Interim Report Period from January 2017 to September 2017
Peptonic Medical AB (publ) org nr 556776-3064
(www.aktietorget.se ticker: PMED)
2017 THIRD QUARTER (Jul-Sep)
- Operating loss KSEK -2,969 (-1,983)
- Loss per share SEK -0.07 (-0.10)
FIRST NINE MONTHS 2017 (Jan-Sep)
- Operating loss KSEK -8,209 (-8,304)
- Loss per share SEK -0.19 (-0.40)
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.
- In June 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. All new shares has been registered at the Swedish “Bolagsverket”.
- 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
- In October the Company announced that it has recruited Mr Erik Sundquist as VagiVital™ Brand Manager. In his role, Mr Sundquist will be responsible for the commercialization of the Product – a vaginal gel developed in-house for the treatment of vaginal atrophy and vaginal dryness.
- On October 31st, the Company announced that it has signed a collaboration and sponsorship agreement with ’1.6 & 2.6 Million Club’. The 1.6 Million Club is a non-profit women's health organization that was founded in 1998 by Alexandra Charles, president ever since. She was inspired by the cardiologist, Karin Schenck-Gustafsson, and gynecology professor, Britt-Marie Landgren, who could both tell of just how male-dominated the field of research was, and how women were discriminated within the health care sector.
From the CEO
Peptonic Medical develops new, effective and safe treatments and products in the field of Women’s Health. We want to contribute to improve the availability and efficacy of products for female specific diseases. In a move to achieve these objectives, the Company has entered a sponsor and collaboration agreement with the ’1.6 & 2.6 Million Club’. This is an non-profit organisation that was founded in 1998, and today it is one of the largest women’s organisations in Sweden. The 1.6 Million Club was established with the purpose of improving and creating equal research and healthcare, and in order to spread objective information, it has approximately 33 000 members today. Ten years later, the 2.6 Million Club was established for younger women, from 25 years and upwards. The 1.6 and 2.6 Million Clubs share the same objective, and anybody over the age of 18 is welcome as a member in the association (including men).
During the third quarter we have focussed on obtaining the CE mark for VagiVital™. To achieve this a Quality Management System needs to be implemented (ISO 13485) and a Technical File has to be produced and approved. So far, the work has progressed according to plan, which means that the CE mark should be obtained during the first quarter of 2018. One this is in place, the product can be marketed and sold throughout Europe. A corresponding registration project for the US market will commence soon after the CE mark.
The first market launch for VagiVital™ will be in Sweden. In preparation for the launch a major effort has to be made around product positioning, design, PR, sales channel development etc. To lead this work, Mr Erik Sundquist has been recruited as the VagiVital™ Brand Manager. Mr Sundquist has a long career and experience from launching and marketing medical devices both in Sweden and internationally.
Associate Professor, Mrs Aino Fianu Jonasson, who acted as principal investigator in the most recent clinical study has accepted to act as Medical Advisor of Peptonic. She will support the Company in medical matters and in the communication with e.g. the gynaecologists concerning VagiVital™.
We also have ambitions to launch VagiVital™ on markets outside Sweden. This in partnerships with distributors. There is a continued great interest in VagiVital™ among partner candidates. Because VagiVital™ is a medical device, the regulatory path is shorter and less costly and for a drug. Discussion with potential distributors are underway.
In Peptonic, we have exciting times ahead of us and we will keep telling the market of the progress we are making.
Stockholm, November 9th, 2017
This interim report has not been reviewed by the Company’s auditors.
The Board of Directors and the CEO certifies that the interim report gives a fair overview of the business, position and profit or loss of the Company.
Year end report, 2017 February 27th 2018
Stockholm, November 9th, 2017
Hans von Celsing, Chairman of the Board Arne Ferstad, Board member
Marianne Östlund, Board member Leni Ekendahl, Board member
Johan Inborr, CEO
For more information please contact:
Johan Inborr, CEO Peptonic Medical AB. Phone: +46 708 853 893
This information is information that Peptonic Medical AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 9th November 2017.