Peptonic Medical proposes a rights issue to finance a new phase IIb study

Stockholm, November 5th, 2015 – The Board of Peptonic Medical AB (publ) -  a company developing pharmaceutical products based on oxytocin -  today announced a proposal to launch a repeat phase IIb study on women suffering from vaginal atrophy. In this study, both a glass syringe and a tube,  that according to stability studies preserves the viscosity of the oxytocin gel on a high level, will be used to deliver the daily dose. The primary clinical endpoint will be to achieve a significant reduction of the Most Bothersome Symptoms compared to placebo.

The Board of Peptonic Medical has called for an extraordinary general meeting on November 19, 2015, to seek shareholder approval for a rights issue of approximately MSEK 22.7 (the “Offer”) in order to finance the proposed phase IIb study.

Background

Between 2000 and 2102 Peptonic performed four clinical studies with Vagitocin as a treatment for Vaginal Atrophy in menopausal and post-menopausal women. The studies showed positive effects, in particular, in reduction of the Most Bothersome Symptoms. However, in the phase IIb study, which concluded in 2015, the primary clinical endpoints were not met. Detailed investigation showed that the aluminium tube used to store the oxytocin gel reacted with the gel to cause a reduction in viscosity, especially when stored in room temperature. This resulted in insufficient adherence of the oxytocin gel to the vaginal mucosal epithelium and therefore an inadequate daily dose.

Study design

The repeat phase IIb study is designed as a double-blind placebo controlled multi-center study of 160-240 subjects. The Board is confident that this study will show a positive effect of oxytocin treatment of women suffering from vaginal atrophy, as demonstrated in previous studies. In this study, planned to be completed by the end of 2016, a glass syringe and the new tube will be employed and patients will be clearly instructed to store the product in refrigerator during the study period.

Subscription undertakings and commitments to underwrite

The Company announces that it has secured subscription undertakings from its existing shareholders to an amount of SEK 11 million to date, of which 2 million are without preferential rights. The Company further announces that its intention is to fully guarantee the Offer through subscription undertakings and commitments to underwrite well in advance of the extraordinary general meeting on November 19, 2015.

Terms of the Offer

The Board of Peptonic has proposed the extraordinary general meeting on November 19, 2015, to resolve on a rights issue. Provided that the Offer is fully subscribed, the Company receives approximately MSEK 22.7 before issuing costs. The Offer involves subscription of a maximum of 8 093 108 new shares where seven (7) existing shares entitles the holder to subscribe for six (6) new shares to the subscription price of SEK 2.80 per share. The Offer will increase the share capital of by a maximum of SEK 809 310.80 to SEK 1 753 506.80 SEK. The number of shares can increase with maximum 8 093 108 shares to 17 535 068 shares. The subscription period is indicatively November 27 – December 11, 2015.

The Offer will be carried out according to the following timetable;

  • Extraordinary general meeting, November 19, 2015.
  • Last day of trading in the shares including right to participate in the Offer, November 23, 2015.
  • First day of trading in the shares excluding right to participate in the Offer, November 24, 2015.
  • Estimated date of publication of the memorandum, November 25, 2015.
  • Record date for participation in the Offer, November 26, 2015.
  • Trading in subscription rights, 27 November – December 9, 2015.
  • Subscription period, November 27 – December 11, 2015.

Advisors

Partner Fondkommission AB is acting as financial advisor to Peptonic.

For further information, please contact:

Johan Inborr, CEO
Phone: +46 708 853 893
E-mail: johan.inborr@peptonicmedical.se

About Peptonic Medical AB (publ)

Peptonic Medical AB (publ) is an innovative Swedish pharmaceutical company developing oxytocin based products e.g. for the treatment of menopausal symptoms, such as vaginal atrophy. Oxytocin has a long history of safe and effective medical use and offers an alternative to estrogen and estrogen-like acting compounds for menopausal and postmenopausal women. Peptonic Medical AB (publ)’s mission is to develop safe and effective drugs based on the known beneficial properties of oxytocin.

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