2019 Q1 report, Period January-March for Panion Animal Health AB

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Period January-March
• Net sales: kSEK 0 (0).
• Operating profit: kSEK -1 663 (-697).
• Earnings per share: SEK -0,07 (-0,05).
• Liquidity at the end of the period: kSEK 4 961 (2 708).

Significant events after the end of the period:
• On April 18, 2019, CombiGene AB (publ) announced a public offer to the holders of shares and warrants of series TO1 in Panion Animal Health AB (publ) to tender all their shares and warrants to CombiGene. The full offer can be viewed on Panion’s and/or CombiGene’s websites. The acceptance period for the offer is expected to commence on or around 23 May 2019 and expire on or around 20 June 2019. Settlement is expected to take place on or around 8 July 2019.
• On April 23, 2019, the annual general meeting was held, and a report was published with the decisions. To enable new issues of shares and warrants, the AGM resolved to amend the limits of the share capital in the articles of association from minimum SEK 550 000 and maximum SEK 2 200 000 to minimum SEK 1 100 000 and maximum SEK 4 400 000, and to amend the limits of the number of shares in the articles of association from minimum 11 801 593 and maximum 47 206 372 to minimum 23 603 186 and maximum 94 412 744. The AGM did not approve the suggested issue of new shares, since the Company is subject to a public offer on the Company’s shares. The AGM decided to authorise the board of directors to, on one or more occasions during the period up to the next annual meeting, resolve to issue new shares, warrants and/or convertible instruments, within the limits of share capital and numbers of shares determined by the AGM.
• On May 21, 2019, Panion’s board announced a recommendation to accept the public offer from CombiGene.

Milestones January-March 2019

On January 11, 2019, Panion had been selected as one of 24 finalist companies to present at the 2019 Animal Health Investment Innovation Showcase, and as one of four in the programme on translational technology from human-to-veterinary pharma. The Animal Health Investment Europe is a premier investment forum showcasing the most exciting investment opportunities in animal health and nutrition and connecting those businesses with financial investors and strategic corporate partners.

On January 15, 2019, the rights issue from December 2018 had been registered by the Swedish Companies Registration Office. Shares and share capital after the registration by the Swedish Companies Registration Office amount to SEK 1,137,110.723254 divided into 24,399,487 shares.

On January 16, 2019, it was announced that the US-FDA has granted a fee waiver for 2019, as for fiscal years 2017 and 2018. This means that also for 2019, the company must not pay the very high fee for a running application to the FDA. The fee waiver is granted as a result of the MUMS determination (Minor Use Minor Species) for Panion’s development product for gene therapy for dog epilepsy.

On January 16, 2019, the Categorical Exclusion for environmental assessment was announced. Panion had applied to US-FDA for claiming a so-called “Categorical Exclusion” under 21 CFR 25.33(e) for the investigational use of CG-01-canine with regards to environmental requirements for the clinical trials to be conducted. This was agreed by the FDA, and therefore neither an environmental assessment (EA) nor an environmental impact statement (EIS) is required for the investigational use in clinical trials. This is a clear reduction of the regulatory and administrative burden for the company, because environmental assessments can be very comprehensive and labor intensive.

On January 23, 2019, Panion drew down a second tranche (SEK 2 million) from the investment fund managed by Yorkville Advisors Global (“Yorkville”). This tranche was later revoked and repaid in March 2019, see below on March 18, 2019.

On February 1, 2019, it was announced that Panion had attracted interest from the agribusiness intelligence and animal health media Animal Pharm, where journalist Sian Lazell had noted the development program from Panion.

On February 12, 2019, the Q4-2018 report was published, covering the period from October to December 2018.

On February 27, 2019, the presentation that was given by Panion’s chairman of the board, Lars Thunberg, at the Animal Health Investment Europe was published. Lars Thunberg informed the audience about the promising business idea in veterinary medicines and the progress over the last two years. The focus was on the commercial elements of Panion’s business plan and set out the possible road to commercialization. The event is a premier investment forum showcasing the most exciting investment opportunities in animal health and nutrition and connecting those businesses with financial investors and strategic corporate partners.

On March 5, 2019, it was announced that Panion’s highly competent advisory board had been expanded with the fourth member, Dr. Dominic J. Marino, DVM, DACVS, DACCT, CCRP, who is the lead investigator of the ongoing clinical study in dogs. Dr. Marino is an experienced veterinary neurologist and neurosurgeon. He is the Chief of Staff of Long Island Veterinary Specialists, the Director of the Canine Chiari Institute, and a founding board member of the New York Veterinary Foundation.

On March 7, 2019, an update from the ongoing clinical study was released. The study will give the first evidence of the level of treatment effect in dogs, which so far has been deducted from multiple rat studies. The announcing of the clinical efficacy study is progressing well with information to dog owners and referring vets in the New York area, and the first dog screenings have been scheduled. The training of personnel and technics are ongoing, and the product itself is manufactured in accordance with the time plan. The first study data are expected by the end of 2019.

On March 8, 2019, the head of LIVS and lead investigator on Panion’s clinical efficacy trial in dogs, Dr. Dominic Marino, held a technical meeting with associate professor David Woldbye in Copenhagen to ensure full transfer of knowledge and technical procedures. The previous two studies in dogs related to Panion’s gene therapy product documented the safety of the treatment and procedures. Both were conducted at the University of Copenhagen under the lead of Dr. Woldbye, who is one of the scientific founders of the innovation and a member of Panion’s advisory board. Dr. Marino as an experienced veterinary neurosurgeon, and Dr. Woldbye as the scientific expert and human medical doctor – exchanged experiences to secure the optimal way to progress the clinical study successfully.

On March 18, 2019, Panion Animal Health, by mutual agreement, revoked the remaining convertibles that were held by US-based Yorkville Advisors; Yorkville then has no outstanding convertibles.

On March 18, 2019, the Board of Directors proposed that in conjunction with the Annual General Meeting on April 23, the AGM could decide to change the number of shares in order to enable a new share issue and to issue a rights issue. The company had received guarantees and subscriptions corresponding to 67% of the issue amount.

On March 26, 2019, the call for the annual general meeting was announced in accordance with the rules.

On March 29, 2019, the annual report was released in Swedish and with an English translation.

On March 29, 2019, Panion released a comment on the auditor’s remark in the annual report, concerning the repayment of a shareholder loan. It was stated that the company had reacted immediately when the error was found and that no damage had occurred.

On March 29, an error in the suggested date of the planned share emission was corrected. (The share emission was later not adopted by the annual general meeting due to the public offer from CombiGene.)

This report contains information which Panion Animal Health AB is obliged to publish according to the EU market abuse regulation (MAR). This information was submitted by Panion’s CEO, Anja E. H. Holm, for publications on May 22, 2019.

Anja E. H. Holm, CEO
+ 45-22 94 66 00

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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