Interim Report January – June 2023 – August 4, 2023
We have certainly had a productive first half of 2023 and we have set the stage for what will be a monumental second half of the year for SynAct, for our shareholders and for the future of how we treat debilitating inflammatory and autoimmune diseases. We focused in the first half of this year on preparing the company for the upcoming data releases, active partnering discussions and building out our pipeline of resolution therapeutics. Now is the time for us to put that preparation into action to meet the tremendous opportunities in front of us.
On the company organization front, I assumed the role of CEO after our AGM in May. I became CEO to lead the company through the exciting future that lies ahead, and I am committed to build upon all the hard work, investment and dedication that has brought us to this exciting inflection point.
As I transitioned from Chairman to CEO, Uli Hacksell stepped up to become the new Chairman. Uli has an extensive track record of building dynamic pharma companies and I am excited to be able to transfer the Chairman’s mantle to him. We were also pleased to announce that Thomas von Koch joined the board, significantly bolstering our board’s strength and capabilities. We also appointed Björn Westberg as CFO. Björn has extensive experience in the life science sector, including both smaller pharmaceutical companies and “big pharma.” His addition will be important for SynAct’s future growth journey.
On the development front, we are very excited about the progress we have made with resomelagon (AP1189) rheumatoid arthritis (RA) program. In July we announced that we completed dosing in the EXPAND 12-week trial of resomelagon in combination with methotrexate (MTX) in newly diagnosed rheumatoid arthritis (RA) patients experiencing severe disease activity. We are excited to see the trial results in September. This is an important patient population who can have a poor disease prognosis given the early severity of their disease. We also announced recently that we have completed enrollment in the Phase 2a portion of the RESOLVE P2a/b trial of resomelagon as add-on therapy to MTX in RA patients who have had an insufficient or incomplete response to MTX (a population known as DMARD-IR patients). We expect the 4-week Phase 2a dose ranging data to be released in October which will set the stage for initiating the 12-week P2b portion of the RESOLVE study in the first half of 2024. Last year we redesigned the nephrotic syndrome study to benefit from the possibility to dose for 12 weeks with our new tablet formulation with aim to have recruitment completed in the second half of 2023.
Despite strong commitment from our investigators it has shown difficult to identify eligible patients. We have therefore initiated work to identify how we with our current and additional sites can ensure that we get eligible patients identified and recruited. However, it is foreseen that it is unlikely that recruitment will be completed in 2023. Operating expenses for the first six months amounted to MSEK 102 (49), an increase of 109%, driven primarily by the two clinical studies.
On the corporate front, we significantly increased our pipeline of resolution assets by acquiring TXP Pharma and its portfolio melanocortin agonists. While our focus remains on resomelagon, these new assets afford the ability to target a wide range of inflammatory and autoimmune disease and provide a much broader platform for long-term growth. We were also able to increase communication with our shareholders by holding a capital market day in May where we were able to take a deep dive on the promise of resolution therapy, progress made with resomelagon and the rationale for the TXP acquisition. We had a strong turnout, highlighting the depth of interest in SynAct and we are grateful to all of those who took the time to join.
With these advancements, we continue to be on the leading edge of delivering on the promise of resolution therapy. The last few decades have witnessed amazing advancements in treating autoimmune diseases like RA with an anti-inflammatory strategy. While these therapies have been game changers, there is still between 50-70% of the patients that do not experience a relief of their symptoms. In addition, the current treatments have also demonstrated the risks that can come with suppressing the immune system. With resomelagon, we seek to go beyond suppression by stimulating the body to resolve inflammation. We have designed aspects of the ongoing trials and initiated additional non-clinical investigations to better demonstrate resolution in action. We hope to have many of these readouts in the second half of the year alongside the clinical trial results.
Over the first half of this year, as has been our approach in the past, we have delivered meaningful advancements in a capital efficient manner. Resomelagon is approaching the stage where development costs and complexity will increase significantly. We continue to talk with key companies in the inflammation space to identify like-minded partners who believe in resomelagon and resolution therapy. Importantly, we are looking for a partner who sees the broad potential for resolution therapy who will develop resomelagon beyond RA into other key inflammatory conditions. In addition to partnering activities, we are also actively working to attract new like-minded institutional investors to our shareholder base. We continue to generate a good deal of interest in SynAct from both potential partners and from new institutional investors in preparation for the fall data releases.
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.
Torbjørn Bjerke | CEO