History – SynAct Pharma

2025

Initiation of the Phase 2b ADVANCE study in Rheumatoid Arthritis
Two financing rounds totaling 11 MEUR. completed over Nasdaq at a premium
Focused cost-effective strategy implemented following replacement of Board and CEO

Acquires TXP Pharma AG and integrates the portfolio of peptide melanocortin agonists in the pipeline. The lead compound is TXP-11.
Resomelagon is assigned as International Nonproprietary Name (INN) for AP1189 by WHO.
Completes the enrollment of patients in EXPAND and RESOLVE Part A and releases the top-line data from the studies.
Carries out a directed issue of SEK 60.5 million in shares and SEK 59.9 million in warrants.

The Company carries out a rights issue of approximately SEK 150 million.
Clinical pharmacokinetic tests with AP1189 as a tablet are successfully completed.
The Company’s shares are listed on the mid-Cap segment at Nasdaq Stockholm’s main market.
The Company initiates the EXPAND Phase 2b clinical study with AP1189 in treatment naïve RA patients with severe disease activity.
The company successfully files and IND with the FDA and initiates the RESOLVE Phase 2a/b trial with AP1189 in patients who have an incomplete response to methotrexate.
The Company carries out a directed issue of SEK 80 million.

The company acquires TXP Pharma AG and integrates the portfolio of peptide melanocortin agonists in the pipeline. The lead compound is TXP-11.
Resomelagon is assigned as International Nonproprietary Name (INN) for AP1189 by WHO.
The company completes the enrollment of patients in EXPAND and RESOLVE Part A and releases the top-line data from the studies.
The Company carries out a directed issue of SEK 60.5 million in shares and SEK 59.9 million in warrants.

The Company investigates AP1189 in patients with COVID-19 and nephrotic syndrome.
SynAct Pharma publishes positive interim data from the Phase 2a study with AP1189 in rheumatoid arthritis.

Recruitment and dosing of patients in a Phase 2a clinical study with the drug candidate AP1189 in patients with active arthritis begins.
A rights issue of approximately SEK 30 million is carried out

The company carries out a rights issue of approximately SEK 22.4 million for the extended development program for AP1189.
The company announces that the tablet formulation of AP1189 used in the initial clinical Phase 1 study was found to give rise to excessively high variance in plasma concentration, which leads to further development with this tablet formulation being discontinued and the company continuing the development of AP1189 with an oral suspension.

The Company reports a delay of the Phase 1 clinical study with AP1189 due to a slow process with the French authorities and decides to move the study to a clinic in Belgium.
The Phase 1 clinical study with AP1189 is initiated in Belgium and SynAct commences preparations for a Phase 2a clinical study with AP1189.
The Company initiates preclinical studies with AP1189 in several disease models representative of diseases in which ACTH (adrenocorticotropic hormone) treatments are currently used (such as arthritis and NS).

SynAct Pharma AB is established.
SynAct Pharma receives approximately SEK 12.7 million through a private placement before issue costs.
SynAct Pharma receives approximately SEK 32.3 million before issue costs through a new share issue prior to listing on AktieTorget.
SynAct Pharma’s share is listed on AktieTorget (later Spotlight Stock Market).
SynAct Pharma finalizes commitments to funding from Seed Fund CAPNOVA through one-off payment.
SynAct Pharma submits the application for the start of a phase I clinical trial with AP1189 to the French Medicines Agency.

SynAct Pharma concludes toxicological, safety pharmacological and metabolism studies.
Patents are approved in Europe (patents in the US were approved in 2011).

SynAct Pharma ApS is founded by Dr. Thomas Jonassen and Dr. Søren Nielsen and starts operations based on acquired intellectual property rights and assets from Action Pharma A/S after Action Pharma A/S’s main asset, AP214, was sold to Abbvie Inc.