Interim Report period from January 2017 to June 2017
Peptonic Medical AB (publ) org nr 556776-3064
(www.aktietorget.se ticker: PMED)
2017 SECOND QUARTER (Apr-Jun)
- Operating loss KSEK -2,559 (-2,770)
- Loss per share SEK -0.12 (-0.14)
2017 FIRST HALF YEAR (Jan-Jun)
- Operating loss KSEK -5,240 (-6,321)
- Loss per share SEK -0.25 (-0.33)
IMPORTANT EVENTS DURING THE PERIOD
- On March 10th, the Company announced that the primary efficacy endpoints of the first part of its phase 2b study, in which the Vagitocin® gel was investigated for the treatment of vaginal atrophy, were not met. However, further analyses of the study data showed that the gel, both without and with the active ingredient (oxytocin), had a marked and statistically significant alleviating effect on the Most Bothersome Symptoms (MBS) after the twelve week treatment. To enter a clinical phase 3 programme, a new phase 2b study would be required. Hence, the Company has decided to focus on bringing the oxytocin-free gel to the market as a non-prescription product.
- On May 17th, the Company announced that the results of the exploratory part of its clinical phase 2b study show comparable treatment effects to the first part (main study). In short, this means that no significant differences were found between placebo and oxytocin for any of the defined clinical endpoints, whereas the placebo gel gave a strong effect on the Most Bothersome Symptom (MBS). All study subjects of the placebo arm (10 out of 10) reported symptom relief and half of them were symptom free at the end of the treatment period.
- At the AGM on the 18th of Mayt Leni Ekendahl and Marianne Östlund were elected as new board members. Arne Ferstad and Hans von Celsing were re-elected, Hans von Celsing as chairman.
- InJune the Company closed a financing round of 13.4 MSEK (before issue costs) consisting of a preferential rights issue (12.3 MSEK) and a private placement (1.1 MSEK).As a result, the number of shares will increase from 20.6 million to 43.0 million.
- On May 30th the Company announced that it has filed a patent application concerning the use of its vaginal gel for the treatment of symptoms associated with vaginal atrophy. The application was filed with The Swedish Patent and Registration Office. During the coming twelve months, the Company will decide in which additional countries the application will be filed.
IMPORTANT EVENTS AFTER THE END OF THE PERIOD
- On 1st of August the new shares issued in the latest financing will be transformed from BTA to ordinary shares.
- On 14th of August the Swedish “Bolagsverket” informed the Company that the last lot of issued shares (1,808,332 shares) have been registered.
From the CEO
During the second quarter much of the activities in Peptionic focused on defining and describing the new strategy of the Company, which is to launch VagiVital™ as a non-prescription product for the treatment of vaginal dryness/atrophy. VagiVital™ is the placebo gel that gave such a good effect in the treatment of the symptoms associated with vaginal atrophy in the most recent clinical study. The magnitude of the effect was on par with those reported from clinical studies with estrogens and estrogen-like products. This was both surprising and encouraging.
Before we can launch VagiVital™ it has to be CE-marked. This, in turn, requires a quality system to be implemented in the Company (according to ISO 13485) and a so called Technical File to be produced and approved. The approval is issued by a so called Notified Body, which is our case is Lloyds Register Quality Assurance Ltd. (England).
To realise our plans, additional capital is required. Hence, we closed a rights issue with preferential rights and a private placement in May-June. The gross proceeds of these two fund raisings were 13.4 MSEK and issue costs amounted to 2.5 MSEK. The rights issue with preferential rights was over-subscribed by 18 per cent, which indicates a positive attitude by the market towards the new strategy of the Company. This is encouraging and gives us energy and motivation to go forward towards a product launch. The proceeds are expected to cover the costs of obtaining the CE mark and for preparing and planning the first launch.
In addition to investing time and resources on obtaining the CE mark, we will work diligently to develop winning strategies for the distribution and marketing of VagiVital™. Outside the Nordic countries we will look for partners. On our home market (Sweden/Nordic countries), we are evaluating different alternatives, but also here we may want to collaborate with well established companies in this product category.
The interest for VagiVital™ among potential partners is at least as high as the interest for our previous candidate product containing oxytocin. VagiVital™ is a medical device product that requires a less complicated and less costly registration process than a drug. Also, VagiVital™ can reach the market much sooner (several years) than our previous candidate drug. Discussions with potential partners are well underway.
In Peptonic, we have an exciting and work intensive autumn ahead of us. We will of course keep the market informed about how the work is progressing.
Stockholm, August 17th, 2017
Peptonic Medical AB (publ) is an innovative Swedish biopharma company developing products within the field of women’s health. The Company was founded in 2009 and its first candidate drug product is Vagitocin® – an estrogen-free product for the treatment of vaginal atrophy.
VagiVital® is a registered trademark of Peptonic Medical. The product is being developed for the non-prescription use for the treatment of vaginal atrophy.
Find out more at www.peptonicmedical.se
Net sales – Currently the company has no sales.
Costs – Costs for the second quarter were KSEK -2,559 (-2,770). Costs for the first half year were KSEK
Result – Loss before taxes for the second quarter was KSEK -2,592 (-2,775). Loss before taxes for the first half year was KSEK -5,273 (-6,312).
Financial position and liquidity – Liquid assets were KSEK 3,333 (16,477) as of June 30, 2017. After finished funding in July 2017 has the company increased the liquidity with 11.0 MSEK after costs.
Equity – The equity amounted to KSEK 56,369 (61,189) as of June 30, 2017. 90 (92) percent of which is shareholders funds.
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 (19,174,412), as of June 30, 2017. After on-going funding it will increased to a total of 43,014,300 shares.