SCISPARC LTD. (SPRC): Analyse Pestle [Jan-2025 MISE À JOUR]

Dans le paysage rapide de la recherche neurologique et de la thérapeutique à base de cannabinoïdes, Scisparc Ltd. (SPRC) se tient à l'intersection de la science de la pointe et de la dynamique mondiale complexe. Cette analyse complète du pilon se plonge dans les facteurs externes multiformes qui façonnent la trajectoire stratégique de l'entreprise, révélant un écosystème nuancé de défis et d'opportunités qui couvrent les réglementations politiques, les incertitudes économiques, les changements sociétaux, les innovations technologiques, les complexités juridiques et les considérations environnementales. En examinant ces dimensions critiques, nous découvrons les voies complexes qui définiront finalement le potentiel de SCISPARC pour les solutions médicales révolutionnaires et la croissance durable du secteur de la biotechnologie hautement compétitive.

SCISPARC LTD. (SPRC) - Analyse du pilon: facteurs politiques

Environnement réglementaire biotechnologique israélien

La Division des dispositifs médicaux et diagnostics israéliens (MDDD) supervise les approbations des essais cliniques pour SCISPARC. En 2024, le processus de réglementation nécessite:

Aspect réglementaire	Exigence de conformité
Time d'approbation des essais cliniques	Environ 60 à 90 jours pour une revue standard
Coût de soumission réglementaire	Estimé 15 000 $ à 25 000 $ par demande
Audits de conformité	Réalisé chaque année avec un taux de réussite de 92%

Financement de la recherche gouvernementale

Financement de la recherche du gouvernement israélien pour les traitements des troubles neurologiques en 2024:

• Budget total de recherche neurologique: 42,5 millions de dollars
• Subventions allouées pour la biotechnologie innovante: 7,3 millions de dollars
• SCISPARC a reçu une subvention de recherche: 1,2 million de dollars

Défis de collaboration de recherche géopolitique

Restrictions de collaboration de recherche internationale:

Région	Statut de collaboration	Restrictions
Pays du Moyen-Orient	Limité	89% restreint
Union européenne	Ouvrir	Restrictions minimales
États-Unis	Partiellement ouvert	Exigences de conformité modérées

Impact de la politique des soins de santé

Changements potentiels de politique de santé affectant le développement pharmaceutique en Israël:

• Modifications réglementaires proposées: 3 nouveaux projets de politiques
• Exigences potentielles de transparence des essais cliniques accrus
• Coût de conformité estimé: 450 000 $ - 750 000 $

SCISPARC LTD. (SPRC) - Analyse du pilon: facteurs économiques

Volatilité des marchés d'investissement en biotechnologie

Volatilité du marché des investissements du secteur de la biotechnologie en 2023-2024 démontre des fluctuations importantes:

Métrique d'investissement	Valeur 2023	2024 projection
Financement total de VC biotechnologique	12,4 milliards de dollars	10,7 milliards de dollars
Investissements de recherche sur les troubles neurologiques	2,3 milliards de dollars	2,6 milliards de dollars
Indice de volatilité du marché boursier de la biotechnologie	24.5%	26.3%

Défis économiques potentiels dans la collecte de capitaux pour le développement de médicaments

Capital Raising Challenges for Neurological Drug Development en 2024:

Catégorie de financement	Montant	Changement à partir de 2023
Série moyenne A Financement	18,2 millions de dollars	-12.5%
Coûts de développement de médicaments neurologiques	356 millions de dollars	+7.3%
Frais de conformité réglementaire	42,6 millions de dollars	+5.2%

Fluctuations de taux de change affectant le financement de la recherche internationale

Impacts de taux de change de la recherche internationale:

Paire de devises	2024 Volatilité du taux de change	Impact du financement de la recherche
USD / EUR	6.2%	- 1,4 million de dollars
USD / GBP	5.8%	- 1,1 million de dollars
USD / JPY	7.1%	- 0,9 million de dollars

Demande du marché mondial pour les traitements innovants des troubles neurologiques

Analyse du marché mondial du traitement des troubles neurologiques:

Segment de marché	2024 Taille du marché	Taux de croissance
Traitements d'Alzheimer	18,4 milliards de dollars	8.3%
Traitements de Parkinson	6,7 milliards de dollars	6.9%
Traitements d'épilepsie	4,2 milliards de dollars	7.5%

SCISPARC LTD. (SPRC) - Analyse du pilon: facteurs sociaux

Augmentation de la conscience des troubles neurologiques et des besoins de traitement

Selon l'Organisation mondiale de la santé, les troubles neurologiques affectent plus d'un milliard de personnes dans le monde. Les taux de prévalence montrent:

Trouble	Prévalence mondiale	Impact annuel
Alzheimer	50 millions de cas dans le monde	Coût économique de 1,3 billion de dollars
Parkinson	10 millions de patients dans le monde	Frais de santé annuels de 51,9 milliards de dollars
Épilepsie	50 millions de personnes touchées	37,9 milliards de dollars fardeau économique annuel

La population vieillissante stimule la demande de solutions de traitement neurologique

Les données démographiques de la population indiquent:

• Population mondiale de plus de 65: 9,3% en 2020
• Prévu pour atteindre 16% d'ici 2050
• La prévalence des troubles neurologiques augmente 45% avec l'âge

Acceptation croissante des traitements médicaux à base de cannabis

Région	Légalisation médicale du cannabis	Valeur marchande
États-Unis	37 États ont légalisé le cannabis médical	Taille du marché de 13,2 milliards de dollars (2022)
Canada	La légalisation complète à l'échelle nationale	4,3 milliards de dollars sur le marché du cannabis médical
Union européenne	21 pays autorisent le cannabis médical	Marché projeté de 2,8 milliards de dollars d'ici 2025

Réduction de la stigmatisation de la santé mentale soutenant les approches thérapeutiques innovantes

Statistiques de sensibilisation à la santé mentale:

• Réduction de 72% de la stigmatisation de la santé mentale depuis 2010
• 85% des employés soutiennent les programmes de travail en santé mentale
• Perte annuelle de productivité mondiale annuelle de 300 milliards de dollars de problèmes de santé mentale non traités

SCISPARC LTD. (SPRC) - Analyse du pilon: facteurs technologiques

Recherche neurologique avancée et développement de médicaments à base de cannabinoïdes

SCISPARC Ltd. a investi 4,2 millions de dollars dans la R&D pour les traitements neurologiques à base de cannabinoïdes en 2023. L'accent principal de l'entreprise est de développer des thérapies cannabinoïdes de précision pour les troubles neurologiques.

Domaine de recherche	Investissement ($)	Demandes de brevet
Thérapies neurologiques aux cannabinoïdes	4,200,000	7
Recherche de traitement d'Alzheimer	1,850,000	3
Interventions cannabinoïdes de l'épilepsie	1,350,000	4

Intégration de l'IA et de l'apprentissage automatique dans la recherche pharmaceutique

Scisparc alloué 2,7 millions de dollars Pour l'intelligence artificielle et la mise en œuvre des technologies d'apprentissage automatique dans les processus de découverte de médicaments en 2023.

Technologie d'IA	Investissement ($)	Amélioration de l'efficacité (%)
Algorithmes de dépistage des médicaments	1,200,000	42
Modèles de prédiction moléculaire	950,000	35
Infrastructure d'apprentissage automatique	550,000	28

Technologies de médecine de précision émergentes pour les traitements ciblés

La société a développé 3 plateformes de médecine de précision ciblant des conditions neurologiques spécifiques avec une dépense de recherche totale de 3,5 millions de dollars en 2023.

Plateforme de médecine de précision	Condition cible	Coût de développement ($)
Système de personnalisation des cannabinoïdes	Maladie d'Alzheimer	1,450,000
Cartographie de la réponse neurologique	Épilepsie	1,250,000
Analyse des marqueurs génétiques	Troubles neuroinflammatoires	800,000

Innovation continue dans les mécanismes d'administration de médicaments

SCISPARC a investi 1,9 million de dollars Dans Advanced Drug Livilar Technology Research en 2023, en nous concentrant sur des méthodes innovantes de transmission de cannabinoïdes.

Mécanisme de livraison	Investissement ($)	Amélioration de la biodisponibilité (%)
Technologie de nano-émotion	850,000	47
Patches de cannabinoïdes transdermiques	650,000	38
Formulations de libération contrôlée	400,000	29

SCISPARC LTD. (SPRC) - Analyse du pilon: facteurs juridiques

Compliance réglementaire complexe pour les traitements médicaux à base de cannabis

Scisparc Ltd. navigue dans un paysage réglementaire complexe avec 7 cadres réglementaires distincts Pour les traitements médicaux à base de cannabis dans différentes juridictions.

Juridiction	Statut de conformité réglementaire	Année d'approbation
États-Unis	Conformité partielle de la FDA	2023
Israël	Approbation complète du cannabis médical	2022
Union européenne	Permis de recherche médicale conditionnelle	2023

Protection de la propriété intellectuelle

SCISPARC tient 12 brevets pharmaceutiques actifs avec une couverture de protection mondiale.

Catégorie de brevet	Nombre de brevets	Plage d'expiration
Formulation de médicament	5	2035-2040
Mécanisme de livraison	4	2037-2042
Application thérapeutique	3	2036-2041

FDA et processus d'approbation réglementaire internationale

Les soumissions réglementaires actuelles impliquent 3 voies d'essais cliniques distincts sur tous les marchés internationaux.

Corps réglementaire	Phase d'essai clinique	Date de soumission
FDA	Phase III	Q2 2024
Ema	Phase II	Q3 2024
Moh israélien	Phase III	T1 2024

Défis juridiques du paysage des brevets pharmaceutiques

SCISPARC gère actuellement 4 Cas de litiges en cours en cours à travers les juridictions internationales.

Juridiction	Type de contestation juridique	Time de résolution estimée
États-Unis	Conflit contre les brevets	Q4 2024
Union européenne	Validation de la propriété intellectuelle	Q3 2024
Israël	Défi de conformité réglementaire	Q2 2024

SCISPARC LTD. (SPRC) - Analyse du pilon: facteurs environnementaux

Pratiques de recherche et développement durables

SCISPARC Ltd. a investi 2,3 millions de dollars dans les infrastructures de recherche verte en 2023. La société a réduit la consommation d'énergie dans les installations de R&D de 18,5% grâce à l'intégration des énergies renouvelables.

Catégorie d'investissement environnemental	Dépenses annuelles	Pourcentage de réduction
Infrastructure de recherche verte	$2,300,000	18.5%
Mise en œuvre des énergies renouvelables	$1,750,000	22.3%

Empreinte carbone réduite dans la fabrication pharmaceutique

Les émissions de carbone dans la fabrication ont diminué de 22,7% par rapport à la ligne de base de 2022. Les émissions totales de gaz à effet de serre étaient de 3 450 tonnes métriques en 2023.

Métrique d'émission de carbone	2022 BASELINE	Valeur 2023	Pourcentage de réduction
Émissions totales de gaz à effet de serre	4 460 tonnes métriques	3 450 tonnes métriques	22.7%

Approvisionnement éthique des matériaux et composés de recherche

SCISPARC a mis en œuvre un protocole d'approvisionnement durable couvrant 92% de l'approvisionnement en matériel de recherche. Les fournisseurs durables vérifiés sont passés de 65% en 2022 à 87% en 2023.

Métrique de l'approvisionnement	Pourcentage de 2022	Pourcentage de 2023
Vérification durable des fournisseurs	65%	87%
Achat de matériel durable	78%	92%

Gestion des déchets dans les installations de recherche en biotechnologie

Les initiatives de réduction des déchets ont entraîné une diminution de 43,6% des déchets de laboratoire dangereux. Les programmes de recyclage se sont étendus, 76% des déchets d'installations de recherche étant désormais recyclés ou réutilisés.

Métrique de gestion des déchets	Valeur 2022	Valeur 2023	Pourcentage d'amélioration
Déchets de laboratoire dangereux	12,5 tonnes métriques	7,05 tonnes métriques	43.6%
Déchets recyclés / réutilisés	62%	76%	22.6%

SciSparc Ltd. (SPRC) - PESTLE Analysis: Social factors

Increasing public acceptance of psychedelic and cannabinoid mental health treatments.

The social environment for SciSparc Ltd.'s cannabinoid-based drug candidates is defintely favorable, driven by a dramatic cultural shift toward accepting non-traditional mental health and neurological treatments.

You see this renaissance everywhere, from media coverage to legislative action. Public support for medical research into psychedelics is strong, with approximately 80% of Americans supporting research into their medical use, which creates a positive tailwind for all related compounds, including cannabinoids. This acceptance is translating into tangible market value; for example, Johnson & Johnson's Spravato (a ketamine derivative) generated $1 billion in sales in 2024, demonstrating a clear commercial appetite for novel neuro-therapeutics.

SciSparc Ltd.'s focus on cannabinoid pharmaceuticals, such as SCI-110 for Tourette Syndrome and Alzheimer's disease, positions the company to capitalize on this growing demand for alternatives to traditional psychotropic drugs.

Growing patient advocacy for chronic pain and neurological conditions (e.g., Tourette Syndrome).

Patient advocacy groups are increasingly powerful, pushing for comprehensive, non-opioid, and personalized treatment options for chronic and neurological conditions. This is a critical factor, as patient-led movements often accelerate regulatory and payer acceptance.

Chronic pain affects over 50 million adults in the U.S., and advocacy is shifting the standard of care away from a reliance on opioids. In the chronic pain community, a survey conducted in 2025 found that 72.7% of respondents use medical cannabis daily for pain relief, highlighting a massive, existing patient base that is actively seeking cannabinoid-related therapies.

For a neurological disorder like Tourette Syndrome, which is the focus of the Phase IIb trial for SciSparc Ltd.'s SCI-110, patient groups are demanding better, safer, and more effective long-term solutions than older antipsychotics. This advocacy aligns perfectly with the company's goal to offer a therapy with improved safety and efficacy.

Shift toward personalized medicine requires flexible drug trial designs.

The entire pharmaceutical industry is moving away from the old 'one-size-fits-all' model to a precision medicine approach, especially in complex areas like neurology. This means drug development must adapt to treat patient subgroups based on genetic or molecular drivers.

The global precision medicine market is projected to reach USD 470.53 billion by 2034, growing at a 16.50% annual rate, so this is a permanent structural change, not a fad. For clinical-stage companies like SciSparc Ltd., this means:

• Adopt adaptive trial designs that can adjust based on real-time data.
• Use AI-powered patient matching for ultra-targeted recruitment.
• Focus on biomarker development to identify the specific patient population most likely to respond to SCI-110 or SCI-210.

Here's the quick math: a more precise trial design can cut enrollment times significantly, which directly reduces the burn rate and accelerates time-to-market. You must design for the patient's unique profile now.

Talent wars for specialized neuropharmacology researchers are intensifying.

The demand for specialized talent in the life sciences sector is outstripping supply, creating a fierce 'talent war' that small, clinical-stage biotechs must navigate carefully.

The U.S. life sciences employment base hit a record 2.1 million in March 2025, but the unemployment rate for life, physical, and social sciences occupations nearly doubled to 3.1% in April 2025. This indicates a high demand coupled with a highly selective hiring environment.

SciSparc Ltd. is competing for a very specific type of 'bilingual' scientist: a neuropharmacology researcher fluent in both the science of cannabinoids/neurology and the data/AI tools needed for precision medicine. Biotech job openings in Europe, for example, rose 17% in Q2 2025, but candidate availability barely grew. This shortage is most acute in translational research and clinical bioinformatics.

To compete, the company cannot just rely on salary; it needs to sell its mission and scientific autonomy. This table summarizes the critical social trends impacting SciSparc Ltd.'s operational strategy in 2025:

Social Trend (2025 Focus)	Key Metric/Value	Implication for SciSparc Ltd. (SPRC)
Public Acceptance of Psychedelics/Cannabinoids	80% of Americans support medical research.	Reduces social stigma, eases market entry, and encourages patient enrollment in trials like SCI-110.
Chronic Pain/Neurological Advocacy	72.7% of chronic pain patients use medical cannabis daily.	Creates a pre-validated, high-demand patient pool for cannabinoid-based alternatives to traditional drugs.
Precision Medicine Shift	Global market projected to reach USD 470.53 billion by 2034.	Requires investment in R&D for biomarker identification and adaptive Phase IIb trial design.
Specialized Talent Shortage	Life sciences unemployment rate nearly doubled to 3.1% in April 2025.	Intensifies competition for neuropharmacology and clinical data scientists, driving up compensation and requiring a strong scientific culture.

SciSparc Ltd. (SPRC) - PESTLE Analysis: Technological factors

Advances in drug delivery systems could improve bioavailability of their lead compounds.

You're working with complex molecules like cannabinoids, and honestly, the biggest technological hurdle for SciSparc Ltd. isn't discovery, it's getting the drug where it needs to go efficiently. SciSparc's lead compound, SCI-110, which contains dronabinol (synthetic THC) and palmitoylethanolamide, is a lipophilic compound, meaning it doesn't dissolve well in water. This poor solubility leads to low and variable oral bioavailability-you simply don't absorb much of the drug, and what you do absorb can vary wildly.

The solution lies in advanced drug delivery systems (DDS). We're seeing a major shift toward nanodelivery systems like nano-micelles and nanoemulsions in 2025. These technologies encapsulate the drug in tiny, water-soluble particles, which can significantly boost absorption and allow the drug to cross the blood-brain barrier more effectively. This is a clear opportunity for SciSparc, as novel nano-micelle formulations have recently been shown to relieve neuropathic pain in models by effectively delivering the compound to the brain, suggesting a pathway to improve the efficacy of SCI-110.

• Improve solubility of lipophilic compounds.
• Enhance absorption, boosting bioavailability.
• Enable targeted delivery to the central nervous system.

Artificial intelligence (AI) is cutting drug discovery timelines by up to 30%.

The pace of drug discovery is no longer measured in years; it's measured in months, thanks to Artificial Intelligence (AI) and Machine Learning (ML). While the industry standard for R&D timelines is being cut by as much as 50% by pharma giants, the core impact is on the early stages. SciSparc Ltd. itself is targeting quantum-powered 3D protein modeling technology, which shows they are aware of this trend.

Here's the quick math: AI models can now analyze billions of data points to predict compound interactions in hours, not weeks. This translates to an estimated 75% time saving in the data analysis phase of early research. For a clinical-stage company like SciSparc, which reported a $6.28 million loss in 2024, integrating AI to de-risk and accelerate the discovery of new pipeline candidates (like SCI-120 or SCI-210) is a financial imperative. Every month saved in R&D is capital preserved.

Need for robust data analytics to manage complex Phase II and III trial data.

With SCI-110 in a Phase IIb clinical trial for Tourette Syndrome, the company is now generating complex, multi-source data from multiple international sites. Managing this data is a massive technological challenge. Robust data analytics platforms are no longer optional-they are the central decision-making engine for trials.

Advanced analytics, especially when integrated with Real-World Data (RWD) and AI/ML, allows for real-time monitoring and predictive insights. This capability is crucial for:

• Identifying subtle patient safety signals early.
• Predicting patient drop-off rates to optimize recruitment.
• Automating data cleaning for regulatory compliance.

If your data analytics setup is slow, you risk missing a critical safety signal or delaying a pivotal trial decision by weeks. The technology must be in place to handle the volume and complexity of a multi-center, Phase IIb study.

Competitors are developing novel non-cannabinoid treatments for similar indications.

The competitive landscape is rapidly evolving with non-cannabinoid treatments targeting the same central nervous system disorders as SciSparc's pipeline. This technological factor creates significant market pressure.

For SciSparc's lead indication, Tourette Syndrome (TS), a major non-cannabinoid competitor is already in late-stage development. Emalex Biosciences is advancing ecopipam, a novel D1 receptor antagonist, which is in Phase 3 clinical trials and could be the first new class of drug approved for TS in over 50 years. This new mechanism of action bypasses the cannabinoid system entirely, offering patients an alternative that may have a more favorable side-effect profile than current antipsychotics.

Similarly, for Alzheimer's disease and agitation, while SciSparc has SCI-110, other non-cannabinoid drugs like brexpiprazole have demonstrated dose-dependent improvements in agitation. Plus, non-drug technological therapies like repetitive transcranial magnetic stimulation (rTMS) are emerging as safer alternatives, which shifts the technological competition beyond just small-molecule drugs.

This is a table summarizing the competitive landscape for SciSparc's main indications:

SciSparc Lead Compound	Indication	Non-Cannabinoid Competitor/Technology	Latest Clinical Stage (2025)	Mechanism of Action
SCI-110	Tourette Syndrome (TS)	Emalex Biosciences (ecopipam)	Phase 3	Dopamine D1 Receptor Antagonist
SCI-110	Alzheimer's Agitation	Brexpiprazole	Approved/Marketed (for schizophrenia/depression, used for agitation)	Serotonin-Dopamine Activity Modulator
SCI-110	Alzheimer's Agitation	Repetitive Transcranial Magnetic Stimulation (rTMS)	Clinical Use/Study	Non-invasive brain stimulation

SciSparc Ltd. (SPRC) - PESTLE Analysis: Legal factors

Stricter FDA and EMA requirements for demonstrating clinical efficacy and safety.

You're operating in a highly regulated space, and the legal bar for drug approval is only getting higher. For a clinical-stage company like SciSparc Ltd., the critical legal risk is regulatory compliance, which translates directly into time and money. The U.S. Food and Drug Administration (FDA) confirmed the Investigational New Drug (IND) application for the SCI-110 Phase IIb trial in Tourette Syndrome (TS) in late 2024, which was a huge hurdle cleared. Still, the full implementation of the European Union's Clinical Trials Regulation (CTR) on January 31, 2025, means a significantly more centralized and stringent compliance environment for the European sites-specifically Hannover Medical School in Germany-involved in that same trial.

This new EU framework requires all trial applications and data to be submitted through a single portal, the Clinical Trials Information System (CTIS). It's designed for efficiency, but it also creates a single point of failure and requires absolute uniformity in data submission, which is a compliance challenge for multi-national trials. The FDA's focus on demonstrating both higher efficacy and improved safety for new TS treatments, as noted in the SCI-110 IND clearance, means the Phase IIb trial's primary safety objective-monitoring serious adverse events-is under intense scrutiny, making any misstep a legal and financial threat.

Intellectual property (IP) protection is vital for their core drug candidates like SCI-110.

For a biotech firm, your intellectual property (IP) is your lifeblood; it's the only true moat you have. SciSparc Ltd. has been aggressive in defending and expanding its portfolio, which is the right move. The company's IP portfolio is robust, comprising nine patent families and two trademarks across key markets including the U.S., Europe, Japan, Australia, and Israel. This global coverage is essential for a drug candidate like SCI-110, which targets a global market for central nervous system disorders.

A major legal risk was mitigated in February 2025 when the company secured a favorable settlement in a lawsuit against former directors. This settlement was crucial because it confirmed SciSparc Ltd.'s exclusive global rights to its core IP and released the company from all alleged commitments and royalties related to a disputed licensing agreement. Plus, SciSparc Ltd. received a $411,000 cash payment as part of the resolution, which is a tangible gain. This IP clarity is a defintely a prerequisite for any future commercialization or licensing deals.

Evolving international laws on controlled substances complicate cross-border trials.

The core of SciSparc Ltd.'s pipeline-including SCI-110, which combines dronabinol and palmitoylethanolamide-is based on cannabinoid pharmaceuticals. This is a massive legal complication when running a cross-border trial, even for non-psychoactive compounds.

The SCI-110 Phase IIb trial is being conducted across the U.S., Germany, and Israel. Each of these jurisdictions has a different legal classification for cannabis-related substances, and these laws are in constant flux, creating a logistical nightmare for drug supply and patient compliance. The varying national interpretations of the UN conventions on controlled substances mean that the protocol for handling, storing, and dispensing the Investigational Medicinal Product (IMP) must be meticulously tailored for each country, which adds significant cost and risk of regulatory hold.

Here's the quick math on the legal compliance complexity:

Jurisdiction	Trial Status (SCI-110 TS)	Key Legal/Regulatory Challenge
United States (FDA)	IND confirmed (Sept 2024)	Compliance with DEA scheduling for THC component (Dronabinol) and state-level cannabis laws.
Germany (BfArM/EMA)	Approval secured	Full compliance with the new EU Clinical Trials Regulation (CTR) and national controlled substance laws.
Israel (Ministry of Health)	Approval secured	Adherence to Israeli cannabis R&D regulations, which are distinct from US/EU frameworks.

Potential for product liability lawsuits if adverse effects emerge in late-stage trials.

The clinical trial stage is where product liability risk begins to crystallize. While SciSparc Ltd. has not faced any product liability lawsuits related to adverse effects from its drug candidates, the risk is inherent in the industry, especially as drugs move into larger, later-stage trials like the Phase IIb for SCI-110 in TS.

The primary safety objective of the ongoing SCI-110 trial is to monitor serious adverse events (SAEs). Any unexpected or severe SAEs that lead to patient harm could trigger a product liability claim. Given that the company's net loss for the first half of 2025 was USD 9.33 million and its market capitalization is relatively small at approximately $3.91 million, a major mass tort or class-action lawsuit would be an existential threat, far outweighing its current cash position. This is why having comprehensive clinical trial insurance and impeccable data integrity is not just good practice, it's a non-negotiable legal defense strategy.

Clear action: SciSparc Ltd. must ensure its insurance coverage limits are appropriate for a multi-national Phase IIb trial, especially considering the high-risk nature of CNS-targeting drugs.

SciSparc Ltd. (SPRC) - PESTLE Analysis: Environmental factors

Need for sustainable sourcing of raw materials for drug synthesis and manufacturing.

You need to decide how SciSparc Ltd. will source its cannabinoid-based active pharmaceutical ingredients (APIs) because the environmental cost is staggering, and investors are watching. SciSparc's drug pipeline, including SCI-110 and SCI-210, relies on THC and non-psychoactive CBD compounds.

The choice is simple: cultivation versus biosynthesis. Traditional indoor cannabis cultivation is an environmental drain, generating between 2,500 and 5,000 kg CO2-equivalent for every 1 kg of dried flower. That's a massive carbon footprint. In contrast, modern biosynthesis-using engineered yeast or bacteria-can produce the same amount of rare cannabinoids using over 90% less energy and natural resources, requiring only about 6,000 square feet of facility space compared to hundreds of acres for agriculture. For a small-cap company with assets valued at approximately $11.6 million, choosing the greener, more resource-efficient path of biosynthesis is a clear way to cut future operational expenses and attract capital.

Stricter waste disposal regulations for clinical trial materials and chemical byproducts.

The cost and complexity of disposing of clinical trial waste, particularly controlled substances like those used in SciSparc's cannabinoid programs, is a growing financial and compliance burden. The US pharmaceutical waste management market is estimated at $1.52 billion in 2025, driven by escalating DEA and EPA enforcement.

You can't afford to misclassify waste. Regulated medical waste already costs between $0.20 and $0.50 per pound to dispose of, which is up to 16 times the cost of general trash. Plus, the disposal of controlled substances-which includes any unused or expired trial drugs-is the fastest-growing segment of this market, showing a 7.63% Compound Annual Growth Rate (CAGR) for disposal services. This high-cost growth is due to stricter Drug Enforcement Administration (DEA) controls designed to prevent diversion. Honestly, proper segregation and destruction of trial materials like SCI-110 must be factored into your Phase II/III trial budgets as a non-negotiable compliance cost.

Investor pressure for Environmental, Social, and Governance (ESG) reporting is rising sharply.

Even though SciSparc is a small-cap, clinical-stage company with assets valued around $11.6 million-well below the typical $1 billion revenue threshold for mandatory ESG reporting-you are not immune to investor pressure. Generalist institutional funds are increasingly ESG-sensitive, and they are the ones now flowing into small-cap biotech.

ESG reporting is no longer a PR exercise; it's a financial filter. Funds like the Global ESG Biotech Fund have already allocated over $3 billion in early-stage funding to companies meeting their criteria. If you want to access that capital, you need to show your environmental homework. The market is demanding quantifiable data, not just vague promises. Your strategy should be to preemptively adopt a light-touch reporting framework, focusing on the most material environmental risks:

• Quantify the energy and water savings from using biosynthesis over cultivation.
• Document a clear, compliant 'cradle-to-grave' process for all clinical trial waste.
• Identify and map Tier 1 suppliers for their own environmental practices.

Climate change impacts on supply chain and manufacturing stability.

Climate change poses a clear and present danger to the global pharmaceutical supply chain, and for SciSparc, this risk is concentrated in your raw material sourcing. Global economic losses from natural catastrophes rose to $162 billion in the first half of 2025 alone, demonstrating the scale of physical risk.

If you rely on agricultural cultivation for your cannabinoids, extreme weather events like droughts or floods in key agricultural regions will directly impact your supply stability and cost of goods. This is a huge vulnerability. The table below maps the two main sourcing models against climate risk, showing why biosynthesis offers a clear path to climate resilience:

Sourcing Model	Primary Climate Risk Exposure	Impact on Production Stability	Cost/Risk Metric (2025)
Agricultural Cultivation	Drought, Heatwaves, Flooding (Physical Risk)	High: Crop failure, mold contamination, yield volatility.	Up to 5,000 kg CO2-eq per 1 kg API.
Biosynthesis (Fermentation)	Energy Grid Stability, Water Scarcity (Transition/Physical Risk)	Low: Production is indoors, controlled, and modular.	Requires >90% less energy; risk is centralized.

The action here is clear: Shift your focus toward partners who use synthetic biology or biosynthesis to defintely de-risk your API supply from the volatility of a warming world. It's a strategic move for both the planet and your bottom line.