Company: INCR
Filing Date: 2025-05-01
Form Type: 20-F
Source: 0001641172-25-007971
Chunk: 5

Company: Intercure Ltd.
Filing Date: 2025-05-01
Form: 20-F
Item: Item 3
Chunk 5
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, safety, efficacy and dosing of cannabis or specific cannabinoids such as cannabidiol (“CBD”), and tetrahydrocannabinol (“THC”), remains in relatively early stages and there have been only a few clinical trials that have been conducted on these topics. We have not completed any clinical trials using cannabis or cannabis-based products to date. We have received IMCA feasibility approval to initiate nine clinical trials and we have commenced one phase 3 clinical trial. We initiated a phase 3 clinical trial in a leading Israeli medical center to study our product’s influence on cognitive and adjacent capabilities on children who are on the autistic spectrum. The patient recruitment for the trial was initiated but was stopped due to COVID-19 challenges and as a result of significant delays resulting from the COVID-19 pandemic, it has not been clear since then when the Company will be able to conduct and complete any of its clinical trials.
 

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Clinical trials are expensive, time consuming and difficult to design and implement. We may not be able to complete all or any of the clinical trials that we have planned. Further, the results of preclinical testing and clinical trials are uncertain, and a product can fail at any stage of clinical development. Even if the results of our clinical trials are favorable, clinical trials for a number of our products may continue for several years and may take significantly longer to complete. The testing process can take many years and may include post-marketing studies and surveillance, which could result in substantial additional expense.
 
The results contained in the articles, reports and studies referenced in this Annual Report are not necessarily predictive of future results. Future research and clinical trials may draw opposing conclusions or may reach different or negative conclusions regarding the medical benefits, viability, safety, efficacy, dosing or other facts and perceptions related to the use of cannabis as a treatment for a medical indication. This could result in restrictions on the distribution of our products, the loss of regulatory approval for an approved medical indication, or an adverse effect on the social acceptance of cannabis for medical use or the demand for our pharmaceutical-grade cannabis products.
 
Our business may be adversely affected if there is a resurgence of the COVID-19 pandemic or outbreak of any other pandemic or epidemic.
 
Public health epidemics or outbreaks could adversely impact our business. If there is a resurgence of COVID-19, or outbreak of any other pandemic or epidemic, its spread may materially affect us economically. While the potential economic impact brought by, and the duration of, any future resurgence of the COVID-19 pandemic, or outbreak