Interim report for second quarter 2021. 1 January – 30 June 2021 Kancera AB (publ.)

Second quarter in brief as well as the period 1 January to 30 June 2021

Net sales for the period (January to June) amounted to SEK 0 million (SEK 0 million), of which the second quarter contributed SEK 0 million (SEK 2,6 million).

R&D costs for the period amounted to SEK 19,3 million (SEK 19,3 million) of which the second quarter contributed SEK 11,1 million (SEK 9,6 million).

Operating profit for the period amounted to SEK -27,2 million (SEK -25,0 million), of which the second quarter contributed SEK -18,2 million (SEK -13,9 million).

Profit after financial items for the period amounted to SEK -27,3 million SEK (-25,5 million), of which the second quarter contributed SEK -18,3 million (SEK -13,8 million).

Earnings per share for the period amounted to -0,67 SEK (-0,93 SEK), of which the second quarter contributed -0,36 SEK (-0,41 SEK).

Cash flow from operating activities for the period amounted to till SEK -23,3 million (SEK -24,1 million), of which the second quarter contributed SEK -14,3 million (SEK -15,4 million).

Equity on 30 June 2021 amounted to SEK 143,7 million (SEK 77,3 million) or 2,6 SEK (1,8 SEK) per share.

The equity/assets ratio on 30 June 2021 amounted to 93 percent (84 percent).

Cash and cash equivalents on 30 June 2021 amounted to SEK 129,9 million (SEK 56,4 million).

Important events during the second quarter

• With the support of authorization from the Annual General Meeting of Kancera on May 28, 2020, the Board carried out a private placement and rights issue, on the same terms, which provided Kancera with a total of SEK 87.4 million after deduction of issue costs of SEK 13.9 million. The new issues correspond to a dilution of approximately 14 percent.
• Kancera announced that the exploratory phase IIa study with KAND567 in acute COVID-19 has been completed after more than 80 percent of the originally planned number of patients were treated. This patient data is considered sufficient to provide important and relevant results that can guide the further clinical development of KAND567 against hyperinflammation, including COVID-19. The study results are expected to be presented during the fourth quarter of 2021.
• Kancera put forward KAND757 in the PFKFB3 project as a drug candidate based on in-house discoveries, amongst which was a doctoral dissertation 2021 on the strengthening effect of DNA-damaging cancer treatment, as well as new positive metabolic effects documented in tumor preparations from patients with rectal cancer.
• Kancera announced that the Annual General Meeting elected Petter Brodin as a new Board member and re-elected former Board members and the Chairman of the Board.
• Kancera announced that a recently published study shows clear signs of immune activation in 4800 patients with widespread heart attack (STEMI) who, in connection with this, had to 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.

Important events after the end of the second quarter

• Kancera has announced that the UK drug and ethics testing authorities have approved the start of a Phase IIa clinical trial of KAND567 following a heart attack. The study is expected to start at the turn of the month September/October.
• Kancera has announced that the first opportunity to redeem warrant TO5 during the period June to November 2021 provided the company with approximately SEK 1.1 million.
• Kancera has decided to keep a patent application that covers the company’s best-qualified HDAC6 inhibitors and to evaluate opportunities to further develop the HDAC project through collaborations in 2022.

CEO statement

Clear progress in our two clinical programs and new funding for efforts against advanced cancer

Since the end of last quarter, Kancera has achieved three important intermediate goals. We have reached a number of patients in the COVID-19 study that is considered sufficient to be able to evaluate the safety and indication of effect of our drug candidate KAND567 and have received the go-ahead to start another phase II study of the same drug candidate in patients with myocardial infarction. Furthermore, we have secured financial resources to carry out crucial steps in the coming years in the development of our drug candidates for treatment-resistant cancer.

Results from the COVID-19 study are expected during the fourth quarter

In mid-June, we announced that the recruitment of patients for the exploratory phase IIa study of KAND567 has been completed after more than 80 percent of the originally planned number of COVID-19 patients had been dosed. The decision was made in light of the fact that the number of patients in need of hospital care has decreased significantly, while the patient data obtained is considered sufficient to provide important and relevant results to guide the further clinical development of KAND567 against hyperinflammation caused by viral infections, including COVID- 19. We now look forward to receiving the study results, which are expected to be presented during the fourth quarter of 2021.

Ready to start Phase II study of KAND567 in patients with myocardial infarction

In July, the UK Medicines Agency gave the go-ahead to initiate a Phase II study to evaluate the safety and efficacy of the KAND567 Fractalkine blocker in patients with a history of myocardial infarction. The study, which is called FRACTAL, will be carried out by the Newcastle upon Tyne Hospital NHS Foundation Trust and is expected to start at the end of September / October 2021. In total, the study is planned to include 60 patients to be treated with either KAND567 or placebo for three days. An evaluation of safety, markers of cardioprotective effect, inflammation and general health will be performed 30 and 90 days after the first dose, respectively.

In the spring, new research results were published (see press release on May 6) that show clear signs of immune activation in the 4,800 patients studied that were suffering from widespread heart attack (STEMI) and undergoing emergency procedures to open the blood vessel blocked by a blood clot. Immune activation in myocardial infarction is linked to the risk of serious complications that can aggravate the heart muscle damage and thereby increase the risk of chronic heart problems or death. The risk is particularly high in patients who have an activated Fractalkine system. The complications associated with the Fractalkine system are impaired function of the important small vessels that supply the heart muscle (microvasculature), and a change in the appearance and function of the heart muscle after the heart attack (remodeling), which is closely linked to chronic heart failure. KAND567 works by blocking the Fractalkine system and thus has the potential to prevent complications and save lives after an acute heart attack.

Funding secured for the development of Fractalkine blockers against ovarian cancer

In May, a directed new share issue was carried out to, among others, Nyenburgh Holding B.V. and Fårö Capital AB, on the same terms as a simultaneous rights issue. The company received a total of approximately SEK 87.4 after deduction of costs, which will be used to expand the development of KAND567 and KAND145 in the area of cancer and inflammation. This initiative is based, among other things, on pioneering preclinical research results, which show that KAND567 has the potential to break down cancer cells’ resistance to chemotherapy and thereby significantly improve the treatment of advanced cancer such as ovarian cancer. We are now planning for clinical preparatory studies with the goal of defining an optimal dosing strategy for KAND567 in the field of cancer. Positive results would enable the start of a clinical study in cancer patients as early as 2022.

New research findings show potential for a new drug candidate for rectal cancer

The results of two recently presented preclinical research studies indicate that Kancera’s drug candidate KAND757 has a unique ability to render resistant rectal cancer sensitive to today’s standard treatment with cytotoxic drugs and radiation. This breaks new ground in the development of new treatments for colorectal cancer – which is the third most common form of cancer in Sweden. Within the framework of our current funding, KAND757 will undergo studies to establish an optimal form of administration, at the same time as we carry out a survey to identify the patients who benefit most from the treatment. A decision to possibly take KAND757 further to clinical development is expected to be made in 2022.

The final steps in the preparations for the start of the myocardial infarction study are now continuing, at the same time as the results from the study in COVID-19 patients are compiled. After the clear progress that has been made in the development of our drug candidates since the start of the second quarter, we can thus look forward to two new – and at least as important – intermediate goals for the rest of the year.

Solna, 20 August 2021
Kancera AB
Thomas Olin, CEO