DanCann Pharma A/S has successfully completed pre-validation batches and expects final approval from the Danish Medicines Agency by the end of summer

COPENHAGEN, Denmark, 26 May 2023 - DanCann Pharma A/S (SS: DANCAN) (OTCQB: DCPXF) ("DanCann Pharma" or the "Company"), a Danish company powered by cannabinoids, is pleased to announce the completion of its pre-validation batches. These batches are paving the way for the Company's forthcoming application to the Danish Medicines Agency for its final inspection of Biotech Pharm1 (“BP1”), seeking approval for the release of its products. This achievement aligns closely with the Company's original expectations, with minor adjustments made along the way.

As communicated in December 2022, three validation batches are required before final approval. DanCann Pharma is pleased to announce that the Company has successfully completed these pre-validation batches and is now ready to apply for final approval.

During the last months, DanCann Pharma has been diligently working to improve the stability and validity of its products since the inspection and EU-GMP certification of the manufacturing facility by the Danish Medicines Agency in November 2022. The Company's focus has primarily been on its initial tetrahydrocannabinol genetics, developed in a flos/herbal substance format. During the validation process, the Company has done some minor performance adjustments to the facility (BP1), resulting in a slight delay in the timeline when it comes to securing the final approval of the products before first sales. In collaboration with the Danish authorities, DanCann Pharma expects to send the final application, regarding the release certificate, during June.

DanCann Pharma is optimistic about successfully obtaining the release certificate, which marks the final checkpoint in the approval process. The final approval can take place shortly after the final documentations has been sent in. However, considering the summer holidays and the involvement of relevant authorities, the Company has decided to postpone its previous guidance for the release certificate attainment in May. The new expected timeframe for this milestone is set to end of summer, which will allow for thorough and comprehensive review by the authorities within the required timeframe to ensure the highest standards of quality and compliance are met.

DanCann Pharma will keep the market informed about the progress regarding the approval and any further developments about the facility.

About DanCann Pharma

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

The Company focuses on discovering, developing, manufacturing, and commercializing new therapeutic cannabinoids in a wide range of disease areas.

DanCann Pharma is EU-GMP-approved by the Danish Medicines Agency under the Danish Pilot Programme for medical cannabis, and have, among other things, license for manufacturing, export, import and distribution. The DanCann Pharma group also owns the subsidiary CannGros ApS, which is the market leader in Denmark with the import and distribution of the products Bedrocan®, Bedica® and Bediol® to all the Danish pharmacies.

DanCann Pharma A/S (SS: DANCAN) is listed on the Spotlight Stock Market in Copenhagen/Stockholm and side listed on OTCQB Venture Market in USA (OTCQB: DCPXF).

For more information, visit: www.dancann.com  

For further information, please contact:

Jeppe Krog Rasmussen, CEO

E-mail: [email protected]

Website: 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.