SynAct Pharma publishes Q2 2022 interim report

“Boosted by the successful rights issue that was completed in the second quarter, SynAct continued to drive progress in its clinical development pipeline for AP1189 and deliver on the commitments on corporate activities,” said Jeppe Øvlesen, CEO.

April – June 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 26,417 (15,603) thousand, an increase of 69%, driven both by increased investments in R&D and higher administrative costs for the application for listing on Nasdaq Stockholm.
• The Group’s loss after tax amounted to SEK 24,754 (13,137) 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 2,871 (2,719) thousand in the quarter.
• The Group’s earnings per share before and after dilution amounted to SEK -0.91 (-0.51).
• Cash flow from operating activities amounted to SEK -36,922 (-16,114) thousand.
• Cash flow from financing activities amounted to SEK 125,158 (0) thousand.
• Cash flow for the period amounted to SEK 88,236 (-16,114) thousand.
• Cash and cash equivalents at the end of the period amounted to SEK 96,466 (62,532) thousand.

January – June 2022

• The Group’s net sales amounted to SEK 0 (0) thousand.
• Operating expenses amounted to SEK 48,722 (29,661) thousand, an increase of 64%, 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 44,809 (24,872) 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 5,133 (5,054) thousand in the first six months.
• The Group’s earnings per share before and after dilution amounted to SEK -1.68 (-0.97).
• Cash flow from operating activities amounted to SEK -53,913 (-26,491) thousand.
• Cash flow from financing activities amounted to SEK 124,916 (74,400) thousand.
• Cash flow for the period amounted to SEK 71,003 (47,907) thousand.

Significant events during the period

• April 1 – SynAct Pharma publishes the prospectus for the rights issue.
• April 25 – SynAct Pharma publishes the outcome of the rights issue. Through the issue, the Company will receive SEK 150 million before issue costs, which are estimated to amount to approximately SEK 24 million. After registration with the Swedish Companies Registration Office, the number of shares will increase by 2,364,208 to 28,370,503 shares and the share capital by SEK 295,526 to SEK 3,546,313.
• May 4 – SynAct Pharma reports successfully completed pharmacokinetic tests with AP1189 tablet. The data confirm that the new tablet formulation is superior to the AP1189 suspension used so far. Further development of AP1189 will be carried out with the new tablet.
• May 12 – Last day for trading in paid subscribed shares (BTA) and number of new shares in SynAct Pharma are reported.
• June 21 – SynAct Pharma submits Clinical Trial Application (CTA) for the Phase 2b study, EXPAND, with AP1189 in patients with newly diagnosed rheumatoid arthritis (RA).
• June 28 – SynAct Pharma receives approval from Nasdaq Stockholm’s listing committee for listing the Company’s shares on the main market.
• June 29 – SynAct Pharma receives pre-IND response from the US Food and Drug Administration (FDA) on its proposed development plan and clinical trial design for AP189 in RA.

Significant events after the end of the period

• July 8 – SynAct Pharma publishes 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 announces a redesign of the ongoing clinical Phase 2a study in iMN patients. The application to amend the study protocol has been submitted to relevant authorities for approval.