Interim Report Q3, 2021 – November 12, 2021

Planning for success with AP1189

The third quarter was another productive period for SynAct Pharma, both from an R&D perspective but also in terms of preparing the company for the intense work ahead and ensuring SynAct is set to take advantage of future opportunities.

I would like to start by focusing on what we have worked on since the summer from an R&D perspective.

Following the encouraging topline results in part 1 of the Phase 2a clinical study, BEGIN for AP1189 in early rheumatoid arthritis (RA), we made the strategic decision to expand the study size to demonstrate statistical significance in the trial. Like many peers in the sector, the COVID-19 pandemic posed significant challenges to patient recruitment for part 2 of the BEGIN study. We were happy to be able to communicate that the last patient was dosed toward the end of October.

SynAct is preparing to close the study and report results once we have the full data in line with earlier communications. This is a massive moment for the company, and we are eager to see the data further establish the potential of AP1189 in the treatment of RA. Following positive results, we intend to engage regulators, first and foremost FDA, to define the path forward.

We are working hard to help AP1189 reach its fullest potential in RA. Our CSO, Thomas Jonassen recently presented results from our Phase 1 and Phase 2a part 1 in a virtual poster at The American College of Rheumatology Convergence (ACR). It is encouraging to see international interest grow for our work.
Following this summer’s full and very encouraging results of the Phase 2a clinical trial of AP1189 in COVID-19, we are progressing with designing a confirmatory trial within this indication as well as exploring paths towards Emergency Use Approval where relevant.

It is also worth mentioning two other items from our R&D efforts that provide significant opportunities for the future of the company’s clinical trials. The first is that we have now formulated AP1189 as a tablet, which is naturally more convenient for patients compared to the liquid suspension. SynAct has started a clinical trial to demonstrate comparable pharmacokinetics of tablet and suspension.

The second point to mention is that all prior and ongoing trials have been limited by the fact that our preclinical development, i.e. toxicology studies only supported up to 4 weeks dosing. It is therefore a critical milestone that we have now completed and reported preclinical development supporting dosing for up to three months in patients.

The advantages mentioned above with a new tablet formulation and extended preclinical documentation, gives us new development opportunities for our clinical development programs. For the RA project, we can now continue into Phase 2b with a tablet in a study design in line with the current regulatory guidelines. For our nephrology program, it opens a number of new opportunities that we currently exploit.

From a business development perspective, SynAct is actively engaged and experience good interest from key companies in the RA and autoimmune/inflammatory space with regards to potential strategic collaborations to amplify and accelerate our AP1189 development efforts. Recently we have participated in the annual Bio-Europe meeting. This year conducted as a virtual conference and we plan to participate in other key industry meetings, including JP Morgan Healthcare Conference and BIO International. We will also attend medical congresses as the recent ACR Rheumatology Convergence to further these discussions and to introduce additional companies and investors to SynAct and AP1189.

To prepare our company for future opportunities, we continued to strengthen our team with three key positions:

  •  Anders Dyhr Toft was appointed Chief Medical Officer (CMO) to head up clinical development and medical affairs in close collaboration with SynAct’s CSO Dr. Thomas Jonassen. Anders brings critical experience to SynAct from his 18 years in R&D, Medical Affairs, Operations and Commercial in Novo Nordisk.
  •  Patrik Renblad was appointed VP Finance. Patrik brings experience to SynAct from 19 years in finance leadership roles at LEO Pharma and Astra Zeneca.
  • Lise Agersted was appointed Director Operational R&D. She brings experience from three years as an independent consultant for biotech startups and before that from eight years at Novo Nordisk in both scientific and project management roles.

The work aimed to prepare for an uplift to Nasdaq Stockholm’s Main market is ongoing. We have completed major parts of the preparations (conversion to IFRS, strengthening of the Board of Directors, implementing Corporate Governance at a level required by Nasdaq, launch of a new web site compliant with Nasdaq’s requirement, etc.). However, compared to the previously announced target to complete the listing late in 2021, the company has decided to postpone the formal application to Nasdaq to 2022, as it would be more logic from a company perspective to do it on the back of completing and reporting the company´s main development program in RA. We thus expect to finalize the listing process within the first half of 2022.

The fourth quarter continues to be exiting. Our focus is on completing the RA trial and reporting the results by the end of November. As I mentioned above, this is a huge moment for the company. Following the results, the company will prepare for an interaction with the FDA early in 2022, continue to progress our COVID-19 program, evaluate the best path forward for demonstrating efficacy and safety in NS, given the new opportunities as described and initiate the final stage of the up-listing to Nasdaq.

On behalf of the entire SynAct team, we want to take a moment to share our appreciation to all those investors who see our long-term potential and support us.

Jeppe Øvlesen, CEO