With the end of the year fast approaching, it is timely to take a step back and reflect on the challenges and achievements for 2025.

We began the year with optimism and momentum, having completed a major financing round late in 2024 (thanks to our incredible group of investors).  We were preparing for filing an IND application for CTH-401 after a very positive pre-IND meeting with the FDA.  And we had committed to establishing our own clinical trial manufacturing capability.

Unfortunately, at the start of the year we encountered problems with our manufacturing process, requiring corrective action and resulting in a delay to our overall CTH-401 timeline.  Thanks to the stellar efforts of the manufacturing team the problems were resolved, allowing us to move into the upgraded clean rooms as soon as they were completed and validated.  We finish the year with our first run in the new clean room being completed just before Christmas, allowing the team to take a well-earned break until the new year.

Our research team was also challenged with results for our tissue factor (TF) CAR-NK cell product that didn’t initially meet expectations.  While early data in a 3D endometriosis model were extremely promising, reproducing those outcomes proved challenging. This prompted us to redesign the CAR construct, a step that has since paid off.  The new design is performing strongly, and we’re closing the year with renewed confidence in our TF-targeting programs, CTH-501 and CTH-502.

Late in the year we decided to move our nascent Alzheimer’s Disease program into a separate, subsidiary company, Evinco Therapeutics.  This allows Cartherics to focus its efforts exclusively on cancer and endometriosis.  At the same time, Alan Trounson stepped down as CEO of Cartherics to take responsibility for Evinco (while retaining his involvement with Cartherics as a Director and Deputy Chair).  We thank Alan for his leadership of Cartherics for its first decade of existence and for his ongoing contribution to the company.

So, Cartherics ends 2025 with a new leadership structure, and renewed focus and enthusiasm for an exciting year in 2026.  No doubt the new year will throw up another set of challenges, not the least of which will be access to ongoing funds, but I am confident that we will solve them, just as we have in 2025.

I have worked in drug development for more than 40 years.  Over that time, I’ve had the opportunity to participate in, and observe, many different teams.  In my experience, the most successful teams have been ones that have worked hard, taken set-backs in their stride, and refused to give up in the face of adversity.  In my mind, perseverance is an, if not the most, essential ingredient for successful drug development.  The Cartherics team has shown in 2025 that it has this ingredient.

Taking a line from the Cartherics credo: “We are committed to developing products that will benefit the health of people worldwide. We will do this with both pride and humility.”  In 2026 we take the next big step towards this goal with our first clinical trial.  We thank our investors for providing the means to get there and, when we achieve that goal, it will be a proud moment for the extended Cartherics team.

Best wishes for the holiday season to our staff, directors and investors.  Enjoy the festivities, get some rest and relaxation, and come back refreshed for a big 2026.

Ian Nisbet

CEO Cartherics