Since 2018, Stenocare has been the sole supplier of medical cannabis oil products for the Danish Pilot Programme. The company currently offers two prescription-based oil products (stage 4) for patients: a THC 30 mg/mL product and a CBD 20 mg/mL product. The company continuously analyse market opportunities and feedback from doctors to qualify the product pipeline and deliver on the mission to provide prescription-based medical cannabis products for treatment of patients.

When a product candidate has been identified, the company addresses several critical success parameters before venturing further with the development. Uncovering which patient indications can potentially be targets and treatment price points are important for defining the market opportunity. Then the company review the manufacturing capabilities internally and with its experienced partners. This is generally a collaborative process involving the supplier, distributors, physicians, and patients.

Denmark is both the Stenocare home market and a valuable test market for products. This is because the Danish Pilot Program and Danish Medicines Agency are leading the regulatory development for standardization of medical cannabis products, and because highly experienced medical specialists are sharing clinical information that is critical for developing the right product formulations. Having products approved for sales in Denmark has been a gateway for the Stenocare to enter other markets with its product portfolio.

Stenocare actively work with their product pipeline to meet needs from medical specialists and offer more choice for patients. The Danish Medicines Agency has a policy of only reviewing one product application at a time (stage 3), and therefore Stenocare carefully manage and prioritize the product pipeline from concept to commercialization in four stages.

STENOCARE
pipeline
stages:
Stage 1 Stage 2 Stage 3 Stage 4
Concept stage: Validation Submission of Commercial stage:
Defining process and application and Prescription based
product stability approval products
standards, testing. process by availability for
specifications Establishing Danish patients
and proof of Medicinal
manufacturing concept, Agency
and release data · Complete
protocols. collection product
to document documentation
regulatory package that is
compliance. compliance with
Danish Drug
Standards
(DLS)Validation
for
completeness

• Circular

review process
concerning
regulatory and
pharma-chemical
topics
STENOCARE
product
pipeline:
Stage 1 Stage 2 Stage 3 Stage 4
New innovative Very high BALANCED OIL THC OIL STENOCARE,
product potency CBD STENOCARE, since April
category based OIL currently due 2022CBD OIL
on a patented formulation, for review by STENOCARE, since
Lymphatic Ready for the Danish January
Targeting oil review for Medicinal 2023
Technologyto regulatory Agency
create rapid compliance
uptake, by the by
greater Danish
absorption and Medicinal
thus efficacy Agency

As more pipeline products reach the commercial stage 4, this is expected to have a significantly positive impact on sales activities in Denmark. Especially the Balanced Oil product in stage 3 is expected to become a hero product - as this product formulation has historically represented +50% of sales volume. The speed of the process towards completion of stage 3 will depend on the Danish Medicines Agency's internal capacity, as they have faced delays in 2023 due to pressure on agency resources, making it challenging for them to meet their own timelines for reviewing applications.

The Stenocare track record for regulatory collaboration and structured work across the four pipeline stages, has created valuable assets for the company and trustworthiness with the health authorities in Europe. Stenocare is recognized as competent participant in the standardization process of medical cannabis extracts with the expert committee under the European Medicinal Agency, and also participating in the important work to evolve the European monography for medical cannabis.