Period from January 2016 to March 2016
2016 FIRST QUARTER (Jan-Mar)
- Operating loss KSEK -3,551 (-2,644)
- Loss per share SEK -0.18 (-0.33)
IMPORTANT EVENTS DURING THE PERIOD
- In March Peptonic Medical received approval to start the planned clinical Phase 2b study from the Swedish Medical Products Agency. Previously Peptonic had received approval from the Ethical Vetting Board.
- The Formulation patent has been approved also in China.Earlier it has been approved i.a. in Europe and the US.
IMPORTANT EVENTS AFTER THE END OF THE PERIOD
- The Nomination Committee will propose to the Annual General Meeting on May 19th, that Mr Hans von Celsing be elected as Chairman of the Board of Peptonic Medical. Present chairman, Ron Long, has announced that he will not be standing for re-election.
- The 3rdof May the first patients entered Peptonic Medical´s clinical phase 2b study. The aim of the study is to investigate the effect of Peptonic Medical’s product candidate Vagitocin® on vaginal atrophy in menopausal and post-menopausal women.
From the CEO
During the past few months, focus has been almost entirely on the preparations of the clinical phase 2b study. We have received the required approvals from the authorities, the first batches of the oxytocin gel have been manufactured, the study sites have been initiated, the study protocol has been presented to the head clinicians, service agreements with laboratories and other providers have been signed and advertising for study subjects has started, etc. Everything has gone according to time plan and budget, which means that the first subjects were randomised in to the study in the beginning of this month.
We will carefully monitor the continued patient recruitment and any feedback from the study sites and study subjects during the coming months. Results from the main study (gel in glass syringes) are expected by the end of this year, whereas the results from the exploratory study (gel in laminated tubes) are expected during Q1 2017.
In collaboration with TEFEN – an international management consulting firm – a market research project targeting the Vaginal Atrophy (VA) markets of the USA, the five largest countries in Europe and the Nordic countries has been concluded. The objectives of this project were to gain a better understanding of the patient flows, who the prescribers and main competitors are, the current value of the VA market, and to develop an interactive valuation model for Vagitocin®. This project has provided valuable information about the most important markets and a useful tool for the anticipated out-licensing negotiations.
The distribution agreement signed in 2009, granting Alium Medical Ltd. (formerly Pharmarama Ltd.) exclusive distribution rights to Vagitocin® in the UK and Ireland has been terminated. This means that Peptonic has regained the right to distribute Vagitocin® in these territories, either through its own sales force or through a future partner. In conjunction with the termination, Peptonic Medical reimbursed Alium Medical for costs incurred for market access activities.
Stockholm May 17, 2016
CEO, Peptonic Medical AB
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 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 oxytocin.
Net sales – Currently the company has no net sale.
Costs – Costs for the first quarter were KSEK -3,551 (-2,644).
Result – Loss before tax for the first quarter was KSEK -3,537 (-2,629).
Financial position and liquidity – Liquid assets was KSEK 21,650 (20,338) as of March 31, 2016.
Equity – PEPTONIC medical AB´s equity amounted to KSEK 63,975 (52,769) as of March 31, 2016, resulting in a solidity of 86 (86) percent.
Organization – The average number of employees during the period was 2 (2). At the end of the period the number of employees was 2 (2).
Share – Total numbers of shares in the company amounted to 19,174,412, as of March 31, 2016.