”We remain optimistic about the prospects of resomelagon in RA and other inflammatory diseases where significant populations of patients are underserved by existing therapies,” said Torbjørn Bjerke, CEO.

July – September 2023

• The Group’s net sales amounted to SEK 0 (0) thousand.
• Operating expenses amounted to SEK 31,692 (26,461) thousand, an increase of 20%.
• The Group’s loss after tax amounted to SEK 31,878 (23,919) thousand.
• The Group’s earnings per share before and after dilution amounted to SEK -1.00 (-0.84).
• Cash flow from operating activities amounted to SEK -14,653 (-41,335) thousand.
• Cash flow from financing activities amounted to SEK -153 (-230) thousand.
• Cash flow for the period amounted to SEK -14,804 (-41,565) thousand.
• Cash and cash equivalents at the end of the period amounted to SEK 28,876 (54,898) thousand.

January – September 2023

• The Group’s net sales amounted to SEK 0 (0) thousand.
• Operating expenses amounted to SEK 133,434 (75,182) thousand, an increase of 77%, driven primarily by the two clinical studies in RA and higher administrative costs caused by the acquisition of TXP Pharma AG.
• The Group’s loss after tax amounted to SEK 125,267 (68,728) thousand.
• The Group’s earnings per share before and after dilution amounted to SEK -3.96 (-2.52).
• Cash flow from operating activities amounted to SEK -79,782 (-95,248) thousand.
• Cash flow from financing activities amounted to SEK -577 (124,686) thousand.
• Cash flow for the period amounted to SEK -79,989 (29,438) thousand.

Significant events during the period

• July 14 – SynAct announces that dosing has been completed in the company’s Phase 2b EXPAND study, which evaluates the daily dose of resomelagon (AP1189) for patients with early rheumatoid arthritis (RA) with severe disease activity.
• July 20 – SynAct announces that it completed patient recruitment for part A of the P2a/b RESOLVE clinical study of resomelagon (AP1189) in patients with an inadequate response to first-line disease modifying anti- rheumatic drugs (DMARD-IR) who are experiencing moderate to severe disease activity.
• Aug 17 – SynAct today announces that dosing has been completed in the Phase 2a portion of the RESOLVE Phase 2a/b clinical study of once-daily oral resomelagon (AP1189) in patients with an inadequate response to first-line disease-modifying antirheumatic drugs (DMARD-IR). A total of 125 patients were randomized into the study with over 20% recruited in the US. With dosing completed SynAct anticipates releasing top-line study data in October of this year.
• Sept 4 – SynAct announces top line data from the 12-week EXPAND P2b clinical trial in severely active newly diagnosed rheumatoid arthritis patients.
• Sept 12 – SynAct announces additional data from the EXPAND P2b clinical trial and identifies population with responsiveness to resomelagon.

Significant events after the end of the period

• Oct 3 - SynAct announces additional data from the EXPAND P2b clinical trial further supporting efficacy and activity seen in patients with elevated CRP.
• Oct 11 - SynAct carries out a directed issue of shares and warrants raising initial gross proceeds of SEK 60.5 million.
• Oct 12 – SynAct publishes prospectus in connection with admission to trading of new shares on Nasdaq Stockholm.

For further information about SynAct Pharma AB, please contact:
Torbjørn Bjerke
CEO, SynAct Pharma AB
Phone: +46 727 44 41 58
Email: TBJE@synactpharma.com
Email: investor.relations@synactpharma.com
 
Björn Westberg
CFO, SynAct Pharma AB 
Phone: +46 733 94 09 53
Email: investor.relations@synactpharma.com