SynAct Pharma publishes Q3 2022 interim report

“It is exciting to see the company’s pipeline continue to advance and the business case around AP1189 strengthening,” said Jeppe Øvlesen, CEO.

July – September 2022

• The Group’s net sales amounted to SEK 0 (0) thousand, which is in line with expectations given the phase the company’s research portfolio is in. The Company is not expected to generate any revenues until after the completion of the clinical phase 2 program for the drug candidate AP1189 planned for the end of 2023.
• Operating expenses amounted to SEK 26,461 (20,885) thousand, an increase of 27%, driven both by increased investments in R&D and higher administrative costs.
• The Group’s loss after tax amounted to SEK 23,919 (18,222) 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 2,650 (2,454) thousand in the quarter.
• The Group’s earnings per share before and after dilution amounted to SEK -0.84 (-0.70).
• Cash flow from operating activities amounted to SEK -41,335 (-18,250) thousand.
• Cash flow from financing activities amounted to SEK -230 (0) thousand.
• Cash flow for the period amounted to SEK -41,565 (-18,255) thousand.
• Cash and cash equivalents at the end of the period amounted to SEK 54,898 (44,402) thousand.

January – September 2022

• The Group’s net sales amounted to SEK 0 (0) thousand.
• Operating expenses amounted to SEK 75,182 (50,546) thousand, an increase of 49%, driven both by increased investments in R&D and higher administrative costs for the application for listing on Nasdaq Stockholm and expenses related to the rights issue that was decided in the first quarter of 2022.
• The Group’s loss after tax amounted to SEK 68,728 (43,094) 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 7,783 (7,508) thousand in the first nine months.
• The Group’s earnings per share before and after dilution amounted to SEK -2.52 (-1.67).
• Cash flow from operating activities amounted to SEK -95,249 (-44,470) thousand.
• Cash flow from financing activities amounted to SEK 124,686 (74,400) thousand.
• Cash flow for the period amounted to SEK 29,438 (29,652) thousand.

Significant events during the period

• July 8 – SynAct Pharma published the prospectus for the list change to Nasdaq.
• July 12 – First day of trading of the SynAct Pharma share on Nasdaq Stockholm.
• July 21 – SynAct announced a redesign of the ongoing clinical Phase 2a study in iMN patients. The application to amend the study protocol had been submitted to relevant authorities for approval.
• August 16 – SynAct informed that resomelagon has been proposed as a non-proprietary name (INN) for the company’s lead substance, AP1189.
• August 25 – The clinical trial application (CTA) for the Phase 2b study EXPAND was approved in Moldova.
• September 14 – Approval of revised protocol for the Phase 2a clinical trial in iMN was obtained.
• September 27 – SynAct Pharma enrolls first patient in Phase 2b study of AP1189 in RA.
• September 30 – SynAct Pharma submits IND for US Phase 2a/b clinical trial. In parallel, CTAs were submitted in Europe.

Significant events after the end of the period

• October 21 – The Nomination Committee for the AGM 2023 was appointed and consist of Niels Ankerstjerne Sloth, Jens Bager, Steen Christensen and Torbjørn Bjerke. Jens Bager was appointed chairman of the Nomination Committee. The AGM will be held on May 25, 2023
• November 1 – SynAct obtains clearance of the IND from US FDA for the Phase 2a/b clinical studies of AP1189 in RA.