Curis, Inc. (CRIS): PESTLE Analysis [Nov-2025 Updated]

You're looking for a clear-eyed view of Curis, Inc. (CRIS) in late 2025, and the biggest takeaway is this: A recent political win significantly de-risked their core asset, but the clock is ticking on their cash position. Their future hinges on the clinical data they're presenting right now.

Political Factors

The political landscape is a massive near-term win for Curis. The July 2025 passage of the One Big Beautiful Bill Act (OBBBA) was a game-changer. Why? It exempted multi-indication orphan drugs like emavusertib from Medicare price negotiation. That single move defintely de-risked the future revenue stream for their core asset.

Still, you can't ignore the long-term headwind of global price pressure. The White House continues to push for aligning US medicine prices with lower international rates, which creates pricing uncertainty down the road. On the flip side, the OBBBA also restored the immediate 100% deduction for domestic R&D expenditures starting in the 2025 tax year, lowering their effective cost of innovation. Political action just gave emavusertib a huge pricing shield.

Economic Factors

Honestly, the Economic picture is the most immediate risk. As of September 30, 2025, Curis had only $9.1 million in cash and cash equivalents. Here's the quick math: with a Q3 2025 Research and Development (R&D) expense of $6.4 million-a necessary but high burn rate-the company expects this cash to fund operations only into the first quarter of 2026. This is a classic biotech cliff.

Their Trailing Twelve Months (TTM) revenue is minimal at just $11.65 million as of November 2025, almost all from Erivedge® royalties. So, the company faces a substantial doubt about its ability to continue as a going concern without securing additional financing soon. Cash runway ends in Q1 2026.

Sociological Factors

The Sociological factors are strongly in Curis's favor because emavusertib targets rare, aggressive cancers like Primary CNS Lymphoma (PCNSL) and Acute Myeloid Leukemia (AML). This high unmet medical need ensures clear patient demand, which is crucial for market penetration post-approval.

Plus, emavusertib is an orally available, small molecule inhibitor. Patients defintely prefer convenient, non-intravenous treatments, which improves adherence and quality of life. Also, strong Rare Disease Advocacy groups successfully lobbied for the recent Orphan Drug legislative changes, and they will provide critical support during drug development and future pricing discussions. High unmet need creates guaranteed patient demand.

Technological Factors

The core value here is the technology. Emavusertib is a first-in-class small molecule inhibitor targeting IRAK4, a novel oncology target. This mechanism could offer a completely new therapeutic approach, moving beyond existing standards of care.

The clinical strategy reflects the current oncology trend: combination therapies. Studies focus on emavusertib plus a BTK inhibitor in PCNSL, which is the standard of care shift to multi-agent regimens. The near-term valuation driver is the key clinical data for emavusertib in PCNSL and AML being presented at major industry conferences (SNO and ASH) in late 2025. Novel IRAK4 target is a true first-in-class opportunity.

Legal Factors

From a Legal standpoint, Curis has built a strong intellectual property (IP) moat. The core patents for emavusertib are expected to expire between 2035 and 2038, providing a long window of market exclusivity post-approval. That's a decade-plus of protection.

Furthermore, the Orphan Drug Designation grants seven years of market exclusivity in the US for each approved rare disease indication. They also secured new US patents in March 2025 and September 2025 covering combination therapies and drug formulations. This recent activity strengthens their IP position against potential competitors. Market exclusivity is locked in until 2035 and beyond.

Environmental Factors

Curis's direct Environmental regulatory risk is low right now. As a small, clinical-stage biotech with TTM revenue of $11.65 million, they are currently below the $1 billion revenue threshold for mandatory US state-level ESG reporting, like California's SB 253. They don't have to worry about the immediate compliance burden.

But, you still need to pay attention to investor ESG pressure (Environmental, Social, and Governance). Major investment firms are now scoring all biotechs on ESG. This means governance and social factors-like clinical trial diversity and pricing-are key to attracting necessary capital. Future EU and US SEC rules will also increase pressure on their supply chain for drug manufacturing and logistics partners, requiring greater environmental transparency. Direct environmental regulation is low, but investor ESG pressure is high.

Curis, Inc. (CRIS) - PESTLE Analysis: Political factors

You're looking at Curis, Inc. in late 2025 and trying to map out the political landscape. The key takeaway is that recent legislation has created a powerful, near-term pricing shield for emavusertib, their lead asset, while a parallel White House initiative introduces a significant, long-term revenue risk. It's a classic biotech dichotomy: regulatory tailwinds meet pricing headwinds.

Expanded Orphan Drug Exemption: The July 2025 One Big Beautiful Bill Act (OBBBA) exempted multi-indication orphan drugs from Medicare price negotiation, a major win for emavusertib.

The passage of the One Big Beautiful Bill Act (OBBBA) on July 4, 2025, was a massive, defintely positive political development for companies like Curis, Inc. This law amended the Inflation Reduction Act (IRA) to broaden the Orphan Drug Exclusion from Medicare price negotiations. Previously, a drug with more than one rare disease indication could lose its exemption and become eligible for negotiation.

The OBBBA now explicitly excludes orphan drugs designated for one or more rare diseases or conditions from the definition of a Qualifying Single Source Drug (QSSD) for negotiation, provided all approved indications are for rare diseases. This is critical for emavusertib, which holds Orphan Drug Designation from the FDA for Primary Central Nervous System Lymphoma (PCNSL), Acute Myeloid Leukemia (AML), and Myelodysplastic Syndromes (MDS). This new framework protects the potential multi-billion-dollar revenue stream from emavusertib in its multiple rare cancer indications from Medicare price controls, at least until it gains a non-orphan indication. That's a huge boost to the drug's net present value (NPV).

Global Price Pressure: The White House is pushing drugmakers to align US medicine prices with lower international rates, creating long-term pricing uncertainty.

Despite the win on the IRA front, the industry faces a renewed and aggressive push from the White House to implement a Most-Favored-Nation (MFN) pricing model. President Trump issued an Executive Order on May 12, 2025, titled 'Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients,' which aims to link US drug prices to the lowest prices paid in other developed nations. The administration is demanding manufacturers commit to aligning US pricing for all brand products without generic or biosimilar competition to the MFN target price.

The MFN target price is defined as the lowest price in an Organization for Economic Co-operation and Development (OECD) country with a Gross Domestic Product (GDP) per capita of at least 60% of the U.S. GDP per capita. The Centers for Medicare and Medicaid Services (CMS) has even launched a voluntary Generating Cost Reductions for U.S. Medicaid (GENEROUS) Model to incentivize manufacturers to offer supplemental rebates that align with international benchmarks. This creates a significant long-term risk for any future Curis, Inc. product pricing, as the US market typically sets a premium that subsidizes global research.

R&D Tax Incentives: The OBBBA restored the immediate 100% deduction for domestic R&D expenditures for tax years starting in 2025, lowering Curis's effective R&D cost.

The same OBBBA that expanded the Orphan Drug Exemption also brought back a critical tax incentive for the biotech sector. The law restored the ability for companies to immediately deduct 100% of their domestic Research and Development (R&D) expenditures, reversing the prior requirement to amortize (spread out) the deduction over five years. This is a direct, positive impact on Curis's bottom line and cash flow.

Here's the quick math: Curis, Inc.'s R&D expenses for the nine months ended September 30, 2025, were $22.4 million. Under the old rule, they would have only been able to deduct a fraction of that amount this year, creating a higher taxable income. The new law allows them to deduct the full $22.4 million in 2025, significantly reducing their tax liability, which is a major benefit for a development-stage company.

Accelerated Approval Pathway: Continued, active dialogue with the FDA and EMA for accelerated approval of emavusertib in PCNSL remains the primary regulatory path.

The primary political and regulatory focus for Curis, Inc. remains the accelerated approval pathway for emavusertib in Primary Central Nervous System Lymphoma (PCNSL). Curis is actively enrolling patients in the TakeAim Lymphoma study, which is specifically designed, following discussions with the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), to support accelerated approval filings in both the US and Europe. This is the most direct path to commercialization and revenue generation.

The regulatory environment for accelerated approval is under constant scrutiny, but the pathway remains robust for rare, high-unmet-need conditions like PCNSL. The company's strategy is clear and hinges on positive clinical data from the ongoing study to satisfy both agencies. The political will to expedite treatments for rare cancers is strong, which is a key advantage for their regulatory strategy.

• Enroll PCNSL patients in TakeAim Lymphoma study.
• Maintain active dialogue with FDA and EMA for filing support.
• Leverage Orphan Drug Designation for PCNSL from both agencies.

Finance: Model the cash flow impact of the $22.4 million R&D deduction for the 2025 fiscal year by Friday.

Curis, Inc. (CRIS) - PESTLE Analysis: Economic factors

The economic outlook for Curis, Inc. is defined by an immediate and critical capital-raising mandate, driven by a high burn rate and a near-term cash runway that is now entirely dependent on securing new financing. The recent sale of its sole revenue-generating asset, Erivedge® royalties, makes the need for a new capital infusion defintely urgent.

Limited Cash Runway

As of September 30, 2025, Curis's cash and cash equivalents totaled just $9.1 million. This is the core number you need to focus on, as management has already stated this existing cash is only expected to fund operations into the first quarter of 2026. This short runway-just a few months from the November 2025 reporting date-is typical for a clinical-stage biotech but forces an immediate and potentially dilutive financing decision.

Here's the quick math on the cash position:

• Cash and Cash Equivalents (Sep 30, 2025): $9.1 million
• Expected Cash Runway: Into Q1 2026
• Net Loss (Q3 2025): $7.7 million

Minimal Royalty Revenue

The company's revenue stream, which has historically been minimal, is now being eliminated. The Trailing Twelve Months (TTM) revenue as of November 2025 stood at $11.65 million, derived almost entirely from Erivedge® royalties. To be fair, this revenue was never enough to cover operating expenses, but it provided a small, consistent floor.

However, on November 6, 2025, Curis sold its Erivedge® business, including the royalty rights, in exchange for $2.5 million upfront and a release of a related liability. This transaction, while clearing a significant liability, means the company will no longer be entitled to any future Erivedge® royalty revenue. This shifts Curis into a pure development-stage company with essentially zero recurring revenue for the foreseeable future.

High Burn Rate

The primary driver of the short cash runway is the necessary, but high, Research and Development (R&D) expense associated with advancing the emavusertib pipeline. In the third quarter of 2025 alone, R&D expenses were $6.4 million. This burn rate is a strategic investment in the clinical trials for emavusertib in PCNSL (Primary Central Nervous System Lymphoma), CLL (Chronic Lymphocytic Leukemia), and AML (Acute Myeloid Leukemia), but it rapidly consumes the cash balance.

The company has shown some control, as R&D expenses were down from $9.7 million in Q3 2024. Still, with total operating expenses for the nine months ended September 30, 2025, at $33.6 million, the pressure to maintain pipeline momentum while conserving capital is intense.

Financing Dependency

The financial situation is so strained that management has already disclosed a conclusion of substantial doubt about the company's ability to continue as a going concern. This is a formal disclosure required by accounting standards (FASB ASU No. 2014-15) when there is significant uncertainty about meeting obligations within the next year.

The company will require substantial additional capital to fund the development of emavusertib and support continued operations. The sale of the Erivedge® royalty stream, while providing $2.5 million upfront, terminates the only non-dilutive revenue source, making the dependency on equity, debt, or collaboration financing even more absolute. Failure to secure this funding in the immediate term could force the company to drastically reduce or even cease drug development programs.

Finance: The immediate next step is to secure an equity financing round before the end of Q4 2025 to extend the cash runway past Q1 2026.

Curis, Inc. (CRIS) - PESTLE Analysis: Social factors

High Unmet Need: Emavusertib targets rare, aggressive cancers like Primary CNS Lymphoma (PCNSL) and Acute Myeloid Leukemia (AML), ensuring a clear patient demand.

The social imperative for Curis, Inc.'s work is clear: they are targeting cancers with devastating prognoses and a critical lack of effective treatments. Acute Myeloid Leukemia (AML) is particularly aggressive, with the American Cancer Society estimating approximately 22,010 new cases and 11,090 deaths in the US in 2025. The survival data is stark; the estimated 5-year overall survival (OS) for AML is only about 32%, and this drops to less than 10% for patients over 60, which is the median age of diagnosis.

Primary CNS Lymphoma (PCNSL) is a rare disease, but its impact is equally severe. The annual incidence rate is roughly 0.4 to 0.5 cases per 100,000 people in the US, making it an orphan disease. Still, the 5-year survival rate for PCNSL patients remains poor, hovering around 30.1% for HIV-uninfected cases, based on the latest long-term data. This high mortality and low survival rate for both AML and PCNSL creates an undeniable and urgent patient demand for novel therapies like emavusertib, a key social driver for the company's valuation.

Here's the quick math on the need:

Oral Therapy Preference: Emavusertib is an orally available, small molecule inhibitor, aligning with the patient preference for convenient, non-intravenous treatments.

The shift toward oral oncology treatments is a major social trend, and emavusertib's formulation as an orally available, small molecule inhibitor directly capitalizes on this. Patients defintely prefer the convenience of taking a pill at home versus spending hours in a clinic for an intravenous (IV) infusion. This preference isn't abstract; it's quantifiable.

A review of oncology patient preference studies found that 84.6% of the articles comparing administration modes reported a patient preference for oral treatment over IV. In fact, one survey showed that a significant 80% of patients would prefer an oral chemotherapy agent if its efficacy was comparable to a parenteral (IV) therapy. This preference is driven by several factors:

• Greater sense of control over treatment (cited by 33% of patients in one survey).
• Ability to receive treatment at home, improving quality of life.
• Elimination of anxiety associated with IV lines and clinic visits.

For a company like Curis, Inc., developing an oral therapy for a relapsed/refractory patient population, this social preference translates directly into higher adherence rates and a more compelling commercial profile against older, IV-based standards of care.

Rare Disease Advocacy: Strong patient advocacy groups successfully lobbied for the recent Orphan Drug legislative changes, which can provide critical support during drug development and pricing discussions.

The rare disease patient community has become a powerful social force, successfully lobbying for legislative protections that directly benefit companies developing Orphan Drugs (ODs) like Curis, Inc. Emavusertib has already been granted Orphan Drug Designation by the FDA for PCNSL, AML, and Myelodysplastic Syndrome (MDS), plus by the European Commission for PCNSL.

A crucial recent development was the signing of the 'One Big Beautiful Bill Act' (OBBBA) on July 4, 2025. This legislation amended the Inflation Reduction Act (IRA) to address a major disincentive for rare disease research. What this estimate hides is the prior risk: the original IRA language threatened to subject ODs to Medicare price negotiation if they were approved for a second rare disease indication. The OBBBA change now ensures that ODs with more than one approved rare disease indication remain exempt from the Medicare Drug Price Negotiation Program, provided all approved indications are for rare diseases. This is a huge de-risking event for Curis, Inc., which is pursuing multiple rare disease indications (PCNSL, AML, MDS, and Chronic Lymphocytic Leukemia (CLL)) for emavusertib. This legislative win, driven by patient advocacy, secures the potential for premium pricing and stronger market exclusivity for emavusertib across all its orphan indications.

Curis, Inc. (CRIS) - PESTLE Analysis: Technological factors

First-in-Class Mechanism: Emavusertib is a first-in-class small molecule inhibitor targeting IRAK4, a novel oncology target that could offer a new therapeutic approach.

The core technological advantage for Curis, Inc. rests on its lead candidate, Emavusertib (CA-4948). This is an oral, small molecule inhibitor that is considered first-in-class because it targets Interleukin-1 receptor-associated kinase 4 (IRAK4). IRAK4 is a critical component of the Myddosome signaling pathway, which is often constitutively active in certain B-cell lymphomas and myeloid malignancies, like Acute Myeloid Leukemia (AML). By blocking this pathway, Emavusertib essentially starves the cancer cells, leading to apoptosis, or programmed cell death.

What makes this technology particularly compelling is its dual mechanism of action. Beyond IRAK4, Emavusertib also inhibits FMS-like Tyrosine Kinase 3 (FLT3), a known mutation in AML. This dual targeting strategy is designed to overcome resistance mechanisms that limit the effectiveness of single-target therapies. Honestly, this is a smart way to approach complex blood cancers.

The company's commitment to advancing this technology is reflected in its financial statements. For the second quarter of 2025, Curis, Inc. reported Research and Development (R&D) expenses of $7.5 million, underscoring the significant investment required to push this novel technology through clinical trials.

Combination Strategy: Clinical studies focus on combination therapies, such as emavusertib plus a BTK inhibitor in PCNSL, reflecting the standard of care shift in oncology to multi-agent regimens.

The modern oncology landscape is all about combination regimens, and Curis, Inc. is defintely playing that game to maximize Emavusertib's potential. The technology is being strategically developed to pair with established drugs, aiming for synergistic effects that improve patient outcomes. The primary focus is the TakeAim Lymphoma Phase 1/2 study, which combines Emavusertib with a BTK inhibitor (Bruton's tyrosine kinase inhibitor), such as Ibrutinib, for relapsed/refractory Primary Central Nervous System Lymphoma (PCNSL) and Secondary CNS Lymphoma (SCNSL).

This combination strategy is crucial because it addresses a significant unmet need. For example, in a patient with PCNSL who had previously not responded to Ibrutinib, adding Emavusertib led to a complete response. This suggests the IRAK4 inhibition is successfully overcoming the BTK inhibitor resistance pathway. Also, the company is testing a powerful triplet combination in frontline AML: Emavusertib with Venetoclax and Azacitidine.

Here's the quick math on the clinical activity seen in the Phase 1/2a TakeAim Leukemia trial for FLT3-mutated AML patients treated with Emavusertib monotherapy (300 mg twice daily):

Near-Term Data Catalysts: Key clinical data for emavusertib in PCNSL and AML is being presented at major industry conferences (SNO and ASH) in late 2025, which will defintely drive near-term valuation.

For a development-stage biotech like Curis, Inc., data releases are the single biggest driver of near-term stock valuation. The technology's future hinges on the results being presented at two major conferences in late 2025. This is a critical period for the company.

The first catalyst is the 30th Annual Meeting of the Society for Neuro-Oncology (SNO), held from November 19-23, 2025. Curis, Inc. is presenting three sets of clinical data on the Emavusertib plus BTKi combination in PCNSL and SCNSL, including a rapid oral presentation. The goal of this trial is to support accelerated approval filings in the US and Europe.

The second, equally important catalyst is the 67th American Society of Hematology (ASH) Annual Meeting in December 2025. Here, the company will report initial data from the frontline AML triplet study, which is the combination of Emavusertib with Venetoclax and Azacitidine. The success of this triplet could significantly expand the addressable market for the drug into a frontline setting, which is a massive opportunity.

The market is waiting on these specific data points:

• Updated efficacy signals (Overall Response Rate, Complete Response Rate) in the PCNSL/SCNSL combination study.
• Safety and tolerability data from the new, high-intensity AML triplet regimen.
• Analysis of genetic mutation profiles and CNS pharmacokinetics in PCNSL patients.

What this estimate hides is that while the Q3 2025 revenue was $3.2 million, the company's valuation is almost entirely dependent on the positive outcome of these upcoming clinical data presentations, not on its current small revenue stream from Erivedge royalties.

Curis, Inc. (CRIS) - PESTLE Analysis: Legal factors

The legal landscape for Curis, Inc. is defined by its core intellectual property (IP) strategy for emavusertib, its lead clinical candidate, and recent strategic divestitures that streamline its focus. The value proposition is heavily weighted on the duration of its patent protection and the market exclusivity granted by regulatory bodies like the FDA.

Long Patent Exclusivity

The company's long-term value rests on its foundational patents for emavusertib (CA-4948). These core composition of matter and method-of-use patents provide a defintely long window of market exclusivity, which is critical for recouping the substantial investment in drug development.

For emavusertib, the primary composition of matter intellectual property is currently expected to expire in 2035, before any potential patent term extensions (PTE) or patent term adjustments (PTA) are applied. This is a strong, multi-year moat. Beyond the core compound, the portfolio includes other issued or allowed U.S. patents that protect various aspects of the drug's use and formulation, with expiration dates extending as far as 2038.

Here's the quick math: Assuming a 2027-2028 potential approval timeline, a 2035 composition of matter expiration provides at least 7 to 8 years of core exclusivity, with the possibility of extensions adding up to five years more under the Hatch-Waxman Act.

Orphan Drug Exclusivity

A key legal advantage Curis has secured is the Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA) for emavusertib in multiple indications. An ODD grants seven years of market exclusivity in the US for each approved rare disease indication, a powerful shield against generic competition post-approval.

Emavusertib currently holds ODD for three distinct indications, significantly multiplying the potential period of market protection.

• Primary Central Nervous System Lymphoma (PCNSL): A high-value, unmet need indication.
• Acute Myeloid Leukemia (AML): A primary focus of the TakeAim Leukemia study.
• Myelodysplastic Syndrome (MDS): Another rare blood disorder indication.

The Orphan Drug Act's exclusivity is additive to patent protection, meaning that even if a patent expires, the drug maintains a monopoly in that specific rare disease market for the full seven years following approval. This structure provides a dual layer of legal defense.

Recent IP Portfolio Action in 2025

While the company is continually filing patents for combination therapies, the most significant legal and financial action in the 2025 fiscal year was the strategic divestiture of the legacy Erivedge (vismodegib) business. On November 6, 2025, Curis sold its interest in Curis Royalty LLC, including the Erivedge intellectual property and rights under the Genentech license, to TPC Investments Royalty LLC.

This transaction had a clear financial and legal impact on the company's 2025 books:

This sale simplifies the IP portfolio and focuses all resources on emavusertib, which is crucial given the company's net loss of $26.9 million for the nine months ended September 30, 2025. The $2.5 million upfront cash helps fund operations, which were projected to be sustainable only into the first quarter of 2026 based on the $9.1 million cash and cash equivalents as of September 30, 2025. The removal of the legacy IP liability is a clean-up move. The legal strategy is now entirely centered on maximizing the emavusertib exclusivity period.

Curis, Inc. (CRIS) - PESTLE Analysis: Environmental factors

Low Direct Regulatory Risk

For Curis, Inc., the immediate environmental regulatory risk is low, mostly because of its size and current business model. The company is a clinical-stage biotech focused on drug development, not large-scale commercial manufacturing. Its Trailing Twelve Months (TTM) revenue is only $11.65 million as of late 2025.

This low revenue shields the company from the most stringent new US state-level environmental, social, and governance (ESG) reporting requirements. For example, California's Climate Corporate Data Accountability Act (SB 253) requires US companies doing business in the state to report their greenhouse gas (GHG) emissions, but only if their annual revenue exceeds $1 billion. Similarly, the Climate-Related Financial Risk Act (SB 261) has a lower, but still prohibitive, threshold of $500 million in annual revenue.

The US Securities and Exchange Commission (SEC) climate disclosure rules, which would have applied to public companies like Curis, are currently under a voluntary stay as of March 2025, pending judicial review. So, you don't have to worry about a massive federal compliance headache right now.

Here's the quick math on why you're not directly in the crosshairs:

Investor ESG Pressure Shifts Focus

Still, you can't ignore ESG. Even with low environmental impact, major investment firms are scoring all biotechs on ESG, which means governance and social factors are key to attracting capital. Firms like BlackRock are actively using ESG ratings and analysis for over 90% of the issuers in their funds, including their Systematic Global SmallCap Fund. They're not just looking at carbon emissions for a company of your size.

For a clinical-stage company, the 'E' in ESG is less about Scope 1 emissions (direct operations) and more about the 'S' and 'G'-specifically, the long-term impact of your product and your internal controls.

• Focus on Equitable Access: Show a clear strategy for making emavusertib (CA-4948) accessible, especially since it targets rare cancers like Primary Central Nervous System Lymphoma (PCNSL).
• Prioritize Diversity in Leadership: Investor models look for inclusive leadership teams as a proxy for better long-term decision-making and risk management.
• Avoid Severe Controversies: Major investors screen for breaches of global norms, like those in the UN Global Compact Principles, which cover human rights and labor standards.

Your ability to raise capital in 2026 and beyond will defintely be tied to these non-financial factors, regardless of your current revenue.

Supply Chain Transparency Risk

The biggest environmental risk for Curis, Inc. actually comes from its manufacturing partners and the extraterritorial reach of European Union (EU) regulations. Since Curis is pursuing accelerated approval filings in the EU for emavusertib, your supply chain will be pulled into the EU's regulatory orbit.

The EU's Corporate Sustainability Reporting Directive (CSRD) and Corporate Sustainability Due Diligence Directive (CSDDD) are the real near-term threats, even though Curis is a US-based company with low EU revenue. The CSDDD forces large companies to identify and mitigate environmental and social risks across their entire chain of activities, including suppliers and distributors.

What this means is that your contract manufacturing organizations (CMOs) and logistics partners-who are likely much larger and already in scope for CSRD reporting-will soon be required to report on their Scope 3 emissions (value chain emissions). They will, in turn, demand detailed environmental data from you, their smaller supplier.

This creates a compliance flow-down risk:

• Your CMOs will send you extensive data requests on the environmental footprint of your drug substance manufacturing.
• Failure to provide this data could make Curis a non-preferred or high-risk partner for large CMOs, potentially disrupting your clinical trial supply or future commercial production.

Actionable step: Proactively engage your primary manufacturing partner's compliance team to understand their 2026 CSRD data requirements now. Finance: Budget for a third-party consultant to map your outsourced manufacturing's carbon footprint by Q2 2026.