Scisparc Ltd. (SPRC): Análise de Pestle [Jan-2025 Atualizado]

No cenário em rápida evolução da pesquisa neurológica e da terapêutica à base de canabinóides, a Scisparc Ltd. (SPRC) fica no cruzamento da ciência de ponta e da complexa dinâmica global. Essa análise abrangente de pestles investiga os fatores externos multifacetados que moldam a trajetória estratégica da empresa, revelando um ecossistema diferenciado de desafios e oportunidades que abrangem regulamentações políticas, incertezas econômicas, mudanças sociais, inovações tecnológicas, complexidades legais e considerações ambientais. Ao examinar essas dimensões críticas, descobrimos as intrincadas vias que finalmente definirão o potencial do SCISPARC para soluções médicas inovadoras e crescimento sustentável no setor de biotecnologia altamente competitivo.

Scisparc Ltd. (SPRC) - Análise de Pestle: Fatores Políticos

Ambiente regulatório de biotecnologia israelense

Os dispositivos médicos de Israel e a Divisão Reguladora de Diagnóstico (MDDD) supervisionam as aprovações de ensaios clínicos para o SCISPARC. A partir de 2024, o processo regulatório requer:

Aspecto regulatório	Requisito de conformidade
Cronograma de aprovação de ensaios clínicos	Aproximadamente 60-90 dias para revisão padrão
Custo de envio regulatório	Estimado US $ 15.000 a US $ 25.000 por aplicativo
Auditorias de conformidade	Conduzido anualmente com taxa de aprovação de 92%

Financiamento da pesquisa do governo

Financiamento de pesquisa do governo israelense para tratamentos neurológicos de transtorno em 2024:

• Orçamento total da pesquisa neurológica: US $ 42,5 milhões
• Subsídios alocados para biotecnologia inovadora: US $ 7,3 milhões
• Concessão de pesquisa recebeu do SCISPARC: US ​​$ 1,2 milhão

Desafios de colaboração de pesquisa geopolítica

Restrições internacionais de colaboração de pesquisa:

Região	Status de colaboração	Restrições
Países do Oriente Médio	Limitado	89% restritos
União Europeia	Abrir	Restrições mínimas
Estados Unidos	Parcialmente aberto	Requisitos moderados de conformidade

Impacto da política de saúde

Mudanças potenciais da política de saúde que afetam o desenvolvimento farmacêutico em Israel:

• Alterações regulatórias propostas: 3 novas políticas de rascunho
• Potencial aumento dos requisitos de transparência do ensaio clínico
• Custo estimado de conformidade: US $ 450.000 a US $ 750.000

Scisparc Ltd. (SPRC) - Análise de Pestle: Fatores econômicos

Volatilidade nos mercados de investimento de biotecnologia

Volatilidade do mercado de investimentos do setor de biotecnologia em 2023-2024 demonstra flutuações significativas:

Métrica de investimento	2023 valor	2024 Projeção
Financiamento total de biotecnologia em vc	US $ 12,4 bilhões	US $ 10,7 bilhões
Investimentos de pesquisa em transtornos neurológicos	US $ 2,3 bilhões	US $ 2,6 bilhões
Índice de Volatilidade do mercado de ações de biotecnologia	24.5%	26.3%

Potenciais desafios econômicos na criação de capital para o desenvolvimento de medicamentos

Desafios de levantamento de capital para o desenvolvimento de medicamentos neurológicos em 2024:

Categoria de financiamento	Quantia	Mudança de 2023
Financiamento médio da série A	US $ 18,2 milhões	-12.5%
Custos de desenvolvimento de medicamentos neurológicos	US $ 356 milhões	+7.3%
Despesas de conformidade regulatória	US $ 42,6 milhões	+5.2%

Flutuações de taxa de câmbio que afetam o financiamento da pesquisa internacional

Impactos de taxa de câmbio de financiamento de pesquisa internacional:

Par de moeda	2024 Volatilidade da taxa de câmbio	Pesquise impacto no financiamento
USD/EUR	6.2%	-US $ 1,4 milhão
USD/GBP	5.8%	-US $ 1,1 milhão
USD/JPY	7.1%	-US $ 0,9 milhão

Demanda do mercado global por tratamentos inovadores de transtorno neurológico

Análise de mercado global de tratamento de transtorno neurológico:

Segmento de mercado	2024 Tamanho do mercado	Taxa de crescimento
Tratamentos de Alzheimer	US $ 18,4 bilhões	8.3%
Tratamentos de Parkinson	US $ 6,7 bilhões	6.9%
Tratamentos de epilepsia	US $ 4,2 bilhões	7.5%

ScisParc Ltd. (SPRC) - Análise de Pestle: Fatores sociais

Aumentar a conscientização sobre os distúrbios neurológicos e as necessidades de tratamento

Segundo a Organização Mundial da Saúde, os distúrbios neurológicos afetam mais de 1 bilhão de pessoas em todo o mundo. As taxas de prevalência mostram:

Transtorno	Prevalência global	Impacto anual
Alzheimer	50 milhões de casos em todo o mundo	Custo econômico de US $ 1,3 trilhão
Parkinson's	10 milhões de pacientes globalmente	US $ 51,9 bilhões de despesas anuais de saúde
Epilepsia	50 milhões de indivíduos afetados	US $ 37,9 bilhões de carga econômica anual

Envelhecimento da população que impulsiona a demanda por soluções de tratamento neurológico

A demografia populacional indica:

• População global acima de 65: 9,3% em 2020
• Projetado para atingir 16% até 2050
• A prevalência de transtorno neurológico aumenta 45% com a idade

Aceitação crescente de tratamentos médicos baseados em cannabis

Região	Legalização de cannabis medicinal	Valor de mercado
Estados Unidos	37 Estados legalizados sobre cannabis medicinal	Tamanho do mercado de US $ 13,2 bilhões (2022)
Canadá	Legalização nacional completa	US $ 4,3 bilhões no mercado de cannabis medicinal
União Europeia	21 países permitem cannabis medicinal	Mercado projetado de US $ 2,8 bilhões até 2025

Redução do estigma de saúde mental Apoiando abordagens terapêuticas inovadoras

Estatísticas de conscientização sobre saúde mental:

• Redução de 72% no estigma de saúde mental desde 2010
• 85% dos funcionários apóiam os programas do local de trabalho em saúde mental
• US $ 300 bilhões para perda anual de produtividade global de condições de saúde mental não tratadas

ScisParc Ltd. (SPRC) - Análise de Pestle: Fatores tecnológicos

Pesquisa neurológica avançada e desenvolvimento de medicamentos baseados em canabinóides

A Scisparc Ltd. investiu US $ 4,2 milhões em P&D para tratamentos neurológicos baseados em canabinóides em 2023. O foco principal da empresa é o desenvolvimento de terapêuticas de canabinóides de precisão para distúrbios neurológicos.

Área de pesquisa	Investimento ($)	Aplicações de patentes
Terapias canabinóides neurológicas	4,200,000	7
Pesquisa de tratamento de Alzheimer	1,850,000	3
Intervenções canabinóides de epilepsia	1,350,000	4

Integração de IA e aprendizado de máquina em pesquisa farmacêutica

SCISPARC alocado US $ 2,7 milhões Para inteligência artificial e implementação da tecnologia de aprendizado de máquina em processos de descoberta de medicamentos durante 2023.

Tecnologia da IA	Investimento ($)	Melhoria de eficiência (%)
Algoritmos de triagem de drogas	1,200,000	42
Modelos de previsão molecular	950,000	35
Infraestrutura de aprendizado de máquina	550,000	28

Tecnologias emergentes de medicina de precisão para tratamentos direcionados

A empresa desenvolveu 3 plataformas de medicina de precisão direcionando condições neurológicas específicas com um gasto total de pesquisa de US $ 3,5 milhões em 2023.

Plataforma de Medicina de Precisão	Condição alvo	Custo de desenvolvimento ($)
Sistema de personalização canabinóide	Doença de Alzheimer	1,450,000
Mapeamento de resposta neurológica	Epilepsia	1,250,000
Análise de marcadores genéticos	Distúrbios neuroinflamatórios	800,000

Inovação contínua em mecanismos de administração de medicamentos

O SCISPARC investiu US $ 1,9 milhão na pesquisa avançada de tecnologia de tecnologia de administração de medicamentos durante 2023, concentrando -se em métodos inovadores de transmissão de canabinóides.

Mecanismo de entrega	Investimento ($)	Melhoria de biodisponibilidade (%)
Tecnologia de nano-emulsão	850,000	47
Remendos canabinóides transdérmicos	650,000	38
Formulações de liberação controlada	400,000	29

ScisParc Ltd. (SPRC) - Análise de Pestle: Fatores Legais

Conformidade regulatória complexa para tratamentos médicos baseados em cannabis

Scisparc Ltd. Navega uma paisagem regulatória complexa com 7 estruturas regulatórias distintas para tratamentos médicos baseados em cannabis em diferentes jurisdições.

Jurisdição	Status de conformidade regulatória	Ano de aprovação
Estados Unidos	Conformidade parcial da FDA	2023
Israel	Aprovação completa da cannabis medicinal	2022
União Europeia	Permissão de pesquisa médica condicional	2023

Proteção à propriedade intelectual

O SCISPARC é mantido 12 patentes farmacêuticas ativas com cobertura de proteção global.

Categoria de patentes	Número de patentes	Faixa de validade
Formulação de drogas	5	2035-2040
Mecanismo de entrega	4	2037-2042
Aplicação terapêutica	3	2036-2041

Processos de aprovação regulatória da FDA e Internacional

As submissões regulatórias atuais envolvem 3 caminhos de ensaio clínico distintos entre mercados internacionais.

Órgão regulatório	Fase de ensaios clínicos	Data de envio
FDA	Fase III	Q2 2024
Ema	Fase II	Q3 2024
Israelense Moh	Fase III	Q1 2024

Desafios legais da paisagem de patentes farmacêuticos

Atualmente, o SCISPARC gerencia 4 casos de litígio de patentes em andamento entre jurisdições internacionais.

Jurisdição	Tipo de desafio legal	Linha do tempo da resolução estimada
Estados Unidos	Disputa por violação de patente	Q4 2024
União Europeia	Validação da propriedade intelectual	Q3 2024
Israel	Desafio de conformidade regulatória	Q2 2024

ScisParc Ltd. (SPRC) - Análise de Pestle: Fatores Ambientais

Práticas sustentáveis ​​de pesquisa e desenvolvimento

A ScisParc Ltd. investiu US $ 2,3 milhões em infraestrutura de pesquisa verde em 2023. A Companhia reduziu o consumo de energia nas instalações de P&D em 18,5% através da integração de energia renovável.

Categoria de investimento ambiental	Despesas anuais	Porcentagem de redução
Infraestrutura de pesquisa verde	$2,300,000	18.5%
Implementação de energia renovável	$1,750,000	22.3%

Pegada de carbono reduzida na fabricação farmacêutica

As emissões de carbono na fabricação diminuíram 22,7% em comparação com a linha de base de 2022. As emissões totais de gases de efeito estufa foram de 3.450 toneladas métricas em 2023.

Métrica de emissão de carbono	2022 linha de base	2023 valor	Porcentagem de redução
Emissões totais de gases de efeito estufa	4.460 toneladas métricas	3.450 toneladas métricas	22.7%

Fornecimento ético de materiais de pesquisa e compostos

O SCISPARC implementou a Protocolo de fornecimento sustentável cobrindo 92% da compra de material de pesquisa. Os fornecedores sustentáveis ​​verificados aumentaram de 65% em 2022 para 87% em 2023.

Métrica de fornecimento	2022 porcentagem	2023 porcentagem
Verificação sustentável de fornecedores	65%	87%
Compras de material sustentável	78%	92%

Gerenciamento de resíduos em instalações de pesquisa de biotecnologia

As iniciativas de redução de resíduos resultaram em 43,6% de diminuição dos resíduos de laboratório perigosos. Os programas de reciclagem se expandiram, com 76% dos resíduos de instalações de pesquisa agora sendo reciclados ou reaproveitados.

Métrica de gerenciamento de resíduos	2022 Valor	2023 valor	Porcentagem de melhoria
Resíduos de laboratório perigosos	12,5 toneladas métricas	7.05 Toneladas métricas	43.6%
Resíduos reciclados/reaproveitados	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.