CEO Statement

"The positive results from the KAND145 Phase I study represent a very important milestone and validates the company's strategy. We now have two drug candidates that have demonstrated good drug properties in human."

Peter Selin, CEO Kancera AB

With the capital injection from the rights issue we are now initiating time-critical development activities to prepare for upcoming clinical trials

“The beginning of 2024 has continued to be eventful for Kancera. Important steps forward have been taken in all three of our clinical projects within the fractalkine program and to enable the continued advancement of our clinical projects, we have recently carried out a rights issue.

KAND567 for the treatment of myocardial infarction patients undergoing percutaneous coronary intervention is our lead project. Within this project, we have recently completed a phase IIa study, the FRACTAL study, from which we reported positive topline results in December 2023. During the first quarter this year, we followed up by presenting the results of the statistical analysis and describing how the signals of cardioprotective effects demonstrated in the FRACTAL study are of high clinical relevance and relate to expected efficacy endpoints in upcoming phase IIb/III studies. In addition, Kancera has entered into a license agreement with the University of Newcastle that gives us exclusive commercial rights to the results from the FRACTAL study, as well as full ownership of a new use patent covering the clinical use of KAND567 and KAND145 for the treatment of myocardial infarction. If approved, this patent is valid to 2044.

In the KANDOVA study, the ongoing clinical phase Ib/IIa study of KAND567 in ovarian cancer, we have seen an increased recruitment rate that can be attributed to the regulatory approval of the amended study protocol. As expected, the amended protocol has led to an increase in the number of patients who meet the enrollment criteria. All five Nordic hospitals participating in the study have now recruited patients that have completed one or more treatment cycles with KAND567. The first part of the study, Phase Ib, aims to define the recommended treatment dose, based on exposure and tolerability. Based on the current status, we expect to finalize phase Ib around mid-year this year.

Recently, we have reported that our first Phase I clinical study with KAND145 has been completed with positive top-line results and that the primary objectives of the study were met. KAND145 is our second generation fractalkine-blocking drug candidate and a further development of KAND567. Overall, the results from the study show that KAND145 is effectively converted into KAND567 in the body and after conversion the pharmacokinetics are similar to those of dosing with KAND567. The results also show that KAND145 is safe and tolerable at the target level of exposure – we achieved the maximum exposure defined in the study protocol. Notably, this exposure far exceeds the level that has been shown to be therapeutically active against inflammation through the results of the FRACTAL study and which we expect to be effective for the treatment of the tumor microenvironment in cancer.

The positive results from the study constitute a very important milestone for Kancera, as they validate our strategy to evaluate the treatment concept with fractalkine blockers through KAND567, in parallel with the first clinical studies with KAND145 being conducted. We can now continue to work according to our strategy and prepare for future patient studies with KAND145. It is highly gratifying to now be able to confirm that Kancera has two drug candidates that have demonstrated good drug properties in human.

Recently, we have also announced that we have made a number of new recruitments and changes to the management team, including the appointment of Robert Edfors as the new Chief Scientific Officer (CSO) and Senior Vice President Clinical Development. The changes reflect Kancera’s strong focus on continuing the clinical development of KAND567 and KAND145 and preparations for future clinical studies. Thomas Olin, who is currently CSO, will continue to work for the company, as a scientific advisor and as a member of the board.

Finally, I would like to express my sincere thanks to all shareholders and guarantors who participated in the rights issue. As described above, the rights issue enables us to drive our clinical development program forward, which is crucial for the continued value creation. With the strengthening of the cash position, we are now initiating important development activities for future planned clinical studies.”

Solna, May 17, 2024