Year-end report 2017

Summary of year-end report

01-10-2017 – 31-12-2017 (Fourth Quarter 2017)

  • The group’s net sales amounted to SEK 0 (0) thousand.
  • The group’s profit/loss after financial items amounted to SEK-7 274 (-9 336) Thousand.
  • The group’s earnings per share amounted to SEK-0.48 (-0.64).
  • The equity ratio was 230.9% (88.7%).

01-01-2017 – 31-12-2017 (full year 2017)

  • The group’s net sales amounted to SEK 0 (0) thousand.
  • The group’s profit/loss after financial items amounted to SEK-18 036 (-16 992) Thousand.
  • The group’s earnings per share amounted to SEK-1.24 (-1.46).

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 – 31-12-2016. “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 Fourth Quarter is 12 417 449 shares and 12 367 417 shares for the entire period.

The number of shares as at 31 December 2017 amounted to 12 417 449.

Equity ratio: Equity divided by total capital.

Significant events during 2017

  • SynAct received approval from the Ethics Committee in France.
  • The utilisation period of Synact’s series TO 1 subscription options fell during March 2017. The utilisation rate of the subscription options was approximately 7.8 per cent and SynAct was administered approximately MSEK 1 before issue costs.
  • SynAct decided to carry out the clinical Phase I study with the candidate drug AP1189 in Belgium instead of France, as previously planned.
  • 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.
  • 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.
  • In October 2017, SynAct announced that three members of the company’s management had increased their respective holdings in SynAct.

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

2017 was a year in which SynAct Pharma reached several important milestones. In May, a clinical Phase I study with AP1189, a drug candidate for the treatment of acute impairments in inflammatory diseases, was initiated. The primary purpose of the study was to evaluate the safety and tolerability of AP1189 in healthy subjects and to study the pharmacokinetics of the substance.

In the first part of the Phase I study (increasing single dose), 64 subjects were dosed and AP1189 has demonstrated a favourable safety profile and a promising pharmacokinetics that provide support for the substance be administered as a dose once a day. Recently, bioequivalence studies of a newly developed tablet have also been successfully completed. The second part of the Phase I study (increasing multiple dose) is expected to start in Q1 2018 and end in Q2 2018.

In parallel with the above, preparations are underway for the first patient study (phase II). Assuming continued positive results from the ongoing Phase I study, we expect to submit an application (Clinical Trial Application; CTA) for the start of a double-blinded placebo-controlled study in patients with active arthritis in Q2 2018.

The pharmacological program to evaluate the potential of AP1189 in further indications continues, and the results are expected in Q2 2018. AP1189 is a biased agonist against melanocortin type 1 and 3 receptors that demonstrated the ability to slow progression of inflammation, and also to contribute to faster healing of the inflammation, with efficacy comparable to those reported for classical agonists against these receptors. The current market for melanocortin-based treatments is dominated by ACTH therapies (including ACHTAR-gel, Mallinckrodt Pharmaceuticals). Over the past decade, ACTH treatments have been used for difficult-to-treat cases of rheumatologic diseases, for patients with multiple sclerosis who suffer from relapses, which are difficult to control with glucocorticoid treatments, for patients with severe Nephrotic syndrome and patients with symptomatic sarcoidosis. The current market for ACTH drugs in the United States amounts to approximately 1.25 billion dollars annually. The reason why the use of ACTH treatments is limited to difficult-to-treat cases is the occurrence of a number of adverse side effects which, based on current knowledge, are not expected to occur during treatment with AP1189, even though this drug candidate has the potential to produce the same efficacy of treatment.

The objective of the ongoing pharmacology programme is therefore to generate pre-clinical proof of concept for AP1189 in a number of disease models, which are representative of the diseases for which ACTH treatments are currently being used. The market potential and the partnership opportunities in this area are deemed to be attractive.

To gain access to further scientific and clinical expertise for the further development of AP1189, SynAct Pharma has established a Scientific council, consisting of Professor Mauro Perretti, PhD, Dean of Research at the Barts and the London School of Medicine, London, Professor Constantino Pitzalis, MD, PhD, Head of the Centre for Experimental Medicine and Rheumatology, William Harvey Research Institute, London and Professor Ernest Choy, MD, Head of Rheumatology and Translational Research at the Institute of Infection and Immunity, Cardiff University School of Medicine.

The company’s Scientific Council represents significant pharmacological and clinical expertise in the field of melanocortin receptors and the pharmacological aspects of inflammation healing, as well as leading clinical expertise in the field of rheumatology with particular focus on psoriasis and rheumatoid arthritis.

In conclusion, we are making good progress in the development of AP1189 and we look forward to being able to initiate the first clinical study in patients during 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: joo@synactpharma.com

Thomas Jonassen
CSO, SynAct Pharma AB
Telephone: +45 40 15 66 69
E-mail: tj@synactpharma.com