PERIOD 1 JAN – 31 DEC 2017 IN BRIEF
• Net turnover for the period amounted to SEK 0.1 million (0.3 million). For the fourth quarter, turnover amounted to 0.0 MEK (0.1 M).
• R & D expenses for the period amounted to SEK 51.1 million (19.1 million), of which the fourth quarter amounted to SEK 11.2 million 5.8 million)
• Operating profit for the period amounted to SEK -56.1 million (-22.3 million), of which fourth quarter amounted to SEK -11.9 million (-6.5 million)
• Profit after financial items for the period amounted to SEK -56.2 million (-22.3 million), of which fourth quarter amounted to SEK -12.0 million (-6.5 million)
• Earnings per share for the period amounted to SEK -0.39 (-0.19), of which fourth quarter amounted to SEK -0.08 kr (-0.05)
• Cash flow from operating activities for the period amounted to SEK -53.5 million (-23.1), of which the fourth quarter amounted to SEK -18.6 million (-5.7 million)
• Shareholders' equity amounted to SEK 38.7 million (59.5 million) as of 31st December 2017, or SEK 0.26 (0.45) per share
• The equity ratio at 31st December 2017 was 76 percent (82 percent). Liquid funds amounted to SEK 27.8 million (57.8 million ) on December 31st 2017.
SIGNIFICANT EVENTS DURING THE FOURTH QUARTER
• Kancera AB reported that the company's ROR inhibitor KAN0441571, after treatment every third day for thirteen days, effectively eliminated ROR1-bearing leukemic cells in a mouse model of human chronic lymphocytic leukemia.
• Kancera AB announced that the company has made the second installment for the Fractalkine project in accordance with an agreement with Acturum Real Estate AB.
• Kancera AB announced that rights to the Fractalkine project in the field of lung disease were acquired from AstraZeneca AB and Acturum Real Estate AB, which means that Kancera AB now has full control over the rights to the project.
• Kancera AB reported that the Phase I study in the Fractalkine project has been completed. In the study, drug properties, safety and tolerability have been documented for KAND567. The results are now subject to quality control and analysis. According to the present plan, these results are expected to be communicated in February 2018.
SIGNIFICANT EVENTS AFTER THE END OF THE FOURTH QUARTER
• Kancera AB has reported results from a Phase I study in healthy subjects with the immunosuppressant drug candidate KAND567. The study has shown that KAND567 is safe and well tolerated up to plasma concentrations that were five to ten times higher than the calculated effective level for therapeutic effect in humans. Upon further increase of the dose, a reversible increase in markers for liver effect was noted. The results also showed that KAND567 blocks the Fractalkine system by reducing the number of Fractalkine receptors on the surface of immune cells.
• Kancera has also reported results from three preclinical disease models showing cardiovascular protection properties of KAND567
• The company has announced that it is now evaluating the conditions for continued clinical development of KAND567 against cancer and inflammatory cardiovascular injuries, eg. in connection with infarction.
STATEMENT FROM THE CEO
During 2017, the number of newly registered drugs increased compared to 2016. Cancer was the disease against which most new drugs were targeted. Kancera contributed to the development of one of these, Enasidenib, by identifying the basic chemical substance on which the drug is based1. Enasidenib is used to treat acute myeloid leukemia (AML).
In the field of inflammation, the presentation of the results from Novartis’ so-called CANTOS study (Canakinumab2 Anti-inflammatory Thrombosis Outcomes Study) was one of the major events in 2017.
The study showed for the first time convincing clinical evidence that anti-inflammatory treatment reduces the risk of complications following myocardial infarction. In addition, the follow-up analysis of the study showed a surprisingly strong and dose-dependent decrease in lung cancer in patients treated with Novartis anti-inflammatory drug.
The findings of the CANTOS study thus also support the further development of Kancera's KAND567, which in a new way controls the immune system. Kancera’s choice to develop KAND567 against cancer and cardiovascular inflammation is further supported by both our own and independent researchers' results in disease models and studies of human biomarkers. The goal of this development is to slow down the aggressive development of some forms of lymphoma (a form of blood cancer) and reduce cardiovascular injury after infarction.
In the recently completed Phase I clinical trial in the Fractalkine project, the results show that KAND567 blocks the Fractalkine system as hoped and the drug candidate is well tolerated in doses up to five to ten times above the calculated effective dose.
We will now continue to deepen our understanding of how KAND567 affects the liver in relation to the desired pharmacological effects in order to develop a clinical development plan for both chronic and acute treatment of inflammatory diseases and cancer. The fact that there is support for the benefit of short-term treatment with KAND567 against, for example, myocardial infarction, gives the project additional opportunities with the good safety margin we have seen in acute treatment.
As Kancera's main resources were dedicated to the Fractalkine project in 2017, the progress of our other pharmaceutical projects have slowed down slightly. However, studies are ongoing to identify the company's next drug candidate for clinical development in the ROR, PFKFB3 and HDAC6 projects.
CEO Kancera AB (publ)
1. Kancera has been fully paid for the company's contribution to the development of Enasidenib. Enasidenib is owned by American Agios and Celgene.
2. Canakinumab is an antibody to IL1beta.