DanCann Pharma A/S with inspection by the Danish Medicine Agency during Q4-2022: expects to get EU-GMP approval before end-2022

COPENHAGEN, Denmark, November 8, 2022 - DanCann Pharma A/S (SS: DANCAN) ("DanCann Pharma" or the “Company”), a Danish company powered by cannabinoids, hereby announces that the Company expects to get the EU-GMP approval of the production facilities Biotech Pharm1 (“BP1”) in Q4 2022.

Earlier this year DanCann Pharma applied for approval of the production facilities BP1. The Danish Medical Agency has informed the Company, that the inspection will take place in Q4 of 2022. The approval will be the most important milestone so far for DanCann Pharma and will open further market possibilities for the Company.  

During 2022 DanCann Pharma has run a significant number of tests in BP1 in Ansager. At the same time, the Company has optimized every process and system in order to comply with requirements for the production of medical cannabis in Denmark and Europe.  

Now the Company is ready to be inspected from the Danish Medicines Agency in order to be approved according to EU-GMP standards. The approval is expected to be in place in 2022. 

Jeppe Krog Rasmussen CEO of DanCann Pharma, comments: 

- The EU-GMP certification of the facility is a recognition of our work, and an important step on the way to achieving quality assured products for partners, and ultimately for the patients. This is essential for the Company’s legitimacy to the market. Uniform product content and a focus on delivering the same quality from time to time is a guarantee that DanCann Pharma is obliged to give to patients who can benefit from a treatment with medical cannabis and cannabinoids. DanCann Pharma was established to make a difference for patients, and we will never compromise on that. 

BP1 is built on best practices from the pharmaceutical industry in combination with advanced environmentally controlled manufacturing technology and vertical cultivation. Selected genetics are developed in multi-storey systems without the use of soil or other media, but with a specially developed system that adds the required amount of fluid and nutrients.

Jeppe Krog Rasmussen comments: 

- The approval marks a significant and defining path on the journey for DanCann Pharma – something we have been working towards for a long time. DanCann Pharma is on the edge of transforming from a project to an actual operation. We are ready to make a recognizable impact on the medical cannabis markets in Denmark and in Europe.  

Following the approval of the facilities, DanCann Pharma faces its biggest milestone to date when the first batch of biomaterial is ready for delivery in the first half of 2023 from BP1. 

About DanCann Pharma

DanCann Pharma A/S (SS: DANCAN) was founded in 2018 and is a Danish biopharmaceutical Company powered by cannabinoids. DanCann Pharma is a vertically integrated, licensed production and distribution Company based in Denmark. The Company focuses on discovering, developing, manufacturing, and commercializing new therapeutic cannabinoids in a wide range of disease areas.

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

For more information, visit: www.dancann.com  

For further information, please contact:

Jeppe Krog Rasmussen, CEO

E-mail: [email protected]  

Website: www.dancann.com  

Disclaimer

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.