CEO Statement

April 25, 2024

During 2023 we completed a turnaround to fully focus on accelerating the circVec platform, and firmly establish Circio as a leader in the emerging circular RNA space. With our circVec 2.1 design we have reached an important technical milestone, outcompeting conventional mRNA expression for reporter systems both in vitro and in vivo. We are committed to drive this unique and powerful technology forward, with the aim to and establish circVec as a new gold-standard expression system for gene therapy and beyond.

Leading with ´CIRC´ in Circio

Under the leadership of CTO and circRNA discoverer Dr Thomas Hansen and CSO Dr Victor Levitsky we have advanced our circVec system to generation 2.1, which has demonstrated up to 10x enhanced protein expression vs. mRNA in multiple settings. We have recently shown, in initial experiments, that this powerful advantage can be maintained in vivo in mouse models for up to four months , with statistically significant enhancement of protein expression from circVec.  This feature is particularly important in gene therapy where low expression is a substantial hurdle for current approaches, and we are therefore selecting genetic medicine as the lead application for our initial circVec therapeutic candidates.

Still progressing in ´IO´

The TG01 cancer vaccine has returned to the clinic in an enhanced format. Armed with a more powerful adjuvant, the same as GSK incorporates in its highly successful shingles, malaria and RSV vaccines, improved dosing and multiple new combination therapies, creating a broad scope of development and future partnering opportunities for our mutant RAS TG01 program. During 2023, three collaborative studies with internationally renowned experts opened for enrolment, two in the USA and one in Norway. Consistent with our strategy of advancing TG01 through collaborative efforts at low cost to Circio, all of these studies are externally sponsored and involve multiple high-profile industry and academic partners. On April 17 2024, Circio terminated its agreement with IOVaxis to develop TG01 in China due to non-payment of license fees. This does not affect the three collaborative studies described above.

Financing to support near-term progress and deliver long-term success

Following the presentation of robust technical in vitro data showing statistically significant enhanced circVec vs mRNA reporter expression as well as encouraging and additionally supportive in vivo data in mouse models, on 17 April 2024 Circio announced a plan to raise around NOK 50-60m in gross proceeds from existing shareholders and new investors in a partially underwritten rights issue to be completed during Q2 2024. This will provide twelve months cash runway and enable Circio to deliver important pre-clinical milestones for its novel circVec gene therapy formats, further enhancing and expanding the platform towards circVec 3.0, and expand the intellectual property portfolio to protect both the technology and its applications.

Looking ahead

The circVec platform can be deployed for a variety of applications, and as we demonstrate this through our ongoing technical and in vivo experimental program, we believe multiple avenues to partnerships will become available. The techincal in vivo data package confirms the potential of the circVec platform, and we are now moving forward to validate these promising data in therapeutically relevant vector formats and disease models, with an AAV-based gene therapy for AATD as the initial lead program. Based on our current data, plans and estimates, we aim to enter our first strategic partnership in early 2025 and select a lead therapeutic candidate for AATD by the middle of 2025.

The team and I are very excited to lead Circio forward to execute on the opportunities that lay ahead.

Erik Digman Wiklund
Circio Group