Interim Report - Period from January 2015 to March 2015
2015 FIRST QUARTER (Jan-Mar)
- Operating loss KSEK -2,644 (-1,004)
- Loss per share SEK -0.33 (-4.39)
IMPORTANT EVENTS DURING THE PERIOD
- In March, the US patent office informed Peptonic Medical that the formulation patent will be approved in the USA. Patent expiry is in 2032.
- Peptonic Medical and Swetox entered a research collaboration on the mechanisms of action of oxytocin. The project will add new safety data to Vagitocin®.
- The company raised SEK 14.4 million in a private placement at a share price equal to the average trading price during the three preceding months.
- Patient recruitment to Peptonic Medical’s ongoing phase 2b study was completed by the end of March.
IMPORTANT EVENTS AFTER THE END OF THE PERIOD
- At the AGM Mr Anders Wiklund and Prof. Emeritus Andris Kreicbergs were elected as new members to the Board. At the same time, Mr. Christer Sjögren and Mr. Ingvar Wiberger resigned from the Board.
- Johan Inborr, CEO, subscribed for 160,000 warrants as authorized by the AGM as part of an adopted incentives scheme.
From the CEO
During the period, activity level has continued to be high, and many positive things have occurred.
Patient recruitment for the clinical phase 2b study continued at a high rate and was completed at the end of March in accordance with the plan. All five clinical centres have seen a steady in-flow of patients. This is probably a sign of the need for new and safe treatments for vaginal atrophy, and that many women are suffering from the symptoms. To date, more than half of the total number of patients to be included have completed the study. Provided there are no major setbacks, results from this study should be announced by end of September.
Proceeds from the private placement in March were SEK 14.4 million. The proceeds will be used primarily for planning and preparing for the next stage in the development of Vagitocin®, that is, the phase 3 clinical studies. These activities are already well underway. Key activities are i.a. manufacturing scale-up, completion of the Swetox research project, planning and preparation for the end-of-phase 2b meetings with the regulatory authorities in the USA (FDA) and Europe (EMA) and creating and maintaining contacts with potential partners going forward.
Globally US is the single largest market for vaginal atrophy. Hence, the grant of the company’s formulation patent in the US is of great importance. This will increase the value and attractiveness of Vagitocin®, and it’s a prerequisite for a favourable outcome of a licensing deal in this territory. With the above grant, the patent is now granted in the USA, Europe and Singapore. The patent has been applied for in many more countries and additional approvals are to be expected within the next few months.
Stockholm May 8, 2015
CEO, PEPTONIC medical AB
PEPTONIC medical AB 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’s mission is to develop safe and effective drugs based on the known beneficial properties of oxytocin.
Net sales – Currently the company has no net sale.
Costs – Costs for the first quarter were KSEK -2,644 (-1,004).
Result – Loss before tax for the first quarter was KSEK -2,629 (-1,004).
Financial position and liquidity – Liquid assets was KSEK 20,338 (4,521) as of March 31, 2015. During the first three months the company received KSEK 14,488 in new share issues, it was still ongoing at the quarter end.
Equity – PEPTONIC medical AB´s equity amounted to KSEK 52,769 (29,904) as of March 31, 2015, resulting in a solidity of 86 (94) percent.
Organization – The average number of employees during the period was 2 (1). At the end of the period the number of employees was 2 (1).
Share – Total numbers of shares in the company amounted to 7,971,054, as of March 31, 2015. After the ongoing registration of the new issued shares will the shares increase with 1,470,906 shares to a total of 9,441,960 shares. It was registered at the Swedish company act the 8th of April 2015.