First quarter in brief
Net sales for the period (January to March) amounted to SEK 0 million (SEK 0 million).
R&D costs for the period amounted to SEK 8,2 million (SEK 9,7 million).
Operating profit for the period amounted to SEK -9,0 million (SEK -11,1 million).
Profit after financial items for the period amounted to SEK -9,1 million (SEK -11,7 million).
Earnings per share for the period amounted to -0,03 SEK (-0,06 SEK)
Cash flow from operating activities for the period amounted to SEK -9,0 million (SEK -8,6 million).
Equity on 31 March 2021 amounted to SEK 66,3 million (SEK 25,0 million) or 1,39 SEK (1,19 SEK) per share.
The equity/assets ratio on 31 March 2021 amounted to 86 percent (45 percent).
Cash and cash equivalents on 31 March 2021 amounted to SEK 45,4 million (SEK 3,2 million).
Important events during the first quarter
- Kancera carried out a merger of shares in accordance with a resolution from the 2020 Annual General Meeting of Kancera. The merger means that ten (10) shares are combined into one (1) share and that Kancera has 47,419,547 outstanding shares.
- The ongoing phase IIa study in COVID-19 was strengthened through collaboration with another hospital in Sweden, Västmanland Hospital in Västerås. Thus, the study is run in total at four hospitals – two in Sweden and two in Denmark in order to enable full recruitment of patients for the study during the second quarter of 2021.
- Kancera reported preclinical research results, which show that the company's Fractalkine blockers have the potential to break down cancer cells' resistance to chemotherapy and thereby significantly improve the treatment of advanced cancer such as ovarian cancer.
Important events after the end of the first quarter
- With the support of authorization from the Annual General Meeting of Kancera on 28 May 2020, the Board has announced a directed new issue of shares of no more than approximately SEK 20.4 million to Swedish and international qualified investors and a new issue of shares of no more than approximately SEK 101.2 million with preferential rights for Kancera shareholders.
- Kancera has provided an operational update for: a) clinical phase IIa study in COVID patients in which two thirds of the patients have been administered doses and b) the PFKFB3 project where new results meant that KAND757 was nominated as a drug candidate after positive effects documented in tumor preparations from patients with rectal cancer.
- Kancera has announced that the company's Nomination Committee proposes the election of Petter Brodin as a new Board member at the Annual General Meeting on May 26, 2021. At the same time, the Nomination Committee proposes re-election of current Board members and re-election of the current Chairman. The Nomination Committee's proposal in its entirety will be stated in the notice convening the Annual General Meeting.
- Kancera has announced that a recently published study shows clear signs of immune activation in 4800 patients with widespread myocardial infarction (STEMI), and who, in connection with this, must undergo an emergency procedure to open the blood vessel blocked by a blood clot. Kancera believes that the study provides new information that underlines the potential of the Fractalkine blocker KAND567 to prolong life after an acute heart attack.
Pioneering research results motivate new investment in advanced cancer while we effectively continue our phase II programs
Kancera is the first in the world to clinically develop small molecule drugs that block the Fractalkine receptor. As more and more research shows the importance of the Fractalkine system in various disease processes, the potential in our projects also increases. We already know that the Fractalkine receptor plays a key role when the body's immune system overreacts and develops hyperinflammation, and that a blockade of the Fractalkine receptor reduces hyperinflammation. Based on this knowledge, we are currently conducting clinical development programs with our drug candidate KAND567 in two disease states where hyperinflammation causes great harm: a phase II study is ongoing in patients with severe COVID-19 and a phase IIa study is planned to start in patients with acute myocardial infarction later this year.
In March, new groundbreaking preclinical results were published which show that our Fractalkine blockers also have the potential to disrupt the resistance of tumor cells to chemotherapy. The results show that KAND567 renders previously treatment-resistant tumor cells sensitive to chemotherapy again already after 72 hours of treatment. Since we have extensive knowledge of our Fractalkine blockers based on our ongoing clinical trials in other indications, we can go directly into clinical trials to establish a treatment plan that has the best effect against cancer. With the right results from these studies, a clinical development program for advanced ovarian cancer may be up and running as early as next year.
With all this momentum, Kancera is currently raising capital through a combined private placement and rights issue with the aim of, in parallel with the funded Phase II projects against hyperinflammation, initiating a new effort against advanced cancer to fully utilize the potential of our unique Fractalkine blockers.
KAND567 has the potential to alleviate COVID-19
This fall, we initiated a Phase II clinical trial of KAND567 in patients suffering from COVID-19. Since the beginning of the year, we have increased the number of participating clinics with two clinics at a university hospital in Denmark and, since April 2021, a clinic at Västmanland Hospital in Västerås. The project schedule has been adjusted slightly due to the extremely tough situation prevailing in healthcare due to COVID-19, but we still expect to be able to complete the study by the end of the first half-year and report the study results as soon as laboratory results are generated and processed statistically. The immunological analyzes are expected to be reported during the third quarter and the final results for clinical observations during the fourth quarter 2021.
Clinical evaluation of cardioprotective effect
In parallel with Kancera's phase II study of KAND567 in COVID-19, there is a strong focus on preparing the upcoming phase II study that will evaluate the safety and efficacy of KAND567 in patients undergoing heart surgery in connection with acute myocardial infarction. A recently published study shows clear signs of immune activation in 4800 individuals in the patient group. The study provided new information that underscores the potential of Fractalkine blockers to prevent complications and prolong life after an acute myocardial infarction. The upcoming Phase II clinical trial is being conducted in collaboration with Freeman Hospital in Newcastle, one of the world's 50 highest ranked university hospitals. We are currently working with our partner to optimize the flow and time management in the operating rooms where the study will be conducted. When the work of optimizing the course of the study is completed, we will apply for the start of studies at the British Medicines Agency MHRA. The start of studies is thus expected to occur during the third quarter of 2021.
Pioneering research paves the way for new treatment for ovarian cancer
Ovarian cancer affects approximately 100,000 women annually and is considered one of the most serious forms of gynecological cancer. The new preclinical research results published in March show that Kancera's Fractalkine blockers have the ability to make previously treatment-resistant cancer cells sensitive to chemotherapy again. The effect is due to the fact that the Fractalkine receptor has been shown to play an important role in orchestrating tumor cell machinery to repair DNA damage. By blocking the Fractalkine receptor, we also block the tumor cells' defenses against chemotherapy and the treatment works once more.
The research project has been made possible through partial funding by the EU project SYNTRAIN. In April, Kancera received approval of the project's final report, which was delivered earlier this year, which means that the EU will make a final payment of SEK 600,000 to Kancera.
New results motivate us to explore further KAND757
In addition to our Fractalkine blockers, we announced at the end of April that a new drug candidate KAND757 had been put forward. The decision was made on the basis of recently published research results that show that the PFKFB3 inhibitor selectively inhibits the metabolism of rectal cancer cells. In combination with previous research, which shows that the drug candidate increases the sensitivity of cancer cells to radiation therapy, KAND757 is judged to have the potential to meet the coveted properties sought for the next generation of drugs for rectal cancer. Within the framework of our current funding, the drug candidate will now undergo studies to establish an optimal form of administration and we will conduct a survey to identify the patients who can benefit most from future treatment. A decision to possibly take KAND757 further to clinical development is expected in 2022 based on the results of the studies.
A leap in the pace of development
Recently, we were able to announce that the company was provided with SEK 3.3 million after the last day for redemption of warrants TO4 on 31 March. The warrant program has brought a total of approximately SEK 42 million to Kancera after transaction costs and contributed to the ongoing clinical studies of KAND567. To ensure that the high rate of development can be maintained, Kancera's Board of Directors decided in April to carry out a private placement and a rights issue of a maximum of SEK 20.4 million and SEK 101.2 million, respectively. The subscription period for the issues takes place during the period 5–19 May and the outcome will be announced around 24 May.
Progress in our development takes place in collaboration with some of the world's most prominent clinical researchers. Ahead of this year's Annual General Meeting, Associate Professor Petter Brodin, physician and research leader in systems immunology at Science for Life Laboratory, is proposed as a new board member to Kancera's board. By linking important expertise to the company, the urgent investment in new drugs that can normalize the lives of patients with complex and life-threatening diseases is strengthened.
Solna, 21 May 2021
Thomas Olin, CEO