Half-yearly report 01-01-2017 – 30-06-2017

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 – 30-06-2016. “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 Second Quarter is 12 373 719 shares and 12 316 556 shares for the first half.

The number of shares as of June 30, 2017 amounted to 12 417 449.

Equity ratio: Equity divided by total capital.

Significant events in the Second Quarter of 2017

• SynAct decided to carry out the clinical Phase I study with the candidate drug AP1189 in Belgium instead of France, as previously planned. In connection with this, the company revised its timetable for presentation of phase I results and initiation of the Phase II study from before year-end 2017/2018 to the First Quarter of 2018.
• SynAct received all the regulatory approvals necessary to start the first clinical study with the candidate drug AP1189. The study was conducted in Belgium and started at the end of May 2017.
• On 11 May 2017, the Annual General Meeting for SynAct was held. A Bulletin of the Annual General Meeting with summary of the decisions that were made is available via the company’s (www.synactpharma.se) and AktieTorget’s (www.aktietorget.se) websites respectively.
• On 7 June 2017, SynAct announced that the clinical study with AP1189 had been initiated and that the first healthy subjects had been dosed.

Significant events since the end of the period

• There have been no significant events since the end of the period.

CEO Jeppe Øvlesen has the word

During the Second Quarter of the year we have worked hard to start the clinical Phase I study of our drug candidate AP1189, a new potential treatment of the significant proportion of psoriatic patients affected by severe joint symptoms, where there is still a great need for new safe and effective treatment options. We decided to carry out the study in Belgium instead of France, because the dialogue with the French Medicines Agency proved to be much more time-consuming than could have been predicted. This led us to revise our timetable for presentation of study results and the initiation of the planned subsequent Phase II study.

The application for a review in Belgium was submitted in April, and we received approval on 10 May from both the Belgian Medicines Agency and the Ethics Committee. We are very pleased to have received this long-awaited announcement and that we are able to initiate the first clinical study with AP1189.

After completing the remaining practical preparations, we were able to announce on 7 June that the clinical study with AP1189 had been initiated and that the first healthy subjects had been dosed. This is a major and important milestone for SynAct because the results of the Phase I study will provide both the company and potential commercial partners with valuable information for the further development of AP1189. Several of the dose levels have already been completed and the study is continuing 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. In the first part of the study, AP1189, which is taken orally, will be given in single ascending doses. In a second part of the study, AP1189 will be given in ascending daily doses for up to 14 days. We will also study how food may affect the uptake of AP1189 by the body. In total, up to 108 healthy test subjects will be studied. Results from the study are expected to become available in the First Quarter of 2018.

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]

This is information that SynAct Pharma AB is obliged to make public pursuant to the EU market abuse regulation and the Securities Markets Act. The information was submitted by the above contact person for publication on 31 August 2017. 

SynAct Pharma AB

SynAct Pharma AB develops medicines for acute deterioration in inflammatory diseases. The company’s candidate drug AP1189 is primarily intended for the treatment of acute deterioration of psoriatic arthritis – a form of joint inflammations that affects approximately 30% of patients suffering from psoriasis.

Preclinical studies show that AP1189 has a unique ability to both reduce inflammation and accelerate the healing of joint injuries. AP1189 has the potential to be administered in tablet form once daily. Results from a Clinical Phase I study are expected to be available in the First Quarter of 2018. The company’s ambition is to then carry out a phase IIa study, and to then sign commercial agreements with one or more major pharmaceutical companies.