2017 Q1 report, January-March for Panion Animal Health

Q1 January-March

  • Net sales: kSEK 0 (0).
  • Operating profit: kSEK -1 267 (-).
  • Earnings per share: SEK -0,11 (-). 
  • Liquidity at the end of the period: kSEK 102 (582).

Significant events after the end of the period:

  • A shares emission running from 8 - 26 May has been successfully finalized.
  • A Letter of Intent has been signed with GeneQuine Biotherapeutics GmbH.
  • Annual Meeting was held 27/4 - the minutes and decisions are published on Panion's website.

CEO statement

During the first quarter of 2017, we have consolidated and prepared Panion for the exiting times ahead. The Board and the Management have settled in and are actively pushing forward our business plan. The procedures and development plans have matured and the company has been made ready to be listed on a market place. A small directed emission of shares facilitated this process.

At the time of writing this report, the emission of new shares to existing and new shareholders has just been finalized with a very satisfying result.

9% of Panions existing shareholders decided to increase their share holdings and in addition Panion managed to attract significant interest from new investors. After the share issue there are 1247 shareholders in Panion and with the new funds of MSEK 7,4 from the share issue, Panion is now well capitalized for the coming 12-18 months. The emission was successfully handled with the qualified assistance of our financial advisors from Regin Corporate Finance in Stockholm.

We have in Q1 continued the work on the epilepsy product for dogs in cooperation with CombiGene AB. 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. We want to develop an effective gene therapy treatment that can alleviate or eliminate the scary and unpleasant seizure attacks and improve the quality of life for these dogs and their owners. The license agreement that we have with CombiGene is now fully operational with a service and supply agreement connected to it. The Board has evaluated the market potentials and opening the process in USA will be the first move towards the realization of the potential of this very interesting product. A US office is established and our US agent in place for the FDA-procedures to progress smoothly. Moreover, we have two US-based specialized consultants connected to Panion and they are ready to help us move forward with the clinical development and approval of the epilepsy product for dogs.

In the meantime, we have continued the search for more in-licensing opportunities. The business model where we develop and commercialize the animal assets of new medicinal projects from the human field, remains the promising core of our strategy. Recently, the first step into a cooperation with the Germany-based company GeneQuine Biotherapeutics GmbH was taken by the mutual signing of a Letter of Intent. GeneQuine, which was established in 2012, develops gene therapy for osteoarthritis, a degenerative joint disease, in humans, horses, and dogs. They hold worldwide exclusive IP rights to specific gene therapy vectors and their use in the treatment of osteoarthritis. The Letter of Intent will facilitate discussions pertaining to a license agreement with regards to these novel veterinary medicines.

It is fantastic to see the company transform from a science based entity to a focused product development company with a clear direction, and I look forward to the coming steps and challenges.

Anja Holm,
vd, Panion Health AB

Future reporting dates
Interim Report for Q2 2017, 21 August 2017
Interim Report for Q3 2017, 21 November
Interim Report for Q4 2017, 22 February 2018

For the complete report, see attached document.

For further information, please contact:
Anja Holm, VD
Phone +45 22 94 66 00
E-mail: anja.holm@panion-animalhealth.com

More information is available at www.panion-animalhealth.com

Nerladdningsbara filer

Panion at European Innovation Day

The European Medicines Agency (EMA) is the regulatory body that authorises biotechnological veterinary medicines in Europe. Thursday the 19.th of April 2018, the Agency held a well-visited day for businesses that work with innovative projects to keep them abreast with the current developments in authorisation requirements; the EMA veterinary medicines innovation day.

Panion expands the cooperation for the clinical development

With an agreement and contract that connects the well-reputed biostatistician Steve Radecki (USA)
to the coming clinical study in dogs with epilepsy, Panion's professional qualifications and competences are expanded. Clinical studies used for approval of medicines must be planned and evaluated with strict statistical methodology to ensure that the results are robust and significant. 

2017 Q4 report, October-December for Panion Animal Health

Period October-December

  • Net sales: kSEK 0 (0).
  • Operating profit: kSEK -854 (-643).
  • Earnings per share: SEK -0,32 (-0,09).
  • Liquidity at the end of the period: kSEK 2 124 (306)

Period January-December

  • Net sales: kSEK 0 (0).
  • Operating profit: kSEK -4 200 (-692).
  • Earnings per share: SEK -0,32 (-0,09).
  • Liquidity at the end of the period: kSEK 2 124 (306)

DRA contract ends & New advisory board member

Panion Animal Health AB's Director Regulatory Affairs, Niels-Erik Manniche, has decided to leave the company.

Panion enters into SEK 9,5 million financing and receives SEK 3 million in first tranche financing

Panion Animal Health AB (the "Company") has entered into a financing agreement with New York based Yorkville Advisors Global ("Yorkville") as the investment manager and on behalf of one or more of its investment funds has agreed to purchase up to SEK 9,000,000 of Convertible Notes of Panion Animal Health AB. In addition, Panion has entered into a financing agreement with Dividend Sweden who has agreed to purchase SEK 500,000 of convertible Notes of Panion Animal Health AB.

Panion's epilepsy product candidate for gene therapy in the dog: FDA has established an Investigational New Animal Drug (INAD) file.

Panion Animal Health AB ("Panion") has in Q4-17 requested the FDA to open an Investigational New Animal Drug application file to carry out the development of our new product for use in the dog. Panion plans to develop and gain approval for the use of CG-01-canine, a recombinant adeno-associated virus vector expressing neuropeptide Y and receptor peptide Y2 to treat drug refractory idiopathic epilepsy in the dog via intracranial injection.

New CFO in Panion, Sofia Josephson

Panion Animal Health AB has had a very satisfactory cooperation with our CFO Anni Acs, who excellently handled the business transition into the stock market, shares issue, and daily financial controlling. Anni has moved to a new job challenge and we wish her all the best.

Panion's epilepsy product classified as MUMS in EU for dogs and cats

Panion Animal Health AB has received the European Medicines Agency's acceptance of the classification as MUMS (Minor Use Minor Species) for our epilepsy product for both dogs and cats. The request for classification was submitted to the Committee for Medicinal Products for Veterinary Use (CVMP) in the European Medicines Agency (EMA) earlier in 2017 and has now been successfully evaluated. 

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