Fourth quarter October – December 2018

• Nets sales: TSEK 0 (0).
• Profit from financial items: TSEK -3,159 (-3,294).
• Earnings per share: SEK -0.06 (-0.20)

Period January to December 2018

• Nets sales: TSEK 8 (3,000).
• Profit from financial items: TSEK -13,146 (-8,958)
• Earnings per share: SEK -0.25 (-0.54)
• Liquidity as per the end of the reporting period: TSEK 31,806 (4,918)
• Equity/assets ratio as per the end of the reporting period: 58 (80) %

Operations during the fourth quarter of 2018

• An extraordinary meeting of shareholders approves terms for the preference issue.
• CombiGene is approved for listing on Nasdaq First North Stockholm, with the first day of trading set to 19 December 2018.
• CombiGene is recognized in an article in Nature, one of the world’s foremost scientific periodicals.

Significant events after the end of the reporting period

• CombiGene strengthens its management team Anna Jönsson appointed CFO

A word from the CEO
In summarizing the events of the past year we are pleased to report that 2018 was a very successful year for CombiGene. Among the major milestones reached during the year are, above all, our collaboration with British CGT Catapult, the capital contribution from Horizon 2020 and the successful rights issue conducted during the autumn of 2018. Funding from Horizon 2020 and proceeds from the preference issue have made it possible for CombiGene to enter a new and more offensive phase.

Strong financial position – a stronger company
Funding from Horizon 2020 amounting to €3.36 million, and the preferential rights issue, which raised 31 million kronor in issue capital before issuing expenses, mean that CombiGene can proceed on the offensive as never before. Two important recruitments were made during the year: Karin Agerman, who is our Chief Research and Development Officer, and Annika Ericsson, Senior Project Manager. Anna Jönsson was employed as CombiGene’s Chief Financial Officer in early 2019. With these recruitments, we have created a platform upon which we have both the resources and the expertise to drive our important CG01 epilepsy project with full forces while at the same time pursuing expansive business development with the long-term ambition of broadening our business with additional gene therapy projects.

International recognition necessitates a new trading platform
CombiGene is active in one of the most dynamic fields of global pharmaceutical development and the company’s epilepsy project is now in a very interesting phase of development. As our epilepsy project has advanced, international interest in CombiGene has increased. Very clear confirmation of this was given by the article on gene therapy and CombiGene’s operations that was published in the very highly regarded scientific periodical Nature. What pleases me most about the article in Nature is that it shows how great an interest there is in gene therapy and – not least – what an impact CombiGene and our research have started to make internationally. The growing international interest in CombiGene is also the reason we have changed the trading platform for our share during the quarter from SPOTLIGHT to Nasdaq First North, which is an internationally more well-known marketplace.

Intensive process development in the epilepsy project
I was very pleased when we signed the agreement with CGT Catapult and our collaboration has proceeded exactly as I had hoped it would. Catapult is a British organization that has amassed a considerable amount of international talent. This international expertise is very valuable, since it means that we in the project team gain access not only to the very best scientific quality, but also that the team has very considerable international contacts and experience. The project is now in a very intensive phase of process development and is making preparations for the toxicology and biodistribution studies.

CombiGene’s business development
CombiGene’s business development strategy is twofold. While we are actively seeking interesting new gene therapy projects that match CombiGene’s business, for several years we have also been working continuously to establish new contacts in the international pharma industry in order to pave the way for future collaboration. These dialogues are ongoing and take place at different types of conferences; for example, at BIO-Europe in Copenhagen in November last year, where we held several partnering meetings.

During 2018 we identified several academic groups that are working with gene therapy solutions which, in the long term, could prove interesting for us. However, it is too soon to say with any certainty exactly when any possible collaboration will be initiated.

Looking ahead
Our development of a manufacturing method in collaboration with CGT Catapult is a time-consuming process, but we will reach several definitive milestones in the project during 2019, among others, the biodistribution and toxicity studies that we plan to initiate later in the year. We will not be able to present project milestones as frequently as we have during 2017/2018, but that by no means implies that the pace of development is slowing down. On the contrary; with capital from the preference issue and Horizon 2020, CombiGene is very well equipped to pursue the project with full force.

Jan Nilsson
CEO