CEO comments on the full year of 2023

2023 has been a transformative year for SmartCella. We have strengthened the organization, most recently with the addition of Nina Bauer as Chief Business Officer and Head of Smartwise, as well as delivered on critical milestones for the company, such as successfully completing the so called GLP Tox study, securing a GMP approval of our clean room and reaching the first commercial licensing agreement on the Extroducer.

You will find more information about each of these milestones below, but in summary, we are very well positioned moving into 2024 with a top team, critical infrastructure and capabilities in place, as well as a proven pipeline of projects that are generating revenue and has great potential to create value for both shareholders and patients in need. I could not be more excited about both what we have achieved and the potential ahead of us!

Procella took major steps in 2023 by completing the required GLP Tox animal study which is part of the development of our heart cells and a prerequisite to start Phase 1 clinical studies (ie in humans). On top of that, we got our GMP manufacturing license from the Swedish Medical Products Agency (Läkemedelsverket), which allows us to start clinical production of heart cells to be used in humans. This is a major achievement, accomplished in record time, and means we now have one of the top facilities in Europe up and running with production of cells for human use.

With those milestones reached, we are now, together with AstraZeneca, gearing up to start production for the planned Phase I clinical trial in patients with heart failure. To be able to restore a damaged heart muscle following a heart attack, and thereby improve the symptoms of heart failure, is both an important development for patients suffering from this debilitating condition, and a highly attractive market given the large number of patients worldwide. It also decreases the costs and suffering associated with heart failure. In parallel, we are in the final stages of bringing in a promising project around dopamine producing cells to treat Parkinson’s Disease. This would expand our pipeline of cell therapies with a very attractive and high potential project, and further strengthen our position as one of the key global players in stem cell therapy development and manufacturing.

Smartwise took an important leap in the end of 2023 when the terms for the first global commercial licensing deal on the Extroducer delivery technology was agreed with a US biotech company. Besides having significant long-term financial potential and providing short-term revenue, it is an important benchmark deal in the market and gives us great confidence in both ongoing dialogues and in the business development efforts that we are now ramping up. The collaborations we have had so far have generated very positive data for both us and our customers, and we look forward to expanding the pipeline of potential licensing partners and signing additional deals in 2024.

Smartwise has also progressed very well with our own study on patients with inoperable pancreatic tumours. In this clinical phase I/II trial, we will use an old chemotherapy drug that is effective at killing cancer cells but has a lot of systemic side effects when administered in the traditional way which limits the efficacy significantly. The theory is that by administering it directly into the tumour, we will be able to improve the efficacy, while avoiding the systemic side effects, and thus give new hope to patients that today have very few options. The study will start mid-year and we expect to have both our own and partner driven clinical trials in humans with the Extroducer initiated in 2024.

In SmartCella Solutions, the development of a cell mediated delivery platform has continued and shown very encouraging data in animal studies. As new mRNA therapies are being developed, one of the constant challenges facing biotech and big pharma companies active in this exciting field of research is how to make the mRNA get to and survive in the organ it is intended to reach and produce enough of the intended protein to have the desired effect. The problem they face, besides the actual delivery to the target organ, is that the immune system attacks and kills the foreign mRNA before it has produced enough protein. Our data shows that with our cell mediated delivery platform, we can protect the mRNA from attack by the immune system inside a stem cell and thus produce both much higher volumes of proteins and over a longer period of time. With the data that has now been generated, we feel excited about approaching potential partners regarding research collaborations around their therapies. We are also progressing our own therapies based on this delivery technology and in December, we initiated animal studies to build our proprietary pipeline of therapeutic projects utilizing the cell mediated delivery of mRNA technology.

Our financial position remains strong, and we are very much looking forward to continuing to build shareholder value in 2024 by delivering on our key milestones and securing more commercial licensing deals on the Extroducer. And simultaneously, bring the magic behind SmartCella’s world-class medical science to patients in need and ultimately transform lives. Thanks for your trust and support!