SELLAS Life Sciences Group, Inc. (SLS): PESTLE Analysis [Nov-2025 Updated]

SELLAS Life Sciences Group, Inc. (SLS) is a high-stakes, event-driven biotech play right now, with its entire valuation hinging on the final analysis of the Phase 3 REGAL trial for galinpepimut-S (GPS) expected by year-end 2025. Your investment decision must map this clinical catalyst against the company's financial runway; they reported a net loss of $6.8 million in Q3 2025, but a strong capital raise in October boosted their cash position to over $73 million, giving them breathing room to execute. This PESTLE analysis cuts through the complexity, showing you exactly how regulatory decisions, market volatility, and the technological success of GPS and their other asset, SLS009, are shaping their near-term risk profile and massive potential opportunity.

SELLAS Life Sciences Group, Inc. (SLS) - PESTLE Analysis: Political factors

US FDA approval process dictates timeline and market access

The U.S. Food and Drug Administration (FDA) regulatory process is the single most critical political factor for a late-stage biopharma company like SELLAS Life Sciences Group, Inc. Your entire valuation hinges on the successful navigation of this pathway. For the lead candidate, galinpepimut-S (GPS), the pivotal Phase 3 REGAL trial is nearing its final data readout, with the Independent Data Monitoring Committee (IDMC) recommending in August 2025 to continue the trial without modification. This positive signal suggests the risk-benefit profile is favorable for continued evaluation.

The final analysis for GPS in Acute Myeloid Leukemia (AML) is anticipated by year-end 2025, triggered by the occurrence of 80 events (deaths) as predefined in the study protocol. A key political-regulatory win is the FDA's Rare Pediatric Disease Designation (RPDD) granted to GPS for pediatric AML. This designation makes the company eligible to receive a Priority Review Voucher (PRV) upon marketing approval, a transferable asset recently valued around $100 million. That's a significant non-dilutive financial option.

For the other key asset, SLS009, a highly selective CDK9 inhibitor, the company expects to receive full topline Phase 2 data and crucial FDA regulatory review feedback in the first half of 2025, which will determine the path to a potential registrational trial.

Potential for new drug pricing legislation impacting future revenue models

The political push for lower drug costs, primarily driven by the Inflation Reduction Act (IRA), creates both risks and opportunities. The good news for SELLAS Life Sciences Group, Inc. is that the IRA's Medicare Drug Price Negotiation Program targets drugs that have been on the market for at least nine years (small molecules) or 13 years (biologics). Since your lead candidates, GPS and SLS009, are still in clinical development, they are excluded from the initial negotiation rounds, protecting their launch price.

However, the political environment still dictates payer behavior. The IRA fully implemented a cap on annual out-of-pocket costs for Medicare Part D beneficiaries at $2,000 in 2025. While this helps patient access-before the IRA, oral cancer drug costs could exceed $11,000 annually-it shifts the cost burden within the healthcare system, potentially increasing scrutiny on the launch price of all new oncology therapies. You should plan for a launch price that can withstand political scrutiny.

Global trade tensions affecting clinical trial supply chain logistics

Geopolitical friction, particularly with China, is directly impacting the biopharma supply chain, making clinical trial logistics a higher-risk operation in 2025. The potential passage of the BIOSECURE Act is the primary concern, as it would prohibit federal agencies, and entities receiving federal funds, from contracting with certain foreign biotechnology companies of concern.

This legislation, even in its anticipation, is forcing a costly and time-consuming shift away from established Contract Development and Manufacturing Organizations (CDMOs) and Clinical Research Organizations (CROs) that may be implicated. Plus, new U.S. import tariffs, with a 10% baseline and some rates soaring up to 25-50% on certain goods, are explicitly targeting medicines and ingredients. This tariff pressure could add an estimated $10-20 billion in annual costs to the industry, which inevitably raises the cost and complexity of running global trials like the REGAL study, which enrolled 126 patients primarily across the U.S. and Europe.

Here's the quick math: higher costs for syringes, reagents, and other supplies translate directly into clinical trial budget overruns. You need a 'just-in-case' supply model now.

Government funding priorities for oncology research and development (R&D)

The political will to fund cancer research remains robust, which is a tailwind for SELLAS Life Sciences Group, Inc.'s oncology focus. The federal commitment to the Cancer Moonshot initiative continues, with mandatory funding of $1.5 billion allocated for 2025 across the National Cancer Institute (NCI), FDA, and other agencies.

The President's Fiscal Year (FY) 2025 budget proposal requested $48.3 billion for the National Institutes of Health (NIH) and an increase of $500 million over FY 2023 for the NCI, totaling $716 million in discretionary funds for cancer-focused research. This sustained high-level funding creates a favorable ecosystem for partnership, grant opportunities, and talent acquisition.

SELLAS Life Sciences Group, Inc. is actively trying to capitalize on this, having applied for non-dilutive grant funding to expand the development of SLS009 into the frontline setting for AML. The Congressionally Directed Medical Research Programs (CDMRP) also provides specific funding streams, including $130.0 million for the Breast Cancer Research Program and $75 million for the Prostate Cancer Research Program in FY 2025.

The political climate is defintely supportive of oncology innovation, but the regulatory and trade risks are rising. You need to focus on securing that PRV and diversifying your supply chain now.

SELLAS Life Sciences Group, Inc. (SLS) - PESTLE Analysis: Economic factors

High interest rates increase cost of capital for financing clinical trials

The persistent high-interest-rate environment in 2025 is a real headwind for pre-revenue biotech companies like SELLAS Life Sciences Group, even if they don't carry significant debt. The Federal Reserve's target for the Federal Funds Rate stood at a range of 3.75%-4.00% following the October 2025 meeting, a level that still makes debt financing expensive and less appealing for high-risk ventures. This elevated baseline rate pushes up the cost of capital (WACC) for all financing, whether it's debt or equity, because investors demand a higher risk-free rate component in their expected returns.

In this climate, the financial markets are less forgiving. Borrowing money (debt) for the Phase 3 REGAL trial or the SLS009 front-line AML trial would be prohibitively expensive and risky, forcing the company to rely almost entirely on the more costly equity route. This is why you see a company like SELLAS Life Sciences Group avoiding traditional credit facilities and instead focusing on equity raises and warrant exercises to fund its operations.

Dependence on equity financing; dilution risk is constant until commercialization

SELLAS Life Sciences Group's strategy is clearly to fund its critical late-stage clinical milestones through equity, which means dilution is a constant reality for existing shareholders. The company has been very active in 2025, significantly bolstering its balance sheet but at the cost of expanding its share count.

Here is a quick look at the financing activity and the resulting dilution through Q3 2025:

The rise from 87.76 million to 108.40 million weighted-average shares in just three quarters shows the continuous pressure. This constant need for capital, driven by a year-to-date net loss of $19.2 million through September 30, 2025, means the threat of further dilution is defintely real until a drug like GPS or SLS009 is commercialized. The market capitalization of $223 million as of November 2025 is entirely dependent on the perceived value of these pipeline assets.

Global inflation pressures increasing costs for R&D and manufacturing

While the US headline Consumer Price Index (CPI) inflation moderated to 3.0% year-over-year in September 2025, the lingering effects of inflation still hit the biotech R&D and manufacturing supply chain hard. The costs for specialized labor, reagents, clinical trial materials, and contract research organizations (CROs) remain elevated.

For a company running pivotal trials, this translates directly to a higher burn rate. Compounding this, the US tax code's Section 174 requires research and development (R&D) expenses to be capitalized and amortized over five years (or fifteen for foreign R&D), rather than being immediately deducted. This change creates a significant cash flow strain for pre-revenue companies, effectively increasing their tax liability without corresponding revenue, despite R&D expenses for the nine months ended September 30, 2025, being tightly controlled at $11.3 million.

Biotech sector valuation volatility impacting fundraising ability

The overall biotech sector's volatility in 2025 makes fundraising a selective, high-hurdle process. Investors are demanding clear clinical efficacy and late-stage assets, shying away from earlier, more speculative ventures.

The market has seen a conservative shift, with overall venture funding for biotechs dropping from $7 billion in Q1 2025 to $4.8 billion in Q2 2025. This forces companies to hit major milestones just to keep the lights on. For SELLAS Life Sciences Group, the positive Phase 2 results for SLS009 and the anticipated final analysis of the Phase 3 REGAL trial by year-end 2025 are not just clinical data points; they are the sole drivers of valuation and future financing ability.

• Venture capital is favoring later-stage biotechs with de-risked assets.
• The IPO market remains cool, limiting exit opportunities for private companies.
• Valuations are highly sensitive to clinical trial outcomes, making the stock price of $1.51 (as of November 11, 2025) prone to sharp swings based on the REGAL trial's event-driven final analysis.

SELLAS Life Sciences Group, Inc. (SLS) - PESTLE Analysis: Social factors

Growing patient and physician acceptance of cancer immunotherapies

The social acceptance of cancer immunotherapies-treatments that harness the body's own immune system-is no longer a question; it is a fundamental pillar of modern oncology practice. Data from the Cancer Research Institute's 2025 report confirms this, showing immunotherapy clinical adoption has increased more than 20-fold since 2011 based on national claims data. This is a massive tailwind for a company like SELLAS Life Sciences, whose lead candidate, galinpepimut-S (GPS), is an innovative immunotherapy targeting the Wilms Tumor 1 (WT1) antigen.

Physicians now routinely integrate these novel therapies, which are now embedded across treatment paradigms for more than 30 cancer types. The U.S. FDA granted 17 new immunotherapy approvals in 2024 alone, signaling continued regulatory and clinical confidence. This widespread acceptance lowers the barrier to entry for GPS and SLS009, making it easier to recruit patients and secure physician buy-in upon potential commercialization.

Strong patient advocacy for novel treatments like WT1-targeting vaccines

Patient advocacy groups for aggressive cancers, particularly Acute Myeloid Leukemia (AML), create a powerful social force demanding new, life-extending options. For AML patients in second complete remission (CR2)-the target population for the Phase 3 REGAL trial of GPS-the historical median survival is tragically short, around six months. This dire prognosis fuels strong advocacy for novel treatments that offer the potential for a durable, long-term response.

The positive interim data from the REGAL trial, which suggested a pooled median survival exceeding 12 months compared to the historical benchmark of approximately 6 months, is exactly the kind of signal that mobilizes patient communities. Honestly, in this space, a potential doubling of survival is a social game-changer, not just a clinical one.

Public perception of clinical trial success or failure directly affects stock price

For a late-stage clinical biopharmaceutical company, public perception of clinical milestones is the primary driver of investor sentiment and stock price volatility. SELLAS Life Sciences' stock (NASDAQ: SLS) operates with a high beta of 2.64, meaning its price swings are significantly more volatile than the broader market, directly reflecting the market's reaction to news. For example, the stock's 52-week range of $0.77 to $2.48 illustrates the dramatic impact of sentiment.

Here's the quick math on recent news impact:

• A positive recommendation from the Independent Data Monitoring Committee (IDMC) in August 2025 to continue the Phase 3 REGAL trial without modification served as a strong positive catalyst, signaling no safety or futility concerns.
• The final, event-driven analysis of the REGAL trial, anticipated by year-end 2025 upon reaching 80 deaths, is the single most critical near-term social-financial event.
• The company's Q3 2025 earnings report, released November 12, 2025, which showed a net loss of $6.8 million (or $0.06 loss per share), actually beat analyst consensus estimates of $0.08 loss per share, which contributed to a stock price rise to $1.60 on November 19, 2025.

Need for diverse patient enrollment in global trials to ensure broad applicability

The societal push for equitable healthcare and the FDA's increasing focus on clinical trial diversity mean that trial demographics are a social factor with regulatory and commercial implications. A lack of diversity can limit generalizability (broad applicability) and delay approval. The Phase 3 REGAL trial, which enrolled 126 patients, showed a concentration risk: study sites in the U.S. and Europe accounted for approximately 75% of patients enrolled, with U.S.-based sites being the highest enrolling country.

What this estimate hides is the potential underrepresentation of certain ethnic and racial groups, which is a common challenge in global oncology trials. To be fair, this geographic concentration is a commercial risk, too, as it may necessitate additional studies to demonstrate efficacy in other major global populations. The planned 80-patient trial for SLS009 in newly diagnosed AML, expected to begin in Q1 2026, must prioritize a more diverse patient base from the start to mitigate future social and regulatory scrutiny.

SELLAS Life Sciences Group, Inc. (SLS) - PESTLE Analysis: Technological factors

The technology underpinning SELLAS Life Sciences Group, Inc.'s lead candidate, Galinpepimut-S (GPS), is a peptide-based cancer vaccine that targets the Wilms Tumor 1 (WT1) protein. Your technological outlook hinges entirely on validating this platform's efficacy against competing, rapidly evolving modalities like CAR-T and novel small-molecule inhibitors. It's a race where a single Phase 3 readout will either validate the core technology or force a complete pipeline pivot.

Success hinges on the efficacy data from the Phase 3 REGAL trial for GPS

The entire near-term value of the GPS program rests on the final overall survival data from the Phase 3 REGAL trial in Acute Myeloid Leukemia (AML) patients in second complete remission (CR2). The technology has already cleared a major hurdle: the Independent Data Monitoring Committee (IDMC) gave a positive recommendation to continue the trial in both January and August 2025, confirming GPS exceeded the predetermined futility criteria and showed no safety concerns.

The interim analysis data is compelling, showing a pooled median survival exceeding 13.5 months for patients in the trial, which compares very favorably to the historical median survival of only 6 months for conventional therapy in a similar patient population. The final, and most crucial, analysis will be triggered once 80 events (deaths) have occurred, and the company anticipates this final readout by year-end 2025. This is the single biggest technological risk and opportunity on the horizon.

Competition from other WT1-targeting therapies and complementary treatments

GPS, as a peptide vaccine, is not the only technology targeting the WT1 antigen. You face competition from more complex, and often more expensive, cell and gene therapies, plus a crowded field of new small-molecule drugs in AML. The core technology needs to prove its clinical superiority or, at least, its cost-effectiveness against these rivals.

For example, while WT1-specific T-cell Receptor (TCR) gene therapy is an advanced approach, a June 2025 Phase I/II trial of a WT1-specific TCR gene therapy (TTCR-C4) for AML post-transplant did not clearly improve outcomes, suggesting the technical challenge of T-cell dysfunction remains a major hurdle for those platforms.

In the non-WT1 space, which is the current standard of care, the technological pace is intense. The FDA approved the menin inhibitor Revumenib in November 2024, and combinations with the BCL2 inhibitor Venetoclax are now standard. GPS must carve out a clear technological niche, likely as a low-toxicity maintenance therapy, in this rapidly evolving landscape.

Here's a quick look at the competitive technological landscape for WT1 targeting:

Advancements in biomarker identification to better select patient populations

The technology of personalized medicine-using biomarkers to select the right patient-is defintely critical for all cancer vaccines. You need to know who will respond. Research in personalized peptide vaccination (PPV) has shown that pre-vaccination inflammatory signatures are powerful prognostic biomarkers. For example, a large study of 2,588 cancer patients indicated that a median percentage of neutrophils $\ge$ 64.8% or a percentage of lymphocytes $\ge$ 25.1% were the most potent unfavorable and favorable factors, respectively, for overall survival.

This suggests that refining the patient selection criteria for GPS based on a simple blood test could dramatically improve the vaccine's efficacy data and regulatory profile. SELLAS Life Sciences is already applying this thinking to its pipeline, with a planned biomarker-enriched trial for its other candidate, SLS009, anticipated to start in Q1 2026. The technology to measure these inflammatory markers is routine, so the challenge is integrating the data into the clinical protocol.

Need to scale up specialized peptide vaccine manufacturing processes

While peptide vaccine technology is inherently simpler and cheaper than cell therapies (like CAR-T), scaling up for commercial supply remains a key technological challenge. The global Peptide Cancer Vaccine Market is projected to reach a valuation of $1.64 Billion in 2025, with a rapid Compound Annual Growth Rate (CAGR) of 27.7% projected through 2034, indicating high commercial potential that demands scalable production.

The good news is that advancements in solid-phase peptide synthesis (SPPS) and automated synthesizers are improving the scalability, consistency, and cost-effectiveness of vaccine production. This is important because the high cost of development and manufacturing is a known barrier for smaller biotechs in this space.

For SELLAS Life Sciences, the R&D expense reduction in the first half of 2025 is telling. Research and development expenses were $7.1 million in the first half of 2025, down from $10.3 million in the first half of 2024, partly due to a decrease in manufacturing costs and clinical drug supply purchases following the completion of REGAL enrollment. This suggests the initial clinical-scale manufacturing phase is complete, but the technology must now transition to a robust, cost-efficient commercial scale to meet the projected market demand.

The technology is ready, but the process needs to be industrialized.

• Improve automated synthesis yields for cost-efficiency.
• Establish commercial-scale Good Manufacturing Practice (GMP) supply chain.
• Secure long-term contracts with peptide manufacturing partners.

SELLAS Life Sciences Group, Inc. (SLS) - PESTLE Analysis: Legal factors

For a late-stage biopharma company like SELLAS Life Sciences Group, Inc., the legal landscape isn't just about paperwork; it's the bedrock of your valuation. Your entire business model hinges on protecting the intellectual property (IP) of your lead candidates, galinpepimut-S (GPS) and SLS009, and maintaining flawless compliance across global clinical trials. Any misstep here translates directly into regulatory delays or catastrophic loss of market exclusivity.

Intellectual property (IP) protection for galinpepimut-S is critical for long-term value

The core value of SELLAS Life Sciences Group is tied to its intellectual property (IP) estate for galinpepimut-S (GPS), which is licensed from Memorial Sloan Kettering Cancer Center. The company has done a good job building layers of protection. Specifically, the patent covering the use of GPS in combination with checkpoint inhibitor therapies extends the exclusivity period to at least 2036 in the U.S..

This long-term IP is defintely the most valuable asset. For the core peptide components of GPS, exclusivity extends to at least 2033 in the U.S.. This layered approach, which includes composition of matter and method of use claims, creates a significant barrier to entry for competitors and generic manufacturers, securing the revenue runway post-approval.

Here's a quick look at the core IP protection:

Potential for patent litigation from competitors in the oncology space

The very success of a novel cancer immunotherapeutic like GPS, which targets the high-priority WT1 protein, makes it a target for litigation. The oncology space is a patent minefield, and competitors are always looking for ways to challenge a major asset's IP, especially with the high stakes involved in a potential blockbuster drug. The recent trend of major biotech patent battles, such as those surrounding mRNA and other blockbuster drugs, shows that litigation risk is a constant, material operating cost in this industry.

You must anticipate preemptive challenges from rivals who may claim infringement or challenge the validity of your patents. This isn't a matter of if but when a competitor tries to chip away at that 2036 exclusivity date. A single, protracted patent lawsuit can cost tens of millions of dollars and divert critical management focus from the final commercialization push.

Strict adherence to global clinical trial regulations (GCP) to avoid delays

Compliance with Good Clinical Practice (GCP) is non-negotiable, especially for a global Phase 3 registrational trial like REGAL for GPS. The trial's success depends entirely on the integrity of the data collected from the 126 patients enrolled. The global nature of the REGAL study, with approximately 75% of patients enrolled across sites in the U.S. and Europe, means you must satisfy multiple, often diverging, regulatory bodies simultaneously.

The positive recommendations from the Independent Data Monitoring Committee (IDMC) to continue the REGAL trial without modification, as announced in August 2025, is a strong signal that current GCP standards for safety and data quality are being met. However, a significant risk remains in relying on third-party Contract Research Organizations (CROs) and clinical sites. Any failure by these external partners to maintain regulatory standards could lead to a partial or full clinical hold by the FDA or EMA, which would be a catastrophic delay for a final-stage product.

Compliance with data privacy laws (e.g., HIPAA) for patient trial data

Managing patient data from a global trial mandates strict compliance with a patchwork of privacy laws. The two most critical are the U.S. Health Insurance Portability and Accountability Act (HIPAA) and the European Union's General Data Protection Regulation (GDPR).

The GDPR risk is particularly high for SELLAS Life Sciences Group, given the significant European enrollment in the REGAL trial. A breach of patient data (special category data in GDPR terms) could result in monumental fines, up to €20 million or 4% of the company's worldwide annual turnover, whichever is higher. This is a material financial risk that must be actively managed through robust data security protocols and vendor agreements with your CROs.

Key compliance risks include:

• Failure to adequately anonymize or pseudonymize patient data.
• Security breaches of third-party CRO or vendor systems.
• Non-compliance with patient consent requirements for data transfer between the U.S. and EU.

The loss of clinical trial data due to a security breach could not only trigger these financial penalties but also invalidate the regulatory submission, forcing costly and time-consuming efforts to recover or reproduce the data.

SELLAS Life Sciences Group, Inc. (SLS) - PESTLE Analysis: Environmental factors

The environmental factors for a late-stage clinical biopharmaceutical company like SELLAS Life Sciences Group are less about large-scale manufacturing pollution and more about the stringent, costly compliance of clinical operations and the increasing pressure from institutional investors regarding Corporate Social Responsibility (CSR) and Environmental, Social, and Governance (ESG) metrics. The company's focus on its pivotal Phase 3 REGAL trial for Galinpepimut-S (GPS) and the advancing SLS009 program means its environmental footprint is primarily generated by global clinical trial logistics and the disposal of specialized waste.

Managing the disposal of specialized biopharmaceutical and clinical waste

Proper management of regulated medical waste (RMW) is a critical, non-negotiable cost driver for SELLAS Life Sciences Group. Since the company is in late-stage trials, they rely on clinical sites (hospitals and clinics) to manage the bulk of this waste, but they bear the financial and regulatory risk for the investigational product (IP) and related materials.

The US pharmaceutical waste management market is estimated to be worth $1.52 billion in 2025, driven by stricter EPA rules. You need to know that disposing of RMW is highly expensive, costing 7 to 10 times more than disposing of ordinary trash. This cost is a direct function of trial size and duration. Considering the Phase 3 REGAL trial is a global, multi-year study, the accumulated waste disposal liability is substantial, even if decentralized across sites. Poor segregation at a clinical site, where non-hazardous waste is mistakenly put into red biohazard bags, can inflate costs by a factor of ten, a risk SELLAS Life Sciences Group must mitigate through tight contract research organization (CRO) oversight.

Here's the quick math on the cost pressure:

• A typical US hospital generates about 7,000 tons of garbage daily.
• The annual disposal cost for US hospitals is around $10 billion.
• SELLAS Life Sciences Group's R&D expenses for the first half of 2025 were $7.1 million, meaning waste disposal costs, while a fraction of this, represent a high-margin expense that must be controlled to preserve cash.

Increasing investor focus on corporate social responsibility (CSR) in drug development

Investor sentiment in 2025 is shifting toward a 'flight to quality,' favoring biotech firms with validated science and operational rigor, but ESG is becoming a key filter. For a company with a market capitalization of approximately $223 million as of November 2025, demonstrating a clear CSR strategy is essential for attracting institutional capital, especially as they move toward potential commercialization.

While SELLAS Life Sciences Group's primary social contribution is the development of novel cancer immunotherapies like Galinpepimut-S (GPS) and SLS009 for high-unmet-need conditions like Acute Myeloid Leukemia (AML), the environmental 'E' in ESG still matters. Honestly, high ESG scores alone don't guarantee profitability for cash-strapped firms, but a lack of basic environmental governance can be a red flag that freezes funding. Investors are prioritizing biotech firms that integrate CSR with innovation and financial prudence, which means showing you're not defintely going to incur massive regulatory fines down the road.

Supply chain sustainability for raw materials used in vaccine production

SELLAS Life Sciences Group's lead candidate, Galinpepimut-S (GPS), is a peptide immunotherapy, and SLS009 is a small molecule inhibitor. While these are not traditional large-volume vaccines, the principle of supply chain sustainability still applies to the sourcing and manufacturing of the active pharmaceutical ingredients (APIs) and excipients. The company relies on third-party contract manufacturing organizations (CMOs) for production, which transfers the operational burden but not the ultimate responsibility.

The main risk here is a lack of transparency (Scope 3 emissions) in the CMO network. You need to ensure your partners are meeting modern sustainability standards, not just basic compliance. This is a supply chain risk, plain and simple.

Minimizing the carbon footprint of global clinical trial operations and travel

Clinical trials are surprisingly carbon-intensive. For SELLAS Life Sciences Group, running the global Phase 3 REGAL trial and the multi-center Phase 2/3 trials for SLS009 means a significant carbon footprint from patient travel, site monitoring, and drug distribution. A single large Phase 3 trial can generate over 3,100 metric tons of CO₂ equivalent gasses (mT CO₂e), which is comparable to the annual emissions of 176 Americans.

The key emission hotspots for clinical trials are clear:

• Investigational Product Manufacturing/Distribution: Accounts for approximately 50% of emissions.
• Patient Travel: Accounts for about 10% of emissions.
• On-site Monitoring Visits: Accounts for about 10% of emissions.

The opportunity lies in adopting decentralized clinical trial (DCT) components, which reduce patient and monitor travel. The industry launched the iLCCT consortium's carbon calculator in 2025, giving SELLAS Life Sciences Group a new tool to measure its impact. Using remote monitoring and virtual visits for the upcoming 80-patient trial for SLS009 in first-line AML, expected to begin enrollment by Q1 2026, is a clear action to mitigate this environmental risk while also improving patient-centricity.