BIO International USA confirms growing interest in resomelagon and SynAct Pharma following the positive effects of the ADVANCE study

Since presenting the positive effects from the ADVANCE study, the Company has seen a clear increase in interest from pharmaceutical companies as well as specialized healthcare investors. During a productive week at the BIO International Convention in San Diego, SynAct held several meetings with potential industry partners, focusing on the clinical data, the unique mechanism of action and the opportunities to further develop resomelagon across inflammatory diseases.

Particular attention has focused on the ACR20 result, one of the most established efficacy measures in rheumatoid arthritis ("RA"). ACR20 is used as a primary endpoint in a large number of registration-enabling Phase III studies and is among the parameters that regulatory authorities and pharmaceutical companies place significant emphasis on when evaluating new RA therapies.

The ACR20 results are viewed as particularly encouraging and provide further support for the compound's potential as it advances toward later-stage clinical development. The combination of clinical efficacy, supportive ACR50 findings, consistent improvements in inflammatory biomarkers and a continued favorable safety profile has been a recurring theme throughout SynAct's discussions with potential industry partners during the conference.

SynAct also notes that the ACR20 levels observed in the ADVANCE study are in line with those historically reported for several established RA therapies when studied in the treatment-naïve patient population, including JAK inhibitors such as Rinvoq and Olumiant, as well as biologic therapies such as Enbrel. Collectively, these therapies have generated cumulative global sales exceeding USD 100 billion since launch and represent some of the most commercially successful medicines in the treatment of inflammatory diseases. Against this backdrop, SynAct believes that the positive effects observed in the ADVANCE study further strengthen support for the continued development and commercial potential of resomelagon.

In addition, the demonstrated reduction in systemic inflammation, reflected by improvements in biomarkers such as C-reactive protein (CRP) and neutrophil-to-lymphocyte ratio (NLR), provides additional support for the potential application of resomelagon beyond RA. Together with the clinical efficacy demonstrated in ADVANCE, these findings reinforce the potential applicability of resomelagon across multiple inflammatory diseases and may further expand the long-term commercial potential of the program.

A recurring observation during discussions with industry participants is the unusual combination of meaningful clinical efficacy and the absence of immunosuppression commonly associated with currently available RA therapies. This is considered the most important differentiating factor in a therapeutic area where safety continues to play an increasingly important role for physicians, patients and healthcare systems.

Following the release of the ADVANCE results, SynAct observed an increase in inbound meeting requests from potential industry partners, further underscoring the growing level of interest generated by the ADVANCE study.

Beyond the ADVANCE program, SynAct looks forward to several additional value-driving milestones during the year. The Company expects to report results from two ongoing Phase II studies in inflammatory diseases. These studies build upon the positive and statistically significant results previously reported in the Company's Phase 2a COVID-19 study and represent further important steps in validating resomelagon's pro-resolving therapeutic mechanism. Together with the positive effects from the ADVANCE study, these upcoming readouts position SynAct for a period with several potentially significant clinical and business development catalysts.

SynAct believes that the positive effects from the ADVANCE study, together with the additional clinical data expected later this year, have materially increased the strategic attractiveness of the resomelagon program. The Company therefore intends to continue evaluating strategic alternatives for the program, including potential partnerships, licensing opportunities and M&A, with the objective of maximizing its long-term commercial potential.

The increasing interest observed during BIO International, combined with the growing clinical evidence supporting resomelagon, reinforces SynAct's confidence in the continued strategic development of the program.

"The response we received during BIO International has been highly encouraging. What has particularly captured attention is resomelagon's ability to deliver strong ACR20 results, one of the most important efficacy measures in RA and a key endpoint used in the evaluation of new RA therapies, together with supportive ACR50 findings that are closely followed by physicians and payers. Combined with its favorable safety profile and encouraging biomarker data, we believe these findings further strengthen resomelagon's position as a compelling development program within inflammatory diseases. At the same time, the growing body of clinical evidence continues to reinforce the program's long-term potential while supporting future strategic partnerships and business development opportunities," said Jeppe Øvlesen, CEO.

SynAct looks forward to a continued active period focused on maximizing the value of the resomelagon program and evaluating the opportunities created by the positive effects of the ADVANCE study.