Second quarter in brief
1 April – 30 June 2019
Net sales for the period (January to June) amounted to SEK 3,1 Million (0 Million) of which the second quarter contributed SEK 0 Million (0 Million).
R&D costs for the period amounted to SEK 20,3 Million (20,8 Million) of which the second quarter contributed SEK 10,1 Million (8,9 Million).
Operating profit for the period amounted to SEK -20,6 Million (-22,9 Million) of which the second quarter contributed SEK -12,7 Million (-10,2 Million).
Profit after financial items for the period amounted to SEK -20,8 Million (-23,1 Million) of which the second quarter contributed SEK 9 Million (10,6 Million).
Earnings per share for the period amounted to SEK -0,11 (-0,15) of which the second quarter contributed SEK -0,06 (-0,07).
Cash flow from operating activities for the period amounted to SEK -21,0 Million (-13,4 Million) of which the second quarter contributed SEK -13,7 Million (-3,5 Million).
Shareholders' equity as of 30 June 2019 was SEK 19,3 Million (56,2 Million) or SEK 0,10 (0,30) per share.
The equity/assets ratio as of 30 June 2019 was 53 percent (75 percent).
Cash and cash equivalents on 30 June 2019 amounted to SEK 8,9 Million (52,7 Million).
Liquid funds exclude payment for a directed issue to Global Corporate Finance of $ 398,125 which was registered and paid during July 2019.
Significant events during the second quarter
- 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.
- Kancera announced that two patent applications within the Fractalkine project are now entering international phase. The patent applications include a new production method and a new series of blockers of the Fractalkine system, including KAND145.
- Kancera announced that the European Society of Cardiology selected Kancera's research for its "outstanding quality", which will result in an oral presentation as part of the session for "New treatments for acute heart conditions" at the major ESC 2019 meeting in September.
- On June 20, Kancera announced positive interim results from the ongoing Phase Ib study of KAND567. The first exploratory part of the study shows that KAND567 has a good safety profile in the short-term intravenous infusion and that the calculated effective plasma concentration can be achieved according to plan. To achieve the required tolerability for long-term infusion, the ratio of infusion rate to concentration of KAND567 in the infusion solution will be adjusted. This adjustment implies that estimated reporting of the results will be in November this year.
- Kancera announced that the agreement with US Global Corporate Finance (GCF) was used to decide on two new issues of a total of 10,000,000 shares (of which 5,000,000 shares were registered and paid in July) against payment of a total of $ 886 887, supported by authorization of the extraordinary Annual General Meeting on December 13, 2018 and the Annual General Meeting on May 27, 2019.
Significant events after the end of the second quarter
- Kancera has announced that the third and final installment payment for the Fractalkine project and KAND567 has been made in accordance with the acquisition agreement. The payment that has been activated in connection with the ongoing Phase Ib study is made through a new issue of two million of the company's shares to Acturum AB.
- Kancera has announced that the company's clinical Phase Ib study according to plan will start again today. The aim is to report the study in November 2019. Kancera also announces new financing through a third new issue of 5,000,000 shares in accordance with the agreement with US Global Corporate Finance.
Kanceras research is recognized for "outstanding quality" by the European Society of Cardiology
Each year, 2 million people suffer from heart attacks in the United States and the EU. A quarter of these die or suffer from further serious heart disease within five years. The need for new treatments that can reduce the risk of complications and relapses is therefore great. Kancera's drug candidate KAND567 prevents the injuries that normally occur in a heart attack in a whole new way, something that is now becoming internationally recognized.
When the European Society of Cardiology (ESC) has its annual conference in September, Kancera's research has been selected for its "outstanding quality". ESC is the biggest scientific meeting of the year in the cardiovascular field, and the meeting brings together both researchers and global industrial players. This recognition means that we will present our preclinical results for KAND567 during a session on future treatments for acute heart disease.
The Fractalkine project, with KAND567 at the forefront, is of interest because our approach builds on the relatively new insight that the acute inflammation that occurs in a heart attack actually causes half of the serious tissue damage in a heart attack. We have reported the overall results in the past, but our position is strengthened when we now have the opportunity to describe them in more detail and to discuss them with the world's leading researchers in the field.
At the same time, the development of the project continues. During the second quarter we have both started the Phase Ib study of intravenously administered KAND567 and obtained the first interim results. In this study, KAND567 is given as an infusion to 27 healthy subjects to evaluate safety, tolerance and exposure. The purpose is to show that intravenously administered KAND567 has as good a safety profile as when the drug candidate is given orally.
The first interim results from the phase 1b study were positive and showed that KAND567 has a good safety profile for shorter infusions and that the calculated effective plasma concentration can be achieved according to plan. However, the follow-up part of the study showed that there was local irritation at the infusion site when the infusion was given for a prolonged period. This is likely to be avoided if you adjust the ratio of the concentration to the speed applied by KAND567. As such an adjustment requires a supplementary approval from the Swedish Medicines Agency, the final results of the phase 1b study will be completed somewhat later than we previously planned for, and we now expect to be able to report the results in November this year.
In connection with the start of the phase 1b study, the third and final payment to Acturum AB for the Fractalkine project was activated. The payment was completed after the end of the second quarter, in mid-July, through a new issue of two million shares to Acturum AB. During the second quarter, Kancera AB also completed two private placements of 5,000,000 shares each to Global Corporate Finance, supported by authorization from the Annual General Meeting on May 27, 2019.
In parallel with the development of KAND567, we recently put forward another drug candidate in the Fractalkine project, KAND145. With another drug candidate, it is possible to develop separate drugs for different uses. At the end of the second quarter, we were able to report that two patent applications linked to KAND567 and KAND145 entered the international phase, which contributes to a stable foundation for continued product development.
However, the focus now is on completing the phase 1b study with intravenously administered KAND567 and then purposefully working to demonstrate in a phase IIa clinical study the cardiac protective effect of KAND567 in patients affected by infarction.
Solna, 23 August 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
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