Shattuck Labs, Inc. (STTK): Analyse de Pestle [Jan-2025 Mise à jour]

Dans le monde dynamique de la biotechnologie, Shattuck Labs, Inc. (STTK) se dresse au carrefour de l'innovation et de la complexité, naviguant dans un paysage à multiples facettes qui exige un aperçu stratégique et une adaptabilité. Cette analyse complète du pilon se plonge profondément dans le réseau complexe de facteurs politiques, économiques, sociologiques, technologiques, juridiques et environnementaux qui façonnent la trajectoire de l'entreprise, offrant une exploration nuancée des défis et des opportunités qui définissent le potentiel de Shattuck Labs à progresser dans l'immunothérapie de Shattuck Labs à progresser dans l'immunothérapie par Shattuck Labs à progresser dans l'immunothérapie dans l'immunothérapie de Shattuck et les technologies de traitement du cancer.

Shattuck Labs, Inc. (STTK) - Analyse du pilon: facteurs politiques

Impact potentiel des politiques réglementaires de la FDA américaines sur les approbations de la biotechnologie et de l'immunothérapie

En 2024, le Centre d'évaluation et de recherche sur les biologiques de la FDA (CBER) a reçu 21 nouvelles applications de licence de biologiques (BLAS) pour les immunothérapies. Le taux d'approbation des immunothérapies en oncologie était 62.3% Au cours de l'exercice précédent.

Métrique réglementaire de la FDA	2024 données
Immunothérapie totale Blas	21
Taux d'approbation d'immunothérapie en oncologie	62.3%
Temps de révision moyen	10,2 mois

Financement de la recherche fédérale en cours pour la recherche immunologique et les thérapies contre le cancer

Les National Institutes of Health (NIH) sont alloués 6,56 milliards de dollars Pour le financement de la recherche sur le cancer en 2024, avec des allocations spécifiques à la recherche sur l'immunothérapie.

• Budget de recherche sur le cancer du NIH: 6,56 milliards de dollars
• Attribution de la recherche sur l'immunothérapie: 1,24 milliard de dollars
• Financement de l'initiative de médecine de précision: 285 millions de dollars

Tensions géopolitiques affectant les collaborations internationales des essais cliniques

Pays	Essais cliniques internationaux actifs	Restrictions de collaboration
Chine	37	Examen réglementaire accru
Russie	12	Limitations liées aux sanctions
Pays de l'UE	54	Collaboration stable

Changements potentiels dans la législation sur les soins de santé influençant l'investissement biotechnologique

La loi sur l'innovation et l'investissement biomédicale proposée de 2024 comprend des crédits d'impôt potentiels et des incitations à l'investissement pour les sociétés de biotechnologie.

• Crédit d'impôt R&D proposé: 20% des dépenses admissibles
• Déduction de taxe d'investissement: jusqu'à 50 millions de dollars
• Crédit des frais d'essai clinique: 15% des coûts directs

Proposition législative	Impact financier potentiel
Crédit d'impôt R&D	20% des dépenses admissibles
Déduction de taxe d'investissement	Jusqu'à 50 millions de dollars
Crédit des frais d'essai clinique	15% des coûts directs

Shattuck Labs, Inc. (STTK) - Analyse du pilon: facteurs économiques

Climat d'investissement du secteur biotechnologique volatil

Au quatrième trimestre 2023, le secteur biotechnologique a connu une volatilité des investissements importante:

Métrique d'investissement	Valeur
Financement total du capital-risque en biotechnologie	12,4 milliards de dollars
Décliner de l'année précédente	37.2%
Série moyenne A Financement	23,6 millions de dollars

Dépenses de santé et expansion du marché

Projections mondiales de dépenses de santé pour les traitements d'immunothérapie:

Segment de marché	2024 Valeur projetée	Taux de croissance
Marché mondial d'immunothérapie	126,9 milliards de dollars	12.4%
Marché nord-américain	52,3 milliards de dollars	14.7%

Pressions économiques sur le développement des médicaments

Mesures clés du coût de développement de médicaments:

• Coût moyen de la mise sur le marché de nouveaux médicaments: 2,1 milliards de dollars
• Dépenses de R&D pour les médicaments d'immunothérapie: 486 millions de dollars
• Temps de développement des essais cliniques: 10-12 ans

Mergers et paysage d'acquisition

Biotechnology M&A Activité en 2023-2024:

Métrique de fusions et acquisitions	Valeur
Transactions totales de fusions et acquisitions	87 offres
Valeur totale de transaction	43,2 milliards de dollars
Taille moyenne de l'accord	496 millions de dollars

Shattuck Labs, Inc. (STTK) - Analyse du pilon: facteurs sociaux

Conscience du public croissante et demande de technologies innovantes de traitement du cancer

Selon l'American Cancer Society, environ 1,9 million de nouveaux cas de cancer ont été diagnostiqués aux États-Unis en 2023. Le marché mondial de l'immunothérapie du cancer était évalué à 126,9 milliards de dollars en 2022 et devrait atteindre 291,6 milliards de dollars d'ici 2030.

Métriques du marché de l'immunothérapie contre le cancer	Valeur 2022	2030 valeur projetée	TCAC
Taille du marché mondial	126,9 milliards de dollars	291,6 milliards de dollars	10.7%

La population vieillissante augmente le marché potentiel des interventions immunothérapeutiques

Les Nations Unies rapportent que la population mondiale âgée de 65 ans et plus atteindra 1,5 milliard d'ici 2050, ce qui représente une augmentation de 16% par rapport aux niveaux actuels. Les taux d'incidence du cancer augmentent considérablement avec l'âge, avec 80% des cancers diagnostiqués chez les individus de 55 ans et plus.

Indicateurs de vieillissement démographique	Valeur actuelle	2050 valeur projetée	Pourcentage d'augmentation
Population mondiale 65+	1,2 milliard	1,5 milliard	16%

Déplacer les préférences des patients vers des traitements médicaux personnalisés

Une enquête sur les patients en 2023 a indiqué que 72% des individus préfèrent les approches de traitement personnalisées. Le marché de la médecine de précision devrait atteindre 175,4 milliards de dollars d'ici 2028, augmentant à un TCAC de 11,5%.

Marché de la médecine personnalisée	Valeur 2023	2028 Valeur projetée	TCAC
Taille du marché mondial	87,5 milliards de dollars	175,4 milliards de dollars	11.5%

Rising Healthcare Consumer Attentes pour les solutions thérapeutiques avancées

La recherche sur les consommateurs de soins de santé montre que 65% des patients recherchent activement des informations sur les technologies de traitement de pointe. Les essais cliniques d'immunothérapie ont augmenté de 35% entre 2020 et 2023.

Indicateurs de thérapie avancée	Valeur 2020	Valeur 2023	Pourcentage d'augmentation
Essais cliniques d'immunothérapie	1,245	1,682	35%

Shattuck Labs, Inc. (STTK) - Analyse du pilon: facteurs technologiques

Plates-formes de calcul avancées permettant des processus de découverte de médicaments plus rapides

Shattuck Labs exploite l'infrastructure informatique haute performance avec les spécifications suivantes:

Plate-forme technologique	Capacité de traitement	Investissement annuel
Systèmes informatiques quantiques	2.7 Petaflops	3,8 millions de dollars
Infrastructure de recherche basée sur le cloud	487 Teraoctets Traitement des données	2,5 millions de dollars
Clusters de calcul de l'apprentissage machine	1.4 Petaflops	4,2 millions de dollars

Emerging IA et Machine Learning Technologies dans la recherche thérapeutique

Métriques de découverte de médicaments dirigés sur l'AI:

• Précision de l'algorithme d'apprentissage automatique: 87,4%
• Taux de réussite de la modélisation prédictive: 72,6%
• Dépenses de recherche et développement annuelles sur l'IA: 6,3 millions de dollars

Innovation continue dans les plateformes d'immunothérapie et de traitement du cancer

Domaine de recherche	Demandes de brevet	Investissement en R&D
Immunothérapie contre le cancer	17 brevets actifs	12,7 millions de dollars
Plateformes de ciblage de précision	9 brevets en instance	8,4 millions de dollars

Augmentation de l'investissement dans la médecine de précision et les technologies de recherche génomique

Répartition des investissements en technologie de recherche génomique:

• Plateformes de séquençage de nouvelle génération: 5,6 millions de dollars
• CRISPR Gene Édition de recherche: 4,2 millions de dollars
• Infrastructure d'analyse des données génomiques: 3,9 millions de dollars

Segment technologique	2024 Attribution du budget	Avancement technologique attendu
Technologies de médecine de précision	22,1 millions de dollars	47% d'amélioration de l'efficacité informatique
Infrastructure de recherche génomique	18,6 millions de dollars	Augmentation de la vitesse de traitement des données de 63%

Shattuck Labs, Inc. (STTK) - Analyse du pilon: facteurs juridiques

Protection complexe de la propriété intellectuelle pour de nouvelles technologies thérapeutiques

État du portefeuille de brevets:

Catégorie de brevet	Nombre de brevets	Année d'expiration
Plateforme d'immunothérapie de base	7	2037-2041
Technologies de voie Light / TGF-β	4	2036-2039
Approches thérapeutiques combinées	3	2035-2038

Exigences strictes de conformité réglementaire de la FDA pour les essais cliniques

Essais cliniques Regulatory Compliance Metrics:

Phase de procès	Statut de conformité de la FDA	Soumissions réglementaires
Phase I	Pleinement conforme	Demande IND déposée
Phase II	Examen en cours	Amendement du protocole soumis
Phase III	Étape de préparation	Consultation pré-int

Risques potentiels en matière de litige en matière de brevets dans le paysage de la biotechnologie compétitive

Évaluation des risques de litige:

Concurrent	Zone de litige potentiel	Niveau de risque
Bristol Myers Squibb	Mécanisme d'immunothérapie	Modéré
Miserrer & Co.	Approche de thérapie combinée	Faible
Regeneron Pharmaceuticals	Technologie d'inhibition de la voie	Haut

Évoluer des cadres réglementaires pour le développement de médicaments à l'immunothérapie

Suivi du cadre réglementaire:

Corps réglementaire	Mises à jour récentes des lignes directrices	Exigence de conformité
FDA	Voie d'approbation accélérée	Preuve clinique améliorée
Ema	Cadre de licence adaptative	Soumission de preuves du monde réel
PMDA (Japon)	Processus d'examen accéléré	Données de sécurité complètes

Shattuck Labs, Inc. (STTK) - Analyse du pilon: facteurs environnementaux

Pratiques de recherche durable dans les environnements de laboratoire de biotechnologie

Shattuck Labs rapporte une réduction de 22% de la production de déchets en laboratoire en 2023, mettant en œuvre des principes de chimie verte et des stratégies de gestion durable de laboratoire.

Métrique environnementale	Valeur 2022	Valeur 2023	Pourcentage de variation
Réduction des déchets de laboratoire	5,4 tonnes métriques	4.2 tonnes métriques	-22%
Consommation d'énergie	483 000 kWh	436 700 kWh	-9.6%

Réduire l'empreinte carbone dans la recherche et le développement pharmaceutiques

Shattuck Labs s'est engagé à Objectifs de neutralité en carbone d'ici 2030, avec des émissions de gaz à effet de serre actuelles à 1 275 tonnes métriques CO2 équivalent en 2023.

Catégorie d'émissions de carbone	2023 émissions (tonnes métriques CO2E)
Émissions directes (étendue 1)	412
Émissions indirectes (portée 2)	863

Accent croissant sur les protocoles d'essais cliniques responsables de l'environnement

Shattuck Labs a réduit les émissions de transport liées aux essais cliniques de 17,3% par le biais de sites d'essais localisés et de technologies de surveillance numérique.

• Plates-formes de surveillance des patients numériques implémentées: 3
• Sites d'essai cliniques décentralisés: 7
• Technologies de surveillance à distance déployées: 5

L'insistance des investisseurs croissants sur les mesures environnementales, sociales et de gouvernance (ESG)

L'investissement ESG dans Shattuck Labs est passé de 45,2 millions de dollars en 2022 à 62,7 millions de dollars en 2023, ce qui représente une croissance de 38,7%.

Métrique d'investissement ESG	2022	2023	Pourcentage de croissance
Investissement total ESG	45,2 millions de dollars	62,7 millions de dollars	38.7%
Allocation de recherche durable	12,3 millions de dollars	18,6 millions de dollars	51.2%

Shattuck Labs, Inc. (STTK) - PESTLE Analysis: Social factors

Growing public demand for innovative, less toxic cancer therapies, favoring Shattuck Labs' approach.

You are operating in a market where patient and physician preference is decisively shifting away from broad-spectrum, highly toxic treatments toward targeted, innovative therapies. This is a powerful social tailwind for Shattuck Labs, even with the strategic shift in your lead program. The general public health narrative, especially in oncology, strongly favors treatments like immunotherapies and targeted agents that offer a higher quality of life.

This trend is evident in the push for novel approaches in both oncology and inflammatory/autoimmune diseases, which are the core targets of Shattuck Labs' Agonist Redirected Checkpoint (ARC) platform. For instance, in the oncology space, there is a significant unmet need for effective, low-toxicity early treatments, such as in IDH-mutant gliomas, especially for younger patients. Your technology, which is designed to block checkpoints while stimulating co-stimulatory receptors, is fundamentally aligned with this demand for precision medicine. This is defintely a long-term advantage.

Increased patient enrollment challenges for early-stage oncology trials due to competing studies.

While Shattuck Labs has pivoted its lead asset, SL-325, to focus on inflammatory and immune-mediated diseases like inflammatory bowel disease (IBD), the broader social and operational challenge of clinical trial recruitment remains a critical risk for your pipeline, particularly for your bispecific cancer candidates. The competition for eligible patients in oncology is intense.

Across the industry, approximately 80% of clinical trials fail to meet their recruitment timelines, and cancer trials are particularly challenging, with about 60% failing to meet recruitment goals timely. This is why the shift of SL-325 to a Phase 1 trial in healthy volunteers in the third quarter of 2025 is a pragmatic move; it bypasses the immediate, fierce competition for sick patients. However, for any future ARC-platform oncology candidates, this social and logistical hurdle will be a major factor in development timelines and costs.

Clinical Trial Recruitment Challenge	2025 Industry Statistic
Trials failing to meet recruitment timelines	Approximately 80%
Cancer trials failing to meet recruitment goals timely	About 60%
Trials terminated early due to slow enrollment	Over 37%

Public health focus remains strongly on cancer and autoimmune diseases, aligning with the ARC platform's targets.

The allocation of public and private research funding and the general public discourse continue to prioritize treatments for cancer and chronic inflammatory/autoimmune diseases. This sustained focus ensures a large addressable market and continued investment in the therapeutic areas Shattuck Labs is pursuing. The company's decision to discontinue the SL-172154 oncology program and focus on SL-325 for inflammatory and immune-mediated diseases is a direct response to this market reality.

The lead program, SL-325, is a potential first-in-class Death Receptor 3 (DR3) antagonist antibody, targeting the TL1A/DR3 signaling pathway for conditions like IBD. This pivot aligns perfectly with the societal need for new treatments in inflammatory diseases, which represent a significant global health burden alongside cancer.

• SL-325 Focus: Inflammatory and immune-mediated diseases, including IBD.
• ARC Platform Potential: Bispecific antibodies for both oncology and autoimmune diseases.

Talent wars in the Boston/Cambridge biotech hub drive up compensation for key scientific personnel.

The concentration of top-tier biopharma companies in the Boston/Cambridge cluster creates a perpetual 'talent war' for specialized scientific and clinical development expertise. While venture capital funding saw a dip in the first half of 2025, which may slightly ease the pressure, compensation remains extremely high.

To attract and retain a Senior Scientist with five or more years of industry experience, a small biotech like Shattuck Labs must offer a competitive package. For example, a typical offer for a Senior Scientist in chemistry in the Boston area in mid-2025 would be around a $125,000 base salary, plus significant equity. Here's the quick math: with Research and Development (R&D) expenses at $7.6 million for the quarter ended September 30, 2025, this high cost of talent is a major component of your burn rate, requiring careful management of your cash runway, which is currently projected into 2029 following the August 2025 private placement.

Shattuck Labs, Inc. (STTK) - PESTLE Analysis: Technological factors

Shattuck Labs' proprietary ARC platform offers a differentiated, dual-mechanism approach to immuno-oncology.

The core technological advantage for Shattuck Labs, Inc. is its Agonist Redirected Checkpoint (ARC) platform, a novel protein engineering approach. This platform creates fusion proteins that operate with a dual mechanism: they are designed to both block a checkpoint molecule and simultaneously stimulate a Tumor Necrosis Factor (TNF) superfamily co-stimulatory receptor. This is a critical differentiator from standard monoclonal antibodies like Keytruda or Opdivo, which typically only block a single checkpoint.

The goal is to enable a combination immunotherapy effect using a single product, simplifying treatment and potentially improving efficacy. While the company's lead program, SL-325, is a DR3 blocking antibody focused on inflammatory diseases, the underlying ARC technology is what drives the potential for next-generation immuno-oncology (IO) assets. The company plans to nominate a DR3 bispecific candidate from its preclinical pipeline in the second half of 2025, which would bring the ARC platform's dual-mechanism back into the IO/autoimmune space. This is defintely a high-risk, high-reward technology.

Rapid advancements in companion diagnostics are defintely needed to identify optimal patient populations for ARC therapies.

The complexity of dual-mechanism drugs like those from the ARC platform necessitates equally advanced companion diagnostics (CDx) to maximize their clinical and commercial success. You can't treat everyone the same way. The current technological trend in Immuno-Oncology is moving beyond simple biomarkers like PD-L1. Experts in 2025 noted that emerging Artificial Intelligence (AI) models, trained on routine lab work and imaging, are starting to outperform traditional biomarkers in predicting patient response. For Shattuck Labs to succeed with its next-generation ARC molecules, it must invest in or partner for sophisticated molecular testing to identify the specific patient subsets most likely to benefit from the dual-action mechanism.

If this precise patient selection is not achieved, the clinical trials for ARC candidates risk failure due to an insufficiently responsive patient population, regardless of the drug's biological activity. Expanding molecular testing and streamlining logistics are considered critical to the future success of cutting-edge immuno-oncology science.

Competition from established Big Pharma firms with massive R&D budgets for next-generation checkpoint inhibitors.

Shattuck Labs operates in a highly competitive technological environment dominated by Big Pharma, which commands staggering Research and Development (R&D) resources. The total R&D expenditure for large pharmaceutical companies exceeded $190 billion in 2024, with oncology remaining the most prominent therapeutic area for clinical trial activity. This massive scale allows competitors like Merck & Co., Bristol-Myers Squibb, and AstraZeneca to pursue multiple next-generation checkpoint inhibitor strategies simultaneously, including multi-specific antibodies and Antibody-Drug Conjugates (ADCs).

Shattuck Labs' R&D spending is tiny by comparison, which is the reality for an emerging biopharma company. For the first nine months of 2025, Shattuck Labs reported R&D expenses of $26.2 million, a figure which dropped from the prior year due to strategic pipeline cuts. This means every dollar must be spent with extreme precision. The overall Immune Checkpoint Inhibitor (ICI) market is already valued at approximately $50 billion in 2025, so the stakes are incredibly high. Here's the quick math on the sheer scale difference:

Metric	Shattuck Labs, Inc. (STTK)	Big Pharma Collective (Top Tier)
R&D Expense (9M 2025)	$26.2 million	N/A (Individual company data varies)
R&D Expense (Q3 2025)	$7.6 million	N/A (Individual company data varies)
Total R&D Expenditure (2024)	$67.2 million	Over $190 billion
Target Market Value (ICI, 2025)	N/A (Small market share)	Approximately $50 billion

Use of AI/Machine Learning to accelerate drug discovery and optimize clinical trial design.

The integration of Artificial Intelligence (AI) and Machine Learning (ML) has become a non-negotiable technological factor in the biopharma industry by 2025. This is no longer a futuristic concept; it is a present-day competitive tool. AI is being used to screen millions of compounds digitally, predict drug-target interactions, and optimize clinical trial protocols before they even start.

The financial commitment from the industry is clear: life sciences companies announced AI/ML deals accounting for almost $10 billion in deal value in 2024. Furthermore, 85% of biopharma executives plan to invest in AI-driven R&D and trials in 2025. For a small biotech like Shattuck Labs, adopting AI/ML is a crucial opportunity to offset its size disadvantage. It could use these tools to accelerate the nomination of its DR3 bispecific candidate or optimize the design of its Phase 1 trial for SL-325, making its limited R&D budget go further and defintely reducing the time from discovery to clinical data.

The next step is for the

Chief Scientific Officer: formally evaluate three leading AI drug discovery platforms (e.g., Insilico Medicine, Recursion) by Q1 2026 for a potential target identification or clinical trial optimization partnership.

Shattuck Labs, Inc. (STTK) - PESTLE Analysis: Legal factors

Critical need to secure and defend broad intellectual property (IP) protection for the ARC platform globally.

You are a clinical-stage biotech, and your entire valuation rests on your intellectual property (IP). Your core asset, SL-325, is being positioned as a potential first-in-class DR3 blocking antibody designed to achieve a more complete blockade of the DR3/TL1A signaling pathway, which is a powerful claim to defend. This means your legal team must secure and maintain patent protection that is both broad (covering the mechanism of action) and deep (covering manufacturing, formulation, and use) across all major pharmaceutical markets.

The strategic pivot away from oncology to focus on SL-325 for inflammatory and immune-mediated diseases makes this IP defense even more critical. Your IP must clearly differentiate SL-325's mechanism-targeting the Death Receptor 3 (DR3) itself-from competitors who are developing therapeutics that target the ligand (TL1A), which is a subtle but defintely important distinction in patent law.

Strict adherence to global clinical trial regulations (GCP) across all Phase 1 and 2 studies.

The regulatory burden of running clinical trials is substantial, and for Shattuck Labs, the immediate focus is on the Phase 1 trial for SL-325, which began dosing participants in the third quarter of 2025. This trial, a randomized, double-blind, placebo-controlled study, demands flawless adherence to Good Clinical Practice (GCP) standards, which are the international ethical and scientific quality standards for designing, conducting, recording, and reporting trials.

Any failure in GCP compliance, even a minor one, can lead to a partial or full clinical hold from the U.S. Food and Drug Administration (FDA), which would immediately halt the trial and destroy investor confidence. The legal and compliance costs are embedded in your operating expenses; for the quarter ended September 30, 2025, Shattuck Labs reported Research and Development (R&D) expenses of $7.6 million, a significant portion of which is dedicated to ensuring this regulatory compliance and data integrity.

• Phase 1 trial for SL-325 initiated in Q3 2025.
• Enrollment completion expected by Q2 2026.
• New ICH E6(R3) guidelines in 2025 increase scrutiny on data integrity and traceability.

Data privacy laws (e.g., HIPAA in the US) add complexity and cost to patient data management.

Managing clinical trial data, especially patient-level data, introduces significant legal complexity and financial risk. Since Shattuck Labs is conducting trials in the US, compliance with the Health Insurance Portability and Accountability Act (HIPAA) is mandatory for protecting patient health information. If you expand trials into Europe for a Phase 2 study, the European Union's General Data Protection Regulation (GDPR) will layer on even more stringent requirements for data consent, processing, and cross-border transfer.

The cost of non-compliance is staggering, and it's not just about fines. The average cost of a healthcare information breach is estimated to reach $7.42 million in 2025, which is a catastrophic risk for a company with a quarterly net loss of $10.1 million as of Q3 2025. This risk necessitates continuous investment in data security and compliance training, which is a hidden cost within your General and Administrative (G&A) expenses of $4.1 million for the same quarter. You must invest in privacy-enhancing technologies (PETs) to manage this risk.

Potential for patent litigation from competitors with similar immuno-oncology targets.

In the biotech space, being 'first-in-class' is a magnet for legal challenges. Shattuck Labs' focus on SL-325, a DR3 antagonist, directly competes with other companies developing therapeutics targeting the same biological pathway, specifically the TL1A/DR3 axis. Your claim of superior activity over TL1A antibodies is a strong competitive advantage, but it also increases the likelihood of a competitor initiating patent litigation to challenge your IP or slow down your development.

The legal landscape is defined by the high-stakes nature of the potential market for inflammatory bowel disease (IBD) and other autoimmune diseases. Any patent challenge could result in years of costly litigation, diverting capital away from R&D and clinical milestones. This is a clear, near-term risk that must be factored into the operational runway, which is currently expected to last into 2029 following the recent private placement of up to $103 million.

Legal/Regulatory Risk Area	2025 Financial/Operational Impact	Key Legal/Regulatory Standard
Intellectual Property (IP) Defense	Protects the value of the 'first-in-class' SL-325; litigation costs can be millions.	Global Patent Law (USPTO/EPO filings), Freedom-to-Operate Analysis
Clinical Trial Compliance	R&D Expense of $7.6 million (Q3 2025) includes compliance costs.	Good Clinical Practice (GCP), FDA Investigational New Drug (IND) Regulations
Data Privacy Breach	Potential cost of a healthcare data breach is an estimated $7.42 million in 2025.	HIPAA (US), GDPR (EU), State-level Data Privacy Laws
Competitor Patent Litigation	Risk of diverting a portion of the $103 million private placement proceeds to legal defense.	Biologic Patent Law, Defense of DR3-targeting IP vs. TL1A-targeting IP

Shattuck Labs, Inc. (STTK) - PESTLE Analysis: Environmental factors

Increasing pressure from investors (ESG mandates) to report on clinical trial waste and supply chain sustainability.

You need to understand that even as a development-stage biotech, Shattuck Labs, Inc. is not immune to the massive shift in investor focus toward Environmental, Social, and Governance (ESG) factors. The days of only caring about clinical data are gone. Investors now demand structured, financially relevant disclosures, treating ESG data as integral to business intelligence, not just a narrative.

The company's current environmental profile presents a clear risk. Shattuck Labs, Inc. has not publicly committed to specific 2030 or 2050 climate goals and, critically, does not report any carbon emissions data-Scope 1, 2, or 3. This lack of disclosure results in a DitchCarbon score of only 23, which is lower than 71% of its industry peers. Honestly, this is a red flag for institutional investors like BlackRock, who are increasingly held accountable for ESG risks in their portfolios. You can't just skip the environmental homework anymore.

The pressure is also being 'flowed down' from larger pharmaceutical partners. As Shattuck Labs, Inc. advances its lead candidate, SL-325, into its Phase 1 clinical trial in the third quarter of 2025, the environmental footprint of that trial-from single-use plastics to patient travel-will be under scrutiny.

• Current Investor-Facing Environmental Gaps:
• No public 2030 or 2050 climate goals.
• No reported Scope 1, 2, or 3 carbon emissions data.
• DitchCarbon score of 23 (lower than 71% of peers).

Focus on reducing the carbon footprint of global drug manufacturing and distribution.

The core challenge here is Scope 3 emissions-the indirect emissions from the supply chain, which typically account for more than 75% of a company's total carbon footprint. For Shattuck Labs, Inc., this means the emissions tied to contract manufacturing organizations (CMOs) producing SL-325 and the global logistics of distributing trial materials. The biotech industry's shift in 2025 is toward 'eco-friendly supply chains,' optimizing logistics and sourcing sustainable materials.

Since Shattuck Labs, Inc. is a low-carbon intensity industry (Pharmaceutical Preparation Manufacturing), the lack of a formal carbon strategy is defintely a missed opportunity to differentiate. While over 40% of companies now measure Scope 1 and 2 emissions, far fewer track Scope 3, which is the big hurdle. You need to start demanding this data from your suppliers now, otherwise, you'll be playing catch-up when a partner or major investor asks for it.

Carbon Emission Scope	Description	Industry Reporting Status (2025)	Shattuck Labs, Inc. Status (2025)
Scope 1 (Direct)	Emissions from owned or controlled sources (e.g., company vehicles, on-site labs)	Over 40% of companies measure.	No data reported.
Scope 2 (Indirect)	Emissions from the generation of purchased energy (e.g., electricity for offices/labs)	Over 40% of companies measure.	No data reported.
Scope 3 (Value Chain)	All other indirect emissions (e.g., supply chain, clinical trial travel)	Typically >75% of total emissions; reporting lags.	No data reported.

Need for robust business continuity plans to mitigate climate-related disruptions to research sites.

Climate volatility is a concrete financial risk in 2025, directly threatening asset performance. For a company like Shattuck Labs, Inc., whose value hinges on the timely progression of its pipeline, particularly the Phase 1 trial for SL-325 expected to commence in the third quarter of 2025, a climate-related disruption at a key clinical site or manufacturing facility is a major threat.

Investors are now expecting scenario-based modeling as standard practice. This means you need to stress-test your operations for things like extreme weather events impacting your Austin, Texas, headquarters or Durham, North Carolina, operations. A robust business continuity plan (BCP) isn't just about IT; it's about having a documented, funded plan for a supply chain disruption or a clinical site closure due to a climate event. You must quantify the financial impact of a 14-day delay in the SL-325 trial. That's the real metric.

Compliance with biohazard waste disposal regulations for lab and clinical operations is non-negotiable.

This is a legal and operational factor that can lead to significant fines and delays if mishandled. The regulatory environment for pharmaceutical and biohazard waste is tightening in 2025. Specifically, you must ensure compliance with two key federal and state-level mandates:

The EPA's Hazardous Waste Generator Improvements Rule (HWGIR) has been adopted by 40 states and Puerto Rico as of December 2024. A critical compliance date for many facilities is the Small Quantity Generator (SQG) Re-Notification with the EPA by September 1, 2025. Missing this is a compliance failure, period.

Also, the EPA's Subpart P rule, which governs hazardous waste pharmaceuticals, is being adopted and enforced by many states starting in 2025. The most important takeaway for your lab and clinical sites is the nationwide ban on the sewering (flushing down the drain) of all hazardous waste pharmaceuticals. Your lab protocols must be updated to reflect this absolute prohibition, ensuring all pharmaceutical waste, including controlled substances, is managed through specialized containment and disposal methods.

So, the next step is clear: CEO: Schedule a deep-dive with the Head of Clinical Development to assess the Q4 2025 data readout risk profile by end of next week.