Interim report January 2015 to September 2015
2015 THIRD QUARTER (Jul-Sep)
- Operating loss KSEK -2,683 (-2,713)
- Loss per share SEK -0.28 (-0.34)
FIRST NINE MONTHS 2015 (Jan-Sep)
- Operating loss KSEK -9,190 (-6,467)
- Loss per share SEK -0.97 (-0.81)
IMPORTANT EVENTS DURING THE PERIOD
- Last patient’s last visit in the Phase IIb study occurred in July.
- In September the results of the Phase IIb study were announced. Primary endpoints were not met. The Board decided to launch a thorough investigation in to all aspects of the study before publishing the results in more detail.
IMPORTANT EVENTS AFTER THE END OF THE PERIOD
- The Board announces that the investigation has been concluded. The investigation found that the most probable cause of this unsatisfactory result was that the aluminium tube used to deliver the daily oxytocin dose, reacted with the oxytocin gel to cause a reduction in viscosity, especially when the product was stored at room temperature. This in turn resulted in less adherence of the oxytocin gel to the vaginal mucosal epithelium and therefore an inadequate daily dose of the active compound was delivered to the tissue. Clinical observation and patient reports of leakage of the gel prompted storage of the tubes in refrigerator temperature instead of room temperature to preserve gel viscosity for the last 76 of 224 patients in the trial. Analysis of this sub-group, after the trial results were known, showed a significant reduction of the most bothersome symptom (one of three primary endpoints) compared with placebo further supporting the notion that decreased gel viscosity was the reason for the unexpected outcome of this study.
- 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.
From the CEO
Vaginal atrophy is a condition affecting approximately one out of two women during or post menopause. The symptoms e.g. vaginal dryness and pain during intercourse, markedly reduce quality of life and negatively impact the life in a partnership of those affected. There is a great need for safe and effective treatments. This we have noticed, for example, during the recruitment of patients to our clinical studies with oxytocin (Vagitocin®). Many are seeking relief, but do not want to or cannot use estrogen based products due to the many serious side effects associated with their use.
Clinical studies with oxytocin up until 2013 showed good effects and safety. The objectives of the latest study during 2014-2015 were to make a leap towards phase 3 clinical development and to show good efficacy of a commercially viable product. This was done by changing the previously used glass syringe and storage in refrigerator to an aluminium tube with a disposable applicator and storage in room temperature. Despite good stability data for oxytocin when stored in the aluminium tube, the results of the clinical study were disappointing. Oxytocin treatment did not result in an improvement compared with placebo for any of the primary endpoints.
During the course of the study, a few patients reported that they felt that the gel was runny. This triggered a suspicion that the viscosity of the gel was lower now than in previous studies. We decided to issue a recommendation to the patients still to be treated to store the gel tubes in a refrigerator during the course of the treatment period. Analysis of the results generated after the issuance of this recommendation showed a significant reduction of the Most Bothersome Symptoms. Further investigations have confirmed our suspicion that the viscosity of the gel was too low. This lead to an insufficient adherence to the vaginal mucosa and daily oxytocin dose.
We are now planning for a repeat clinical study using both a glass syringe and a new type of tube. This tube has shown to preserve gel viscosity as well as glass syringes. We are confident that the clinical endpoints can be obtained and that we can take the next important step towards phase 3 and a subsequent commercial launch. This study is to be concluded during 2016 and carried out as cost-effectively and professionally as the previous one. The physicians at the clinical sites have long experience from both conducting clinical studies and from oxytocin. This is a guarantee that both patients and data collection are in good hands.
The vaginal atrophy market is estimated to USD 2 billion annually. Based on its unique properties we believe that Vagitocin® will capture a significant share of this market and make it grow. We are able to offer a safe and effective treatment for everyone – both to those that do not want to use estrogens, but also to those that must not use estrogens.
Peptonic Medical is not only focusing on Vagitocin®. There are patents owned by the company covering many therapeutic areas of great commercial potential such as pain, wound healing and cancer. Patent applications for additional indications have been submitted, and more are under development. In addition, new oxytocin formulations have been developed for use in either existing or new indication areas.
There are many potential medical applications for oxytocin not yet developed. It is the aim of Peptonic Medical to develop products based on oxytocin for indications with a pronounced need for new treatments and great market potential.
Stockholm November 11, 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 third quarter were KSEK -2,683 (-2,722). Costs for the first nine months were KSEK -9,190 (-6,476).
Result – Loss before tax for the third quarter was KSEK -2,683 (-2,714). Loss before tax for the first nine months was KSEK -9,175 (-6,469).
Financial position and liquidity – Liquid assets was KSEK 10,537 (15,212) as of September 30, 2015. During the first six months the company received KSEK 14,522 in a private placement.
Equity – PEPTONIC medical AB´s equity amounted to KSEK 46,257 (44,119) as of September 30, 2015, resulting in a solidity of 81 (97) 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 (2).
Share – Total numbers of shares in the company amounted to 9,441,960 as of September 30, 2015.