Year-end report for the financial year 2018

The report is available on the company’s and Spotlights Stock Market’s websites (www.synactpharma.com and www.spotlightstockmarket.com). See the enclosed year-end report in the press release.

Summary of year-end report

01/01/2018 – 31/12/2018 (twelve months)

• The group’s net sales amounted to SEK 0 (0) thousand.
• The group’s profit/loss after financial items amounted to SEK -28 244 (-18 036) thousand.
• The group’s earnings per share amounted to SEK -1.71 (-1.24).
• The equity ratio was 73.5% (84.8%).
• The average number of shares for the period amounts to 13,747,338.

01/10/2018 – 31/12/2018 (Fourth Quarter)

• The group’s net sales amounted to SEK 0 (0) thousand.
• The group’s profit/loss after financial items amounted to SEK -7 517 (-7 274) thousand.
• The group’s earnings per share amounted to SEK -0.42 (-0.48).
• The average number of shares for the period amounts to 14,675,167.

“SynAct Pharma AB” refers to 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 before dilution: Profit/loss for the period divided by the average number of outstanding shares in the period.
• Earnings per share after dilution: Profit/loss for the period divided by the average number of outstanding shares in the period and outstanding subscription options.
• Equity ratio: Equity divided by total capital.

Significant events during 2018

• On 23th March 2018, the Board of Directors of SynAct proposed a rights issue of SEK 22.4 million in order to increase the market potential of AP1189 and convened an Extraordinary General Meeting.
• On 10th April, 2018, the Extraordinary General Meeting was held in SynAct. The meeting resolved to use a rights issue to provide the company with approximately SEK 22.4 million before issue costs.
• On 14th May 2018, SynAct announced that the company’s rights issue was oversubscribed by 196 percent. SynAct raised approximately SEK 20.7 million after issue costs through the rights issue.
• SynAct announced on the 12th June 2018 that the company had adapted the continued development programme for AP1189 based on new results from the Phase I study.
• 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 study 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.
• 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.
• On December 10 2018 SynAct announced that candidate drug AP1189 exhibited continued favourable safety and plasma profiles in the multiple-dose part of the Phase I study.
• On 21st December SynAct announced that dosing with the candidate drug AP1189 in the third and final cohort of the ongoing multiple-dose part of the Phase I study is completed.

Significant events since the end of the period

• On 12th February 2018 SynAct announced that the company’s positive preliminary data in the completed Phase I study had identified the doses to be used in phase II studies with the candidate drug AP1189. SynAct also announced that the Phase II study with the candidate drug AP1189 will be carried out in two parts to expand the drug candidate’s potential. SynAct intends to initiate activities to secure an additional SEK 20 million In the First Quarter of 2019, in order to carry out the second part of the Phase II study.

Submission of year-end report

Lund, 12th February 2019
SynAct Pharma AB
Board

For further information

Jeppe Øvlesen
CEO, SynAct Pharma AB
Telephone: +45 28 44 75 67
E-mail: [email protected]