DanCann Pharma has received confirmation of regulatory approval for the distribution of two additional products in the Danish medicinal cannabis market from the Danish Medicines Agency. This regulatory milestone further strengthens DanCann Pharma's strategic positioning and leadership within Denmark's tightly regulated framework for medicinal cannabis and underscores the Company's ongoing commitment to broadening patient access to standardized, high-quality cannabinoid-based therapies.

Bedrolite® and Bedrobinol®

Bedrolite® represents the first Cannabidiol ("CBD")-dominant granulate product to be approved under the Pilot Programme in Denmark. The product contains approximately 9% CBD and less than 1% delta-9-tetrahydrocannabinol ("THC"). It is based on a sativa-dominant strain and is delivered in granulate form, making it suitable for controlled dosing and vaporization.

Due to its pharmacological profile, Bedrolite® is expected to serve as a first-line treatment option for patients initiating cannabinoid-based therapies. Its minimal THC-content makes it particularly appropriate for patients with low THC tolerance, or those initiating treatment, thereby offering greater tolerability and a basis for gradual titration.

Bedrobinol®, on the other hand, is a THC-dominant flos product with a moderate THC concentration of 13.5%, and less than 1% CBD. It is based on a sativa-dominant strain, similar to the Company's Bedrocan® product (22.0% THC), but with lower concentration of THC, making Bedrobinol® suitable for patients requiring THC-dominant therapy with a more tolerable onset. The Company also includes Bedica® (14.0% THC) in its product portfolio, which differs from the aforementioned products by being indica-dominant and delivered in granulate form, as opposed to the flos format used for Bedrobinol® and Bedrocan®.

The Danish Medicines Agency will formally list Bedrolite® and Bedrobinol® on the official register of approved medicinal cannabis products under the Danish Pilot Programme. Following this, DanCann Pharma will launch Bedrolite® and Bedrobinol® to the Danish market during June/July 2025 for patient access.

Inhalation as delivery method and reimbursement for medicinal cannabis

All products are intended for inhalation via vaporization and are recommended to be used with certified medical-grade vaporizers, such as the Mighty+ Medic (Storz & Bickel), which holds CE certification for medical use. Inhalation as a delivery method allows for rapid onset of action, typically within 5-10 minutes, which is advantageous for managing acute symptoms. The method also enables precise self-titration by patients and avoids first-pass hepatic metabolism, thereby improving bioavailability compared to oral formulations (e.g. oils, extracts and tinctures).

Under the current framework of the Danish Pilot Programme for medicinal cannabis, the products are prescribable by all licensed medical practitioners and are eligible for public reimbursement in accordance with the reimbursement scheme established under the Pilot Programme for medicinal cannabis.

Reimbursement for treatment under the Danish Pilot Programme for medicinal cannabis

Under the Danish Pilot Programme for medicinal cannabis, patients are eligible for government reimbursement covering 50% of their annual treatment costs, up to a maximum of DKK 20,000 per year. The expected retail price for the newly approved products (Bedrolite® and Bedrobinol® in 5-gram units) is approximately DKK 500.00, inclusive of VAT and pharmacy fees.

After reimbursement, the effective out-of-pocket cost to the patient is approximately DKK 250.00 per unit-equivalent to around DKK 50.00 per gram. This cost may be further reduced for patients who are members of the private health insurance scheme "Danmark", depending on their membership group and applicable coverage terms.

Comments from the Company

The addition of these two new products enhances DanCann Pharma's medicinal cannabis portfolio, expanding the Company's offering to encompass a broader range of therapeutic needs across both flos (flower) and granulate formats. With the introduction of Bedrolite® and Bedrobinol®, the Company now covers a comprehensive spectrum of cannabinoid profiles, reinforcing its ability to serve diverse patient populations with tailored, pharmaceutical-grade treatment options.

The Company had anticipated the regulatory approval of these products, and therefore the expected revenue contribution has already been incorporated into the financial outlook for 2025. Nevertheless, the distribution of the two products is expected to have a positive impact on sales development and further solidifies DanCann Pharma's position as a leading and agile operator in the regulated Danish medicinal cannabis market. 

Jeppe Krog Rasmussen, CEO of DanCann Pharma A/S, comments:

"This regulatory milestone represents a strong expansion of DanCann Pharma's product portfolio under the national framework, and an important step toward improving access to standardized, pharmaceutical-grade cannabinoid-based medicines for patients in Denmark.

Expanding the therapeutic toolkit available to physicians and patients alike is essential, and this development marks yet another step toward fulfilling that objective.

I am very pleased with the approval of these new products. We are committed to delivering the highest quality cannabinoid-based medicines, and this achievement is a testament to the capabilities of our team in navigating the complexities of regulatory compliance.

The addition of these products strengthens our competitive position in the market, and we remain focused on pursuing further product approvals as we identify high-quality candidates that can improve patient outcomes."

For more information, please see: https://www.dancann.com/products

For further information, please contact:

Jeppe Krog Rasmussen,

Chief Executive Officer

E-mail: jkr@dancann.com

About DanCann Pharma A/S

DanCann Pharma A/S (SS: DANCAN) was founded in 2018 and is a Danish biopharmaceutical Company powered by cannabinoids.

DanCann Pharma A/S (SS: DANCAN) is listed on the Spotlight Stock Market in Copenhagen/Stockholm.

For more information, please visit: www.dancann.com

Forward-looking-statement:

Some statements in this release may contain forward-looking information. All statements, other than of historical fact, that address activities, events, or developments that the Company believes, expects, or anticipates will or may occur in the future (including, without limitation, statements regarding potential acquisitions and financings) are forward-looking statements. Forward-looking statements are generally identifiable by use of the words "may", "will", "should", "continue", "expect", "anticipate", "estimate", "believe", "intend", "plan" or "project" or the negative of these words or other variations on these words or comparable terminology.

Forward-looking statements are subject to several risks and uncertainties, many of which are beyond the Company's ability to control or predict, that may cause the actual results of the Company to differ materially from those discussed in the forward-looking statements. Factors that could cause actual results or events to differ materially from current expectations include, among other things, without limitation, the inability of the Company, to obtain sufficient financing to execute the Company's business plan; competition; regulation and anticipated and unanticipated costs and delays, the success of the Company's research strategies, the applicability of the discoveries made therein, the successful and timely completion and uncertainties related to the regulatory process, the timing and outcomes of regulatory or intellectual property decisions and other risks disclosed in the Company's public disclosure record on file with the relevant securities regulatory authorities.

Although the Company has attempted to identify important factors that could cause actual results or events to differ materially from those described in forward-looking statements, there may be other factors that cause results or events not to be as anticipated, estimated or intended. Readers should not place undue reliance on forward-looking statements. The forward-looking statements included in this presentation are made as of the date of this presentation and the Company does not undertake an obligation to publicly update such forward-looking statements to reflect new information, subsequent events or otherwise unless required by applicable securities legislation.