Summary of the interim report
01-07-2017 – 30-09-2017 (Third Quarter 2017)
- The group’s net sales amounted to SEK 0 (0) thousand.
- The group’s profit/loss after financial items amounted to SEK-2 148 (-2 087) Thousand.
- The group’s earnings per share amounted to SEK-0.15 (-0.17).
- The equity ratio was 92.5% (97.5%).
01-01-2017 – 30-09-2017 (nine months)
- The group’s net sales amounted to SEK 0 (0) thousand.
- The group’s profit/loss after financial items amounted to SEK-10 773 (-7 672) Thousand.
- The group’s earnings per share amounted to SEK-0.78 (-0.63).
- The equity ratio was 92.5% (97.5%).
The operating subsidiary SynAct Pharma ApS started operations in 2012. SynAct Pharma AB was founded on 12th April 2016. Thus, the group relationship arose 12/04/2016. For this reason, comparative periods relating to the group and the parent company relate to the period 12-04- 2016 – 30-09-2016. “SynAct Pharma AB” means the parent company SynAct Pharma AB with company registration number 559058-4826. “The Company” or “SynAct” means the group, that is, SynAct Pharma AB and its wholly-owned subsidiary SynAct Pharma ApS.
Definitions
Earnings per share: Profit/loss for the period divided by the average number of shares. The average number of shares for the Third Quarter is 12 417 449 shares and 12 350 557 shares for the entire period.
The number of shares as at 30 September 2017 amounted to 12 417 449.
Equity ratio: Equity divided by total capital.
Significant events in the Third Quarter of 2017
- There were no significant events in the Third Quarter of 2017.
Significant events since the end of the period
- In early October 2017, SynAct announced that the single-dose part of the Phase I study with AP1189 has been successfully implemented and that the development programme could thus continue according to plan. Preliminary data showed that AP1189 exhibited a good safety profile and is well tolerated at doses that exceed the expected therapeutic effect by a good margin.
- SynAct announced in October 2017 that three members of the company’s management had increased their respective shareholding in SynAct.
CEO Jeppe Øvlesen has the word
During the Quarter we have worked hard on our ongoing clinical Phase I study with AP1189, which is proceeding according to plan. The primary purpose of the Phase I study is to evaluate the safety and tolerability of AP1189 in healthy subjects and to study the pharmacokinetics of the substance, i.e. how it is absorbed and metabolized (broken down) in the body.
Shortly after the end of the Third Quarter we were able to announce that we have successfully completed the single-dose part of the Phase I study.
AP1189 was administered to a total of 48 healthy subjects during this initial part of the ongoing double-blinded Phase I study. Preliminary results show that AP1189 in single dose has a good safety profile up to doses that give 10 times higher concentrations in the blood than the expected dose levels for therapeutic use. This, together with the good pharmacokinetic profile, supports the continued development of AP1189 for dosing once daily.
The phase I programme continues in the autumn of 2017 with a study in which AP1189, in the form of a newly developed tablet, will be given with and without food in order to investigate how food intake affects the uptake of the candidate drug by the body. Thereafter, AP1189 will be given once daily for two weeks to 36 subjects in a final multiple-dose component. Full analysis and presentation of the data will take place after the entire study has been completed and unblinded.
We are, of course, very excited about the outcome of the initial part of the clinical Phase I study and look forward to continuing the development of AP1189. We are now focusing on the remaining parts of the Phase I study, but preparations are also underway, in parallel, for the first patient study (phase II), which is scheduled to start in the first half of 2018.
In October we also announced that I, together with two of my colleagues, have chosen to increase our holdings in SynAct through the purchase of the shares currently trading on Aktietorget.
Jeppe Øvlesen
CEO – SynAct Pharma AB
For further information about SynAct Pharma AB, please contact:
Jeppe Øvlesen
CEO, SynAct Pharma AB
Telephone: +45 28 44 75 67
E-mail: [email protected]
Henrik Stage
CFO, SynAct Pharma AB
Telephone: +45 40 26 09 00
E-mail: [email protected]