Circio Holding ASA: June 2022 company update

Oslo, Norway, 15 June 2023 – Circio Holding ASA (OSE: CRNA), a biotechnology company developing next generation RNA therapeutics, today provides a general company update, demonstrating substantial progress for the company’s circRNA platform development.

“Over the recent months we have accelerated the development of our unique circular RNA platform. The transition into a dedicated circRNA technology company has now been completed, with the aim to fully capture the potential of our differentiated approach and early mover advantage in this exciting new therapeutic area. The prioritization of resources to pre-clinical circRNA development over the ONCOS-102 phase 2 clinical program also significantly reduces our cash burn rate and financing needs, and allows us to fully focus our time and resources on the program that is most technologically innovative and provides the best opportunity for value creation in the short- to mid-term," said Circio’s CEO Dr. Erik Digman Wiklund.

Dr. Erik Digman Wiklund will give an online presentation to investors, analysts, and the press at 10:00 CET today (details below),

2022 year-to-date highlights

Corporate development

• The new R&D strategy prioritized to accelerate the circular RNA (circRNA) platform development, a rapidly emerging area in RNA therapeutics receiving strong interest from global pharma and specialist investors
• To reflect the strategic shift towards circRNA development, the name of the company was changed to Circio, under the Euronext Oslo ticker: CRNA  
• Chief Medical Officer Dr. Lone H Ottesen and VP Regulatory Affairs Dr. Ingunn M Lindvig have resigned to join other Nordic biotechnology companies. We thank them for their service and highly valued contributions to Circio 
• The organization has now been streamlined for pre-clinical development of the circRNA platform, resulting in a net staff reduction of 40%, with core scientific operations based at the Karolinska Institute in Stockholm, Sweden

Finance

• Up to NOK 300m in financing over the next 3 years was secured through a convertible bond facility from Atlas Capital Markets, providing Circio flexible access to capital during a period of challenging biotech market conditions

circRNA platform development

• Key technical proof-of-concept data was established for circVec, Circio’s differentiated vector delivery approach for efficient and durable circRNA expression, including demonstration of 15x extended half-life versus linear mRNA
• An important patent application expanding circVec coverage to novel vector systems was filed in March, adding to the general circVec genetic cassette design filed in late 2022
• Cancer gene therapy, protein replacement for rare disease and vaccines were selected as the first three therapeutic areas to be explored for circVec

Mutant KRAS platform

• The first patient has been dosed in the trial in pancreatic cancer at Kansas University Cancer Center, where TG01 will be tested in combination with PD1 checkpoint inhibitor balstilimab from collaboration partner Agenus
• The TG01 trial in multiple myeloma at Oslo University Hospital received regulatory approvals to proceed and the first patient has been enrolled
• Important cancer vaccine data was presented by US-based biotechs at major scientific conferences, validating the clinical benefit of neoantigen cancer vaccines in post-surgical settings 

Presentation

We invite to a live webcast today at 10.00 CET. Click here to join the webcast. It will be possible to submit questions during the presentation.

For further information, please contact:
Erik Digman Wiklund, CEO
Phone: +47 413 33 536
Email: erik.wiklund@circio.com

Renate Birkeli, Investor Relations
Phone: +47 922 61 624
Email: renate.birkeli@circio.com

Media enquires:
Andreas Tinglum - Corporate Communications (Norway)
Phone: +47 9300 1773
Email: andreas.tinglum@corpcom.no

About Circio

Building next generation RNA therapeutics

Circio Holding ASA is a biotechnology company developing novel circular RNA and immunotherapy medicines.

Building on deep experience in RNA biology, immunotherapy and viral vector engineering, Circio has established a unique circular RNA (circRNA) platform to develop novel circRNA medicines for cancer, vaccines, protein replacement for genetic disorders and cell therapy. The proprietary circVec technology is based on a modular genetic cassette design for efficient biogenesis of multifunctional circRNA from DNA-based vectors that can be deployed for multiple purposes. The most advanced therapeutic concept, circAde, builds on the company´s experience in oncolytic viruses to use engineered adenoviruses for delivery of circRNA to cancer cells. This unique approach is the only currently known circRNA program targeting solid tumors. Circio´s strategy is to develop novel circAde cancer medicines in-house and seek partnerships in other therapeutic areas to demonstrate the broad potential of the circVec platform and accelerate our circRNA pipeline development. The circRNA R&D activities are being conducted by the wholly owned subsidiary Circio AB based at the Karolinska Institute in Stockholm, Sweden.

Circio´s clinical immunotherapy programs are designed to activate the patient´s own immune system to fight cancer cells and provide benefit to patients with no or few treatment alternatives. Lead candidate ONCOS-102 is an oncolytic adenovirus (AdV5) carrying a genetic cassette for mRNA-based expression of the cytokine GM-CSF, designed to selectively target cancer cells and drive an anti-tumor immune response. ONCOS-102 has demonstrated an excellent safety profile, strong immune responses and clinical efficacy in several cancer types in Phase 1/2 studies, both as monotherapy and in combinations with checkpoint inhibitors or standard-of-care chemotherapy. Circio is aiming to progress ONCOS-102 into a phase 2 trial in melanoma patients resistant to PD-1 checkpoint inhibitor treatment, subject to additional external financing and/or partnerships to support the program.

Circio’s second clinical stage program is an immunotherapy targeting KRAS driver mutations. Lead candidate TG01 has previously shown robust immune responses and encouraging clinical benefit in surgically resected pancreatic cancer, and is currently being tested in two clinical trials in RAS-mutated pancreatic cancer and multiple myeloma in the USA and Norway. These studies are being run through industry and academic collaborative networks, supported by prestigious research grants from Innovation Norway and the Norwegian Research Council, creating broad future optionality for the TG01 program at low cost to Circio.