INTERIM REPORT FOR THE FIRST QUARTER 2019, 1 January – 31 March 2019
First quarter in brief
1 January – 31 March 2019
Net sales for the period (January to March) amounted to SEK 0.0 million (SEK 0.0 million)
R&D costs for the period amounted to SEK 10,2 million (SEK 11,8 million).
Operating profit for the period amounted to SEK -7.9 million (SEK -12.7 million).
Profit after financial items for the period amounted to SEK -8.0 million (SEK -12.5 million).
Earnings per share for the period amounted to SEK -0.04 (SEK -0.07).
Cash flow from operating activities for the period amounted to SEK -5.8 million (SEK -9.8 million).
Shareholders' equity as of March 31, 2019 amounted to SEK 25.4 million (SEK 26.2 million) or SEK 0.13 (SEK 0.14) per share.
The equity/assets ratio as of March 31, 2019 was 60 percent (65 percent).
Cash and cash equivalents on March 31, 2019 amounted to SEK 15.2 million (SEK 18.0 million).
Significant events during the first quarter
Kancera announced that two milestones were achieved prior to the planned start of clinical studies with the drug candidate KAND567, with the aim of showing reduced tissue damage in connection with heart attack. In a recently completed preclinical toxicological study, KAND567 has demonstrated a favorable safety profile for intravenous administration, while significant progress was made in the development of a large-scale production method.
Kancera announced that the results of a study of lymphoma patients' immune cells show that the Fractalkine system is activated in the cancers of chronic lymphocytic leukemia, diffuse large cell B cell lymphoma and Hodgkin's lymphoma. In view of this discovery, the company will now extend studies of how drug candidates, such as KAND567, that interact with the Fractalkine system may play a role in future treatments of these diseases.
Kancera announced that the agreement with US Global Corporate Finance (GCF) is capitalized in accordance with authorization from the Extraordinary General Meeting on December 13, 2018. The activation is made by Kancera paying a fee in the form of shares corresponding to SEK 2.1 million, after which Kancera has the right to call for investments in exchange for shares up to a total of SEK 60 million.
Significant events after the end of the first quarter
Kancera has announced that the Medical Products Agency and the Ethics Committee have approved the application for a Phase Ib study with the drug candidate KAND567. A supplement has been submitted to the Medical Products Agency regarding additional information on a standardized method for intravenous administration of KAND567. The study can start after approval of this supplement, which is expected to occur in June.
Kancera has reported that the company's project portfolio was further strengthened by nominating the drug candidate KAND145. Together with the clinical drug candidate KAND567, KAND145 is covered by a patent application from July 2018 and forms the basis of a new concept for the treatment of acute and chronic inflammation.
The first quarter of the year was characterized by intensive preparations for the clinical trial with our main candidate KAND567 in acute myocardial infarction, which we plan to initiate in 2019. In January, we received the results from a preclinical toxicological study showing that the Fractalkine inhibitor KAND567 also has a favorable safety profile when given intravenously, which is very important in acute treatment. At the same time, we were able to announce that significant progress was made in the development of a large-scale production method for the intravenous dosage form, which made it possible to begin the production of study drugs. There have been good results for safety tests and oral dosing of KAND567 in humans before, but in acute myocardial infarction, KAND567 will need to be given intravenously to rapidly reach effective levels of KAND567 in the blood. During the summer we therefore conduct a complementary phase Ib study in healthy subjects to determine the appropriate intravenous dosage rate for the future patient study. After the end of the reporting period, we were pleased to announce that the Medical Products Agency and the Ethics Committee approved our application to carry out the Phase Ib study, expected to start in June.
The intravenous dosage form of KAND567 is intended to be used in the Phase IIa study in patients treated with acute myocardial infarction. The application to the authorities for a trial permit for that study can only be made later this year when final results are available from the phase Ib study. The results from the patient study are expected to be reported approximately 12 months after the start of the study, and will constitute an important basis for negotiations on the out-licensing of KAND567 to pharmaceutical companies.
We recently nominated another drug candidate in the Fractalkine project, KAND145. With two independent drug candidates covered by separate patent applications, the possibility of developing two independent products in the future increases. Potentially, this may result in a drug for the treatment of inpatient heart attack and another drug targeted at the treatment of inflammatory diseases.
Fractalkine blockers also have the potential to develop into effective drugs against various forms of cancer. During the first quarter of 2019, a study was completed to clarify whether the Fractalkine system is activated and possibly causative in patients suffering from lymphoma. The results, which include blood cell analyzes from 66 patients, show that there is a statistically significant activation of the Fractalkine system in the lymphoid patients compared to a control group consisting of healthy subjects of the same age distribution. The study was carried out by researchers at Karolinska Institutet in collaboration with Kancera. Based on the research results, Kancera has decided to deepen its laboratory studies with the aim of determining whether drugs that control the Fractalkine system have the potential to develop into an improved treatment of lymphoma. These follow-up studies are expected to be completed during the third quarter of this year.
However, our focus remains on the development of KAND567 to reduce the harmful inflammatory process that arises in connection with the treatment of acute myocardial infarction. We are now looking forward to initiating the first clinical study with the intravenous dosage form to be used in the continued development program.
Solna, 24 May 2019
Thomas Olin, CEO
About Kancera AB (publ)
Kancera develops drugs that counteract damage during acute and chronic inflammation. The Fractalkine blocker KAND567 is primarily developed to effectively and selectively reduce the inflammation of the heart and vessels following a heart attack and is expected to enter the clinical phase II study in 2019. Since scientific studies have shown elevated levels of fractalkine not only in heart attacks but also in inflammatory diseases and certain forms of cancer, there are several possible development opportunities for the fractalkine blockers KAND567 and KAND145. Kancera also develops preclinical drug projects against cancer aimed at stopping survival signals in the cancer cell and preventing the cancer cell's ability to be repaired. Kancera operates at Karolinska Institutet Science Park in Stockholm. The share is traded on Nasdaq First North. FNCA Sweden AB (tel. 08-528 00 399, email@example.com) is the company's Certified Adviser. MD PhD Charlotte Edenius, MD PhD Anders Gabrielsen, Professor Carl-Henrik Heldin and Professor Håkan Mellstedt are all scientific advisors and board members of Kancera AB.
For further information, contact:
Thomas Olin, CEO: +46-(0)735-20 40 01
Kancera AB (publ)
Karolinska Institutet Science Park
SE 171 48 Solna