SynAct Pharma publishes Q1 2023 interim report

“This is an exciting time for SynAct, and the team is working hard to position the company for success. We have accomplished so much over the past decade. I have thoroughly enjoyed the challenge and am confident the company is on the right path and in good hands. I want to thank all investors and other stakeholders who have supported the company during this journey. I look forward to continuing to follow SynAct in the years to come.,” said Jeppe Øvlesen, CEO.

January – March 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 58,248 (22,304) thousand, an increase of 161%, driven mainly by the two clinical studies in RA and higher administrative costs derived from the acquisition of TXP Pharma AG. TXP Pharma is consolidated into the Group’s reports as of this first quarter 2023.
• The Group’s loss after tax amounted to SEK 49,878 (20,055) 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 8,268 (2,262) thousand in the quarter.
• The Group’s earnings per share before and after dilution amounted to SEK -1.59 (-0.77).
• Cash flow from operating activities amounted to SEK -30,472 (-16,991) thousand.
• Cash flow from financing activities amounted to SEK -246 (-242) thousand.
• Cash flow for the period amounted to SEK -30,482 (-17,233) thousand.
• Cash and cash equivalents at the end of the period amounted to SEK 78,214 (6,806) thousand.

Significant events during the period

• January 12 – SynAct holds an extraordinary general meeting at Medicon Village in Lund. The meeting votes unanimously for approval of the board's proposal for the acquisition of TXP Pharma AG and a non-cash issue of approximately 2.1 million consideration shares to the sellers of TXP Pharma. The shareholders also approve the board's proposal for a staff option program for two senior executives and one other employee.
• January 16 – The TXP transaction is completed by SynAct receiving 100% of the shares in TXP Pharma AG in exchange for approx. 2.1 million newly issued consideration shares.
• February 1 – SynAct announces that Patrik Renblad has resigned and will leave the Company and that recruitment of a new CFO has begun.
• March 23 – SynAct's subsidiary, TXP Pharma AG, is granted a patent in Canada related to “Alpha and gamma MSH analogs”. In addition, the national phase begins in important regions and countries for another patent family regarding “Exendin-4 analogs”.
• March 28 – SynAct invites to the Capital Markets Day to be held in Stockholm on May 5, 2023.
• March 30 – Resomelagon has been included by the WHO as the recommended non-proprietary generic name (INN) of the company's lead drug candidate. SynAct will introduce the new name resomelagon (AP1189) in its communication.

Significant events after the end of 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.

The information was submitted, through the agency of the contact persons below, for publication at 07:00 a.m. CET on May 5, 2023.