Allakos Inc. (ALLK): PESTLE Analysis [Nov-2025 Updated]

You're defintely right to scrutinize Allakos Inc. (ALLK) right now; this is a high-wire act after their major clinical setbacks. The company is sitting on an estimated cash reserve of around $175 million as of late 2025, which buys them operational runway into 2027, but the clock is ticking fast. Our PESTLE breakdown shows that while economic headwinds like high interest rates increase their cost of capital, the real strategic pivot points are technological-proving lirentelimab with better companion diagnostics-and legal, specifically navigating stricter FDA pathways and protecting their core Intellectual Property. You need to see how political scrutiny on drug pricing and shareholder litigation risk are amplifying the pressure on their remaining pipeline assets.

Allakos Inc. (ALLK) - PESTLE Analysis: Political factors

The political landscape for Allakos Inc. is now fundamentally a question of regulatory risk management for a subsidiary, not a growth-stage biotech, following its acquisition by Concentra Biosciences, LLC on May 15, 2025. The primary political factors shift from securing market access for a new drug to navigating the residual value and strategic alternatives for the remaining entity.

Increased political scrutiny on US drug pricing and PBM practices

The intense political focus on US drug pricing and the practices of Pharmacy Benefit Managers (PBMs) creates a significant headwind for any future commercialization efforts by Concentra Biosciences, LLC using the Allakos platform or its remaining assets. In 2025, bipartisan legislation, such as the 'Pharmacy Benefit Manager (PBM) Reform Act of 2025' (H.R. 4317), is actively being pushed to ban practices like spread pricing in Medicaid and decouple PBM compensation from a drug's list price. This scrutiny is not a fleeting trend; it's a structural shift aimed at increasing transparency and lowering patient costs, which will ultimately compress the net realized price for novel biologics. You should assume new drugs will face a tougher pricing environment.

The Inflation Reduction Act (IRA) drug negotiation program is also in its second year, further signaling a long-term commitment by the US government to intervene in drug costs. For a company like Allakos, which had to discontinue its lead program AK006 in January 2025, this environment means that any new drug candidate emerging from the acquired platform would have a lower projected peak sales figure than in previous years. This directly impacts the valuation of the remaining intellectual property and the viability of any strategic alternative the new parent company explores.

Potential for stricter FDA approval pathways for novel biologics

While the FDA is actively promoting expedited review for truly innovative therapies, the political and public pressure for safety and efficacy remains high, translating to a rigorous bar for novel biologics. The agency is using designations like Breakthrough Therapy and Priority Review to accelerate promising candidates, and even unveiled a new 'plausible mechanism pathway' in November 2025 for highly individualized drugs. This focus on acceleration for the best means a de-facto stricter pathway for everything else.

For Allakos, whose clinical-stage asset AK006 was discontinued after disappointing Phase 1 results in January 2025, the political environment is unforgiving of clinical failure. The FDA approved 50 new molecular entities in 2024, with 24 designated as first-in-class, showing the volume of competition. Any future novel biologic from the Allakos platform would need to show exceptional data to secure a fast-track designation and avoid the prolonged, resource-intensive traditional approval route. The political climate rewards clear-cut success and punishes ambiguity.

Uncertainty over R&D tax credit stability impacting cash burn rate

The uncertainty around R&D tax credits has largely been resolved in a favorable way for 2025, which is a positive for Allakos's remaining cash position. The 'One Big Beautiful Bill Act (OBBBA),' signed in July 2025, restored the immediate expensing of domestic Research & Development (R&D) costs. This is a huge win for biotech cash flow, as it reverses the prior requirement to amortize R&D expenses over five years.

This stability means the remaining entity can fully deduct any qualified US-based R&D expenses in the year they are incurred, improving the liquidity of the remaining cash, cash equivalents, and investments, which are estimated to be in the range of approximately $35 million to $40 million by June 30, 2025. Furthermore, small businesses can still use R&D credits to offset payroll taxes, up to $500,000 per year, which is valuable even with the reduced workforce. The political risk here has decreased, defintely helping the cash runway.

• Immediate expensing of domestic R&D costs is restored in 2025.
• This reversal provides an immediate tax deduction, boosting available cash.
• Startups can still offset up to $500,000 in payroll taxes with R&D credits annually.

Geopolitical tensions affecting global clinical trial site access and supply chain

Geopolitical tensions are a major and increasing risk to the global pharmaceutical supply chain, which impacts all biotech companies, including Allakos's successor. A 2025 survey found that 55% of businesses cited geopolitical factors as a top supply chain concern, a significant jump from 35% in 2023. This risk is driven by factors like the Russia-Ukraine war, Red Sea disruptions, and rising US-China tensions.

The most direct political risk is the potential enactment of legislation like the BIOSECURE Act, which targets Chinese influence in the life sciences supply chain. If passed, this act could fundamentally shift long-term drug manufacturing and supply chain operations, requiring costly and time-consuming diversification of suppliers for raw materials, active pharmaceutical ingredients (APIs), and contract manufacturing organizations (CMOs). For a company exploring strategic alternatives, this risk complicates the valuation of any remaining manufacturing or development-stage assets that rely on a global supply chain, particularly those tied to China or other politically volatile regions.

Here's the quick math on the risk: Geopolitical risk to supply chains surged by approximately 30% from 2020 to 2024, according to the Geopolitical Risk with Trade (GPRT) index. This volatility translates directly into higher costs and longer timelines for clinical trials and manufacturing, which is a major concern for any company looking to revive a drug candidate.

Next Step: Concentra Biosciences, LLC's leadership team should immediately task their regulatory and supply chain advisors with drafting a contingency plan for a 15% cost increase and a 6-month delay on any future clinical program due to geopolitical supply chain disruption, specifically addressing the risk of the BIOSECURE Act's passage.

Allakos Inc. (ALLK) - PESTLE Analysis: Economic factors

The economic factors for Allakos Inc. in 2025 are a clear-cut case of capital market reality meeting clinical failure, culminating in the company's acquisition. You need to understand that the macro environment-high interest rates and inflation-didn't cause the failure, but they defintely made it impossible to recover. The company's financial fate was sealed on May 15, 2025, when the merger with Concentra Biosciences, LLC was completed for $0.33 per share in cash. This was the ultimate economic outcome of a failed drug pipeline.

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

In 2025, Allakos Inc. faced a high-interest-rate environment that dramatically increased the cost of any potential new capital, whether debt or equity. The Federal Reserve's target range for the federal funds rate was set at 3.75%-4.00% following a cut in October 2025. For a clinical-stage biotech with no revenue, this is a killer. This elevated benchmark rate means that securing debt financing (loans) would have been prohibitively expensive. More importantly, it pushed investors toward less risky assets, making them demand a much higher rate of return on speculative biotech equity, which in turn drove down Allakos's valuation and increased its effective cost of equity capital. You just can't raise money easily when the risk-free rate is high.

Investor skepticism following clinical trial failures limits access to fresh capital.

Investor skepticism was the single most damaging economic factor, directly leading to the company's sale. Following the disappointing Phase 1 results for AK006 in chronic spontaneous urticaria (CSU) in January 2025, the stock plummeted by 76% to 77% in a single day. This massive loss of market capitalization, which had already been hit by the earlier failure of Lirentelimab (AK002), signaled to the market that the company's core assets were worthless. The market capitalization fell so low that the company faced a potential Nasdaq delisting for trading below the $1.00 minimum bid price. No venture capital or institutional investor would inject fresh capital into a company whose primary pipeline had failed and whose stock was trading for pennies.

Here's the quick math on the market's reaction:

Significant cash reserves, estimated around $175 million as of late 2025, fund operations into 2027.

The reality is that Allakos Inc.'s cash reserves were nowhere near $175 million in late 2025; this is a critical correction. The company ended the fourth quarter of 2024 with approximately $81 million in cash, cash equivalents, and investments. The subsequent decision to discontinue the AK006 program triggered a major restructuring, costing an estimated $34 million to $38 million in closeout and severance payments, primarily paid in the first half of 2025. This cash burn meant the company's estimated cash reserves would be reduced to a narrow range of $35 million to $40 million by June 30, 2025. The operational runway was not into 2027, but a much shorter period, which forced the immediate sale of the company to preserve the remaining capital for shareholders.

Inflationary pressures driving up costs for clinical trials and raw materials.

The persistent inflationary environment in 2025 put a ceiling on Allakos's ability to stretch its shrinking cash reserves. The US annual inflation rate was 3.0% in September 2025, but the costs specific to the biotech sector were rising even faster. For instance, the average per-patient clinical trial costs in the U.S. had risen by 12% compared to 2023, partly due to tariffs on active pharmaceutical ingredients (APIs) and lab reagents. While Allakos discontinued all clinical development and cut its workforce by 75% to about 15 employees to stop the burn, these rising costs meant that even a modest new clinical program would have required a disproportionately larger capital raise, which the market was unwilling to provide.

The economic headwinds were severe, but the internal clinical failures were the fatal blow. The macro factors simply ensured there was no lifeline.

Next Step: Review the Concentra Biosciences, LLC acquisition filing to confirm the final disposition of the remaining cash and intellectual property.

Allakos Inc. (ALLK) - PESTLE Analysis: Social factors

Growing patient advocacy for rare, eosinophil-driven diseases creates market pull.

The core social factor for Allakos Inc. is the intense, unmet need within the rare disease community, particularly for Eosinophilic Gastrointestinal Diseases (EGIDs). This patient advocacy creates a strong market pull, even after clinical setbacks. You see this pull quantified in the rising prevalence data. For example, Eosinophilic Esophagitis (EoE), a related condition, has an estimated U.S. prevalence of 142.5 per 100,000 persons, extrapolating to roughly 472,380 cases.

The specific conditions Allakos targeted, non-EoE EGIDs like Eosinophilic Gastritis (EoG) and Eosinophilic Duodenitis (EoD), are rarer but often more severe, driving focused advocacy. The total estimated patient population for non-EoE EGIDs is less than 50,000 in the U.S., but these patients report a worse quality of life compared to those with EoE. This severity means any viable therapeutic option will have immediate, high demand. The patient community is defintely a powerful, enduring force here.

Public perception of clinical trial risk is heightened after Phase 3 failures.

The company's history has severely damaged public and investor confidence, a critical social factor in biotech. The 2021 Phase 3 failures of Lirentelimab in the ENIGMA 2 and KRYPTOS trials, where the drug met the histologic (biomarker) endpoint but failed the symptomatic endpoint, erased nearly 90% of the company's market capitalization. That was a huge, painful lesson for the market.

This perception of high risk was reinforced in early 2025 when the follow-up candidate, AK006, failed its Phase 1 trial for chronic spontaneous urticaria (CSU). The data showed the placebo group improved by 12.4 points on the disease scale, which was a greater mean improvement than the AK006 cohort's 8.2 points. The result prompted a 75% workforce reduction and a pivot to exploring strategic alternatives, leaving the company with an estimated cash balance of only $35 million to $40 million by June 30, 2025. The market cap as of November 2025 sits at approximately $29.74 million.

• Risk perception is now extreme.
• The failure to translate eosinophil reduction into patient symptom relief remains a fundamental scientific and social question for the company's technology platform.

Increased demand for personalized medicine and biomarker-driven therapies.

The Lirentelimab failure-biomarker success, symptom failure-perfectly illustrates the need for better personalized medicine (PM) approaches in immunology. The global Personalized Medicine Market is a massive and growing field, estimated to be valued at $89.15 billion in 2025. The immunology and autoimmune diseases segment is projected to show the fastest growth, with a Compound Annual Growth Rate (CAGR) of 10.2% from 2024 to 2030.

The social demand is shifting from a one-size-fits-all drug to therapies that use diagnostics to stratify patients who will truly benefit. The diagnostics segment of the PM market is expected to hold 64.6% of the market share in 2025, underscoring the focus on identifying the right patient for the right treatment. For Allakos Inc. to regain credibility, any future program must be deeply rooted in a biomarker strategy that correlates definitively with patient-reported outcomes, not just histology.

Demographic shifts increasing the prevalence of allergic and inflammatory conditions.

A broader social trend is the rising prevalence of allergic and inflammatory conditions across all demographics, which creates a long-term tailwind for companies in this space. The prevalence of EoE, for instance, has seen a 5-fold increase since 2009. This increase is driven by a complex mix of genetic, environmental, and lifestyle factors.

The high co-occurrence of atopic comorbidities is also a factor; a significant portion of patients with EoG have other allergic conditions, like asthma or eczema. This demographic reality means the pool of patients with eosinophil-driven diseases is expanding, and the need for new, effective treatments is becoming a larger public health concern. This social pressure will continue to drive investment and research, even as individual companies like Allakos Inc. face major setbacks.

Allakos Inc. (ALLK) - PESTLE Analysis: Technological factors

You're looking at Allakos Inc. (ALLK) and trying to figure out the technological landscape, but honestly, you have to start with the fact that the company, as an independent entity, is gone. It was acquired by Concentra Biosciences in May 2025 for just $0.33 per share, following a series of clinical setbacks. This acquisition, coupled with the discontinuation of both lead programs, means the technological risk has fully materialized. The analysis here is less about future opportunity and more about dissecting a high-risk, high-reward monoclonal antibody (mAb) strategy that failed to translate bench science into patient benefit.

Core technology is a monoclonal antibody (mAb) platform targeting Siglec-8.

The core technology was a humanized IgG1 monoclonal antibody, lirentelimab (AK002), which targeted the inhibitory receptor Siglec-8, found on mast cells and eosinophils. The idea was precise: deplete the inflammatory cells. In the Phase 3 ENIGMA 2 and Phase 2/3 KRYPTOS trials, lirentelimab successfully reduced eosinophil counts-a key histological endpoint-but it repeatedly failed to meet the symptomatic co-primary endpoint in eosinophilic gastrointestinal diseases (EGIDs). The anti-Siglec-8 program was discontinued in early 2024. This is a classic example of a technology that was biologically sound but clinically insufficient.

The company shifted its focus to AK006, a Siglec-6 mAb targeting mast cells, but that, too, was abandoned in January 2025 after disappointing Phase 1 results in Chronic Spontaneous Urticaria (CSU) showed insufficient therapeutic activity. That was the final blow. The entire Siglec-targeting mAb platform, once valued highly, has been effectively shelved by the end of the 2025 fiscal year.

Rapid advancements in companion diagnostics (biomarkers) are crucial for patient selection.

The failure of lirentelimab was fundamentally a diagnostic problem, not just a drug problem. The technology could clear the eosinophils, but the patients didn't feel better. This highlights a critical technological gap in the EGID space: the lack of companion diagnostics (CDx) that reliably link a histological change (like eosinophil count) to a patient-reported outcome (symptom relief). The broader EGID field is seeing a push for less invasive diagnostic methods, and the Digestive Disease Week (DDW) in May 2025 emphasized the need for personalized treatment plans. Without a CDx to select the patients whose symptoms are driven solely by eosinophil or mast cell counts, even a perfect drug can fail its trial.

Here's the quick math: If your drug hits the target 100% of the time but the target only causes the symptom 40% of the time, your trial will fail. Better biomarkers are the real technological bottleneck here.

Competition from emerging modalities like gene therapy and mRNA vaccines.

While Allakos Inc. was struggling with its mAb platform, the competitive landscape in biologics and emerging modalities was accelerating. Monoclonal antibodies remain a dominant 'new modality' in 2025, accounting for a significant portion of the projected pipeline value of $197 billion, a 17% increase from 2024. However, the competition within the mAb space is intense. For EGIDs, Dupilumab is already FDA-approved for Eosinophilic Esophagitis (EoE), and other biologics like barzolvolimab (a mast cell depleter) are showing promise in Phase 2 trials as of May 2025. These competitors are often targeting well-validated inflammatory pathways (like IL-4/IL-13) rather than a novel, less-validated target like Siglec-8.

The broader threat comes from the sheer pace of innovation in biopharma. While gene therapy and mRNA vaccines have 'stalled' in some areas, the overall trend is toward rapid market entry for first-in-class products, which now account for about 50% of the market share. For Allakos, the failure to advance its Siglec-targeting technology means it missed the window to establish a first-in-class position, leaving the field open to more successful, and often conventional, biologic rivals.

Need for defintely more robust data analytics for complex Phase 2/3 trial design.

The complexity of running trials in heterogeneous diseases like EGIDs demands advanced data analytics, especially when endpoints are subjective. Allakos's failure to correlate histology with the Dysphagia Symptom Questionnaire (DSQ) score in its Phase 3 trials is a clear case for needing better data science. The industry is rapidly adopting Artificial Intelligence (AI) and machine learning to analyze vast data sets, screen compounds, and design trials, which has reportedly led to Phase 1 success rates greater than 85% in some cases. Allakos's post-hoc analysis, which tried to salvage the data by excluding confounding conditions like active Irritable Bowel Syndrome, was a manual, reactive attempt at patient stratification.

Going forward, any strategic move by Concentra Biosciences to revive the underlying science would require a massive investment in computational biology and trial design analytics to identify the correct patient subpopulation before Phase 3 enrollment. The old way of trial design is too expensive and too slow for a company with a market cap of only $29.74 Million USD (as of November 2025) and a history of clinical failure.

• Invest in AI to predict symptomatic responders.
• Develop non-invasive, objective biomarkers for EGID symptoms.
• Focus on a smaller, genetically-defined patient cohort.

Next Step: Concentra Biosciences: Complete a full technological audit of the Siglec-8 and Siglec-6 IP portfolio by year-end to determine residual value or potential out-licensing opportunities.

Allakos Inc. (ALLK) - PESTLE Analysis: Legal factors

The legal landscape for Allakos Inc. in 2025 is less about future drug approval hurdles and far more about the legal fallout from its corporate dissolution. The company's failure to achieve clinical success with its two lead candidates, lirentelimab and AK006, directly triggered a low-value acquisition by Concentra Biosciences, LLC, which closed on May 15, 2025. This event shifts the legal focus entirely to shareholder litigation, regulatory compliance during wind-down, and the disposition of distressed intellectual property (IP) assets.

Strict FDA requirements for demonstrating clinical benefit in new indications.

The core legal risk here materialized as a corporate failure, stemming from the inability to meet the U.S. Food and Drug Administration (FDA) and other global regulatory standards for efficacy. For a clinical-stage biotech, the FDA's requirement for statistical significance in a primary endpoint is the ultimate legal gateway to revenue. Lirentelimab (AK002) failed this test in January 2024, missing the primary endpoints in both the Phase 2 ATLAS trial for atopic dermatitis and the Phase 2b MAVERICK trial for chronic spontaneous urticaria (CSU).

The subsequent candidate, AK006, also failed in January 2025, with Phase 1 results in CSU showing a mean reduction in the Urticaria Activity Score 7 (UAS7) of only 8.2 points for the drug group, compared to a better 12.4-point reduction for the placebo group. This failure to demonstrate clinical benefit, a non-negotiable legal requirement, was the final blow, leading to a massive 75% workforce reduction and the decision to explore strategic alternatives.

Intellectual Property (IP) protection for lirentelimab is critical for long-term value.

The IP portfolio, once the company's primary asset, is now a distressed component of the acquisition. While the theoretical patent life for a new drug in the U.S. is generally 20 years from the earliest filing date, the practical value of lirentelimab's IP is near zero without a viable path to market. The IP's value is now merely a component of the total merger consideration of $0.33 per share paid by Concentra Biosciences, LLC.

The IP's remaining value is in its potential as a research asset or for a different indication not yet explored, but this is a high-risk proposition. The IP protection for lirentelimab (anti-Siglec-8) and AK006 (anti-Siglec-6) is now primarily a legal liability for the acquirer, requiring maintenance fees and defensive litigation readiness, despite the core programs being terminated. The company's accumulated deficit of $1.2 billion as of September 30, 2024, shows the staggering cost of developing this IP without success.

Evolving global data privacy laws (e.g., GDPR) complicate multi-national trials.

Even with the clinical programs halted, the legal and financial obligations tied to global data privacy laws remain a near-term cost. Allakos Inc. conducted multi-national trials, meaning it collected sensitive personal data, or 'special category data,' from European Union (EU) citizens, subjecting it to the General Data Protection Regulation (GDPR).

Compliance is not about new data collection, but about the legally mandated retention and wind-down process. The acquirer must ensure the proper pseudonymization and secure retention of all clinical trial data for the legally required period, which is a significant, non-discretionary cost. Here's the quick math: the estimated restructuring costs to close out AK006 development, including contractual payments and wind-down activities, are between $34 million and $38 million, a substantial portion of which is dedicated to legally compliant termination of contracts and data handling in the first half of 2025.

• Retain data for up to 25 years post-trial completion under some regulatory mandates.
• Maintain a Data Protection Officer (DPO) and EU Representative for GDPR compliance.
• Ensure data subject rights (e.g., right to access) are honored without compromising the integrity of the clinical trial data.

Increased litigation risk from shareholders following major stock price volatility.

The company is defintely facing a heightened risk of litigation, primarily from shareholders who suffered massive losses. The series of clinical failures and subsequent corporate actions have already triggered multiple legal actions, and the low-value merger in 2025 is a catalyst for more. You're looking at a classic securities fraud risk profile.

The first major class action lawsuit was filed in March 2020 following allegations that the company made false and misleading statements regarding the Phase 2 ENIGMA trial for AK002 (lirentelimab). A new wave of investigation was launched in January 2024 after the stock fell 60.2% on the news of the Phase 2 lirentelimab failures.

The final acquisition price of $0.33 per share on May 15, 2025, is a fraction of its historical value, creating a strong legal incentive for shareholders to challenge the board's decision-making process and fiduciary duty in the merger. This legal risk is now the primary outstanding liability for the acquiring entity.

The next step is for the acquiring entity, Concentra Biosciences, LLC, to finalize the wind-down of all outstanding legal liabilities, including the defense of the pending shareholder lawsuits.

Allakos Inc. (ALLK) - PESTLE Analysis: Environmental factors

You're looking at Allakos Inc. in a challenging year, and the Environmental (E) factor of PESTLE is a classic example of how industry-wide pressure still hits the smallest players. For a clinical-stage biotech like Allakos, which is currently focused on strategic alternatives with only about 15 employees by mid-2025, the primary environmental risks aren't in manufacturing, but in the stringent compliance required for clinical trial waste and the carbon footprint of its global logistics. Compliance is non-negotiable; your failure to manage bio-hazardous waste correctly can trigger immediate regulatory action, regardless of your size.

Growing ESG investor pressure on pharmaceutical supply chain sustainability.

Even though Allakos is not a large commercial manufacturer, it operates within a pharmaceutical sector facing intense Environmental, Social, and Governance (ESG) scrutiny. Investors, including major funds, are increasingly using ESG metrics to assess long-term stability and reputational risk. The industry's greenhouse gas (GHG) emissions are a massive concern, being 55% greater than the automotive sector's per dollar of revenue.

The core of this pressure for a company like Allakos is its Scope 3 emissions-the indirect emissions from its value chain, like contract research organizations (CROs) and logistics. These supply chain emissions typically account for 60% to 80% of a biotech's total carbon footprint. While Allakos's direct environmental spend is minimal compared to the $5.2 billion yearly spent by major pharma companies on environmental programs, its reliance on third-party suppliers means it must still demand ESG adherence to mitigate its own risk. Your small size doesn't give you a pass on your suppliers' environmental practices.

Regulations on bio-hazardous waste disposal from clinical sites and manufacturing.

The regulatory landscape for bio-hazardous waste is tightening significantly in 2025, directly impacting Allakos's ongoing and concluding clinical trial activities. The U.S. Environmental Protection Agency (EPA) is enforcing its 40 CFR Part 266 Subpart P rule in many states, which includes a nationwide ban on the sewering (flushing down the drain) of all hazardous waste pharmaceuticals. This means every vial, syringe, and residual drug product from a clinical site must be meticulously segregated and disposed of as regulated medical waste.

For a company winding down trials, the critical task is ensuring the correct final disposition of all investigational product and associated clinical materials. Furthermore, the Resource Conservation and Recovery Act (RCRA) compliance is shifting, with a new rule taking effect on December 1, 2025, which will require all hazardous waste generators to register for and use the EPA's electronic manifest system (e-Manifest). Compliance failure here, even due to a simple paperwork error, can lead to substantial fines and regulatory delays that could hinder any future strategic transaction.

Need for transparent reporting on the environmental impact of drug manufacturing.

While Allakos is currently a virtual company without its own manufacturing plants, the push for transparency extends to its contract manufacturing organizations (CMOs). New regulations, like the EU's Corporate Sustainability Reporting Directive (CSRD), which begins reporting phases in 2025, are creating a ripple effect, demanding greater supply chain data.

Investors want to see data on the environmental impact of the active pharmaceutical ingredient (API) production, which often involves energy-intensive steps and hazardous solvents. The pressure is on to report on Scope 3 emissions, even if you are just a customer of the manufacturer. For Allakos, this means that any potential partner or acquirer will scrutinize the environmental data of its API production to assess future compliance costs and climate-related risks. You have to know your contract manufacturer's footprint as if it were your own.

Focus on reducing the carbon footprint of global clinical logistics and travel.

The carbon footprint of clinical logistics is a growing focus area, particularly for a company that runs multi-site, global clinical trials. The transportation of temperature-sensitive materials (cold chain), investigational drugs, and patient samples contributes significantly to emissions. For road transport, emissions can range drastically from 239.57 to 6156.80 gCO2e/t-km depending on vehicle, load, and route efficiency.

The industry trend is toward Decentralized Clinical Trials (DCTs) to reduce patient and staff travel, which is a major carbon culprit. The use of single-use plastics in clinical packaging, like tubing and containers, is also under fire, with global waste from this source projected to reach 112,000 tonnes per year globally by 2025. Allakos's wind-down of trials means its immediate focus shifts to the carbon-efficient reverse logistics-getting remaining materials back and disposing of them responsibly. This is the last mile of your environmental responsibility.

Here is a quick look at the environmental challenges Allakos faces, mapped to its current operational reality:

The reality is that environmental compliance is a cost of doing business, even when cash reserves are tight, projected to be only $35 million to $40 million by mid-2025. You defintely can't cut corners on hazardous waste disposal to save a few dollars.

Next Step: Operations/Supply Chain: Finalize contracts with certified waste disposal vendors to ensure 100% Subpart P compliance for all remaining clinical trial waste by Q3 2025.