2018 Q1 report, Period January-March for Panion Animal Health AB

Period January-March

• Net sales: kSEK 0 (0). 
• Operating profit: kSEK -697 (-1 267).
• Earnings per share: SEK -0,05 (-0,11).
• Liquidity at the end of the period: kSEK 2 708 (102).

Significant events after the end of the period:

• On April 25, 2018, the annual report was published.
• On May 4, 2018, the board of Panion decided to start a new emission of shares. Terms and conditions can be seen on Panion’s website.

Milestones January-March 2018 

• On January 3, 2018, Panion entered into a financing agreement with the Yorkville Advisory Global Yorkville (Yorkville). As investment manager, and on behalf of one or more of its investment funds, Yorkville decided to purchase convertible debentures up to SEK 9,000,000 by Panion Animal Health AB.
• On January 3, Panion entered into a financing agreement with Dividend Sweden, which has decided to purchase convertible debentures of SEK 500,000 by Panion Animal Health AB.
• On January 3, it was also announced that the FDA has established an investigative veterinary drug application (INAD) for Panion’s development product for gene therapy for dog epilepsy.
• On January 19, Panion’s head of regulatory affairs, Niels-Erik Manniche, decided to leave the company. He was available to the company until March 31st. His duties are covered internally until further notice.
• On February 16, 2018, we announced that an international study that is independent of Panion’s and CombiGenes’s research, but which uses the same neuropeptide NPY for the treatment of rats with chronic and generalized epilepsy, was published online. The study shows both reduced number and duration of seizure in rats and increases the knowledge of NPY’s effect in different brain regions.
• On February 19, 2018, final data from CombiGene’s long-term rat study show clearly positive effects in terms of fewer and shorter attacks. This is directly relevant to the development of Panion’s gene therapy product for dogs.
• On March 6, CEO Anja Holm presented Panion’s plans, progress, and future for Feminvest investors at an event in Malmö. A video link in English is available on our website.
• On March 13, we announced the cooperation with biostatistician Steve Radecki (USA) with regards to the coming clinical study in dogs with epilepsy.
• On March 14, 2018, the first conversion of Yorkville’s convertible debentures to shares took place. Panion Animal Health AB’s Board of Directors has, under the terms of the Panion financing arrangement and an investment fund managed by Yorkville Advisors Global announced on January 9, 2018, decided to approve Yorkville’s request to convert a share of SEK 200,000 of the convertible debt securities to shares.
• In Q1, the planned safety study in dogs was started in cooperation with Copenhagen University and under the lead of Associate Professor David Woldbye, Department of Neuroscience, KU. The announcement of the start of the study was released on April 25.
• The preparations for a pilot field trial in the USA continued with the assistance of the US consultants and investigator.

CEO statement

CEO statement Panion’s business and product development would not be possible without the support of all our investors and cooperation partners, so first I wish to send out a grateful thanks to you!

The first quarter of 2018 in Panion has been dedicated to two intensive and important issues; the start of a dog study, and the financial structure for future business and trials.

The dog study was planned and is running under the lead of Associate Professor David Woldbye from the University of Copenhagen, Department of Neuroscience. It will lead us to a better understanding of the safety of the vector, secure the data we need in terms of vector behavior, and hopefully help to expand the potential patient base for the product in the longer run. The results are expected to be released in Q3 of this year.

For a small company, it is essential that there is a robust financial underpinning of the future plans before contracts can be signed with researchers and other businesses. Panion’s chairman of the board has secured a future-based solution, so the next steps in our product development can be started. Running a clinical trial, even a smaller version of a clinical trial engaging client-owned animals in the study, is a major undertaking and we want to ensure that we succeed in the best possible way.

Panion’s epilepsy product is a very innovative treatment, and close cooperation with the regulatory authorities is necessary. We are therefore very pleased that the European Medicines Agency has invited us to a meeting with their Innovation Task Force. The meeting will create a possibility for their scientific and regulatory experts to learn about our project, and for us to ask their view on some of the steps in the development plan. We hope to benefit a lot from this meeting, and we are sure that it will increase the regulators understanding of the technology and the prospects we see in it.

Epilepsy in dogs is a serious disease that affects millions of family dogs across the world and for which medicine is not effective in approximately 30% of cases. The prospect of treating epilepsy – and other chronic diseases in animals – with gene therapy is very promising and we continue to work hard to realize the potential.

It is Panion’s ambition to extend our product portfolio and we will continue our search for a promising and accessible product candidate in the coming time. The biotech world is booming again after the difficult years with the financial crisis and we hope to lift the potential of an interesting human project over to the veterinary field and develop it for the benefit of the animals.

We will continue to inform about the progress and development as early as possible and within the framework of the stock market. I encourage you to follow our news and read more details about Panion on our website in both Swedish and English.

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.