1st Quarter 2022

Torbjörn CEO
During the first quarter of the year, we took important steps in the work of further developing and optimizing the formulations of our two main projects, Amp01 and Empli03, where we follow the plan that we presented in connection with the IPO.

Within Amp01, our consumer project with nicotine products, we have both developed different taste formulations, evaluated various alternatives for production on a larger scale, and filed a new patent application.

Accompanied by previous development of a suitable bio ceramic with release profiles for nicotine, this means that we are moving ever closer to a finished product profile.

Amplicon will premiere two products with different taste formulations already at the international Global Forum on Nicotine in Warsaw in June this year. In parallel with product development, the discussions on outlicensing continue with a number of stakeholders.

Within Empli03, our drug candidate for chronic pain, we have completed the final formulation to be used in the clinical study during the quarter.

In addition, we have successfully transferred the manufacturing method to Quotient Sciences in the UK, which is our partner for the manufacture of the tablets to be evaluated in the clinical study. This transfer was an important milestone for the clinical study. We have also developed and documented methods in production and analysis for Empli03.

Developments in both our operations continuously show that one of the absolute strengths of our patented bioceramics is the way we can create, modulate, direct and control different release profiles.

In common of Amp01 and Empli03 is that they are being developed on Emplior, our patented bioceramic platform for oral products. The fact that the products are developed on a common platform gives us synergy effects in both product development and in IP, as we can use our progress to develop IP in more product areas.

Additionally, developing products within two operations also means that we will have more business opportunities as well as risk diversification, both in terms of development and commercialization.

Amp01

Amp01 is a dry nicotine formulation with unique release profiles of nicotine and flavorings. The formulation will be packaged in conventional pouches for nicotine products and is intended for the consumer market. It can also be further developed into a new nicotine replacement product.

White oral nicotine has an annual turnover of just over USD 2 billion in a global market. The market is in its infancy and is expected to grow annually by more than 50 percent, and have sales of more than USD 20 billion in 2025.

The development towards the finished product is done within Amplicon AB. Our goal is to be able to offer a product with a better customer experience through a significantly longer release of both nicotine and taste than what is on the market today.

During the first quarter and together with partners, we have developed the flavors that will be included in the final product, and carried out pilot projects regarding production methods and machine packaging in various types of pouches on a larger scale. An additional patent application was completed during the quarter and filed on April 1.

The Amp01 project is based on own nicotinespecific patents. We drive innovation in-house by developing a product ready for large-scale production and commercialization as a consumer product. In parallel, discussions are being held on outlicensing agreements.

Empli03

Empli03 is a buccal tablet (a tablet that is placed under the lip) and is being developed for treatment of chronic pain. It contains the active substance buprenorphine, which is a milder opioid. Chronic pain is a large and growing market, with a clear medical need; one in five people is affected by chronic pain in some form. In the USA, this corresponds to about 67 million people. The market for opioid drugs for chronic pain is expected to grow to USD 5.5 billion by 2025, in the G7 countries alone.

With Empli03, we see the opportunity of being able to offer the patient a new product for chronic pain. It has a fast initial release of buprenorphine, making the patient pain free, which is followed by a slower phase that ensures relief. The goal is to develop a product that enables individualized patient-controlled treatment of chronic pain. Empli03 also has properties that reduce the risk that the opioid can be abused.

Emplicure has developed and documented the formulation to be used in the clinical study with Empli03. The study is a pharmacokinetic study in which the concentration of buprenorphine is measured in the blood of a small number of healthy volunteers. The aim of the study is, in part, pharmacokinetic documentation of Empli03, but also documentation of the Emplior platform in humans.

We believe we will be able to present results from the clinical study during the fall this year. The results will be used as a basis for a regulatory consultation with the FDA and for business contacts regarding both Empli03 and the Emplior platform.

In parallel with the preparations for the clinical study, there is ongoing planning of initial discussions on licensing and cooperation agreements.

Patents

During the quarter, we received prior information about several patent approvals for the Emplihale platform regarding inhalation of drugs and nicotine. This gives additional strength to our project portfolio and our upcoming projects. We believe that our IP protection is strong, and that we thereby will have good prerequisites in discussions with potential licensees and other business partners.

Financing

At the same time as this report is released, the implementation of warrants series TO1 is in progress, with a measurement period between April 12 and April 27, and a subscription period between April 29 and May 13.

In connection with the listing on Nasdaq First North last summer, the company raised SEK 40 million in an oversubscribed unit issue to take Empli03 through a clinical study and to develop Amplicon and the organization.

The company is delivering on this and is now obtaining financing through subscription warrants of the TO1 series to accelerate the development of Empli03, to continue the completion of Amp01 to create a finished product, to drive business development, and to continue developing our portfolio with projects within the two operations pharmaceutical development and consumer products.

We look forward to a year full of progress where we will continue to develop our products quickly and resolutely, and deliver on the trust given to us by our shareholders.

Torbjörn W. Larsson
CEO

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