Interim report second quarter, January 1 – June 30, 2022, Kancera ab (publ.), org.nr. 556806-8851

Second quarter in brief
 
As well as the period 1 January to 30 June 2022
 
April – June
Financial summary for the second quarter and the period January - June 2021
· Net sales amounted to SEK 0 million (SEK 0.0 million).
· R&D costs amounted to SEK 14,7 million (11,1 million).
· Operating profit for the second quarter amounted to SEK -15,4 million (-18,2 million).
· Profit after financial items for the second quarter amounted to SEK -15,6 million (-18,3 million).
· Earnings per share, before and after dilution, for the second quarter amounted to SEK -0,28 kr (-0,36 kr).
· Cash flow from operating activities for the second quarter amounted to SEK -14,4 million (-14,3 million).
· Equity as of June 30, 2022 amounted to SEK 95,0 million (143,7 million) or 1,69 kr (2,58 kr) per share.
· The equity / assets ratio as of June 30, 2022 was 87 percent (93 percent).
· Cash and cash equivalents on June 30, 2022 amounted to SEK 82,3 million (130,0 million).
 
January – June
Financial summary for the entire period
· Net sales during the period amounted to SEK 0 million (0 million).
· Research and development costs for the period amounted to SEK 25,3 million (19,3 million).
· Operating profit for the period amounted to SEK -27,2 million (-27,2 million).
· Profit after financial items for the period amounted to SEK -27,6 million (-27,3 million).
· Earnings per share, before and after dilution, for the period amounted to SEK -0,49 kr (-0,67 kr).
· Cash flow from operating activities for the period amounted to SEK –23,8 million (-23,3 million).
· Equity as of June 30, 2022 amounted to SEK 95,0 million (143,7 million) or 1,69 kr (2,58 kr) per share.
· The equity / assets ratio as of June 30, 2022 was 87 percent (93 percent).
· Cash and cash equivalents on June 30, 2022 amounted to 82,3 million (130,0 million).
 
Significant events during the second quarter

• · Kancera announced in an operational update on the Fractalkine project that:

o   The KAND567 FRACTAL study: Out of a total of 60 patients to be included in the study, 28 have been treated so far. This means that progress is being made towards the goal of including all patients in the study in 2022.
o   Second-generation Fractalkine blocker: 28-day GLP toxicology studies of KAND145 have been conducted and are currently being analyzed in parallel with the KAND145 product being manufactured for future clinical studies.
o   Increased potential against cancer: new research results support the idea that Fractalkine blockers can act against cancer by inhibiting the tumor's surrounding support functions (the so-called microenvironment).

• Kancera announced that Peter Selin has started his employment as Executive Vice President Corporate Development and Vice President responsible for business development, strategic partnerships and out-licensing

• Kancera announced that the United States Patent Office (USPTO) is issuing a patent protecting the chemical structure of Kancera's Fractalkine blocker KAND145. This patent, US 11,339,183, is owned by Kancera and is valid through 2039.

• The board assesses that the war in Ukraine may have a negative effect on the company's operations in 2022, but that the board cannot currently assess how large that effect may be.

• It is hereby reported that the FRACTAL study has so far enrolled 45 patients, which is gratifying and means that progress is being made according to plan to include all 60 of the study's patients during the year.

Important events after the end of the second quarter

• It is hereby reported that the FRACTAL study has so far enrolled 45 patients, which is gratifying and means that progress is being made according to plan to include all 60 of the study's patients during the year.

CEO Statement

Continued strong recruitment of patients to the FRACTAL trial in cardiac patients being conducted in England. Decisions regarding the clinical cancer study will be made during September.


The FRACTAL study in myocardial infarction patients
is developing according to plan
 
In the fourth quarter of 2021, Kancera initiated the phase IIa clinical study FRACTAL, which aims to document the safety and cardioprotective effect (with biomarkers) of the Fractalkine blocker KAND567 in patients who have suffered an infarction in the anterior wall of the heart chamber. The study is run in collaboration with the NHS Foundation at the two prominent university hospitals Freeman Hospital and James Cook Hospital in Great Britain.
The FRACTAL study has so far enrolled 45 patients, which is gratifying and that progress is being made according to plan to include all 60 of the study's patients during the year.
Cardiovascular diseases are the most common cause of premature death in the world today, and of these, heart attacks dominate. Annually, approximately 500,000 individuals suffer from a large heart attack in the US and Europe, and approximately 25% of those affected develop a serious complication or die within five years. The need for adequate and effective treatments is therefore extensive.

Strong alternatives for continued value building within the Fractalkine project
Kancera's preclinical research has shown that Fractalkine blockers have the potential to address significant medical needs in both cancer and acute inflammation (in the heart and kidney). During the summer, Kancera completed a series of research studies that provide support that the company's Fractalkine blockers have a slowing effect in preclinical models of ovarian cancer. The question that remains to be investigated is how these results can be translated into clinical reality. That analysis is ongoing in collaboration with gynecological oncology expertise and will provide the basis for a decision during the month of September if Kancera chooses to apply for permission for a first clinical study with KAND567 against recurrent ovarian cancer. In parallel with this analysis, Kancera and the Nordic expert network against gynecological cancer (NSGO) have signed a letter of intent with the aim of preparing a possible study in collaboration with large university hospitals and leading cancer researchers in Sweden, Denmark and Norway.

All in all, during the autumn we look forward to a continued strong development of the FRACTAL study in heart patients and a decision on direction for continued value building within the Fractalkine project.

Solna, August 19, 2022
Kancera AB
Thomas Olin, CEO