CEO Erik Kinnman comments on the Q3 report and provides a operational update.

CEO review

Interim report for the period January – September 2023

The hard work during the first half of the year continued in the third quarter as Vivesto set its foundation as an oncology-focused research and development company with the potential to take a leading position within specific areas where we can make a difference. Following the strategic review and steps to streamline the company to reduce costs this year, the Vivesto Board of Directors decided after the end of the third quarter to focus the company’s resources on the Cantrixil and Paccal Vet development programs.

Vivesto took additional steps aimed at reducing costs in the company, including discontinuing all further development related to the XR-18 technology platform and closing the company’s laboratories in Uppsala. I regret that this closure means staff reductions, but it needs to happen for us to move forward with this new focus.

This new strategic direction to become a pure development company with a focus on early-stage oncology projects where there is a clear need for more effective drugs is expected to reduce costs by more than SEK 35 million on an annual basis and enables Vivesto to deliver several important milestones and secure the company’s financial position and continued operations until the end of 2026. Targeting our investments toward the Cantrixil and Paccal Vet programs increases our ability to achieve success in our clinical development and enhance long-term value for our stakeholders.

Vivesto’s animal business Paccal Vet is a great opportunity. There is a tremendous unmet medical need for improved veterinary drugs. There are more than 180 million dogs in the U.S. and in Europe, and owners are increasingly spending more to care for their pets, including $39.6 billion on vet care and product sales in 2022 in the U.S., according to the American Pet Products Association.

The Paccal Vet clinical development program is progressing according to plan. During the summer of 2023, Vivesto had a successful pre-submission meeting with the US FDA’s Center for Veterinary Medicine regarding the development of Paccal Vet. Preparations for our clinical pilot study to investigate the effect of Paccal Vet in dogs are ongoing and we expect all necessary activities for the start of patient recruitment to be in place by the end of 2023.

To maximize the commercial potential of the cancer program Cantrixil, we decided to target our development resources to bladder cancer and blood cancer, both of which are indications clearly in need of additional solutions and with significant commercial potential. We have had positive results from the pre-clinical tests and, based on those, we will decide on the continued development plan for Cantrixil. Additional important results are expected early next year.

Earlier in the year, the American pharmaceutical company Elevar Therapeutics said it intended to transfer the rights and obligations of the cancer drug Apealea to a third Party. Vivesto has had a global partnership with Elevar since 2020, but Apealea was only launched in Germany by Elevar’s partner Inceptua. Development in the rest of the world and sales in Europe have gone slower than expected so we view this as an opportunity to find a better partner. Vivesto is negotiating a termination agreement with Elevar. Activities with aimed at identifying potential new partners have been initiated and discussions with several potential partners are ongoing.

Vivesto’s updated focus is an opportunity for the company. The streamlined development plan, combined with significantly lower cash burn rate, provide the possibility to build long-term value and anchor the company as an early-stage oncology development company.

Thanks for following Vivesto.

Erik Kinnman, CEO of Vivesto