Interim report 01/01/2018 – 30/09/2018
Summary of the interim report
01/07/2018 – 30/09/2018 (Third Quarter)
- The group’s net sales amounted to SEK 0 (0) thousand.
- The group’s profit/loss after financial items amounted to SEK -7 407 (-2 148) thousand.
- The group’s earnings per share amounted to SEK -0.45 (-0.15).
- The equity ratio was 78.2% (92.5%).
01/01/2018 – 30/09/2018 (nine months)
- The group’s net sales amounted to SEK 0 (0) thousand.
- The group’s profit/loss after financial items amounted to SEK -20 844 (-10 773) thousand.
- The group’s earnings per share amounted to SEK -1.30 (-0.78).
The operating subsidiary SynAct Pharma ApS started its operations in 2012. SynAct Pharma AB was founded on 12th April 2016. Thus, the group relationship arose 12/04/2016. “SynAct” 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.
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 14,675,167 shares and 13,434,663 for the first nine months 2018. Number of shares as at 30th September 2018 amounted to 14,675,167.
Equity ratio: Equity divided by total capital.
Significant events in the Third Quarter 2018
- On 23rd July 2018, SynAct announced that the Belgian Medicines Agency, the Federal Agency for Medicine and Health Product (FAMHP) and the local Ethics Committee had approved the company’s application to complete the multiple-dose part of the ongoing Phase I study with a suspension formulation of candidate drug AP1189.
- On 20th August 2018 SynAct announced that the company had received positive data from a preclinical study in nephrotic syndrome. The study showed that daily dosing for four weeks with candidate drug AP1189 resulted in a significant reduction of proteinuria (protein loss via the kidneys) in a trial model for nephrotic syndrome.
- On 13th September 2018 SynAct announced that the last part of the company’s ongoing phase I programme with candidate drug AP1189 had started and that the first group of subjects in the final multiple-dose part had commenced dosing with a suspension of AP1189.
Significant events since the end of the period
- On 22nd October 2018 SynAct announced that candidate drug AP1189 demonstrated a promising plasma profile in the first cohort of healthy subjects after 14 days of repeated dosing. SynAct also announced the initiation of the second cohort in the ongoing Phase I study.
CEO Jeppe Øvlesen has the word
At the end of July this year, we received the pleasing announcement from the Belgian Medicines Agency and the Ethics Committee that our application to complete the multiple-dose part of the ongoing Phase I study with the suspension formulation of the candidate drug AP1189 had been approved. The suspension formulation of AP1189 in the initial part (single dose) of the ongoing Phase I study showed good results in both safety and tolerability, in doses which exceed those expected to give therapeutic effect.
During September and October 2018, we have administered AP1189 in increasing doses once a day to groups of healthy subjects, of which nine people per group have received AP1189 and three people received a placebo in a double-blind, randomised study design. On October 22, 2018, we were able to announce that preliminary data showed that we had a very attractive plasma profile for our drug candidate AP1189 with repeated dosing. It is very promising that we had already reached a level of exposure that is expected to give therapeutic effect after dosing in the first cohort. Preliminary and blinded data showed that the pharmacokinetic profile after dosing in the first cohort confirmed the attractive pharmacokinetic properties previously observed after single doses in the first part of the Phase I study. The dose used in the first multiple-dose cohort (50 mg) produced a robust exposure with low inter-and intravariability and the plasma levels of AP1189 are judged to be high enough to have a therapeutic effect.
Based on the results achieved so far, the final part of the Phase I study is expected to be completed by the end of 2018. Full analysis and presentation of the data will be carried out after unblinding, that is, when the treatment code has been withdrawn.
In parallel with the ongoing Phase I study, in a preclinical study in nephrotic syndrome, we have received positive data with the candidate drug AP1189. The preclinical study shows that daily dosing with AP1189, over a time span of four weeks, provides a significant reduction of proteinuria (protein loss via the kidneys) in a trial model for nephrotic syndrome. Nephrotic syndrome is characterised by proteinuria, decreased levels of plasma protein and oedema development. Untreated, the disease leads to chronic renal failure, where dialysis and transplantation are the only treatment options. Chronic renal failure leads to a markedly increased risk of cardiovascular diseases, including high blood pressure and myocardial infarction. Nephrotic syndrome can in many cases be considered an autoimmune disease and is often seen as manifestation in systemic inflammatory diseases. Approximately 40% of all patients with systemic lupus erythematosus (SLE) have symptoms of impaired renal function with proteinuria.
Overall, I see our continued development of the candidate drug AP1189 to be very positive.
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]
Thomas Jonassen
CSO, SynAct Pharma AB
Telephone: +45 40 15 66 69
E-mail: [email protected]