Year end report

Period from January to December 2016

Peptonic Medical AB (publ) org nr 556776-3064

(www.aktietorget.se,  ticker: PMED)

2016 FOURTH QUARTER (Oct-Dec)

• Operating loss KSEK -3,016 (-4,793) 
• Loss per share SEK -0.24 (-0.25)

FULL YEAR 2016 (Jan-Dec)

• Operating loss KSEK -11,320 (-13,983)
• Loss per share SEK -0.55 (-0.73)

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. Hence, a total of 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.
  
  
• 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, the Company announced that 177 patients had been screened and 119 of them had started treatment after randomization.
  
  
• 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.
  
  
• On the 21st of December the Company announced that it has filed two patent applications for the use of oxytocin for the treatment of vestibulitis and genital herpes, respectively.

IMPORTANT EVENTS AFTER THE END OF THE PERIOD

• On the 13th of January the Company announced that the last study subject of the Company’s phase 2b clinical study has been enrolled and started the treatment. This concerns the second (exploratory) part of the clinical phase 2b study, in which the oxytocin gel is stored in laminated tubes and administered using disposable applicators. In total, 40 study subjects are participating in this part of the study.
  
  
• On 1st of February the Company announced that all of the randomized subjects of the first part of the ongoing phase 2b study (main study) now have completed the treatment and exited the study. In this study, the effect of treating menopausal and post-menopausal women suffering from vulvar and vaginal atrophy (VVA) with Peptonic Medcial’s oxytocin gel (Vagitocin®) is being investigated. A glass syringe has been used for storage and administration of the gel. In total, 161 randomized subjects participated in the study. The Company reported, that more than 97 per cent of the subjects have completed the 12-week treatment and attended all of the follow-up visits during the course of the study. This is a very satisfactory outcome and provides a good basis for assessing the effects of the treatment with oxytocin. With the exception of a slower than planned patient recruitment, the study has progressed well and in accordance with the plan and there are no major deviations or treatment related serious adverse effects to report.

From the CEO

During the past year, the planning and the execution of the clinical phase 2b study have been the most important activities of the company. Thanks to the competence and experience of our own staff and that of the staff of the clinical sites regarding designing clinical trials, the first study subjects were screened already in April.

Recruitment to the study followed the set time plan until late summer. At this time, summer vacations caused a shortage of staff at the clinics and patient in-flow slowed down. This, in turn, resulted in a delay in the time plan so that study results couldn’t be reported by end of the year as initially planned.

In all other aspects the study has progressed well. No serious adverse events have been reported that could be linked to the Vagitocin® treatment.

In July, the company closed a directed share issue (private placement) of 5.4 MSEK (net), the purpose of which was to broaden the ownership of the company and to provide cash to last until the results of the phase 2b results will be publicised. In addition, the proceeds are to be used for preparations for phase 3 programme and for evaluating new medical indications for oxytocin.

The financial outcome of last year indicates good cost control and efficient use of both internal and external resources. This is very satisfying and this is the way we will be operating also in the future.

In December, the company filed two patent applications for the use of oxytocin in two new indications, namely vestibulitis and gential herpes. The documented and published physiological effects of oxytocin makes it highly probable that the use of oxytocin will result in very good treatment outcomes and symptom alleviation in these indications. The company has recently submitted applications to the Swedish MPA for approval to start clinical studies in these indications.

We are ready to move in to phase 3 as soon as the phase 2b results are on hand and we are currently evaluating different financing alternatives. The final decision on how to finance the phase 3 programme will be a result of discussions with both financial advisors and pharmaceutical companies.

We have actively maintained close contacts with potential partners for phase 3. As a result of further market research and company presentations the network of partner candidates has expanded to also include Chinese companies.  

Finally, I want to take this opportunity to thank our shareholders, the board members, suppliers and service providers for their support and assistance, and my closest colleagues for their invaluable efforts during last year.

Stockholm, 27th of February 2017

Johan Inborr, CEO

COMPANY BRIEF

Peptonic  Medical AB (publ) is an innovative Swedish pharmaceutical company developing oxytocin based products including for the treatment of menopausal symptoms, such as vaginal atrophy. Peptonic Medical’s mission is to develop safe and effective drugs based on the well-known beneficial properties of oxytocin.

About Oxytocin

Oxytocin is a peptide hormone that is produced within the neurons of the brain and released in to the blood stream. It is well known for its key role in labour and breast feeding, stimulating the contraction of the uterus and promoting milk ejection. Oxytocin has been used clinically since the 1960s as an IV drip and is also administered as an injection after childbirth to reduce uterine bleeding. More recently, oxytocin has been found to possess additional medicinal benefits as an anti-inflammatory agent, in promoting the healing of tissues as well as the possible reduction in certain types of pain.  

Oxytocin is the active substance of Vagitocin®, which is currently being investigated for the treatment of vaginal atrophy in menopausal women. In this application, the oxytocin gel is administered vaginally.    

FINANCIAL INFORMATION

Net sales – Currently the company has no net sale.

Costs – Costs for the fourth quarter were KSEK -3,016 (-4,793). Costs for the full year were KSEK -11,320 (-13,983). 

Result – Loss before tax for the fourth quarter was KSEK -2,964 (-4,785). Loss before tax for the full year was KSEK -11,258 (-13,960).

Financial position and liquidity – Liquid assets was KSEK 12,169 (28,431) as of December 31, 2016. During the full year the company received KSEK 5,386 (40,564) in new share issues.

Equity – PEPTONIC medical AB´s equity amounted to KSEK 61,643 (67,513) as of December 31, 2016, resulting in a solidity of 91 (91) percent.

Organization – The average number of employees during the period was 2 (2). At the end of the year the number of employees was 2 (2).

Share – Total numbers of shares in the company amounted to 20,602,984 as of December 31, 2016.