“We are truly at an exciting inflection point for SynAct. I am excited to continue to work with the talented management team we have at SynAct, and we are all eagerly awaiting the upcoming clinical trial results that will build off the strong data demonstrated in the BEGIN study. I want to express our sincere appreciation to our shareholder base for supporting our shared vision of resomelagon and the promise of resolution therapy. Our combined resolve remains strong,” said Torbjørn Bjerke, CEO.

April – June 2023

• The Group’s net sales amounted to SEK 0 (0) thousand, which is in line with expectations given the development phase that SynAct’s projects are in. The Company is not expected to generate any revenues until after the completion of the clinical phase 2 program for the drug candidate resomelagon (AP1189), at the earliest in 2024.
• Operating expenses amounted to SEK 43,495 (26,417) thousand, an increase of 65%, driven mainly by the two clinical studies in RA and higher administrative costs.
• The Group’s loss after tax amounted to SEK 43,511 (24,754) thousand.
• Profit after tax is improved by the effect that arises because of the Danish tax credit scheme, which means an early tax refund related to part of the research and development costs incurred. The effect of this tax credit was SEK 90 (2,871) thousand in the quarter.
• The Group’s earnings per share before and after dilution amounted to SEK -1.37 (-0.91).
• Cash flow from operating activities amounted to SEK -34,657 (-36,922) thousand.
• Cash flow from financing activities amounted to SEK -179 (125,158) thousand.
• Cash flow for the period amounted to SEK -34,704 (88,236) thousand.
• Cash and cash equivalents at the end of the period amounted to SEK 44,421 (96,465) thousand.

January – June 2023

• The Group’s net sales amounted to SEK 0 (0) thousand.
• Operating expenses amounted to SEK 101,743 (48,722) thousand, an increase of 109%, 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 93,389 (44,809) thousand.
• Profit after tax is improved by the effect that arises because of the Danish tax credit scheme, which means an early tax refund related to part of the research and development costs incurred. The effect of this tax credit was SEK 8,358 (5,133) thousand for six months.
• The Group’s earnings per share before and after dilution amounted to SEK -2.96 (-1.68).
• Cash flow from operating activities amounted to SEK -65,129 (-53,913) thousand.
• Cash flow from financing activities amounted to SEK -425 (124,916) thousand.
• Cash flow for the period amounted to SEK -65,186 (71,003) thousand.

Significant events during the period

• April 3 – SynAct's board appoints current board chairman Torbjørn Bjerke as new CEO. He succeeds Jeppe Øvlesen, who has been CEO since 2015, in connection with the general meeting on May 25. The nomination committee proposes that the AGM elects current board member Uli Hacksell as new chairman and Thomas von Koch as new board member.
• April 24 – Recruitment to SynAct’s phase 2b clinical trial, EXPAND, with resomelagon (AP1189) in patients with severe, newly diagnosed rheumatoid arthritis (RA) is completed ahead of schedule. 127 patients have been randomized to the study. The company expects to be able to report key results within five months.
• May 15 – SynAct announces that Björn Westberg has been appointed CFO and member of the group management in SynAct. Björn has extensive experience from the life-science sector, from smaller pharmaceutical companies to contract manufacturing and "Big Pharma". He will take office on 15 June 2023.
• May 25 – SynAct's annual general meeting was held in Malmö. The meeting confirmed the financial statements and accounts for 2022 and disposition of the company's results. The board and the CEO were granted discharge for the financial year 2022. Board members Thomas Jonassen, Terje Kalland, Uli Hacksell, Marina Bozilenko and Kerstin Hasselgren were re-elected, and Thomas von Koch was elected as a new board member. Uli Hacksell was elected as the new chairman of the board. KPMG was given renewed trust as auditor and remuneration to the board and auditor and the remuneration report for 2022 was determined. In addition, the meeting decided on changes to the articles of association, authorization for the issue of shares and an employee option program. Jeppe Øvlesen resigned and Torbjørn Bjerke took office as CEO.

Significant events after the end of 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. SynAct expects to be able to publish top-line data from the study in September.
• 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. A total of 125 patients were randomized into the study. With all patients recruited SynAct anticipates releasing top-line study data in October this year.

The information was submitted, through the agency of the contact persons below, for publication at 07:30 a.m. CET on August 4, 2023.

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: +46 703 33 91 23
Email: BWE@synactpharma.com