A year marked by clinical progress, pipeline expansion and strategic momentum
As we close out 2025, I have been reflecting on the important year it has been in Sitryx’s evolution. Over the past 12 months, we have fully transitioned into a clinical-stage company, advanced multiple pipeline programs and welcomed outstanding talent to our leadership team. The year has been defined by focused execution and teamwork, to advance a pipeline of first- and potentially best-in-class candidates to help people living with autoimmune and inflammatory diseases. I am proud of what we continue to accomplish as a team.
Advancing our pipeline
In the spring, we initiated our first-in-human Phase 1a clinical trial with SYX-5219, a first-in-class oral PKM2 modulator for the treatment of atopic dermatitis. Atopic dermatitis is a condition affecting over 200 million people worldwide which results in persistent inflammation and severe itching, significantly impacting patients’ quality of life. Modulation of PKM2 has the potential to rebalance immune function and deliver durable disease remission, with preclinical data demonstrating reductions in inflammatory markers, itch and improved skin barrier repair. We built positive momentum for this program in 2025, with FDA clearance of our IND application and MHRA / EMA approval of our CTA to advance to a Phase1b trial in the UK, US and mainland Europe. This trial is anticipated to start in Q1 2026 and will provide insights from atopic dermatitis patients to guide the next stages of development.
Our second clinical asset, SYX-1042, is a mimetic of the natural anti-inflammatory metabolite itaconate. A Phase 1 first-in-human study of SYX-1042 was completed successfully by our partner Eli Lilly in 2025. There is a wealth of preclinical evidence supporting the role of itaconate as an anti-inflammatory mechanism that could be applied to many chronic inflammatory diseases. The candidate is now back in the hands of Sitryx, and we look forward to exploring its efficacy in psoriasis patients in the coming year.
Swiftly following are our novel oral MTHFD2 and GLS-1 inhibitor programs. The MTHFD2 lead compound was nominated for clinical development in Q1 2025 and has been progressing through IND-enabling studies. While there are multiple indications of interest for the MTHFD2 mechanism, we believe there is a unique value proposition in psoriatic arthritis, a chronic and debilitating autoimmune disease which results in joint inflammation and affects over a million people in the US alone. The team has already generated a wealth of compelling preclinical data to support the potential of this differentiated mechanism targeting key disease-driving immune cells. Our GLS-1 program has also made great strides, with exciting preclinical data supporting the important role of this mechanism on the interface of inflammation and tissue remodelling. We are optimistic that we will be in a position to nominate a development candidate in 2026.
Strengthening Our Scientific and Investor Presence
With so much progress within the company I’m delighted that we shared updates at key scientific conferences, presenting data from our MTHFD2 and PKM2 programs at ACR Convergence, the European Academy of Dermatology and Venereology Congress and the Inflammatory Disease Skin Summit. Our increased presence at these congresses highlights our position at the forefront of immunology research and the increasing interest in the central role that metabolic pathways play in regulating immune cell function.
The leadership team and I also presented at key healthcare investor conferences – events where scientific innovation converges with investment strategies. We have continued to build interest and enthusiasm in the potential of our novel, metabolic-targeting immunology pipeline.
Building a world-class team
Delivering on our clinical ambitions requires a strong and capable leadership team, and I was delighted to further strengthen ours this year with the appointment of Adam Mostafa as our Chief Financial Officer. His impressive financial and strategic experience, gained across multiple high-growth biotechnology companies, is key to the next phase of our journey. In just a few short – and busy! – months working together, I have already seen the impact he is bringing to the business.
In fact, across the whole organization, every one of our teams has continued to demonstrate extraordinary commitment to progressing this company. Transitioning from an early stage start up to a fully integrated clinical-stage company is no small feat and I am proud of the resilience our team has shown throughout 2025.
Looking Ahead to 2026
As we prepare for next year, our priority is clear: to continue advancing our pipeline, generating the important data that will guide the next stages of our development. We are excited to start patient studies with two novel immunometabolic therapies that have the potential to provide transformational efficacy.
I am grateful to our team for their continued work and dedication and to our partners and investors for their ongoing support as we enter the new year. I wish everyone a restful holiday season and a successful year ahead.
Iain Kilty
Chief Executive Officer