Atossa Therapeutics, Inc. (ATOS): PESTLE Analysis [Nov-2025 Updated]

You're betting on Atossa Therapeutics, Inc.'s (ATOS) Z-endoxifen to disrupt the breast cancer market, but a clinical-stage biotech is a tightrope walk between scientific promise and macro-risk. With a market capitalization around only $35 million and a quarterly cash burn of roughly $4.5 million pushing the runway into Q4 2026, every external factor-from FDA political shifts and interest rate hikes to the social demand for less-toxic treatments-matters immensely. You defintely need to know exactly how the Political, Economic, Sociological, Technological, Legal, and Environmental (PESTLE) forces are shaping their path to commercialization, because navigating this landscape is the difference between a breakthrough and a bust.

Atossa Therapeutics, Inc. (ATOS) - PESTLE Analysis: Political factors

FDA's accelerated approval pathway for oncology remains a key factor.

You're a clinical-stage oncology company, so the regulatory landscape is your primary political risk and opportunity. The US Food and Drug Administration's (FDA) Accelerated Approval (AA) pathway is a crucial lever for Atossa Therapeutics, Inc. to get its lead drug candidate, (Z)-endoxifen, to market faster.

This pathway remains heavily skewed toward cancer, with oncology indications accounting for a striking 80% of all Accelerated Approvals in 2024. This is a massive tailwind for any oncology-focused firm. Atossa Therapeutics is actively trying to capitalize on this, having requested a Type C meeting with the FDA in September 2025 to discuss an accelerated regulatory strategy for low-dose (Z)-endoxifen in breast cancer risk reduction. They expect to meet with the FDA in November 2025 to discuss a development plan intended to support a New Drug Application (NDA).

Still, the pathway has its limits. Of the 226 oncology agents granted AA between 1992 and 2024, only 54.0% have been converted to full approval, meaning a significant 31.0% are still awaiting confirmatory data. This means a faster path to market comes with the political risk of eventual withdrawal if post-marketing trials don't confirm clinical benefit.

Increased US government focus on cancer moonshot initiatives.

The US government's renewed commitment to the Cancer Moonshot initiative creates a favorable funding and collaboration environment, which helps validate and accelerate your focus on oncology. For the Fiscal Year (FY) 2025 budget, President Biden requested a substantial increase in discretionary funds for the National Cancer Institute (NCI) of $716 million, which is a significant boost over FY 2023 funding.

More directly, the Cancer Moonshot initiative received mandatory funding of $1.5 billion, which is distributed across the NCI, the FDA, the Centers for Disease Control and Prevention, and the Advanced Research Projects Agency for Health (ARPA-H). This funding is designed to drive breakthroughs, expand access to screenings, and increase diversity in clinical trials, all of which can indirectly benefit Atossa Therapeutics by improving the clinical trial ecosystem and patient recruitment for its Phase 2 studies of (Z)-endoxifen in ER+/HER2- breast cancer. This is a clear signal: the government is putting its money where its mouth is on cancer research.

Geopolitical tensions affecting global supply chains for clinical trial materials.

The global political environment is introducing new, measurable costs and delays into the pharmaceutical supply chain, which directly impacts your clinical trial timelines and budget. Specifically, new US tariffs, announced in July 2025 and effective August 1, 2025, on pharmaceutical imports from over 150 countries are a major concern. Initial tariff rates range from 20% to 40% on various goods, with a warning of up to 200% tariffs on pharmaceuticals manufactured overseas.

Here's the quick math on the risk: these tariffs are expected to increase Active Pharmaceutical Ingredient (API) costs by 12%-20% for widely used molecules, a cost that will inevitably flow through to your clinical trial material and manufacturing expenses. Small-cap biotechs like Atossa Therapeutics, which rely on global Contract Manufacturing Organizations (CMOs) for their drug substance, must now factor this trade uncertainty into their cash runway projections. To be fair, this pressure is forcing a necessary, long-term shift toward supply chain diversification and potential US-based reshoring.

Potential for shifting tax incentives on US-based pharmaceutical R&D spending.

The political landscape has swung back in favor of domestic research spending, which is defintely a boon for Atossa Therapeutics' US-based R&D activities. A major legislative shift occurred in July 2025 with the signing of the 'One Big Beautiful Bill (OBBB).'

This bill reverses the costly 2022 requirement to amortize (spread out) research and development expenses over five years. Now, effective for the 2025 tax year, US businesses can once again fully deduct domestic R&D expenses in the year they are incurred. This immediate expensing significantly improves cash flow for clinical-stage companies that are still burning cash on R&D, as it reduces their taxable income right away.

Plus, the long-standing R&D Tax Credit (Section 41) remains available, offering a credit that can range from 6% to 20% of eligible expenses. This combination of immediate expensing and the R&D tax credit makes continued investment in US-based clinical trials, like the Phase 2 studies for (Z)-endoxifen, significantly more attractive from a financial perspective.

Atossa Therapeutics, Inc. (ATOS) - PESTLE Analysis: Economic factors

High R&D costs for Z-endoxifen Phase 2/3 trials continue to pressure cash flow.

You need to see the real cost of advancing a key asset like (Z)-endoxifen, and the numbers show the pressure is real. For the third quarter of 2025, Atossa Therapeutics' total operating expenses-a solid proxy for their cash burn-hit $9.3 million. That's a sharp increase from the previous year, driven by the intense focus on clinical development. Specifically, Research and Development (R&D) expenses alone were $5.4 million for Q3 2025, a 57% increase year-over-year for the quarter. This spend is tied directly to their (Z)-endoxifen trials, including the streamlined Phase 2 EVANGELINE study and preparations for the metastatic breast cancer program.

The company is making a clear, strategic trade-off: accelerating their regulatory path for a potential 2026 New Drug Application (NDA) in exchange for a higher near-term cash burn. It's a calculated risk, but you have to monitor that expense line closely.

• Q3 2025 Operating Expenses: $9.3 million
• Q3 2025 R&D Expenses: $5.4 million
• Q3 2025 Net Loss: $8.7 million

Cash runway is projected to last into Q1 2027, based on a quarterly burn rate of roughly $9.3 million.

The company's cash position is strong, but the burn rate is the critical variable. As of September 30, 2025, Atossa Therapeutics held $51.8 million in cash and cash equivalents, with no debt. Management has stated this cash reserve is sufficient to fund operations for at least one year. Here's the quick math using the Q3 2025 operating expense as the quarterly burn: $51.8 million cash divided by $9.3 million per quarter equals approximately 5.57 quarters.

What this estimate hides is the potential for further cost reductions, like the recent streamlining of the EVANGELINE trial, or the need for a major, expensive Phase 3 trial initiation. Based on the current Q3 2025 operating rate, the cash runway is projected to extend into the first quarter of 2027, which gives them a solid window to hit key clinical milestones before needing to raise more capital.

Interest rate environment makes new debt financing expensive, favoring equity raises.

The current macro-economic environment, marked by elevated interest rates, heavily influences Atossa Therapeutics' financing strategy. As of November 2025, the Federal Reserve's target range for the federal funds rate is 3.75%-4.00%, which translates to a high Bank Prime Loan rate of 7.00%.

Since the company has no debt, this high-rate environment makes new debt financing-like a term loan-an expensive proposition, especially for a clinical-stage biotech with no revenue. This reality pushes them to favor equity financing (selling new shares) to fund their R&D, a common but dilutive path for the sector. To be fair, management has been disciplined, choosing not to use their At-The-Market (ATM) facility at recent share price levels, indicating a focus on minimizing dilution.

Market capitalization currently sits around $104 million, making it sensitive to dilution.

The company's market capitalization is a key economic factor, reflecting market sentiment and its vulnerability to financing moves. As of November 2025, Atossa Therapeutics' market capitalization is approximately $104 million. This is a significant increase from the lower figure you might have seen previously, but it still puts them in the small-cap biotech category, where valuation is highly sensitive to clinical news and financing. The high cash balance of $51.8 million compared to the market cap offers a strong floor, but any significant equity raise would still cause substantial dilution for existing shareholders, given the current valuation.

Large market opportunity for new non-toxic breast cancer treatments drives valuation.

The long-term opportunity for (Z)-endoxifen is the single biggest driver of the company's intrinsic valuation. The global Estrogen Receptor Positive (ER+) Breast Cancer Treatment market is substantial, projected to grow to $34.3 billion in 2025, with the broader Estrogen Receptor Modulators (SERM) market anticipated to reach $48.9 billion by 2035. Since (Z)-endoxifen is a next-generation SERM that has shown promising results in trials with minimal side effects compared to older drugs like tamoxifen, it targets a critical unmet need for a non-toxic alternative for both treatment and prevention.

The potential for (Z)-endoxifen to capture even a small fraction of this multi-billion-dollar market justifies the current R&D spend and the long-term optimism from analysts. The sheer size of the target market provides a massive ceiling for the company's valuation if they successfully navigate the clinical and regulatory hurdles.

Atossa Therapeutics, Inc. (ATOS) - PESTLE Analysis: Social factors

Strong patient advocacy groups for breast cancer (e.g., Susan G. Komen) influence trial enrollment.

Patient advocacy groups are a critical social force, directly impacting the clinical development timeline and the public perception of new therapies. These organizations, like Susan G. Komen, act as influential stakeholders who can significantly accelerate or impede clinical trial enrollment (the process of recruiting participants for a study).

For Atossa Therapeutics, Inc., this influence is a double-edged sword. While patient groups champion promising new treatments, they also demand efficiency and transparency. Data shows that only about 14% of breast cancer clinical trials reach optimal enrollment, which is a massive hurdle for any company. This low rate means Atossa Therapeutics, Inc.'s ability to execute its streamlined Phase 2 EVANGELINE study for (Z)-endoxifen is under intense scrutiny from the patient community.

The company's October 2025 decision to amend the EVANGELINE trial to a non-registrational design, prioritizing a potential 2026 New Drug Application (NDA)-enabling package, reflects a necessary focus on financial discipline and faster objective readouts, which ultimately serves the patient need for quicker access to effective drugs. A slow trial is a failed trial, defintely.

• Advocacy groups drive urgency for faster drug development.
• They can boost enrollment for trials offering less-toxic options.
• Their scrutiny demands rigorous data and ethical trial conduct.

Growing public demand for less-toxic, oral treatment alternatives like Z-endoxifen.

The market is experiencing a powerful push from patients and clinicians for less-toxic treatment options, particularly oral therapies that improve quality of life. Current treatment options for metastatic breast cancer often come with 'substantial side effects,' creating a clear unmet need that Atossa Therapeutics, Inc.'s lead candidate, (Z)-endoxifen, is positioned to address.

The drug is a Selective Estrogen Receptor Modulator (SERM) that has shown a favorable safety profile and is well-tolerated in previous trials, making it highly attractive in this environment. The broader pharmaceutical landscape confirms this trend, with major players like Eli Lilly and AstraZeneca competing in the oral Selective Estrogen Receptor Degrader (SERD) space, a direct competitor to SERMs like (Z)-endoxifen. This public preference for convenience and tolerability supports a premium pricing strategy for a successful oral drug that minimizes hospital visits and debilitating side effects.

Here's the quick math on the market shift:

Health equity focus drives pressure for diverse enrollment in clinical trials.

The societal focus on health equity and closing racial and ethnic disparities in healthcare is a major factor shaping clinical trial design in 2025. This pressure is intense because a lack of diversity limits the generalizability of drug efficacy and safety data across the entire patient population.

The data paints a stark picture of the challenge Atossa Therapeutics, Inc. and its partners face: in a review of nine industry-sponsored breast cancer trials since 2020, White participants were overrepresented at 70.7%, while Black participants were significantly underrepresented at only 2.35%. Black women, for instance, are estimated to be only 1% to 3% of participants in breast cancer clinical trials, despite facing worse outcomes.

To be fair, this is a systemic issue, but a company that successfully implements strategies to improve diversity will gain a significant social and regulatory advantage. Strategies like standardized prescreening have shown immediate impact, leading to a 5.5-fold rise in minority representation in one practice in 2024. Atossa Therapeutics, Inc. must demonstrate a concrete plan to address this in its upcoming Phase 2 and planned Phase 3 trials to secure public trust and regulatory favor.

High societal cost of breast cancer treatment supports premium pricing for successful drugs.

The sheer economic burden of breast cancer in the U.S. provides a strong argument for premium pricing of any successful therapy that improves outcomes or reduces the need for costly later-stage interventions. The total direct medical cost of breast cancer treatment in the U.S. was estimated to be $32.7 billion in 2024, a figure that continues to rise.

The average cost of treatment per patient can range from $60,000 to $134,000, depending on the stage and type of cancer. A drug like (Z)-endoxifen, which is being investigated for early-stage disease (like Ductal Carcinoma In Situ or DCIS) and for risk reduction, has the potential to move the needle on this societal cost by preventing the progression to more expensive, advanced-stage disease.

A therapy that offers a better safety profile and is orally administered, potentially improving patient compliance, offers significant value to the healthcare system by reducing hospitalizations and managing side effects. This value proposition justifies a premium price, but Atossa Therapeutics, Inc. must clearly articulate the cost-benefit analysis to payers. The total operating expenses for Atossa Therapeutics, Inc. for the nine months ended September 30, 2025, were approximately $22.8 million, demonstrating the significant investment required to bring a high-value drug to market.

Next step: Finance: Draft a preliminary cost-effectiveness model for (Z)-endoxifen in the DCIS setting, comparing it to standard-of-care tamoxifen by month-end.

Atossa Therapeutics, Inc. (ATOS) - PESTLE Analysis: Technological factors

Advancements in personalized medicine require precise biomarker identification for patient selection.

The core of Atossa Therapeutics' strategy rests on precision medicine, which demands highly accurate patient selection. You can't just throw a drug at a disease anymore; you need to know who will respond. For their lead candidate, (Z)-endoxifen, a potent Selective Estrogen Receptor Modulator (SERM), the technology hinges on identifying patients whose tumors are estrogen-receptor positive (ER+).

In the Phase 2 I-SPY 2 sub-study, the company demonstrated this by tracking the Ki-67 biomarker, a key measure of cell proliferation. The data, released in May 2025, showed the median Ki-67 dropped significantly from 10.5 percent at baseline to just 5 percent by Week 3 in the low-dose arm. This is a clear, measurable anti-proliferative effect. What's more, 65 percent of patients achieved a Ki-67 $\leq$ 10 percent at that early time point. This focus on rapid, measurable biomarker response is defintely a technological strength.

The company is also addressing a major technological challenge in endocrine therapy: acquired resistance. Recent research, highlighted in November 2025, shows that (Z)-endoxifen maintains its function against ESR1 mutants-genetic alterations that often cause tumors to stop responding to standard endocrine drugs. That's a critical technological edge in metastatic breast cancer.

Use of AI/Machine Learning to accelerate clinical trial data analysis and predict outcomes.

The sheer volume of data in oncology trials makes Artificial Intelligence (AI) and Machine Learning (ML) a necessity, not a luxury. Atossa Therapeutics has been using advanced AI systems in silico (computer modeling) to accelerate its pharmacological development, specifically to predict optimal drug combinations. Here's the quick math: the global AI in clinical trials market was valued at USD 2.05 billion in 2024 and is projected to grow at a 14.0% CAGR, so this is a major industry trend.

The company's internal modeling, driven by AI, indicated that (Z)-endoxifen is 'probably the best agent to partner with the CDK4/6 class of agents,' which is a major class of breast cancer drugs. This prediction is now being tested in the ongoing I-SPY 2 trial, which is an efficient way to guide R&D spend. Also, the company is supporting the AI-driven SMART study, a Phase 2 trial enrolling 70,000 women in Sweden to validate an AI-based breast cancer risk assessment model. This helps them find the right patients for prevention trials later on.

Oral drug delivery technology (Z-endoxifen) offers a significant patient convenience advantage.

A simple, patient-friendly drug delivery system is a powerful technological advantage. (Z)-endoxifen is a proprietary oral formulation that solves a major problem with the older drug, tamoxifen, which requires the body to metabolize it into the active form. That process is highly variable between patients, meaning some women get little benefit.

Atossa Therapeutics' solution is an enteric-coated pill. This technological step bypasses stomach acid, which would otherwise convert the active (Z)-isomer into its inactive (E)-form, ensuring consistent therapeutic exposure. This is a huge convenience factor, especially when you compare it to an injectable therapy like fulvestrant, which is a standard of care for some ER+ metastatic breast cancer patients. A pill is just easier to take.

Competition from gene editing and cell therapy platforms in the broader oncology space.

While Atossa Therapeutics is focused on a small molecule endocrine therapy, the technological landscape in oncology is dominated by massive, high-growth platforms like gene editing and cell therapy. These technologies represent a long-term competitive threat because they aim for a cure, not just chronic management. You need to keep an eye on this scale.

The sheer size of these competing markets shows the capital flow and technological momentum they possess:

The technological sophistication of these platforms-like CAR T-cell therapy for lymphomas and leukemias, and CRISPR for precise gene correction-is immense. Even though (Z)-endoxifen targets a different patient population (solid tumors, breast cancer), the rapid growth and massive investment in these fields mean they attract top talent and capital, constantly raising the bar for what constitutes a breakthrough in cancer treatment. Atossa Therapeutics must keep demonstrating superior efficacy and safety to compete with the promise of these revolutionary, albeit more expensive and complex, therapies.

Atossa Therapeutics, Inc. (ATOS) - PESTLE Analysis: Legal factors

You're operating in the most regulated sector of the economy, so legal compliance isn't just a cost center; it's a critical path to revenue. For Atossa Therapeutics, this means managing a web of global regulatory bodies, defending key intellectual property, and ensuring patient data integrity. The near-term focus is on the U.S. Food and Drug Administration (FDA) and protecting the proprietary enteric formulation of Z-endoxifen.

Strict FDA and European Medicines Agency (EMA) regulations govern clinical trial conduct and data integrity.

The path for Z-endoxifen is entirely dependent on meeting the stringent standards of the FDA and, eventually, the EMA. The good news is that Atossa Therapeutics is moving fast and with regulatory alignment. In July 2025, the company received highly constructive written feedback from the FDA, which supported the proposed dose optimization trial for metastatic breast cancer (mBC) and eliminated the need for a pre-Investigational New Drug (IND) meeting. This validation accelerated the planned IND submission to the fourth quarter of 2025.

The FDA's support of the dose optimization strategy aligns with their Project Optimus initiative, which is a major legal and scientific hurdle cleared. Still, any setback in a Phase 2 trial-like the streamlined EVANGELINE study-could trigger a new regulatory hold, costing the company millions. For the six months ended June 30, 2025, Atossa's Net Loss was $(15,141) thousand, showing how expensive these regulated development programs are. One missed deadline can burn a lot of cash.

Intellectual Property (IP) protection for Z-endoxifen's composition and method of use is critical.

The value of Atossa Therapeutics is tied directly to its Intellectual Property (IP) estate for its proprietary enteric oral formulation of Z-endoxifen. The company has been aggressively fortifying this position in 2025, but it faces active challenges. This is a high-stakes legal battle.

The IP portfolio is robust, encompassing multiple claims related to the drug's composition, manufacturing, and method of use. However, the legal environment is not without risk:

• U.S. Patent No. 12,275,684 and U.S. Patent No. 12,281,056 were granted in April and May 2025, respectively, strengthening protection for the enteric oral formulations.
• The total U.S. patent portfolio now includes four issued patents with over 200 claims.
• Two of Atossa's patents are currently the subject of active post-grant challenges (PGR and IPR petitions filed April 3, 2025) by a competitor, Intas.
• A prior Patent Trial and Appeal Board (PTAB) decision in January 2025 found one patent unpatentable, underscoring the ongoing intellectual property litigation risk.

Increased scrutiny on data privacy (HIPAA) for patient information collected during trials.

As a company conducting clinical trials in the U.S. and globally, Atossa Therapeutics is a Covered Entity or Business Associate under the Health Insurance Portability and Accountability Act (HIPAA). This means any patient data collected from the over 700 subjects who have received Z-endoxifen in clinical studies must be protected with rigorous security protocols.

The selection of a global Contract Research Organization (CRO), PSI, in August 2025 to manage the pivotal metastatic dose-ranging study is a key action to manage this legal risk. The CRO selection shifts the operational burden of compliance-including adherence to data privacy laws like HIPAA and the EU's General Data Protection Regulation (GDPR)-but Atossa remains ultimately responsible for oversight. A single data breach could lead to significant fines and severely compromise future trial enrollment, which is a defintely material risk.

Compliance with Good Manufacturing Practice (GMP) for drug substance production.

Good Manufacturing Practice (GMP) compliance is a non-negotiable legal requirement for any drug moving toward commercialization. The FDA's positive feedback in July 2025 on the nonclinical safety data package for Z-endoxifen implicitly confirms that the Chemistry, Manufacturing, and Controls (CMC) data-which includes GMP-was adequate to support the planned IND filing in Q4 2025.

The company's IP strategy, which includes claims covering 'manufacturing methods that enrich the Z-isomer via stepwise crystallization and solvent control,' shows a legal focus on the purity and consistency of the drug substance. This legal protection reinforces the technical and regulatory requirement for high-purity Z-endoxifen, specifically an enteric formulation comprising at least 90% by weight Z-endoxifen. The goal is to ensure the drug product is safe, pure, and effective, which is the core of GMP regulation.

Next step: Legal counsel should provide a probability-weighted assessment of the Intas patent challenges by the end of the year.

Atossa Therapeutics, Inc. (ATOS) - PESTLE Analysis: Environmental factors

The environmental factor for Atossa Therapeutics, Inc., a clinical-stage biopharmaceutical company, centers on managing the ecological footprint of its clinical trials and supply chain. Since Atossa Therapeutics does not own large-scale manufacturing facilities, its primary environmental risks are indirect, falling under Scope 3 emissions (supply chain) and the ethical disposal of its investigational product, (Z)-endoxifen. The immediate takeaway is that a lack of formal Environmental, Social, and Governance (ESG) reporting creates a silent risk, even as the industry moves toward standardized measurement.

Growing investor and public pressure for Environmental, Social, and Governance (ESG) reporting on clinical trial ethics

You can't ignore the ESG wave anymore. Investor demand for structured, financially relevant ESG disclosures is escalating in 2025, moving beyond simple narratives to verifiable business intelligence. While most small, non-revenue-generating biotechs like Atossa Therapeutics are currently exempt from mandatory US laws like California's SB 253 (which targets companies with over $1 billion in annual sales), institutional investors are still applying pressure. Your silence on these matters can lead to exclusion from key sustainable finance opportunities, making it a 'right to play' issue, not just a moral one. Honestly, not having a clear ESG policy is a competitive disadvantage now.

This pressure is driving a new focus on the 'S' (Social) and 'E' (Environmental) aspects of clinical trials, which includes the ethical treatment of trial participants and the environmental impact of the drug itself. Major pharmaceutical companies are already collaborating through groups like the Pistoia Alliance to develop a new industry-wide standard for measuring the carbon footprint of different clinical trial delivery methods.

Need for sustainable disposal of laboratory and drug waste from R&D activities

The disposal of investigational products (IPs) and lab waste is a critical environmental and regulatory risk for any clinical-stage company. Your lead product, (Z)-endoxifen, must be managed via a 'cradle-to-grave' model throughout all Phase 2 and planned Phase 3 trials. Improperly discarded pharmaceuticals can enter the environment as Environmental Persistent Pharmaceutical Pollutants (EPPPs), which can disrupt aquatic ecosystems, even at trace concentrations.

To mitigate this, Atossa Therapeutics must ensure its Contract Research Organizations (CROs) and clinical sites adhere to strict Standard Operating Procedures (SOPs) for the return and destruction of unused or expired drug product. Failure to secure a formal Certificate of Destruction for all returned and unused Investigational Medicinal Products (IMPs) can lead to significant regulatory fines and legal liabilities. This is a compliance point that must be audited, not assumed.

Focus on minimizing the carbon footprint of global clinical trial logistics

Clinical trials are a major contributor to the healthcare sector's carbon footprint, which is estimated to be around 5% of global greenhouse gas emissions. For a company like Atossa Therapeutics conducting Phase 2 trials, the environmental cost per patient is substantial. A recent life cycle assessment of clinical trials found that the mean emissions per patient for a Phase 2 trial is approximately 5,722 kg CO2e. This is a huge number.

The carbon footprint of a clinical trial is primarily driven by three factors, which you need to manage through your third-party vendors:

• Drug Product (API production and manufacturing) accounts for a mean of 50% of emissions.
• Investigational Medicinal Product (IMP) shipping and distribution accounts for 16% of emissions.
• Patient travel to and from sites accounts for 11% of emissions.

Using decentralized trial elements like telemedicine, as well as optimizing packaging and transport routes for temperature-sensitive samples, are clear actions to reduce this footprint, which is a growing expectation from all stakeholders.

Climate-related risks to manufacturing sites and supply chain stability

As a virtual biotech, Atossa Therapeutics is highly exposed to the climate-related risks of its third-party partners. For most pharmaceutical companies, Scope 3 emissions-the indirect emissions from the supply chain-represent up to 90% of their total carbon footprint. This means your risk is entirely tied to your Contract Manufacturing Organizations (CMOs) and CROs.

The global pharmaceutical supply chain is increasingly vulnerable to physical climate risks, such as extreme weather events. For instance, Hurricane Maria in 2017 severely impacted drug manufacturing plants in Puerto Rico, causing long-term shortages across the U.S. This kind of disruption can halt a clinical trial overnight. You need to know your CMOs' climate risk exposure.

Here's a quick map of the supply chain risks you are currently exposed to:

Finance: draft a detailed 18-month cash flow projection by Friday, assuming a 15% R&D cost increase in 2026. Here's the quick math: based on your Q3 2025 R&D expense of $5.4 million, that 15% increase means your 2026 quarterly run-rate will jump to about $6.21 million per quarter.