Period from January 2018 to March 2018
Peptonic Medical AB (publ) org nr 556776-3064
(www.aktietorget.se ticker: PMED)
2018 FIRST QUARTER (Jan-Mar)
- Operating loss KSEK -2,756 (-2,681)
- Loss per share SEK -0.06 (-0.13)
IMPORTANT EVENTS DURING THE PERIOD
- On March 22nd the Company informed that it is close to CE mark for VagiVital®. This after the Company has received the report of the evaluation of its so called Technical File. The evaluation has been performed by Lloyd’s Register Quality Assurance, Ltd. (LRQA) in England, acting as the Notified Body.The Company submitted the Technical File in January but due to a heavy work load at LRQA the evaluation report was delayed until now.The report lists a number of items of the Technical File that need clarification or need to be complemented. It is the view of the Company that these items can be addressed based on the existing documentation on VagiVital® and no further tests are required. Hence, the Company’s response to the evaluation report will be submitted in the near future. This means that the approval of the CE mark can be expected during April.
- At the AGM On March 28th, all Board Members were re-elected
IMPORTANT EVENTS AFTER THE END OF THE PERIOD
- On April the 10th 2018 Peptonic Medical announced its plans for a partly underwritten rights issue of 12.5 MSEK with pre-emptive rights for existing shareholders. Issue price was set at 0.29 SEK per share.
- On April the 24th, 2018, the company announced that it has entered an agreement for the commercial supply of its hormone-free selfcare product VagiVital® with Orion Corporation (‘Orion’), with headquarters in Espoo, Finland. The supply agreement is non-exclusive and a result of a successful transfer of the manufacturing technology under the technology transfer agreement signed by the two companies in December 2017.
- On May the 8th, 2018, did the Company announced that the rights issue have been heavily oversubscribed. In total, the Company raised 12.5 MSEK before cost.
From the CEO
During the first quarter of this year our focus has been on securing the CE mark for VagiVital®, and on preparations for the launch of this first product from Peptonic Medical later this year. The journey to this point has been a roller coaster ride, but we have great confidence in the product. This not least based on the compelling clinical documentation on its striking effects and the key opinion leaders behind it.
Hence, the launch preparations are underway with full speed. An agreement concerning the supply of commercial volumes of VagiVital® was recently signed with Orion Corporation (Finland). Orion is a competent and experienced manufacturer of both pharmaceutical and self-care products. This warrants high quality and secure supply.
Our ambition is to have established VagiVital® on the Swedish market within one year. We are also continuing discussions with potential distributors outside Sweden. Our ambition is to expand our offering in the women’s health segment as soon as possible and to become a significant player in this fast growing segment of the market. We already have established contacts with a number of foreign companies specialised in women’s health wanting to enter the Nordic market.
I want to take this opportunity to wish our shareholders and collaboration partners a summer filled with sun and great holidays. You can follow us in the media and on our website (www.peptonicmedical.se) on our exciting journey with women’s health and well-being in the forefront of our minds.
Stockholm, May 15th, 2018
Peptonic Medical is an innovative Swedish development company. Our vision is to offer safe and effective treatments for women specific diseases and medical conditions.
VagiVital® is a trademark of Peptonic Medical. The product is hormone free and is being commercialised for the non-prescription use for the treatment of vaginal atrophy.
The pipeline of Peptonic Medical also includes Vagitocin®, which is an oxytocin-based vaginal gel for the treatment of VA. This product candidate is in clinical development phase 2. The development of Vagitocin® is on hold pending additional data on i.a. the mechanism of action.
In July 2014, Peptonic Medical was listed on the AktieTorget stock exchange (www.aktietorget.se, ticker: PMED) in Stockholm.
For more information: www.peptonicmedical.com
VagiVital® is a hormone free self-care product for the treatment of vaginal atrophy and vaginal dryness. The product has been tested in randomised clinical studies (vaginal atrophy) with very positive results for both subjective (most bothersome symptoms, such as vaginal dryness, vaginal irritation/itching, dyspareunia and dysuria) and objective (vaginal pH and proportion of superficial cells in the vaginal mucosa) and parameters. The magnitude of symptom relief is on par with that demonstrated with e.g. estrogen based products on the market today. It was very well tolerated and caused no serious adverse effects.
Peptonic Medical plans to launch VagiVital® as a non-prescription self-care product in 2018.
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 net sales of products.
Costs – Costs for the first quarter were KSEK -2,822 (-2,681).
Result – Loss before tax for the first quarter was KSEK -2,758 (-2,681).
Financial position and liquidity – Liquid assets was KSEK 3,369 (7,373) as of March 31, 2018.
Equity – PEPTONIC medical AB´s equity amounted to KSEK 56,936 (58,961) as of March 31, 2018, resulting in a solidity of 91 (86) 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 43,014,300, as of March 31, 2018.
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 15th May 2018.