period.

A delay in patient enrollment, a request for additional data, or an unexpected result in the primary endpoint (weekly cataplexy episodes) would immediately push back the New Drug Application (NDA) filing timeline. This is defintely a binary event risk. The market is currently pricing in a high probability of a positive outcome, but until the NDA is filed and accepted, the regulatory clock is the only one that truly matters.

Shifting US healthcare policy could impact future drug pricing and reimbursement for CNS treatments.

The US drug pricing landscape is under immense political pressure in the 2025 fiscal year, creating a headwind for any new, high-cost CNS treatment. The key policy shifts are coming from two directions: the Inflation Reduction Act (IRA) and new executive action.

• Inflation Reduction Act (IRA): The IRA's provisions are already impacting planning. While Medicare price negotiation for a select list of high-cost drugs doesn't start until 2026, the law's cap on out-of-pocket spending for Medicare beneficiaries at $2,000 per year began in 2025. This is a positive for patient access, but it shifts cost burden onto payers and changes the overall revenue model for manufacturers.
• Most-Favored-Nation (MFN) Pricing: An Executive Order issued in May 2025 is pushing for a Most-Favored-Nation pricing policy. This policy aims to align US drug prices with the lowest prices paid by other economically comparable countries. Given that US drug prices are often three to five times higher than those abroad, a successful implementation of MFN pricing would drastically limit the peak sales potential for a new drug like Quilience.

Swiss-US trade relations affect capital flows and operational ease for the Zug-based company.

As a company headquartered in Zug, Switzerland, NLS Pharmaceutics AG is directly exposed to the bilateral trade relationship with its largest potential market, the US. The good news is that a major point of political uncertainty was resolved in November 2025 with a new trade framework agreement.

This deal significantly reduced the risk of punitive tariffs on Swiss exports, including pharmaceuticals, which had previously been threatened by high levies. The agreement is a clear positive for operational stability and capital flow.

Here's the quick math: cutting the potential tariff exposure from 39% to 15% immediately reduces a major external risk for a company planning a US commercial launch.

Government funding or tax incentives for rare disease (orphan) drug development remain a key opportunity.

Quilience has already secured Orphan Drug Designation (ODD) from both the FDA and the EMA for narcolepsy, which is a significant political and financial advantage. The ODD status is the government's way of making the economics of a small patient population work.

The current US incentives are robust, but there is an opportunity for them to get even better in 2025. The political debate is focused on increasing the financial benefits to spur more development in the rare disease space, which has a projected market size exceeding $190 billion by 2030.

Key ODD incentives NLS Pharmaceutics AG benefits from:

• Market Exclusivity: 7 years of statutory market exclusivity in the US post-approval, regardless of patent status.
• Tax Credit: A 25% federal tax credit for qualified clinical research expenses incurred in the US.
• Legislative Opportunity: Lawmakers are actively discussing legislation to restore the Orphan Drug Tax Credit to its original 50% rate (from the current 25%), which would double the financial incentive for US-based R&D spending.

The political will to support orphan drugs remains strong, but still, the final outcome of any legislative change is a toss-up.

NLS Pharmaceutics AG (NLSP) - PESTLE Analysis: Economic factors

The economic environment for NLS Pharmaceutics AG is defined by a tight cash position, extreme stock price volatility, and the increasing macro-cost pressures hitting the biotech sector. For a clinical-stage company, economic factors are less about revenue and more about capital access and burn rate-it's all about extending the cash runway until a major clinical inflection point.

High cash burn rate, estimated to be near $1.5 million per quarter for R&D and G&A in 2025.

You need to look closely at the cash flow statement, not just the balance sheet. NLS Pharmaceutics' operating cash flow over the last twelve months was negative $4.81 million. This translates to an average quarterly cash burn of roughly $1.20 million, which is a critical figure for a company with a small cash reserve. Here's the quick math: with only $3.07 million in cash on the balance sheet, the company's existing cash runway is very short-just over two quarters-before factoring in the recent financing. Still, the company has been active in shoring up its finances in 2025.

The company successfully closed equity financing transactions in Q1 2025, raising aggregate gross proceeds of $2.5 million. Plus, they secured an additional $1 million in gross proceeds through an equity financing amendment in June 2025. Most significantly, they have a $25 million equity facility commitment, which is the lifeline for their R&D efforts and the pending merger with Kadimastem Ltd..

Extreme stock price volatility, with shares trading significantly below the 2021 IPO price of $4.00.

The stock price history shows a high-risk profile, which makes future capital raises through equity challenging without significant dilution. The company's stock has seen a -81.55% price change over the last 52 weeks, a clear sign of extreme market uncertainty and volatility. While the unadjusted Initial Public Offering (IPO) price in January 2021 was $4.00 per share, the stock has traded at various lows and highs, including a recent price of approximately $7.62 per share as of late November 2025, after a 1:40 reverse split in September 2024 and a 1:10 split in October 2025. The market is defintely pricing in the high risk of a clinical-stage biotech.

This volatility is a major economic factor because it increases the cost of capital. Investors demand a higher premium for such a volatile stock, making it harder and more expensive to tap into that $25 million equity facility.

Success of the Phase 3 trial is defintely needed to trigger milestone payments or partnership deals.

For a clinical-stage company, a major clinical milestone is the only thing that can fundamentally change the economic outlook. Success in a Phase 3 trial for a key asset, like Quilience (Mazindol ER) for narcolepsy, is the required catalyst. It's what triggers lucrative, non-dilutive financing events, such as a major partnership or a milestone payment.

The company has already demonstrated the ability to secure milestone payments, though on a smaller scale, with the merger asset. For instance, the collaboration with Kadimastem and iTolerance for the iTOL-102 diabetes treatment secured a $166,000 USD milestone payment from the BIRD Foundation in 2025, bringing the total foundation support to nearly $882,352 USD. But a successful Phase 3 readout for Quilience would unlock a potential nine-figure deal, an order of magnitude larger, which is what truly matters for long-term economic stability.

Global inflation pressures increase the cost of clinical trials and API (Active Pharmaceutical Ingredient) sourcing.

Global economic pressures are not abstract; they directly impact the cost of running a biotech. Inflation and geopolitical trade policies, like the US tariffs on pharmaceutical ingredients, are inflating the cost of R&D. Average per-patient trial costs in the U.S. have risen by 12% compared to 2023.

This rising cost of goods is a significant headwind for NLS Pharmaceutics.

• API cost increases: Tariffs on Active Pharmaceutical Ingredients (APIs) from key sourcing regions like China and India have led to reported cost hikes of 12-20% for widely used molecules.
• Trial input costs: Tariffs have inflated input costs for early-phase trials by as much as 8% in some cases.
• Increased complexity: Each protocol amendment in a complex trial can incur costs believed to be several hundred thousand dollars.

So, the $1.20 million quarterly cash burn is under constant pressure to rise, forcing the company to be extremely capital-efficient or risk accelerating its reliance on the dilutive equity facility.

NLS Pharmaceutics AG (NLSP) - PESTLE Analysis: Social factors

The social environment for NLS Pharmaceutics AG is defined by a strong, organized patient community and a critical public health challenge around central nervous system (CNS) stimulant use. Your opportunity lies in the clear, unmet demand for better quality of life treatments, but you must defintely navigate the risk of stimulant misuse perception.

Growing patient advocacy for narcolepsy and idiopathic hypersomnia creates strong market demand.

The patient community, led by groups like Narcolepsy Network and Project Sleep, is a powerful, active force that directly shapes the market. These organizations are not just support networks; they are actively engaging with medical, government, and industry stakeholders to accelerate the development of new therapies and improve access to care. This active advocacy creates a receptive environment for a novel treatment like Mazindol ER (Quilience), which is positioned as a partial orexin-2 receptor agonist and triple monoamine reuptake inhibitor. This means patient groups will be vocal champions for a differentiated product.

In November 2025, advocacy efforts included Project Sleep's Sleep Advocacy Forum in Washington, DC, bringing patient voices directly to policymakers. This level of organization translates into significant pressure on payers (insurance companies) and regulators to consider new treatment options that address the high symptom burden.

• Advocacy groups actively shape new therapy development.
• Patient voice is critical in clinical research, especially for rare diseases.
• Engagement with policymakers helps secure better insurance coverage.

Public perception of CNS stimulants requires careful messaging to avoid misuse and addiction concerns.

NLS Pharmaceutics AG must be acutely aware of the public health crisis surrounding prescription stimulant misuse, as Mazindol ER acts on the CNS. The general public and regulatory bodies like the FDA view all stimulants with caution due to high rates of non-medical use. For example, in the U.S., about 5 million people (or 2.1% of adults) misuse prescription stimulants.

Among those who use prescription stimulants, a significant portion report misuse, and a concerning number develop a disorder. Your communications strategy must clearly differentiate Mazindol ER's mechanism of action-its dual role as a partial orexin agonist and a triple monoamine reuptake inhibitor-from traditional, high-abuse-potential amphetamines. This is a crucial risk to manage, as data shows that individuals using amphetamines had a 3.1 times higher prevalence of misuse and 2.2 times higher prevalence of Prescription Stimulant Use Disorder (PSUD) compared to those using methylphenidate. You need to show your drug is different.

Increased awareness of sleep disorders drives higher diagnostic rates, expanding the potential patient pool.

The narcolepsy and idiopathic hypersomnia patient pool is significantly larger than the currently diagnosed population, representing a massive untapped market opportunity. Narcolepsy affects an estimated 200,000 Americans, but historically, only about 25% to 50% of those individuals are properly diagnosed. The average time to diagnosis is still far too long; approximately 31% of patients reported waiting $\geq$ 10 years for a definitive diagnosis after first speaking with a clinician.

Increased awareness campaigns, like World Narcolepsy Day (September 22), are helping to shorten this diagnostic delay. As more clinicians recognize the symptoms-especially the frequent misdiagnosis as depression, which occurred in 73% of initially misdiagnosed cases-the number of identified patients will rise. This expanding, newly diagnosed patient base will be actively seeking novel, effective treatments, directly benefiting NLS Pharmaceutics AG as they enter the market.

Focus on quality of life improvements in chronic diseases aligns with modern healthcare consumer trends.

Modern healthcare consumers, especially those managing chronic diseases, prioritize treatments that deliver tangible improvements in daily functioning and quality of life, not just symptom suppression. This trend is driving the complex and chronic condition management market, where the neurological disorders segment is projected to be the fastest-growing segment.

For NLS Pharmaceutics AG, this focus is a competitive advantage. Narcolepsy is a profoundly debilitating condition; 76% of patients reported an extremely or very severe impact on their daily life. The most desired treatment outcome for 77% of patients is simply to stop sleeping during the day. Quilience's Phase II data, showing a clinically meaningful reduction of 7.1 points on the Epworth Sleepiness Scale (ESS) from baseline, directly addresses this core quality of life need. This focus also helps justify the high cost of specialty drugs, as narcolepsy carries a substantial economic burden, with an annual mean excess health-related cost, including social transfers, of €9,572 per patient. Showing a clear return on investment through improved quality of life and reduced societal costs is key to payer negotiation.

NLS Pharmaceutics AG (NLSP) - PESTLE Analysis: Technological factors

For a clinical-stage company like NLS Pharmaceutics AG, technology is not just about the drug itself; it's about the intellectual property protecting the drug, the efficiency of the clinical process, and the competitive landscape of next-generation treatments. Your biggest near-term technological risk is the speed of innovation from competitors in the non-stimulant space, which could render your current candidate less competitive before it even launches. We need to look at patent strength and the disruptive power of new science.

Patent protection for Mazindol's specific formulation is critical for securing market exclusivity post-approval.

NLS Pharmaceutics AG's core technological asset is not a new chemical entity, but a proprietary extended-release (ER) formulation of an old drug, mazindol. This reformulation, marketed as Quilience (Mazindol ER), is designed as a multilayer tablet containing both immediate-release and sustained-release components. This formulation technology is what secures your market exclusivity, not the molecule itself.

The company has successfully secured intellectual property (IP) protection in major markets. For instance, the European Patent Office granted Patent No. EP3426232, and the Japanese Patent Office granted patent application 2018-546837, both covering this specific formulation for narcolepsy and other sleep-wake disorders. A Notice of Allowance for a similar U.S. patent application was announced in 2021. This IP shield is defintely the most important technological moat you have right now.

Here's the quick math on IP protection:

Use of advanced clinical trial technology (e.g., remote monitoring) helps streamline data collection and reduce costs.

The pharmaceutical industry in 2025 is rapidly shifting to decentralized clinical trials (DCTs) and hybrid models, especially for Central Nervous System (CNS) disorders. This is a critical technological factor for your Phase 3 AMAZE trial for Mazindol ER. DCTs use digital platforms for real-time data capture and employ wearables-like a specialized actigraphy device-to continuously monitor patient sleep-wake cycles and activity, which are the primary endpoints for narcolepsy studies.

Adopting this technology allows you to reduce site visits, improve patient recruitment diversity, and capture more reliable, real-world data. In 2025, the CNS therapeutic area accounts for approximately 686 planned clinical trials, making the competition for patient enrollment fierce. Using digital tools to make participation easier is no longer optional; it is a necessity for efficient trial execution and to potentially lower the overall cost per patient, which can be substantial in a long-duration Phase 3 program.

Competition from established CNS drug manufacturers (e.g., Jazz Pharmaceuticals) requires a superior efficacy profile.

You are competing against a market leader, Jazz Pharmaceuticals, which dominates the sodium oxybate space. Their low-sodium oxybate product, Xywav, generated $415.3 million in net product sales in the second quarter of 2025 alone, with approximately 10,600 narcolepsy patients using it. Your Mazindol ER must demonstrate a clearly superior, or at least a highly differentiated, efficacy and safety profile to capture market share from such an entrenched incumbent.

Mazindol ER's technological advantage is its dual mechanism: it is a triple monoamine reuptake inhibitor (TMRI) and a partial Orexin-2 Receptor (OX2R) agonist. This unique combination could offer a better balance of wakefulness promotion and cataplexy control than current stimulants or oxybates. If the Phase 3 data shows a statistically significant improvement in the Multiple Sleep Latency Test (MSLT) or Epworth Sleepiness Scale (ESS) compared to placebo, the differentiated mechanism will be your key technological selling point against the established players.

Development of non-stimulant treatments could technologically disrupt the current narcolepsy market.

The most significant technological risk comes from the new class of non-stimulant, disease-modifying therapies: the Orexin 2 Receptor (OX2R) agonists. These drugs aim to replace the lost orexin (hypocretin) signaling, addressing the root cause of Narcolepsy Type 1. This is a true technological leap beyond symptomatic relief.

The pipeline is very active as of 2025:

• Alkermes is advancing its non-sulfonamide ALKS 2680.
• Takeda Pharmaceutical Company Limited has its Phase 3 candidate, TAK-861 (formerly known as oveporexton).
• Centessa Pharmaceuticals has ORX750 in Phase 2a.

These are full OX2R agonists, whereas Mazindol ER is only a partial agonist. If one of these full agonists secures FDA approval and demonstrates a complete reversal of excessive daytime sleepiness and cataplexy with a favorable safety profile, it would represent a major technological disruption. This would force Mazindol ER to compete as a second-line or combination therapy, significantly lowering its peak sales potential in a global narcolepsy therapeutics market projected to reach $3.95 billion by the end of 2025.

NLS Pharmaceutics AG (NLSP) - PESTLE Analysis: Legal factors

Maintaining Orphan Drug Designation (ODD) for Quilience in the US and Europe is vital for market protection.

The core of NLS Pharmaceutics AG's commercial legal strategy rests on securing and maintaining Orphan Drug Designation (ODD) for its lead candidate, Quilience (Mazindol ER), for narcolepsy and Idiopathic Hypersomnia (IH). This designation is not just a regulatory milestone; it is a critical legal shield that grants significant market exclusivity after final approval.

The U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have both granted ODD for Quilience for narcolepsy and IH. For the U.S. market, ODD provides seven years of marketing exclusivity from the date of FDA approval, a period that is crucial for a small biotech to recoup its development investment. This exclusivity is the primary legal barrier to entry for competitors. The IH ODD in the U.S. was secured in November 2022, following the EU grant in July 2022.

Losing this status due to a regulatory change or a finding that the drug no longer meets the rare disease criteria would be a catastrophic legal and commercial event. This is not a static benefit; it requires continuous legal and regulatory vigilance.

Successful defense of existing patents against potential generic challenges is a constant legal overhead.

The company's long-term value is tied directly to its intellectual property (IP) portfolio, which protects the proprietary extended-release formulation of Mazindol. While the active ingredient, Mazindol, is an older compound, the extended-release formulation is the key patentable innovation.

A successful defense against generic challengers is expensive, even when the company ultimately wins. For the first half of the 2025 fiscal year, NLS Pharmaceutics AG reported a net loss of USD 2.22 million. A significant portion of these operational expenses, while not isolated in public reports, goes toward legal and professional fees for maintaining and defending the IP estate globally. The company has secured patents in key regions, including an Israeli patent covering Mazindol for ADHD and other sleep disorders that is expected to expire no earlier than 2037.

The legal team must continually monitor for potential Abbreviated New Drug Application (ANDA) filings in the U.S. that would trigger a patent infringement lawsuit under the Hatch-Waxman Act, a necessary but costly legal battle.

• Protect formulation patents against generic ANDA filings.
• Monitor global IP landscape for infringement risks.
• Allocate capital for high-cost patent litigation defense.

Compliance with stringent FDA and EMA Good Clinical Practice (GCP) and manufacturing standards is non-negotiable.

As NLS Pharmaceutics AG advances its Phase 3 AMAZE program for Quilience, which began in the summer of 2023, the legal requirement for strict adherence to Good Clinical Practice (GCP) standards becomes paramount. Non-compliance can lead to the FDA or EMA rejecting the New Drug Application (NDA), forcing costly and time-consuming re-trials, or even criminal penalties.

The regulatory environment is tightening. The International Council for Harmonisation (ICH) is set to finalize the E6(R3) Good Clinical Practice (GCP) guidelines in 2025. This update, which emphasizes risk-based quality management and the integration of digital technologies, requires immediate and defintely costly updates to the company's internal compliance protocols and its eClinical systems.

The company must also ensure its contract manufacturing organizations (CMOs) comply with Good Manufacturing Practice (GMP) standards, as any manufacturing-related warning letter from a regulator would halt commercialization post-approval.

Potential for litigation related to clinical trial outcomes or adverse event reporting always exists.

Every clinical-stage biopharma company faces the inherent legal risk of product liability and litigation stemming from clinical trial activities. Even with a favorable safety profile in Phase 2, like the one Quilience demonstrated, the larger Phase 3 trials increase the patient exposure and thus the risk of an unexpected serious adverse event (SAE).

Any failure to accurately or timely report an SAE to the FDA or EMA can result in severe regulatory action, including clinical hold or hefty fines. The company's forward-looking statements consistently highlight the risk that their products may harm recipients or that results in the lab may not translate to equally good results in real clinical settings, which forms the basis for potential future litigation. The company's merger with Kadimastem, expected to close around October 30, 2025, also introduces new legal complexities and integration risks, requiring extensive legal oversight of the combined entity's clinical programs and regulatory filings.

The concrete next step is for the Legal and Regulatory Affairs teams to finalize the ICH E6(R3) GCP implementation plan by the end of Q4 2025.

NLS Pharmaceutics AG (NLSP) - PESTLE Analysis: Environmental factors

You're looking at NLS Pharmaceutics AG, a clinical-stage company, so the environmental risk profile is fundamentally different from a large-scale manufacturer. The key takeaway is that while their direct footprint is small, the increasing investor focus on Environmental, Social, and Governance (ESG) factors means their lack of a formal ESG framework is a real financial risk that could complicate future capital raises.

Here's the quick math: based on the last 12 months of fiscal 2025 data, the company reported cash and cash equivalents of $3.07 million and a negative operating cash flow (burn rate) of $4.82 million annually. That burn rate translates to about $1.205 million per quarter, giving the company a runway of roughly 2.55 quarters before needing another capital raise. That makes the Phase 3 readout the ultimate near-term action item.

Minimal direct environmental impact compared to large-scale manufacturing, but lab waste disposal must comply with strict regulations.

As a clinical-stage biopharma with a small team-only 7 full-time employees reported recently-NLS Pharmaceutics AG doesn't have the massive carbon footprint or water consumption of a commercial drug factory. Their environmental impact is primarily tied to research and development (R&D) activities, specifically the handling of laboratory waste. This waste, which includes solvents, chemical reagents, and potentially biohazardous materials from clinical trial sample processing, must be managed under stringent local and international regulations.

The upcoming merger with Kadimastem, a cell therapy company, complicates this, as cell therapy introduces new waste streams and a greater reliance on specialized cold chain logistics (maintaining specific low temperatures for biological samples). This means the combined entity will need to formalize its waste management protocols, particularly for:

• Chemical Waste: Proper segregation and disposal of R&D chemicals.
• Biohazardous Waste: Sterilization and disposal of materials from cell culture and clinical samples.
• Cold Chain Waste: Managing disposal of specialized packaging and refrigerants used for cell therapy transport.

Increasing investor focus on ESG (Environmental, Social, and Governance) factors may influence future capital raising.

Investors defintely care more about ESG now. In 2025, sustainability is a core strategy for major pharmaceutical companies, and this focus trickles down to smaller biotechs. While a small company like NLS Pharmaceutics AG typically gets a pass on a full ESG report, the absence of even a basic environmental policy can be a red flag for institutional investors, especially those with ESG mandates. The market is actively asking if the company can 'attract ESG capital inflows'.

The risk here isn't a massive fine today, but a higher cost of capital tomorrow. To mitigate this, the company needs to start documenting its environmental practices now, turning its low-impact status into a competitive advantage for attracting capital.

Need to ensure a sustainable and ethical supply chain for the active pharmaceutical ingredients.

Even a clinical-stage company relies on a supply chain for its Active Pharmaceutical Ingredients (APIs) and excipients. The industry trend in 2025 is a push for greener supply chains, including reducing air freight and shifting to sea, rail, or road transport to lower carbon emissions.

For NLS Pharmaceutics AG, the immediate action is supplier due diligence. They must ensure their contract manufacturers and API suppliers meet basic environmental and ethical standards. This transparency is crucial because a major supply chain disruption or an ethical breach by a third-party supplier would directly impact their clinical trial timelines and, consequently, their valuation.

Energy consumption related to research facilities and data centers requires monitoring for operational efficiency.

The company's energy usage is concentrated in its corporate and R&D facilities, including data centers used for clinical data management. While the absolute consumption is low due to the small scale, monitoring this is a simple, high-impact way to show commitment to operational efficiency and environmental stewardship. The goal is to move beyond mere compliance toward efficiency.

Simple steps like tracking energy use per employee or per clinical trial phase can provide an easy-to-digest metric for investors. Furthermore, the pharmaceutical sector is seeing over 85% of biopharma executives investing in AI and digital tools to optimize logistics and manufacturing, which also leads to energy efficiency gains. Even a small company should look at cloud-based solutions to minimize local data center energy load.

Next Step: Management: Draft a one-page Environmental Policy Statement by the end of Q1 2026, focusing on lab waste protocols and supply chain due diligence, to address investor ESG concerns.