Interim report Period from January 2016 to September 2016

2016 THIRD QUARTER (Jul-Sep)

• Operating loss KSEK -1,983 (-2,683)      

• Loss per share SEK -0.10 (-0.28)

FIRST NINE MONTHS 2016 (Jan-Sep)

• Operating loss KSEK -8,304 (-9,190)

• Loss per share SEK -0.40 (-0.97)

IMPORTANT EVENTS DURING THE PERIOD

• Mr Hans von Celsing was elected as new Chairman of the Board and Mr Arne Ferstad as Board member in May and July, respectively.
• On the 3rd of 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. The Phase 2b study is a double-blind, placebo-controlled, multi-centre study and comprise two arms of 80 patients each, in total 160 patients.
• In July the company completed a private placement of 6 MSEK (before transaction costs equivalent to 10% of the total rights issue amount) to a selected group of 10 new investors. This in accordance with the mandate given to the Board of Directors at the AGM in May. A total of 1 428 572 shares were issued at a subscription price of SEK 4.20 per share.

By 30th of September 177 patients had been

IMPORTANT EVENTS AFTER THE END OF THE PERIOD

• On the 25th of October the company announced that the last study subjects of the ongoing phase 2b study had been accepted to be enrolled. The last patients were expected to enter the study within a fortnight. In total, 160 study subjects are participating in the study, the objective of which is to investigate the effect of Peptonic Medical’s candidate drug Vagitocin® in the treatment of vaginal atrophy in post-menopausal women. In this study, a glass syringe is used for containing and administration of the vaginal gel.

From the CEO

This week, the last study subjects of the ongoing phase 2b study will be enrolled and start the treatment. We are pleased to have reached this point, despite this delay in the time plan. The recruitment for the explorative study will continue without delay and we expect it to be completed in early December.

The reason for the extended recruitment period is the slower than expected patient recruitment during the early autumn. Recently, an intensified advertising has led to an increased patient in-flow.

Generally, the study has progressed well with no practical problems.

We have also started the preparations for  the clinical phase 3 programme . Our aim is to cut the lead times between the phase 2 and 3 studies , for example, by scaling up the manufacturing process to produce material for stability studies and for the clinical studies.

During the autumn, we have spent time and resources on investigating new potential indications for oxytocin. We have consulted medical experts and assessed the medical needs of these indications. We have also developed regulatory and clinical development plans for the different alternatives. What remains is to assess the probability of reaching the market within a certain time period, obtain assumed prices and reach certain market penetration rates. Our aim is to complete this work and make final decisions before the end of the year.

Stockholm

10 November 2016

Johan Inborr

CEO

COMPANY BRIEF

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.

FINANCIAL INFORMATION

Net sales – Currently the company has no net sale.

Costs – Costs for the third quarter were KSEK -1,983 (-2,683). Costs for the first nine months were KSEK -8,304 (-9,190). 

Result – Loss before tax for the third quarter was KSEK -1,982 (-2,683). Loss before tax for the first nine months was KSEK -8,294 (-9,175).

Financial position and liquidity – Liquid assets was KSEK 16,477 (10,537) as of September 30, 2016. During the third quarter has the company completed a private placement which has increased liquidity with KSEK 5,400 net.

Equity – PEPTONIC medical AB´s equity amounted to KSEK 64,607 (46,257) as of September 30, 2016, resulting in a solidity of 92 (81) 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 20,602,984 as of September 30, 2016.