2017 Q3 report, July-September for Panion Animal Health AB

Period July-September

  • Net sales: kSEK 0 (0)
  • Operating profit: kSEK -923 (-43)
  • Earnings per share: SEK -0,25 (-0,01)
  • Liquidity at the end of the period: kSEK 1 166 (541)

Period January-Sept

  • Net sales: kSEK 0 (0).
  • Operating profit: kSEK -3 501 (-43)
  • Earnings per share: SEK -0,25 (-0,01)
  • Liquidity at the end of the period: kSEK 1 166 (541)

Milestones July-September 2017

  • Panion’s business and structure was approved by AktieTorget on the 3.rd of July and the shares could then be listed on the MTF under the name “Panion”. First trading day was the 6.th of July 2017.
  • The license agreement with CombiGene was clarified and re-signed on the 3rd of July, specifically regarding the compensation that Panion will receive in case CombiGene would need to withdraw the license.
  • A successful MUMS status and the connected fee waiver was received from the US FDA in September. This means that Panion will not have to pay the large annual fee for its application in the USA, which helps the development of our lead product candidate, CG01-canine.
  • An agreement was reached with Copenhagen University for use of the data from a very relevant safety study in dogs conducted with the gene therapy vectors.
  • The confidentiality agreement with the preferred clinical investigator with special expertise in canine epilepsy has been signed in July and the preparations for a trial initiated.
  • The Letter of Intent with GeneQuine Biotherapeutics GmbH was extended to the end of this year to facilitate a robust review and the dialogue has been continued

Significant events after the end of the period:

  • Animal Pharm magazine (Informa) published an article about Panion: “MUMS designation for Panion’s gene therapy takes it to forefront of innovation in pet epilepsy”. A link can be found on Panion’s website.

CEO statement
First, I wish to thank all our investors and cooperation partners, who support Panion’s intriguing and important work!

In the third quarter of 2017, Panion was listed on AktieTorget on the 3.rd of July with first trading day on the 6.th of July. The review process performed by AktieTorget’s lawyers and financial experts leading up to the listing is a thorough investigation of the documents, procedures, persons, and business of a company. This is a genuine quality-stamp for Panion and it shows that we have a robust and healthy company structure.

Now we are focusing on the development of our epilepsy project with the product candidate CG01-canine.
The development plan is progressing, qualified consultants are connected, and we have signed the confidentiality agreement with the preferred dog-epilepsy center. Our initial plan was to have a precise enrolment schedule, but this may extend the time-period until we can present results, so we are currently working to broaden the inclusion criteria for the trial, and hence eventually extending the applicability of the product in the future market.

We have successfully applied for a MUMS status in the USA, which gives Panion the financial incentives of a fee waiver for the application procedure. This means that we save a lot of money which we prefer to spend on product development. MUMS is short for “Minor Use and Minor Species” and is a framework of incentives for products that for example covers an unmet medical need in animals. We can now open the so-called Innovative New Animal Drug application with CVM in FDA and start the exchange with the authorities of veterinary medicines approval. This is coordinated by Panion’s representation office in New York, managed by our US-based director of business development Carlos N. Velez.

The USA is the market that we target first and in July Panion’s chairman of the board, Lars Thunberg, conducted a roadshow to interested investors and potential financial partners to level the way for future cooperation. The market for gene therapy in US is very interesting and we continue the dialogue with potential in-licensing opportunities.

We aim to inform our investors well, and Panion representatives have given interviews in the Swedish Investarbrevet in August, and in Animal Pharm in September, and we will continue  to inform about the progress.
I encourage you to read more details in the full company description of Panion, which can be found on our website in both Swedish and English.

Epilepsy in dogs is 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 – with gene therapy is very promising and we continue to work hard to fulfill the potential.
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.

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