2018 Q4 report, Period October-December
Period October-December
- Net sales: kSEK 0 (0)
- Operating profit: kSEK -2 184 (-854)
- Earnings per share: SEK -0,10 (-0,06)
- Liquidity at the end of the period: kSEK 306 (2 124)
Period January-December
- Net sales: kSEK 0 (0)
- Operating profit: kSEK -4 716 (-4 200)
- Earnings per share: SEK -0,25 (-0,32)
- Liquidity at the end of the period: kSEK 306 (2 124)
CEO statement
Panion’s epilepsy project for dogs has taken some big steps forward and I want to start with thanking all our investors for their support and trust in our idea.
During the year, the new clinical safety study in dogs was finalized successfully at the University of Copenhagen, and the results have been released. It was encouraging to see that all the treated dogs were without observable adverse reactions. A few of the microscopic analyses of tissue and vector expression are still being worked on, and the final report is awaited from the researchers, but these last analyses are more of academic interest than of importance to Panion’s project.
The pre-submission meeting with the US-FDA in Maryland/Washington DC was a major milestone achieved this year. Panion’s gene therapy product against epilepsy was presented for authority reviewers from FDA. We had prepared and submitted a long document to the FDA including a list of questions that we wanted to get the reviewers feedback on. The answers will help us make the development plan as concrete as possible, including getting a firmer estimate of the development costs and timelines.
The most important milestone this year was the starting of the clinical pilot-study in privately owned dogs with drug-refractory epilepsy in a large veterinary clinic in New York. It is an impressive specialist veterinary clinic with full equipment and highly skilled staff, including veterinary neurosurgeons and neurologists. The study is officially started and the screening for patients to be enrolled ongoing. Each dog must first be screened over a number of weeks to document its type and frequency of epilepsy, before the treatment with Panion’s gene therapy takes place, followed by the period of monitoring for efficacy, i.e. reduced epilepsy. We are overly excited to learn the first results of how the product works in real epileptic cases.
The information from the pilot-study will direct us towards the next step of a regulatory safety study and if the efficacy from the pilot study is good, these two studies may be sufficient to get a so-called conditional approval in USA. This would mean that we can start to sell the product, while we collect data for the pivotal regulatory clinical efficacy study, which is needed for a full approval.
The latest share emission in December 2018 was not very successful, and we must admit that it was probably a wrong timing for an emission just before Christmas. Other sources of financing are identified and pursued in the short horizon.
However, in February we have been invited to present Panion at a large investor forum in London, Animal Health Investment – Europe. Here all the large companies and many animal health investors are present and will hear about our plans and good development over the last 2 years. We hope that options and connections for good future cooperation will result from this meeting.
It is Panion’s firm ambition to extend our product portfolio and we are investigating several options of potential in-licensing 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.
Thank you very much for your interest.
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.