Interim report 3, 2016

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, no comparative periods relating to the group and the parent company can be presented. “SynAct Pharma AB” means the parent company SynAct Pharma AB with company registration number 559058-4826. “The Company” or “SynAct” refers to the group, that is, SynAct Pharma AB and its wholly-owned subsidiary SynAct Pharma ApS.

Summary of the interim report

01-07-2016 – 30-09-2016

  • The group’s net sales amounted to SEK 0 Thousand.
  • The group’s profit/loss after financial items was SEK-2 087 Thousand.
  • The group’s earnings per share amounted to SEK-0.17.
  • The equity ratio was 97.5%.

12-04-2016 – 30-09-2016

  • The group’s net sales amounted to SEK 0 Thousand.
  • The group’s profit/loss after financial items was SEK-7 672 THOUSAND.
  • The group’s earnings per share amounted to SEK-0.63.

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: 12,260,021 shares. The number of shares as at 30 September 2016 amounted to 12 260 021 shares.

Equity ratio: Equity divided by total capital.

Significant events in the Third Quarter 2016

  • SynAct shares and subscription options were listed on Aktietorget on July 11.

Significant events since the end of the period

  • SynAct fulfilled final commitments to the financier Seed Fund CapNova by a one-off payment of DKK 3.3 million.

Significant events in the first half of the year

  • In May/June 2016, a share issue was carried out, which was subscribed to approximately 203%. The issue raised approximately SEK 32.3 million for the company before issue costs.

CEO Jeppe Øvlesen has the word

Based on a unique platform technology, SynAct is developing a new class of drug candidates, targeting acute deterioration in inflammatory diseases. Our focus is on the development of candidate drug AP1189 for the treatment of psoriatic arthritis.

SynAct has now been listed on Aktietorget for just over four months and our work is proceeding according to plan. During that period, the company has continued preparations for the planned Phase I clinical trial. The focus has been on the formulation development and production of AP1189 for use in the Phase
1-study. Furthermore, the work to complete the documentation required to start the clinical study has progressed well and it remains the intention to submit the application to the regulatory authority before the end of the year. Reckoning on 60 days of administration time by the authorities, we are ready to start dosing at the beginning of 2017. The results from the Phase I study are expected to be reported in 2017. Assuming positive data, the plan is to initiate a Phase II study in psoriatic patients the same year. The intention is that after completion of the Phase II study, which is planned for 2018, to find a strategic partner to acquires the project for further development and marketing.

So far, the Seed Fund CapNova and the Danish state have financed the AP1189 medicine project. In return, SynAct has undertaken to pay up to DKK 17 Million in the form of milestone payments and royalties on any future net sales. In October, SynAct decided to use an opportunity to evade the obligation to pay future compensation by paying CapNova a lump sum of DKK3.3 Million, which the board deemed beneficial to the company’s shareholders.

We look forward with confidence to the future and are continuing our work towards the goal of having both completed the Clinical Phase I study and started the Phase II clinical trial with AP1189 in 2017.

Jeppe Øvlesen

CEO – SynAct Pharma AB

Psoriasis

Psoriasis is a common skin disease all over the world – about two to three percent of the population of the Western world suffers from the disease. About 30% of patients suffer from psoriatic arthritis, a chronic inflammatory joint disease that causes pain and stiffness. In its most severe form, psoriatic arthritis leads to debilitating symptoms. Despite significant advances in drug developments in recent decades and the introduction of new treatments, a large proportion of patients do not respond to current treatments or suffer significant side effects.

SynAct Pharma AB

SynAct is a biotechnology company that conducts research and development in inflammatory diseases via the wholly owned Danish subsidiary SynAct Pharma ApS. The company has a platform technology based on a new class of drug candidate targeting acute deterioration in chronic inflammatory diseases, with the primary purpose of stimulating natural healing mechanisms. SynAct Pharma’s main focus is on the development of the candidate drug AP1189, which strengthens the body’s own cells and fights flares in inflammation by accelerating recovery and thereby reducing the risk of chronic inflammation deterioration.

SynAct has conducted preclinical toxicological and safety pharmacology studies and plans to submit an application to initiate a Phase I clinical study to the regulatory authorities before the end of the year.

Business model

Synact’s business model is to run projects into clinical development in order to secure proof-of-concept, i,e support for clinical relevance. Based on clinical data, the company intends to identify a strategic partner that can acquire the project for further development.

Development plan – objectives and milestones

2016

  • Produce medicines for use in the Phase I clinical study.
  • Prepare and start clinical Phase I study with AP1189.
  • Initiate research regarding other indications for AP1189.

2017

  • Summary and final report of the clinical Phase I study with AP1189.
  • Prepare and start clinical Phase II study with AP1189 in psoriatic arthritis.
  • Initiate pre-clinical study of SynAct’s second indication.
  • Extended planning for commercial business with AP1189.

2018

  • Summary and final report of clinical Phase II study with AP1189.
  • Conduct commercial business with AP1189.
  • Potentially initiate clinical study of AP1189 in other indication(s).

Group relationship and shareholding

SynAct Pharma AB is the parent company of a group that includes the wholly owned subsidiary SynAct Pharma ApS. All operations are carried out by the subsidiary, thus SynAct Pharma AB’s only operational business is owning the subsidiary SynAct Pharma ApS. In addition to the above, SynAct has no further shareholdings in other companies.

Operational risks and uncertainty factors

In summary, the risks and uncertainties to which Synact’s activities are exposed are related to, drug development, competition, technology development, patents, government requirements, capital requirements, currencies and interest rates, among other things. No significant changes in the risk or uncertainty factors have occurred during the current period. For more detailed reporting of the risk and uncertainty factors, please refer to the previously published prospectus, published in May 2016.

Shares

Shares in SynAct were listed on Aktietorget on 11 July 2016. Aktietorget is a trading name for ATS Finans AB, which is a securities company supervised by Finansinspektionen (Swedish Financial Supervisory Authority). AktieTorget operates a Multilateral trading facility (MTF). As per 30 September 2016, the number of shares in SynAct was 12 260 021.

Subscription options

In connection with the company’s issue prior to listing on Aktietorget during 2016, there was a new issue (in addition to 5 050 000 shares) of 2 020 000 series TO 1 subscription options. The first trading day for the subscription options on Aktietorget was 11 July 2016. Possession of one (1) Series TO 1 subscription option warrant entitles the holder to subscribe to one (1) newly issued share at a rate of SEK 6.40. Subscription to shares with the support of series TO 1 subscription options may take place from 9 March 2017 until 23 March 2017. The subscription option’s ISIN code is SE0008320972. In the event that all series TO 1 subscription options are utilized, SynAct will raise approximately SEK 12.4 Million after the issue costs of approximately SEK 0.5 Million have been deducted.

List of owners

Below is a list of shareholders with an ownership interest in SynAct Pharma AB of more than five per cent, as of 30 September 2016.

Name Number of shares Share of votes and capital
TJ Biotech Holding AB (1) 2 182 845 17.80%
Quantass ApS (2) 1 338 524 10.92%
GLCapital AB (3) 714 524 5.83%
Other 8 024 128 65.45%
Total 12 260 021 100.00%
(1) Owned 100 percent by board member and CSO Thomas Jonassen.
(2) is 50 percent owned by CEO Jeppe Øvlesen.
(3) Owned 100 percent by Chairman of the Board Torbjørn Bjerke.

 

Principles for preparation of the interim report

This interim report has been prepared in accordance with the Swedish Annual Accounts Act and the General Council of Accounting Law BFNAR 2012:1 “K3”. For further information see the Company prospectus published in July 2016.

Review by the Company’s auditor

The interim report has not been subject to review by the company’s auditor.

Forthcoming financial statements

SynAct establishes and publishes a financial report at each Quarter-end. The following upcoming reports are planned :

  • Year-end report for 2016, 9 February 2017
  • Annual General Meeting, 11 May 2017

Submission of interim report

Lund, 4 November 2016

SynAct Pharma AB

Board

For further information

Jeppe Øvlesen

CEO, SynAct Pharma AB

Telephone: +45 28 44 75 67

E-mail: joo@synactpharma.com

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 4 November 2016.