2018 Q3 report, Period July-September for Panion Animal Health AB
Period July-September
- Net sales: kSEK 0 (0).
- Operating profit: kSEK -536 (-923).
- Earnings per share: SEK -0,03 (-0,25).
- Liquidity at the end of the period: kSEK 1 987 (1 166).
Period January-September
- Net sales: kSEK 0 (0).
- Operating profit: kSEK -2 532 (-3 501).
- Earnings per share: SEK -0,03 (-0,25).
- Liquidity at the end of the period: kSEK 1 987 (1 166).
Significant events after the end of the period:
Panion held a Presubmission Conference with the Center for Veterinary Medicines in the US FDA in October 2018, week 43, where important discussions took place about the structure and content of the documentation package for the dog epilepsy product. The innovative gene therapy product was presented for authority reviewers from both FDA and other authority centers, who gave their views on the project and asked questions. From Panion, three persons participated in person; regulatory FDA-expert Dave Petrick, Director of Business Development Carlos N. Velez, and CEO, DVM Anja Holm. In addition, the FDA project manager had established a telephone connection to two of Panion’s scientific experts, so they could listen in and answer specific questions.
Panion is also progressing the next step in the development plan after the recently finalized safety study in dogs; a pilot study in family dogs with true drug-refractory epilepsy, and in the same week, meetings were held at the investigator clinic concerning details of the study plan, roles, responsibilities, and timelines.
In the end of October 2018, a new CFO for Panion, Katarina Holm from Lund in Sweden, will take over from Sofia Josephson, who has accepted a new job. The transfer is well planned and will take place in smooth cooperation.
CEO statement
Panion’s epilepsy project for dogs is moving steadily forward and I want to start with thanking all our investors for their support and trust in our idea. During the year, we have worked hard on progressing the development of our gene therapy product for dogs. I am proud to say that the new clinical safety study in dogs has been finalized successfully at the University of Copenhagen, and the first preliminary results have been released. It was encouraging to see that all the treated dogs were without observable adverse reactions. Neurological examination of the dogs before and after the treatment showed no related changes, and the dogs exhibited ordinary behavior shortly after the gene therapy treatment procedure. At the time of writing, we are still analyzing samples and data from the study and compiling it all into a final study report. The final report and all the data behind will be an important piece in the puzzle that we assemble and submit to the registration authorities for getting a market authorization and permission to sell the product.
In week 43, 2018, Panion was invited to a meeting with the US-FDA in Maryland/Washington DC where the development product was presented for authority reviewers from both FDA and USDA. From Panion, three persons participated in person; regulatory FDA-expert Dave Petrick, Director of Business Development Carlos N. Velez, and CEO, DVM Anja Holm. In addition, the FDA project manager had accepted to establish a telephone connection to two of Panion’s scientific experts, so they could listen in and answer specific questions. We are really excited that this important meeting has taking place now. A presubmission meeting with the authorities, who will evaluate the application in the end, is of utmost importance. We had prepared and submitted a long document to the FDA including a list of questions that we wanted to get the reviewers feed-back on. The answers given will help us make the development plan as concrete as possible, including getting a firmer estimate of the development costs and timelines.
The next step in the product development will be the pilot study in privately owned dogs with drug-refractory epilepsy, which we intend to conduct in a specialized clinic in North America. We have established a good cooperation with a specialist veterinary clinic with full equipment and highly skilled staff, including veterinary neurosurgeons and neurologists. The experts at the clinic are very interested in our innovative treatment for this group of dogs that are currently lacking good treatment options, and they seem optimistic with regards to the speed of enrollment in the study, which is very encouraging for us. We aim at good progress in the pilot-study and expect to send out further details when results start to emerge.
We have followed the successful progress in manufacture development, which is directly relevant for Panion, and with the unusually strong financial support of 3.36 million Euro that they received from the EU in the Horizon 2020 program earlier this year. 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 and to visit the two most recent video/webcast presentations from Malmö and Aarhus, respectively. 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.