N E W S F R O M CO M B I G E N E A B
NUMBER 3 • 2018
CombiGene – World-leading Swedish gene-therapy company EDITORIAL: Preference issue................................................ page 2 Preference issue................................................ page 2 CombiGene seeks project manager.............. page2 Dynamic development in gene therapy..... page 3 Sign up for our newsletter.............................. page 3
The Board of Directors of CombiGene AB (publ) has prepared a prospectus in relation to a new issue. This prospectus has been prepared in accordance with the Swedish Financial Instruments Trading Act (1991:980), Directive 2003/71/EC of the European Parliament and Commission Regulation (EC) No 809/2004. This prospectus has been approved by, and registered with, Finansinspektionen (Sweden’s financial supervisory authority) in accordance with chapter 2, sections 25 and 26 of the Financial Instruments Trading Act (SFS 1991:980). Please note that this document is only a brief excerpt from the prospectus and that every decision to invest in CombiGene must be based on the information contained in the prospectus in its entirety. The prospectus is available at www.combigene.com and at www.fi.se (avaible only in Swedish). The prospectus can also be obtained, free of charge, from CombiGene AB (publ), Medicon Village, 223 81 Lund, Sweden. Enquiries concerning the issue and payment may be directed to Hagberg & Aneborn Fondkommission AB, telephone +46 (0)8 408 933 50.
This newsletter has been produced by CombiGene AB
2018-09
The future has never been closer Gene therapy is currently one of the most exciting areas of pharmaceuticals development. Leading researchers and scientists the world over are committed to fulfilling the promise that gene therapy can radically improve the quality of life for millions of people. Early in 2018 more than 300 clinical studies in gene therapy were conducted and gene therapy projects attracted some USD 3.1 billion in global investment during the first quarter of this year. (source: Alliance for Regenerative Medicine. That the field is also attracting attention in Sweden was evidenced by a gene therapy seminar that was held at Almedalen this summer. This dynamic research and development environment is home to CombiGene, Sweden’s only listed gene therapy company. During 2016 and 2017 we conducted three important preclinical studies. All three studies were carried out according to the original schedule and delivered, or exceeded, the expected results. These successes have not gone unnoticed. In 2017 Horizon 2020 (the EU framework programme for research and development) awarded CombiGene a Seal of Excellence, and in May of this year Horizon 2020 announced that it would invest 3.36 million euros in the development and commercialization of our gene therapy project. Prior to the Horizon 2020 decision to support CombiGene we had signed an agreement for development with the British organization CGT Catapult. This also bears testament to the high quality of CombiGene’s work. For me personally, the announcement of funding from Horizon 2020 and the agreement with CGT Catapult are two highlights of my long career within the Swedish and international pharma industry. CombiGene must meet several conditions before the funds from Horizon 2020 can be disbursed. Among other things, we must secure part-funding amounting to 30 percent of the cost of the project. Securing this part-funding is the reason for the recently announced preference issue. With the capital from Horizon 2020 and a fully-subscribed preference issue, we can continue our project and business development with full force. During 2018, together with CGT Catapult, we will pursue process development for our candidate drug, CG01, in order to begin the obligatory biodistribution and toxicity studies during 2019. This means that CombiGene can now take the leap from medical research to drug development. The future has never been closer! Jan Nilsson, CEO, CombiGene
EDITORIAL STAFF Contact: redaktionen@combigene.com Legally responsible publisher: Jan Nilsson Production: Wiberg & Co Reklambyrå. Text: Michael Vallinder English translation: Mark Wilcox CombiGene AB (publ) Medicon Village, SE-223 81 Lund, Sweden info@combigene.com The company is listed on Spotlight Stock Market (formerly AktieTorget). Please read our press releases and newsletters, available on our website.
www.combigene.com
This newsletter has been produced by CombiGene AB
COMBIGENE’S EPILEPSY PROJECT
A fully-subscribed preference issue will create the conditions for advanced pharmaceutical development During the period 4-18 September 2018 CombiGene will carry out a preferential rights issue which, if fully subscribed, will raise about 31 million kronor in issue capital before issuing expenses. The issue is guaranteed to about 75 percent. Funding amounting to 3.36 million euros from Horizon 2020 (the EU framework programme for research and development), together with the capital raised from the rights issue, if fully subscribed, will strengthen CombiGene’s financial position and enable the company to bring the CG01 epilepsy project to the clinical-studies stage. CombiGene can thereby take the leap from medical research to advanced drug development. Thanks to the capital injection from Horizon 2020 and a fully-subscribed rights issue, CombiGene will be able to carry the epilepsy project forward with full force while at the same time actively developing the business with an aim to adding at least one more gene therapy project to the company’s portfolio. Our objectives for 2018 and 2019 are as follows:
Objectives for the second half of 2018 • Pursue process development for CG01. • Business development with an aim to adding further gene therapy projects. • Participate in a partnering conference with an aim to maintaining established contacts and building new relations with potential partners.
Objectives 2019 • Production of material for the necessary biodistribution and toxicity studies. • Initiate biodistribution and toxicity studies. • Business development with an aim to adding further gene therapy projects.
CombiGene can take the decisive leap from medical research to drug development.
Facts about Horizon 2020 and CombiGene • Horizon 2020 is the EU’s biggest-ever programme, with nearly 80 billion euros in funding available for the period 2014 to 2020. • In July 2017 CombiGene was awarded a Seal of Excellence by Horizon 2020. • The Seal of Excellence is a mark of quality for excellent innovations that are promising investments. • In May 2018 Horizon 2020 decided to contribute 3.36 million euros towards development of CombiGene’s gene therapy for difficult-to-treat epilepsy.
• CombiGene must meet several terms before the funds can be paid out. Among other things, we must secure our own part-funding of the project amounting to 30 percent of the cost of the project. • I f fully subscribed, the rights issue that CombiGene is carrying out in September 2018 will help the company to secure part-funding with a broad margin. • The official starting state for the project, which is expected to take three years, is 1 August 2018.
2018-09
COMBIGENE SEEKS PROJECT MANAGER
Advanced drug development requires a strong organization ▪ Since CombiGene is now taking the decisive step from medical research research to advanced drug development, the company now faces new and higher demands with respect to project management capabilities. CombiGene is therefore seeking an experienced, dynamic and committed senior project manager. The successful candidate has solid experience in project management, a good knowledge of drug development and, preferably,
experience in process development of production processes and the gene therapy field. A small company like CombiGene needs someone who is prepared to work very hard. In addition to project management, tasks will include production of study documentation, procurement of services and realization of scientific activities. Work will be conducted in close collaboration with other company employees, including the CEO. More information is available on CombiGene’s website. http://combigene.com/senior-projectmanager-pre-clinical/
Gene therapy continues to maintain a strong position as one of the pharma industry’s most interesting fields of development ▪ Gene therapy has been an interesting field of research for many years. Gene therapy reached a decisive milestone in 2017, when the US Food and Drug Administration (FDA) approved the first gene therapy for clinical treatment of acute lymphoblastic leukaemia. In terms of research results, clinical studies and commercial activity, we are now witnessing rapid development in
gene therapy. Earlier this year, AbbVie, a large pharma company, announced that it would enter into a strategic collaboration and development agreement with Voyager Therapeutics, a deal which is estimated to be in the region of one billion USD. The agreement concerns gene therapy candidates for treating Alzheimer’s disease that are, like CombiGene’s CG01candidate, treatments based on adeno-associated viral (AAV) vectors. Recently, several other exciting gene-therapy news items have appea-
red. Pfizer announced that it had begun a phase-III study for gene therapy treatment of haemophilia, and Boehringer Ingelheim has partnered with Oxford BioMedica for manufacturing and commercialization of a cystic fibrosis gene therapy. During the first quarter of 2018 global investment in gene therapy amounted to 3.1 billion USD, which means that we will continue to see very dynamic growth in the industry.
Read all of our news in one place We would like to keep you well informed about what is happening in the company. Therefore, we are now launching CombiGene’s digital newsletter to allow you to read all of our news first-hand. Subscribe via our website, where you can register the e-mail address to which you wish the newsletter to be sent. Use the link ”Subscribe to our newsletter” at the top-right corner of the page. The subscription is free of charge and you can cancel it whenever you please. Read ”More from the company” and our Press Releases at: www.combigene.com
Sign up here! http://combigene.com/ anmalan-nyhetsbrev/
Famous people with epilepsy That epilepsy is a serious disease is well known. There are numerous examples of famous people who were sufferers of epilepsy and left their mark on history. These historical figures include Greek philosopher Socrates, ruler Alexander the Great, Roman emperor Julius Caesar and artist Michelangelo. The famous Italian sculptor, architect, painter and poet Michelangelo di Lodovico Buonarroti Simoni, better known as Michelangelo, was born 6 March 1475 in Caprese, north of Arezzo, in present-day Italy and died on 18 February 1564 in Rome. He lived and worked in Florence and Rome during the Renaissance. Source: https://sv.wikipedia.org/wiki/Michelangelo
This newsletter has been produced by CombiGene AB
2018-09
For many sufferers, there is no help – yet. We hope to change this. We are in the process of developing a world-leading method for treating epilepsy. The potential is enormous, the outlook is good. For very many people.
The gene therapy explorer CombiGene’s objective is to develop treatment methods that can improve the quality of life for millions of people throughout the world.
www.combigene.com