CureVac N.V. (CVAC): PESTLE Analysis [Nov-2025 Updated]

You're wrestling with how to value CureVac N.V. (CVAC) right now, and honestly, the old models are obsolete. The company isn't just a biotech firm anymore; it's a strategic asset being absorbed by a major player, BioNTech SE, and that process is the single biggest driver of its near-term future, plus they just secured a massive $740 million cash infusion from a patent settlement. This PESTLE analysis cuts through the noise to show you exactly where the external risks and opportunities lie, because the political and legal clearance for this deal is now the only thing that defintely matters.

Political Factors: The M&A Scrutiny

Government policy is less about R&D funding and more about M&A clearance now. The German government's early financial support, like the €300 million provided in 2020, showed a clear national interest in the company's success. But today, the focus is entirely on the pending BioNTech SE acquisition.

That acquisition needs regulatory sign-off in key global jurisdictions, which is a political risk that can delay or derail the deal. Also, shifts in US government policy post-January 2025 could change how the FDA and Health and Human Services (HHS) handle new vaccine pathways, so you need to watch Washington just as closely as the European Medicines Agency (EMA) in Amsterdam.

• Track global antitrust filings for the BioNTech deal.

Economic Factors: Cash Windfall vs. Burn Rate

The patent win turned a high burn rate into a strong, multi-year runway. CureVac's financials are a tale of two cities. On one hand, Q2 2025 revenue was a tiny €1.2 million, reflecting a dramatic 91% year-over-year drop. This shows the commercial failure of their initial vaccine efforts.

On the other, the August 2025 patent settlement secured an aggregate payment of $740 million plus US royalties. This cash injection, added to the existing strong cash cushion of €392.7 million as of June 30, 2025, provides a runway into 2028. Here's the quick math: the $740 million essentially covers years of the Q1 2025 operating loss of €54.7 million.

• Model the impact of the $740 million on the cash runway.

Sociological Factors: Shifting Focus and Public Trust

Moving past the COVID-19 vaccine failure is critical for talent and perception. The company is strategically moving into high-unmet-need areas like oncology (glioblastoma, lung cancer) and prophylactic vaccines (UTI). This shift is necessary and smart.

Still, public perception is heavily linked to the high-profile, but commercially unsuccessful, COVID-19 vaccine program. To be fair, the 2024 workforce reduction of approximately 30% aimed to create a leaner organization, but it impacts local employment in Tübingen, Germany, which is a factor for corporate social responsibility. They support local science education to build goodwill.

• Assess the new pipeline's market size in oncology.

Technological Factors: The RNA Platform Advantage

Their non-chemically modified mRNA platform is a genuine differentiator. CureVac's core strength is its proprietary, non-chemically modified messenger RNA (mRNA) platform and its Lipid Nanoparticle (LNP) technology. Key intellectual property (IP) includes the 'split poly-A tail technology,' which is crucial for enhanced protein expression.

They are also developing 'The RNA Printer' for fast, automated, and potentially decentralized mRNA production, which is a long-term strategic asset. Plus, their pipeline has off-the-shelf and personalized cancer immunotherapy candidates advancing to Phase 1 trials in H2 2025, showing the platform's versatility.

• Compare the 'split poly-A tail' IP against competitors' platforms.

Legal Factors: Patent Validation and Acquisition Clearance

The legal risk profile has dramatically improved post-patent settlement. The company resolved major US patent litigation with Pfizer, Inc. and BioNTech SE in August 2025, securing that large cash payment and royalties. This patent strength is a massive win.

Also, the European Patent Office (EPO) upheld the validity of key patents (EP 3 708 668 B1 and EP 4 023 755 B1) in amended form in March and May 2025. Still, the BioNTech SE acquisition is a definitive Purchase Agreement, but it absolutely requires regulatory clearance to close. The company is also subject to the German Supply Chain Due Diligence Act (LkSG) on human rights and environmental standards.

• Review the specific terms of the August 2025 royalty agreement.

Environmental Factors: Compliance and Ethical Supply Chain

Standard biotech manufacturing risks require continuous ethical oversight. The company adheres to a Human Rights Policy Statement and a Supplier Code of Conduct for ethical supply chain management. They also maintain an internal Speak up portal for reporting environmental and human rights concerns.

What this estimate hides is the fact that biotech manufacturing processes inherently carry risks related to waste disposal and energy use, so careful management is required to maintain compliance and reputation. They must manage these internal risks while adhering to the German Supply Chain Due Diligence Act (LkSG).

• Audit the waste disposal process at the Tübingen facility.

Legal/Strategy: Create a detailed timeline and risk matrix for all required global regulatory approvals for the BioNTech SE acquisition by the end of next week.

CureVac N.V. (CVAC) - PESTLE Analysis: Political factors

The political landscape for CureVac N.V. in 2025 is dominated by the pending acquisition by BioNTech SE and the shifting regulatory environment in its core markets, the European Union (EU) and the United States (US). The most immediate political factor is the need for required regulatory approvals to close the BioNTech transaction, which is expected in late 2025. This merger is viewed positively by the German government, which remains a significant stakeholder.

German government provided significant early funding (e.g., €300 million in 2020)

CureVac's foundational stability and early development were heavily influenced by direct political support from its home country. In June 2020, the German Federal Government invested €300 million in the company through the state-owned bank Kreditanstalt für Wiederaufbau (KfW). This equity financing secured a minority stake of approximately 23% in CureVac at the time, explicitly aiming to accelerate development and secure a domestic supply of mRNA technology. This early political backing was crucial, especially following allegations of US interest in acquiring the vaccine for exclusive use, which the German government publicly resisted, stating, 'Germany is not for sale.'

The German state's continued influence is evident in the BioNTech acquisition. KfW still holds 13.32% of CureVac's shares on behalf of the Federal Republic of Germany and is expected to support the transaction, confirming the government's positive view on merging the two German mRNA pioneers.

Pending acquisition by BioNTech SE requires regulatory approval in key global jurisdictions

The €1.25 billion all-stock acquisition of CureVac by BioNTech, announced in June 2025, is a major political and regulatory event. The deal, which is expected to close in late 2025, is contingent on satisfying a minimum acceptance threshold of at least 80% of CureVac's shares and receiving all necessary regulatory approvals.

While the German government's support is secured, the transaction requires clearance from multiple global jurisdictions due to the combined entity's market power and intellectual property (IP) portfolio. The political risk here is one of delay or conditional approval from antitrust bodies in major markets, including the EU and the US. To be fair, this acquisition also immediately resolves complex and costly patent litigation between CureVac, BioNTech, and Pfizer in the US, which is a significant de-risking factor for the combined company's future operations.

• Deal value: €1.25 billion (approximately $1.34 billion).
• German government stake (KfW): 13.32% of CureVac shares.
• Expected closing: Late 2025, pending regulatory approvals.

Shifts in US government policy post-January 2025 could alter FDA/HHS regulatory pathways for new vaccines

The political climate in the US is injecting new uncertainty into the regulatory pathway for all vaccine developers, including CureVac, which is a Nasdaq-listed company. The new US executive administration has initiated significant policy shifts at the Food and Drug Administration (FDA) and the Department of Health and Human Services (HHS) in 2025.

For new or updated vaccines, the FDA has tightened its evidence requirements. They now require randomized, placebo-controlled trials to approve COVID-19 vaccines for the general population (those not considered high-risk). This is a substantial change from the previous practice of relying on immunogenicity data for boosters, and it will increase the cost and time for any future CureVac vaccine candidate seeking broad US approval. Plus, the FDA has rescinded Emergency Use Authorizations (EUAs) for COVID-19 vaccines, limiting new approvals to specific high-risk groups.

Operating in the EU subjects the company to stringent European Medicines Agency (EMA) clearance processes

As a German-based company, CureVac is fundamentally subject to the stringent regulatory framework of the European Medicines Agency (EMA). While the company withdrew its first-generation COVID-19 vaccine (CVnCoV) from the EMA's rolling review in 2021, the current focus is on their oncology pipeline, which still requires EMA clearance.

The EMA's high bar for approval is a constant political factor. For example, in Q2 2025, CureVac successfully received Clinical Trial Application (CTA) clearance from the EMA for its proprietary off-the-shelf cancer immunotherapy candidate, CVHNLC, which targets squamous non-small cell lung cancer. This clearance is a necessary step to start clinical trials and demonstrates the company's ability to navigate the complex European regulatory system for its new generation of mRNA therapeutics. The political environment in the EU strongly supports domestic biotech innovation, but it will not compromise on the high standards for safety and efficacy.

CureVac N.V. (CVAC) - PESTLE Analysis: Economic factors

The economic landscape for CureVac N.V. in 2025 is a study in contrasts: a dramatic collapse in near-term revenue against a sudden, massive influx of cash from a patent settlement. Honestly, the settlement money changes the entire financial risk profile, moving the focus from immediate cash burn to strategic capital deployment.

Q2 2025 Revenue Was Low at €1.2 Million, Reflecting a Dramatic 91% Year-over-Year Drop.

CureVac's revenue for the second quarter of 2025 was a meager €1.2 million, which is a sharp, painful drop of 91% compared to the €14.4 million recorded in the same period in 2024. This isn't a surprise; it's the direct result of the July 2024 restructuring of the partnership with GlaxoSmithKline (GSK) from a collaboration into a licensing agreement, plus lower sales to CRISPR Therapeutics. The core business model is shifting away from early collaboration revenue toward a pure-play research and development (R&D) focus, so the revenue line will defintely look weak until a product hits the market.

Q1 2025 Operating Loss Was €54.7 Million, Showing High Research and Development (R&D) Burn Rate.

Despite significant cost-reduction efforts initiated with the strategic restructuring in July 2024, the company is still burning cash to fund its pipeline. The operating loss for the first quarter of 2025 was €54.7 million. This loss, while an improvement from the €73.3 million loss in Q1 2024, reflects the high cost of running a clinical-stage biotech company. The Q2 2025 operating loss was even higher at €61.7 million. This R&D burn rate is the price of admission in the mRNA space.

Here's the quick math on the half-year performance, showing the continued operational expense:

Patent Settlement in August 2025 Secured a Substantial Aggregate Payment of $740 Million Plus US Royalties.

The economic game-changer came in August 2025 with the resolution of the US patent litigation against BioNTech and Pfizer. The settlement agreement is a major financial win, providing a significant capital injection and a new revenue stream. CureVac and GSK will receive an aggregate payment of $740 million and ongoing single-digit royalties on US sales of COVID-19 vaccines. Specifically, CureVac is set to receive a direct payout of $370 million from BioNTech, plus an additional $50 million from GSK for monetizing a portion of future US product royalties.

The settlement also establishes a royalty structure:

• BioNTech and Pfizer will pay CureVac and GSK a 1% royalty on US sales of licensed mRNA-based COVID-19 and influenza products.
• These royalties are retroactive, applying to all sales from January 1, 2025, onward.
• The agreement grants BioNTech and Pfizer a non-exclusive license for these products in the US, which will expand to a worldwide license upon the closing of BioNTech's acquisition of CureVac.

Strong Cash Cushion of €392.7 Million as of June 30, 2025, Providing a Runway into 2028.

Even before the patent settlement cash lands, CureVac was in a strong financial position, a crucial factor in the high-risk biotech sector. As of June 30, 2025, the company held cash and cash equivalents of €392.7 million. This cash cushion is projected to provide a financial runway that extends into 2028. This is a massive competitive advantage, giving the R&D team the time and capital to hit clinical milestones without the immediate pressure of a dilutive equity raise. The settlement payment further solidifies this runway, providing a substantial buffer to accelerate pipeline development and weather any unforeseen clinical delays.

CureVac N.V. (CVAC) - PESTLE Analysis: Social factors

The social landscape for a biotech company like CureVac N.V. is defined by public trust, local employment impact, and the perceived value of its scientific mission. You need to understand that the ghost of the commercially unsuccessful COVID-19 vaccine program still colors public perception, even as the company makes a sharp, necessary pivot to high-unmet-need areas.

Strategic focus shifted to high-unmet-need areas like oncology (glioblastoma, lung cancer) and prophylactic vaccines (UTI)

CureVac has strategically shifted its research and development (R&D) focus away from the crowded, high-profile infectious disease market (like COVID-19) toward areas with significant patient need and higher potential for differentiation. This shift is critical for rebuilding a positive social narrative centered on life-saving therapies, not just mass-market vaccines.

The core of this new focus is oncology, specifically with programs like CVGBM for glioblastoma and CVHNLC for squamous non-small cell lung cancer (sqNSCLC). The glioblastoma study completed Phase 1 Part B enrollment in Q1 2025, with a decision on moving to Phase 2 expected in H2 2025. Simultaneously, the prophylactic vaccine pipeline is advancing, with the Urinary Tract Infection (UTI) vaccine candidate expected to have its Investigational New Drug (IND) filing in H2 2025. This pipeline focus is a clear signal: they are chasing high-impact, not high-volume, patient benefits.

Workforce reduction of approximately 30% in 2024 aimed to create a leaner organization, impacting local employment

To fund this pivot and streamline operations, CureVac initiated a significant strategic restructuring in July 2024, which included a workforce reduction of approximately 30% of its global staff. This action, while financially prudent for the company's long-term cash runway into 2028, had a palpable effect on local employment, particularly at its Tübingen, Germany headquarters.

Here's the quick math: the headcount at the end of 2024 was 983 employees, a reduction of 189 people or 16.13% compared to the previous year. This restructuring is projected to decrease annual personnel costs by approximately €25 million from 2025 onward. That's a huge cost saving, but still, losing that many highly-skilled jobs in a local community creates a social headwind, even if the financial rationale is defintely sound.

Public perception is still heavily linked to the high-profile, but commercially unsuccessful, COVID-19 vaccine program

The company's initial, high-profile foray into the COVID-19 vaccine race ended with disappointing Phase 3 trial results, showing an efficacy of only 48%. This low figure, compared to competitors, created a lasting negative association with the CureVac name in the global public eye. This is a brand liability, or what we call a 'reputational anchor,' that the firm is actively trying to shed.

The new strategy, including the licensing of the COVID-19 and influenza programs to GSK, is a deliberate move to de-emphasize this chapter. However, the public still needs to be re-educated on the new focus: a precision-mRNA platform for complex diseases like cancer, not a mass-market vaccine producer. The ongoing intellectual property (IP) litigation against BioNTech/Pfizer, with an infringement hearing set for July 1, 2025, is another high-profile event that keeps the company in the news, but this time, it's about the foundational strength of their mRNA technology, which is a better narrative.

Supports local science education and community sports in Tübingen, Germany, for corporate social responsibility

CureVac maintains a strong local presence and corporate social responsibility (CSR) commitment in its home base of Tübingen, Germany. This local support is a vital counter-narrative to the job cuts and the reputational anchor of the failed COVID-19 vaccine.

Key CSR activities include:

• Sponsor the Basketball Bundesliga team Tigers Tübingen and their youth counterpart, the Young Tigers.
• Support science and technology education through the student research center Südwürttemberg, which funds 500 student researchers.
• Created a free permanent exhibition, "Cradle of Biochemistry," in the Ancient Culture Museum in Tübingen.

These actions help cultivate goodwill, particularly with the next generation of scientists and the local community, which is crucial for a biotech firm that relies heavily on a skilled regional talent pool.

CureVac N.V. (CVAC) - PESTLE Analysis: Technological factors

You need to see CureVac N.V. not just as a biotech company, but as an intellectual property (IP) and manufacturing technology firm built on a core idea: non-chemically modified messenger RNA (mRNA). That proprietary platform is the engine, and the development of 'The RNA Printer' is the key to unlocking its full potential for personalized medicine, but you must keep a close eye on the ongoing patent litigation.

The company's technological strength is anchored in its unique approach to the mRNA molecule, which avoids the chemical modifications used by some competitors. This non-chemically modified mRNA platform, combined with proprietary next-generation lipid nanoparticle (LNP) technology, is designed to generate a strong immune response at a low dose, which is what we call dose efficiency. The LNP design is now being specifically tailored for either prophylactic vaccines (like infectious disease programs) or cancer vaccines, a critical strategic pivot.

Core strength is its proprietary, non-chemically modified messenger RNA (mRNA) platform and LNP technology.

CureVac N.V.'s core technological differentiator is its precision mRNA Backbone, which is sequence-engineered but not chemically altered. This is a deliberate choice to optimize the mRNA for better protein expression. The delivery system is equally important, using advanced, proprietary next-generation Lipid Nanoparticles (LNPs). These LNPs are designed to ensure high stability and maximize mRNA uptake into immune cells for cancer applications, while also offering stability for long-term storage, even at less demanding temperatures like 2-8°C for some formulations.

Here's the quick math on the company's financial position backing this technology: CureVac reported cash and cash equivalents of €392.7 million as of June 30, 2025, which provides a projected cash runway into 2028. This capital gives them the breathing room to execute on their R&D strategy without immediate financial pressure, even with an operating loss of €116.5 million for the first half of 2025.

Key intellectual property (IP) includes the 'split poly-A tail technology' for enhanced protein expression.

The company's intellectual property (IP) is a major asset, especially the 'split poly-A tail technology.' This foundational invention is crucial because it enhances the medical efficacy of the mRNA constructs by improving the expression of the encoded protein. Protecting this IP is defintely a high-stakes game, and the legal developments in 2025 are pivotal.

The European Patent Office (EPO) largely upheld the validity of two key patents related to this technology (EP 3 708 668 B1 and EP 4 023 755 B1) in amended form in Q1 2025. That's a big win for validating their pioneering role. The next critical date is the infringement hearing against BioNTech scheduled for July 1, 2025, before the Regional Court Düsseldorf. A positive infringement decision there would trigger proceedings to assess damages, which could be a significant financial windfall.

Developing 'The RNA Printer' for fast, automated, and potentially decentralized mRNA production.

The RNA Printer is CureVac N.V.'s vision for the future of manufacturing. It's a mobile, automated mRNA 'printing' facility designed to be an end-to-end solution for Good Manufacturing Practice (GMP)-grade RNA. This is not just a lab tool; it's a strategic asset for decentralized production.

This technology is meant to support two key areas:

• Rapid response for outbreaks, allowing for quick deployment.
• Personalized medicine, enabling on-demand production of individualized therapeutic cancer vaccines.

The RNA Printer is critical for the personalized precision immunotherapy strategy, which is expected to see its first Phase 1 study start in the second half of 2026. The ability to automate and decentralize manufacturing cuts down on the long lead times and massive capital expenditure associated with traditional large-scale biopharma production.

Pipeline includes off-the-shelf and personalized cancer immunotherapy candidates advancing to Phase 1 trials in H2 2025.

The technology platform is directly translating into a dual-pronged oncology pipeline: off-the-shelf and personalized precision immunotherapies. This is where the rubber meets the road for investors, and 2025 is a year full of catalysts.

Specifically, the company is advancing its off-the-shelf candidate, CVHNLC, which targets squamous non-small cell lung cancer (sqNSCLC). The U.S. Phase 1 trial initiation is anticipated in H2 2025 after receiving FDA Investigational New Drug (IND) clearance. Also, data from Part B of the Phase 1 study for CVGBM (glioblastoma) is on track for release in H2 2025, which will determine if the program advances to a Phase 2 trial. The glioblastoma study completed enrollment of at least 20 patients in Q1 2025.

CureVac N.V. (CVAC) - PESTLE Analysis: Legal factors

Resolved major US patent litigation with Pfizer, Inc. and BioNTech SE in August 2025 for a large cash payment and royalties.

You need to see the patent litigation with Pfizer, Inc. and BioNTech SE not as a risk that just disappeared, but as a substantial, immediate cash injection and a new, long-term revenue stream. The resolution of all pending US patent litigation related to mRNA-based COVID-19 vaccines was announced on August 8, 2025, which clears a major legal cloud ahead of the acquisition.

Under the terms of the settlement, CureVac and its partner GSK plc will receive an aggregate payment of $740 million, plus single-digit royalties on US COVID-19 vaccine sales going forward. The quick math shows a significant financial benefit directly to CureVac: BioNTech SE will pay CureVac $370 million upon the acquisition closing. Plus, CureVac also received $50 million from GSK for monetizing a portion of its US product royalties. This immediately strengthens the cash position, which was already strong at €392.7 million as of June 30, 2025.

The settlement also includes a 1% royalty on US sales of licensed products, effective from January 1, 2025, which is a defintely valuable royalty stream. In return, CureVac granted a non-exclusive US license for mRNA-based COVID-19 and influenza products to BioNTech SE and Pfizer, Inc., which converts to a worldwide license upon the acquisition closing.

European Patent Office (EPO) upheld the validity of key patents (EP 3 708 668 B1 and EP 4 023 755 B1) in amended form in March and May 2025.

The European patent landscape remains a core legal asset, and the EPO decisions this year have strongly validated CureVac's foundational mRNA technology. The EPO Opposition Division upheld the validity of two key patents, both in amended form, which is a major win.

The patents, EP 3 708 668 B1 and EP 4 023 755 B1, cover CureVac's proprietary 'split poly-A tail technology,' a foundational invention that enhances the medical efficacy of mRNA constructs by improving protein expression. The first patent, EP 3 708 668 B1, was upheld in amended form in March 2025. The second, EP 4 023 755 B1, received the same positive validity decision in May 2025.

This validation is critical because it strengthens CureVac's position in the parallel infringement proceedings against BioNTech SE in Germany. A hearing on the infringement of both patents was scheduled for July 1, 2025, before the Regional Court Düsseldorf. A positive infringement ruling would trigger a separate proceeding to assess damages, potentially leading to substantial European royalties. You have solid IP protection.

BioNTech SE acquisition is a definitive Purchase Agreement, but still requires regulatory clearance to close.

The definitive Purchase Agreement for BioNTech SE to acquire all shares of CureVac was signed on June 12, 2025, with an implied aggregate equity value for CureVac of approximately $1.25 billion. This transaction is the single biggest legal and financial event for the company this year, but it's not a done deal yet.

The acquisition is expected to close in 2025, but it is still subject to customary closing conditions, including a minimum acceptance threshold of at least 80% of CureVac's shares, and, crucially, required regulatory approvals. The legal risk here is a failure to secure these approvals, which could delay or derail the merger. However, the US patent settlement was structured to set a framework for resolving ongoing patent disputes outside the US upon the closing of the acquisition, suggesting the parties are confident in the deal's eventual completion.

Here is a quick summary of the BioNTech SE acquisition details:

Subject to the German Supply Chain Due Diligence Act (LkSG) on human rights and environmental standards.

As a German-based company, CureVac is subject to the German Supply Chain Due Diligence Act (LkSG), which mandates due diligence on human rights and environmental standards across the supply chain. The Act applies to companies with more than 1,000 employees in Germany, requiring a comprehensive risk management system.

The legal compliance landscape is currently shifting. In September 2025, the German Federal Cabinet approved a draft amendment to the LkSG, specifically aiming to abolish the reporting obligation. This is a move to reduce bureaucracy, but it doesn't eliminate the core legal responsibilities.

What this means for you is that the substantive due diligence obligations remain in force. You still need to:

• Establish a risk management system.
• Conduct regular risk analyses for your own operations and direct suppliers.
• Implement preventive and remedial measures.
• Set up an effective complaints mechanism.

The LkSG is ultimately expected to be replaced by a new national law that transposes the broader EU Corporate Sustainability Due Diligence Directive (CSDDD). So, while the reporting requirement is likely going away for now, the underlying legal pressure to maintain a clean and ethical supply chain is only increasing.

CureVac N.V. (CVAC) - PESTLE Analysis: Environmental factors

The environmental (E) factors for CureVac N.V. are less about a massive carbon footprint and more about managing the high-risk, specialized waste and energy demands inherent to a cutting-edge biotech operation. You need to look past the R&D focus and see the manufacturing reality.

While the company's financial reports for the 2024 fiscal year (released in 2025) focus on the €535.2 million in revenue and the €481.7 million cash position from strategic collaborations, the non-financial data, which is critical for a complete environmental assessment, is less transparent in the public filings. This lack of specific, consolidated environmental key performance indicators (KPIs) is a near-term risk for investors focused on ESG (Environmental, Social, and Governance) compliance, especially with the EU's Corporate Sustainability Reporting Directive (CSRD) looming.

Adheres to a Human Rights Policy Statement and a Supplier Code of Conduct for ethical supply chain management

CureVac N.V. has established a clear governance structure to manage its supply chain risks, which is a significant factor in the pharmaceutical sector's environmental and social impact. The company's commitment is formalized in its Human Rights Policy Statement and a Supplier Code of Conduct. This is defintely a necessary step, especially since the German Supply Chain Due Diligence Act (LkSG) requires this level of oversight.

The Supplier Code of Conduct contractually obligates direct suppliers to adhere to CureVac's human rights and environmental expectations. This moves the environmental responsibility beyond their own walls and into the global network of raw material and component providers. Here's the quick math: a single raw material failure in the supply chain can halt a program that has seen €153.0 million in R&D costs in 2024 alone.

• Actionable Insight: Compliance extends to all partners.
• Policy Alignment: Aligns with the UN Guiding Principles on Business and Human Rights.
• Risk Mitigation: Annual and ad hoc risk analyses are performed on direct suppliers.

Has an internal 'Speak up' portal for reporting environmental and human rights concerns

A functional, accessible complaints mechanism is the operational layer that makes the formal policies real. CureVac N.V. maintains a complaints system, the 'Speak up' portal, which allows both employees and external parties, including supplier employees, to report potential compliance violations. This is a crucial risk management tool.

The system is designed to handle reports concerning both human rights and specific environmental risks or violations of environmental obligations. Reports can be submitted anonymously and in multiple languages, which is important for a multinational company with sites in Germany, the Netherlands, Switzerland, and the U.S.. The company explicitly prohibits retaliation against good-faith reporters.

Biotech manufacturing processes carry inherent risks related to waste disposal and energy use, requiring careful management

The core business of mRNA technology is resource-intensive. Manufacturing messenger ribonucleic acid (mRNA) and lipid nanoparticles (LNP) requires specialized, energy-intensive equipment like ultracold freezers for storage and highly purified solvents and reagents, all of which generate complex waste streams.

While specific 2024/2025 environmental performance data (like Scope 1 and 2 emissions in metric tons of CO2 equivalent or total hazardous waste generated) is not publicly disclosed in the recent financial filings, the inherent risks are clear. The biotech sector's environmental footprint is characterized by:

• High Energy Demand: Maintaining -80°C ultra-low temperature freezers for mRNA and LNP storage is a major energy draw.
• Hazardous Waste: Chemical solvents, biological waste from cell culture, and discarded single-use plastics from Good Manufacturing Practice (GMP) environments require specialized, high-cost disposal.
• Regulatory Burden: Compliance with national and local environmental, health, and safety (EHS) laws is non-negotiable, and failure can result in material adverse effects on the business.

The company's focus on its proprietary second-generation mRNA backbone, which is designed for improved stability, has a secondary environmental benefit-if the product is more stable, it reduces the risk of spoilage and the associated waste and energy loss from failed batches or storage issues.

Next Step: Finance and Operations must prioritize the disclosure of 2025 environmental KPIs (GHG emissions, water use, waste volume) in the next annual report to fully satisfy growing investor and regulatory scrutiny.