2018 Q2 report, Period April-June for Panion Animal Health AB
Period April-June
- Net sales: kSEK 0 (0).
- Operating profit: kSEK -1 299 (-1 156).
- Earnings per share: SEK -0,08 (-0,21).
- Liquidity at the end of the period: kSEK 15 (796).
Period January-June
- Net sales: kSEK 0 (0).
- Operating profit: kSEK -1 996 (-2 423).
- Earnings per share: SEK -0,08 (-0,21).
- Liquidity at the end of the period: kSEK 15 (796).
Significant events after the end of the period:
Panion’s shares emission that was running from 16-30 May and raised appr. 5.2 MSEK before emission costs, has been completed and all payments processed.
Panion runs a safety study in dogs with the innovative product candidate GC01-canine in cooperation with the University of Copenhagen under the lead of associate professor David Woldbye, Department of Neuroscience. Despite a slight delay in time the study is progressing well, and the animal phase is so far without negative or unforeseen events for all dogs in the study. A report of preliminary results will be released as soon as possible.
Panion has been assigned a Presubmission Conference with the Center for Veterinary Medicines in the US FDA in October, where important discussions will take place about the structure and content of the documentation package for the dog epilepsy product.
About Panion’s epilepsy project
Epilepsy is a serious disease with recurrent seizure attacks and it affects about 1% of all dogs. Millions of family dogs across the world suffer from epileptic seizures and approximately 30% of these are not well controlled with the current medicines. This reduces the quality of life for both the dog and the owner, and such dogs may eventually be euthanized. By combining progress in neurological research with modern gene therapy techniques we want to create a unique new treatment opportunity for dogs. Panion’s exclusive license agreement with CombiGene covers important markets in the USA, Europe and Switzerland.
CEO statement
Sometimes things move really fast and other times we are waiting impatiently for the next step forward. In Panion’s development, it felt as if we had a very busy spring and a slow summer, but we have steadily worked on the progress of our plans in the company.
The new shares emission, which was started to ensure fair opportunity for the existing shareholders, was finalized with good results during this spring. In particular, I welcome that several members of the board and management have entered the list of active shareholders in Panion. Panion’s financial situation is secured for the coming time and we are focusing our minds and efforts on the projects.
When new medicine is invented, developed and getting ready for marketing, the competent medicines authorities will oversee that the quality, safety
and efficacy of a medicinal product is adequate for the use. This is a good thing for all of us as customers to be able to trust the medicines that we take or that we give to our animals. In Europe, the European Medicines Agency is the leading body together with the many national medicines agencies. In the US, FDA has several departments, and veterinary gene therapy belongs to Center for Veterinary Medicines (CVM). Panion’s epilepsy product is a very innovative treatment, and close cooperation with the authorities is necessary for planning and conducting the right type of trials for approval. It is of outmost importance to keep in good contact with the authorities that approve our product in the end; for us to understand their scientific requirements and legal situation and for them to understand our innovation. In Panion, we have had useful exchanges with EMA this spring, which will be incorporated in the development plan. Earlier this year, we opened the application file with FDA and renewed the MUMS (“Minor Use and Minor Species”) status with market exclusivity rights and feewaiver, and we have now been assigned a physical meeting with the CVM-FDA in the autumn. These meetings increase our chances of success and reduce the risk of wasting time and money on irrelevant studies.
During Q2, we have worked hard on progressing the development of our epilepsy project for dogs. The new safety study in dogs has been running at the University of Copenhagen and we are eagerly waiting for the outcomes. These will be released as soon as possible, because we know that our investors are as interested as we are. The next step in the product development of the gene therapy for epileptic dogs will be the pilot study in privately owned dogs, which we intend to conduct in specialized clinics in North America.
We have followed the successful progress of our licensing company, CombiGene, in the recent period. We are overly exited about their elegant and robust studies, which are directly relevant for Panion, and over the unusually strong financial support of 3.36 million Euro that they received from the EU in the Horizon 2020 program. This truly is a stamp of confidence in gene therapy for epilepsy.
It is Panion’s firm ambition to extend our product portfolio and we are investigating several options of potential inlicensing opportunities, to select promising candidates. We will continue to inform about the progress and development as early as possible. I encourage you to read more details about our business on the website and to visit the two most recent video/webcast presentations from Malmö and Aarhus, respectively.
Finally, I wish to say a great thanks to all our interested investors for your continued support!
Anja Holm,
CEO, Panion Animal Health AB
Anja E. H. Holm, CEO
+ 45-22 94 66 00
anja.holm@panion-animalhealth.com
Bolaget ska utveckla och kommersialisera genterapi för behandling av epilepsiliknande tillstånd hos hundar och andra djur, samt utveckla och kommersialisera andra veterinärmedicinska produkter och nya behandlingsformer som kan ge sjuka djur bättre livskvalitet.
Panion will develop and commercialize a gene therapy treatment for dogs with drug refractory epilepsy, and other new animal health products and treatments that improve the quality of life for animals suffering from chronic diseases.