4th Quarter 2021

Torbjörn CEO

The activities of the last quarter followed the path of foundation and growth.

We signed an agreement with Quotient Sciences, UK. Quotient will be responsible for the manufacturing and will also perform the first pharmacokinetic study of Empli03, our drug candidate for chronic pain.

To choose partner for manufacturing and clinical trials is a complex and critical process, especially when working with opioids. It is partly a question of ensuring that all national and international permits and approvals are in place and that there is a guar- anteed logistics around the whole. It is also about finding each other in the business arrangement with time axes, division of responsibilities and remuneration models, and I am glad we now have a good partner in Quotient.

Empli03 has a very interesting release profile and is judged to be able to fill a large medical need. The tablet provides an immediate release of active substance to make the patient pain-free and then a significantly lower, but constant and stable release over time for individual pain relief.

Within Amp01, our consumer project with tobacco- free nicotine for oral use, discussions are ongoing in different phases with potential licensing partners and takers. In parallel with these, we are simultaneously driving the development of Amp01 further towards a finished product and according to a developed product profile. The development work is carried out with both own staff and external consultants. Continuing to drive the development and completion of a product gives it a higher commercial value while providing a clearer profile of what a partner can expect. It is essential that we constantly move forwards and upwards in this value chain.

As I mentioned in the previous report, we then started the recruitment process of another full-time resource to strengthen the development side within Amp01. Glebs Kiselovs has now been in place for some weeks and he is working full-time to take Amp01 further towards a finished product.

At the end of the year, our CFO Anna-Lena Nicolson chose to end her assignment. She made a comprehensive and valuable contribution with us, especially in connection with our IPO and we thank her for the work she has done.

Erik Magnusson took over as new CFO on 1 January. Erik has more than 25 years of combined experience in financial planning, financial management and Investor Relations, with finance and management roles within Systembolaget, Aleris and Coop, among others. He also has a background as a financial analyst, including at ABG Sundal Collier, where he covered the Nordic medtech and healthcare sectors.

In 2021, Emplicure hired a total of six new employees, which can be a challenge for the team dynamics in a smaller organization. These recruitments are now in place and I note with satisfaction that the organization acts as a unit. The work is focused on documentation of the drug for the clinical study as well as the development of a tobacco-free oral nicotine product.

In December, we received the formal approval of a US patent for inhalation of medicines. The US is an important market for us and inhalation is one of the three platforms we currently use in our development projects. The patent strengthens our ability to develop and commercialize new unique and patent-protected products for inhalation.

2021 is already history. In 2022, we will conduct our first clinical study in Empli03 and we are driving Amp01 forward. I look forward to another exciting year and to communicating our news.

Torbjörn W. Larsson


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